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GLOBAL MEDI-CAL DRUG USE REVIEW (DUR) BOARD MEETING AGENDA State of California

DEPARTMENT OF HEALTH CARE SERVICES

Notice is hereby given that the Global Medi-Cal DUR Board will conduct a public meeting on Tuesday, May 19, 2020. Pursuant to Governor Newsom’s Executive Order N-29-20 on March 17, 2020, this meeting will be held via webinar only.

9:30 AM-12:30 PM All times shown are approximate and are subject to change

Registration link to attend meeting via webinar

Report Type* Agenda Item Presenter Time

C 1. Welcome/Announcements/Introductions/Roll Call Pauline Chan, RPh, MBA

930-940

I/D 2. Call to Order/Guidelines/Robert’s Rules Timothy Albertson, MD, MPH, PhD

940-945

R/A/D 3. Review and Approval of Minutes from February 25, 2020 Timothy Albertson, MD, MPH, PhD

945-950

4. Old BusinessR/I/D a. Review of Board Action Items from February 25, 2020

b. Recommended MCP Action Items from February 25, 2020c. FFY 2019 DUR Annual Report to CMS: MCO Surveyd. Global DUR Board Activities

i. Update: Asthma Affinity Groupii. Update: Antihyperglycemic Medications

e. Pharmacy Update: Medi-Cal Rx and HR6

Pauline Chan, RPh, MBA

Ivana Thompson, PharmD

950-1100

Break 1100-1105 5. New Business

R/A/D a. UCSF Updatei. Review of DUR Publicationsii. DUR Educational Outreach to Providersiii. Prospective DUR: Fee-for-Serviceiv. Retrospective DUR

Shalini Lynch, PharmD and Amanda Fingado, MPH

1105-1215

R/D b. Looking ahead: Call for future meeting agenda topicsi. Health Plan of San Joaquin – Smoking Cessation

Pauline Chan, RPh, MBA

1215-1220

C 6. Public Comments ** 1220-1230

I 7. Consent Agendaa. Meeting feedbackb. Next meeting: Tuesday, September 15, 2020

1700 K Street1st Floor Conference Room Sacramento, CA 95814

8. Adjournment 1230 * REPORT TYPE LEGEND: A: Action; C: Comment; D: Discussion; I: Information; R: Report** Comments from the public are always appreciated. However, comments will be limited to five minutes per individual.

You can obtain the Global DUR Board agenda from the Medi-Cal DUR Main Menu Web site (http://files.medi-cal.ca.gov/pubsdoco/dur/dur_home.asp).

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GLOBAL MEDI-CAL DUR BOARD MEETING PACKET SUMMARY

May 19, 2020

• Suggested Sections to Review Prior to Meeting:o FFY 2019 DUR Annual Report to CMS: MCO Survey (Pages 23 – 28)

▪ These slides provide an overview of the FFY 2019 DUR annual report to CMS for MCOs. CMS released the fillable .pdf document on May 1, 2020 and has postponed the final submission due date by states to CMS to September 30, 2020.

o Evaluation Report: 1Q2020 (January – March 2020) (Pages 118 – 137)▪ Please review the evaluation report, which covers six DUR

educational articles published during the 2nd and 3rd quarters of 2017 as there is not enough time during the meeting to cover the report in its entirety. A summary of the report will be covered during the retrospective DUR portion of the meeting presented by UCSF.

o The following dates for 2020/2021 DUR Board meetings have been proposed:

▪ Tuesday, September 15, 2020▪ Tuesday, November 17, 2020▪ Tuesday, February 23, 2021▪ Tuesday, May 18, 2021▪ Tuesday, September 21, 2021▪ Tuesday, November 16, 2021

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COVID-19 Resources

Federal sources for COVID-19 information: • White House Coronavirus Task Force• Centers for Disease Control and Prevention• Centers for Medicare & Medicaid Services

State sources for COVID-19 information: • State of California• Department of Health Care Services (DHCS)• California Department of Public Health (CDPH)• California Board of Pharmacy• Medical Board of California

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General Meeting Guidelines

• Governor’s Executive Order exempts this Board meetingfrom the Bagley-Keene Open Meeting Act

• Be familiar with Robert’s Rules of Order• Be courteous, respectful, and open minded of other’s

comments• Be prepared by reviewing materials and downloading

documents on PC/tablet in advance• Board Members are able to mute and unmute their own

phones• Attendees must use the chat feature to communicate

and ask questions

Robert’s Rules of Order

Purpose: • Supports an orderly and democratic decision process• Facilitates group decisions

Motion: • A member presents a formal proposal requesting the

group to take a certain action or position• A main motion is required to begin the decision making

process• A motion occurs prior to discussion

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The Main Motion Process 1

• Member makes a clearly worded motion to take action on a position. • “I moved…..”. Motion recorded in minutes

2 • Motion must be seconded. A motion without a second does not move forward. • “Second!” A second allows discussion to occur; it does not signify approval.

3 • Chairperson restates the motion. This provides clarity. • “It is moved and seconded that…..”

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• Discussion/debate occurs. • Maker of motion starts discussion. • If amendments offered – return to step 1 to amend motion: “I move to amend the motion by…..”

5 • Chairperson closes discussion and states the question/asks for a vote. • “The question is on the adoption of the motion that….”(Repeat the motion word for word)

6 • Chairperson provides voting directions: “Those in favor of the motion, say aye”, “those oppose,

say no”.

7 • Chairperson announces the result of the vote: The “ayes have it, and the motion is adopted” or

“the nos have it, and the motion is lost”. Recorded in minutes.

What to Say…. Purpose Motion Say

Debate allowed

Vote Required

Introduce business Main “I move that…” Yes Majority

Second a Motion Second “Second” No No

Change the wording/clarify a motion

Amend “I move to amend the motion by….” Yes Majority

Postpone action until a specific time

Postpone “I move the motion be postponed until…” Yes Purpose

Take break Recess I move to recess for (x) minutes No Majority

Close meeting Adjourn I move to adjourn No Majority

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GLOBAL MEDI-CAL DRUG USE REVIEW (DUR) BOARD MEETING MINUTES

Tuesday, February 25, 2020 9:30 a.m. – 3:00 p.m.

Location: Department of Health Care Services (DHCS) 1700 K Street, 1st Floor Conference Room

Sacramento, CA 95814

Topic Discussion 1) WELCOME/

INTRODUCTIONS/ROLL CALL/ANNOUNCEMENTS

• The Global Medi-Cal Drug Use Review Board (the “Board”) members and meetingattendees introduced themselves.

• Board members present: Drs. Timothy Albertson, Michael Blatt, Jose Dryjanski, StanLeung, Janeen McBride, Robert Mowers, Yana Paulson, Randall Stafford, Vic Walker,and Andrew Wong.

• Board members absent: Drs. Lakshmi Dhanvanthari, Johanna Liu, and MarilynStebbins.

• DHCS Pharmacy Benefits Division (PBD) staff present included Samira Ahantab,PharmD, Pauline Chan, RPh, MBA, David Do, PharmD, Paul Nguyen, PharmD, IvanaThompson, PharmD, and Jose Villalobos, MPA. Dorothy Uzoh, PharmD attended viawebinar.

• Representatives present from other Medi-Cal managed care plans (MCPs) attending in-person included Clarence Chung, PharmD, MBA (Kaiser), Adam Horn, PharmD (CenCalHealth), Amit Khurana, PharmD (Aetna Better Health of California), Helen Lee, PharmD,MBA (Alameda Alliance for Health), Jessica Shost, PharmD (San Francisco HealthPlan), Flora Siao, PharmD (California Health & Wellness), and Ramon Tran Tang,PharmD (Alameda Alliance for Health).

• Representatives from other Medi-Cal managed care plans (MCPs) attending via webinarincluded Yasmeen Altawaty, PharmD (CalOptima), Anthony Dao (AIDS HealthcareFoundation), Biyan Feng, PharmD (Health Plan of San Mateo), Riona Fujinaga,PharmD, (Inland Empire Health Plan), Kris Gericke, PharmD (CalOptima), Dang Huynh(Santa Clara Family Health Plan), Viral Panchal, PharmD (Community Health Group),Lynette Rey, PharmD (Partnership HealthPlan of California, Inc.), Ankit Shah, PharmD(UnitedHealthcare Community Plan of California, Inc.), Ashley Teijelo, PharmD(Community Health Group), Mimosa Tran, PharmD (Molina Healthcare of CaliforniaPartner Plan, Inc.), Michael Tsai, PharmD (Blue Shield of California), Bruce Wearda,RPh (Kern Family Heath Care), Shea Wilson (Molina Healthcare of California PartnerPlan, Inc.), Jacob Veigel, MA (Rady Children’s Hospital), Andrew Yau, PharmD (HealthPlan of San Mateo), and Adam Yu, PharmD (CalOptima).

• Ms. Chan went through each of the meeting announcements. Ms. Chan reported thatDr. Chris Chan resigned from the Global Medi-Cal DUR Board effective November 25,2019. DHCS and the Board thanked him for his service. Ms. Chan also noted thatBradley Gilbert, MD, MPP, began as the new DHCS Director on February 24, 2020. Ms.Chan gave a brief status update on the California Advancing and Innovating Medi-Cal(CalAIM) Initiative, which is now called Medi-Cal Healthier California for All. Ms. Chanshared that there are many DUR resources and helpful content available on the DrugUtilization Review web page of Medicaid.gov. She also informed the Board about arecent DHCS News Release entitled, “DHCS Tackles Opioid Crisis by ExpandingAccess to Treatment.” Finally, she gave the proposed Board meeting dates for 2021,and requested Board members to let her know if there are any known conflicts.

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2) CALL TO ORDER/GUIDELINES/ROBERT’S RULES

The Chair of the Board, Dr. Timothy Albertson, called the meeting to order. Dr. Albertson reviewed the general meeting guidelines and stated that everyone should have the mindset to be courteous, respectful, and open-minded. Dr. Albertson then provided a brief summary of Robert’s Rules of Order. Finally, Dr. Albertson stated that he is viewing an electronic copy of the agenda and packet in order to follow the agenda and attachments being presented. He explained that any Board members using personal computing devices during the meeting are viewing the same materials as were provided to the public. This statement is required by Open Meeting Act rules.

3) REVIEW ANDAPPROVAL OFPREVIOUSMINUTES FROMNOVEMBER 19,2019

The Board reviewed the minutes from the Board meeting held on November 19, 2019. Dr. Albertson motioned that the minutes be approved. The motion was seconded. There was no discussion. The Board voted to approve the minutes.

AYE: Albertson, Blatt, Dryjanski, Leung, McBride, Paulson, Stafford, Walker, and Wong NAY: None ABSTAIN: None ABSENT: Dhanvanthari, Liu, Mowers, and Stebbins

ACTION ITEM: Post the November 19, 2019, minutes to the DUR website.

4) OLD BUSINESS a. Review of Board Action Items from November 19, 2019:i. Write a DUR educational bulletin discussing the current American Diabetes

Association (ADA) and American College of Cardiology (ACC) policies on usingsodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA) in the treatment of type 2 diabetes – Ms. Chan notedthis bulletin topic was approved by DHCS and has been added to the queue foreducational bulletins as a high priority for publication in 2020.

ii. Recommend DHCS review of the process for Medi-Cal fee-for-service (FFS)patients to obtain a SGLT2 inhibitor and a GLP1-RA to identify potential barriersFFS patients may have in obtaining either of these two classes of medication anddetermine if any identified barriers can be mitigated – Ms. Chan reported that DHCSreceived the recommendation and has completed the review of these medications.

iii. Recommend MCPs review the process for MCP patients to obtain a SGLT2 inhibitorand a GLP1-RA to identify potential barriers MCP patients may have in obtainingeither of these two classes of medication and determine if any identified barriers canbe mitigated – Ms. Chan stated that DHCS has received the recommendation andthat it was added to the MCP Action Items for the November 19, 2019 Boardmeeting.

iv. Accept edits to bylaws, with the addition of one clarification on Page 3: “A simplemajority of members shall constitute a quorum. Once a quorum has beenestablished, a simple majority of those members present is needed for a motionto pass” – Ms. Chan noted that the annual review of bylaws by DHCS is in-progress.

v. Recommend California participate in an action-oriented affinity group in designingand implementing quality improvement (QI) projects related to improving asthmacontrol, including input from the DUR program and MCPs – Ms. Chan reported thatDHCS is planning to apply for participation in the affinity group and the DURprogram will be kept updated on future communications regarding the affinity group.

vi. Repeat educational letter to prescribers with patients that are at high risk foradverse events and have an overridden additive toxicity alert – Amanda Fingado,MPH (UCSF) stated this mailing was approved by DHCS and that letters were sentin January 2020. She also noted more information on this topic would be presentedlater today.

b. Recommended Action Items for MCPs from November 19, 2019: Ms. Chan presentedthe recommended action items for MCPs from the Board meeting held on November 19,2019. Recommendations are separated into two categories: required action items andsuggested action items.

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c. Pharmacy Update: Medi-Cal Rx and HR6 – Dr. Thompson noted that there is not muchto update regarding H.R. 6, the SUPPORT for Patients and Communities Act(SUPPORT Act), other than DHCS is beginning to receive policy and proceduresubmissions from plans. DHCS had originally established an April 1 submissiondeadline, in conjunction with the deadline for the annual report to CMS. However, Dr.Thompson noted that because the annual report survey will not be released by CMSuntil April 1, the submission deadline would be extended until April 30. Dr. Thompsonalso stated that fee-for-service reporting for H.R. 6 might be presented at the upcomingBoard meeting in May.

Regarding Medi-Cal Rx, Dr. Thompson shared that Magellan Rx won the bid forservices and that they are currently in the requirements phase. Dr. Thompson reportedthat Medi-Cal Rx incorporates pharmacy services billed on pharmacy claims, as well asphysician-administered drugs (PADs) billed on pharmacy claims. She noted there is notyet delineation on which drugs would be pharmacy claims and those that would beconsidered medical claims. Dr. Thompson stated that some attendees who haveparticipated in Medi-Cal Rx stakeholder events might have heard that there are plannedpolicy ges during the transition to Medi-Cal Rx to minimize impact in access to care,including a proposal to remove the six-prescription limit per month and a proposal toformally eliminate the $1 co-pay. Dr. Thompson shared that while the pharmacy benefitwill not change, some policies may change to the extent that they will ensure fewerbarriers to the access to care. For example, allowing approved Treatment AuthorizationRequests for certain classes of maintenance drugs to be valid for more than one yearand implementation of enhanced automatic adjudication processes to remove barriersand streamline access to care.

Dr. Paulson asked if Dr. Thompson was referring to the benefit for Medi-Cal managedcare beneficiaries. Dr. Thompson affirmed the pharmacy benefit would be carved out sothese policy changes will apply to Medi-Cal managed care beneficiaries as well. Dr.Paulson asked if this is being regulated under the California Department of ManagedHealth Care. Dr. Thompson recommended addressing any regulatory or legal issueswith plan compliance officers and also suggested reviewing the Medi-Cal Rx website fordates and important information for upcoming stakeholder meetings. Dr. Thompson alsoshared there are smaller, targeted managed care workgroups that are not open to thepublic but are open to managed care plans and their representatives.

Dr. Stafford noted that in the Governor’s State of the State address, Medi-Cal wasmentioned prominently as a source for solutions for addressing the homeless issue inCalifornia. Dr. Stafford noted that medications are a big part of managing vulnerablepopulations, for both physical and mental conditions. He asked how the PharmacyBenefits Division plans to play a role for this population and address them using thewhole person approach. Dr. Thompson stated that it was her understanding that themental health pharmacy benefit is currently carved out to fee-for-service, except forspecific pilot programs that have it carved in. Dr. Thompson stated that one of thereasons for this is because the state wishes to avoid disparity amongst formularies andutilization management practices, especially for beneficiaries living with mental illness.Dr. Thompson also noted that one of the pillars of the Medi-Cal Healthier California forAll (formerly known as CalAIM) program is enhanced care coordination.

Dr. Paulson questioned how the outpatient pharmacy benefit would be better managed,since the benefit will be fractured from the managed health care plans and plans willneed funding for integrated care due to this fracturing. Dr. Thompson noted there aredifferent venues and department is accepting suggestions for how to manage thetransition and implementation of the benefit. Dr. Blatt stated he had suggested anadministration fee to continue clinical programs within the clinical pharmacy unit andasked if there was any update on this proposed fee. Dr. Thompson stated the finaldecision has not been made and that DHCS will be meeting with plan CFOs would bemeeting in March. Dr. Blatt noted that the CalAIM program recommends quarterlymedication reconciliation that does not appear to be addressed in Medi-Cal Rx. Dr. Blatt

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encouraged the use of the clinical pharmacists for this medication reconciliation. Dr. Thompson reported she was unaware of where that discussion is currently happening.

Dr. Wong shared that different county plans have different tiered systems and some local plans may currently get better rates for certain medications. Dr. Wong questioned how Medi-Cal Rx would ensure the best prices for medications and asked how this change would impact all the tiered plans. Dr. Thompson stated that plans would no longer be financially responsible for the pharmacy benefit and that DHCS would continue to look at past and current utilization and develop strategies to align utilization management between the plans and FFS, in order to remove obstacles to care. Dr. Thompson shared that DHCS is analyzing which drugs are being used and the Medi-Cal List of Contract Drugs may be adjusted as opportunities for alignment are identified. Dr. Thompson emphasized the process is ongoing. Dr. Albertson noted that in a program the size of Los Angeles County that also has a pharmacy, there might be unique strategies for consideration. Dr. Leung suggested that this Board would continue to be vital for reviewing and making recommendations, as he is unclear that uniformity of the pharmacy benefit would translate to parity. Dr. Leung stated the Board should continue to be involved with utilization review.

5) NEW BUSINESS a. Health Plan Presentation by Alameda Alliance for Health: Opioid Stewardship – Helen Lee, PharmD, MBA [Senior Director of Pharmacy] and Ramon Tran Tang, PharmD [Clinical Pharmacist] began their presentation with an overview of the distribution of members by city within the Alameda Alliance for Health population. Dr. Tang then reviewed trends in opioid prescription count and opioid-related overdose within their population and shared some of the tools they used across the continuum of care for prevention, intervention and treatment, and recovery support. As a part of prevention, Dr. Tang provided details on pharmacy safeguards, including quantity limits on selected opioids and benzodiazepine medications. Dr. Tang also reviewed opioid morphine milligram equivalent (MME) utilization trends and described the Alameda Alliance for Health pilot provider education and community outreach program. Dr. Tang shared that this program is ongoing and involves multiple provider education resources, including provider packets, a quarterly opioid and benzodiazepine overdose report, educational presentations, academic detailing, and letters to high-risk members. Dr. Tang summarized their intervention and treatment program for member education, which is also ongoing. Dr. Tang stated these efforts include targeted introduction letters for high risk (> 300 MME) and rising risk (chronic opioid use in the past 6 months) members, monitoring member grievances, and providing strategies for medication–assisted treatment (MAT) to the appropriate organizations and providers. Dr. Tang shared that there is no longer an initial prior authorization requirement for acupuncture and chiropractic services and they are considering Tele-health for Mental Health Services. Dr. Tang concluded by noting that the recovery support is still under development but would ideally include integrated care and case management for those with chronic opioid use.

Dr. Stafford asked about the factors affecting the delay between identifying overdose reduction in prescribing to overdose. Dr. Tang stated this is not really known but that under the care management program they are trying to identify these gaps in care. Dr. Albertson asked if pain specialists were under restriction and how cancer specialists would differ from pain specialists. Dr. Lee stated that currently only oncologists are unrestricted for prescribing opioids and they are evaluating whether this should be expanded to other providers. Dr. Stafford noted that a specific diagnosis might exempt a patient from restrictions as well. Dr. Albertson asked if fentanyl patches and buprenorphine were restricted. Dr. Lee noted fentanyl requires prior authorization and buprenorphine is a carved-out medication.

Ms. Chan asked about their experience with MME tapering. Dr. Tang stated that at this phase they are working on a provider packet for tapering and creating an opioid tapering tool. Dr. Lee shared that the packet is about to go out to providers and will focus on

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face-to-face interaction. Dr. Lee reported they have identified approximately five to ten doctors to target and that she and the quality improvement (QI) pharmacist will meet with these target doctors. Dr. Lee shared there is reluctance among providers to manage and/or taper these patients and they welcome the support. Dr. Siao asked how members were grandfathered and at what point is a prior authorization going to be required. Dr. Tang shared that when quantity limits were started, there were many members who exceeded the limits. The decision was made to indefinitely grandfather, in conjunction with a discussion with the medical director. Dr. Lee reiterated it would take a strong community alliance for program to be successful.

b. Global DUR Board Activitiesi. Annual Review: 2019 – Dr. Stafford reviewed the 2019 highlights of the Global Medi-

Cal DUR Board. Dr. Stafford stated he was very pleased with the successfultransition from the fee-for-service DUR program to a Board that now includesrepresentation from managed health care plans, although he shared some concernthat Medi-Cal Rx might create a temporary barrier to continued collaboration. Ms.Chan thanked Dr. Stafford for his leadership, vision, and persistence during the pastyear.

ii. Board Goals/Priorities: 2020 – Dr. Albertson also thanked Dr. Stafford for hisleadership during 2019, the second full year after the Board expansion. Dr.Albertson then presented the goals for the Global Medi-Cal DUR Board for 2020,which included the following:• Support DHCS Medi-Cal Rx Initiative• Continue to promote dialogue and collaboration between FFS and MCPs• Align goals with Medi-Cal Healthier California for All (formerly CalAIM)• Align goals with DHCS Comprehensive Quality Strategy• Join the CMS-led Affinity Workgroup to develop strategies and approaches to

improve asthma control• Revisit Healthcare Effectiveness Data and Information Set (HEDIS) measures• Implement DUR requirements in Section 1004 of the Substance Use–Disorder

Prevention that Promotes Opioid Recovery and Treatment for Patients andCommunities Act

• Continue to use the Vital Directions Framework to focus on the three DURpriority areas established in 2018-2019:o Optimizing Drug Prescribing and Dispensing, including specialty drugso Optimizing Pain Management and Opioidso Optimizing Chronic Disease Management, including prevention

iii. Update: Asthma Affinity Group – Dr. Albertson provided updated information on theCMS initiative, “Improving Asthma Control Learning Collaborative,” includingbackground, objectives, structure, and next steps. Dr. Stafford asked what theproposed structure of California’s application was, and Ms. Chan reviewed theapplication questions and highlighted the selection criteria. Ms. Chan stated theapplications are due March 4, 2020, and states selected for participation would benotified by April 1, 2020.

iv. Retrospective DUR Proposal: Use of Antipsychotics among Children andAdolescents – Dr. Stafford presented a proposal for a retrospective DUR reviewevaluating the use of antipsychotics among children and adolescents. He notedthere might be some unanticipated change in prescribing as a function of the policychange that required an approved Treatment Authorization Requests forantipsychotic medication for children and adolescents younger than 18 years of age.

Dr. Stafford stated there has been little information on which medications, if any,might be being substituted for antipsychotics. Dr. Stafford reported some evidencethat other psychoactive medication use may be increasing in this population,including antidepressants and stimulant use. Dr. Stafford is proposing to look at useof psychoactive medications among all children over time to see if there are any

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trends that need further evaluation. Ms. Fingado noted that while we have focused on antipsychotic medication use on three occasions, there has been no evaluation of other psychoactive medication drug classes, either as potential replacements or on their own.

Ms. Fingado suggested evaluating the same five-year timeframe as the antipsychotic medication evaluations and review how use of these other medication classes has been affected. Dr. Albertson suggested looking at antidepressants, stimulants, and benzodiazepines and agreed he would be interested to see if there has been a shift. Ms. Fingado noted that now we are capable of looking at utilization data on these medication classes for both FFS and MCP beneficiaries. Dr. Stafford made a motion to analyze patterns of psychotropic drug use more generally by class, in order to identify any prescribing patterns. Dr. Stafford also suggested, if possible, stratifying by foster youth and non-foster youth to see if data drives further recommendations. Ms. Fingado reported she may not have access to these data but would investigate. Dr. Stafford suggested aid code might be a surrogate data point if social services data are unavailable.

Dr. Walker suggested looking at who the specific prescribers are and if there is a subgroup of providers that specialize in these patients. Dr. Stafford said the short answer is yes, there is a mandated process for foster youth and there are psychiatrists that focus on youth within county programs. Dr. Shost said that San Francisco Health Plan looks at specialty of provider to see if the prescription is coming from primary care or specialty care providers. Ms. Fingado asked if they used National Provider Identifier (NPI) specialty data. Dr. Shost replied that this is what they use currently, and Ms. Fingado stated she had access to this information and could include in the retrospective DUR review. There was no further discussion. The motion was seconded. The motion passed.

AYE: Albertson, Blatt, Dryjanski, Leung, McBride, Mowers, Paulson, Stafford, Walker, and Wong NAY: None ABSTAIN: None ABSENT: Dhanvanthari, Liu, and Stebbins

ACTION ITEM: The DUR Board recommendation to conduct a retrospective DUR review of psychotropic use over time by class among Medi-Cal beneficiaries 18 years of age or younger from October 1, 2013, to September 30, 2014 through calendar years 2015-2019, stratifying by prescriber specialty and foster care status (if possible) will be submitted to DHCS.

v. CMS Initiative: Improving Asthma Control Learning Collaborative – Dr. Albertsonreported that CMS has launched a new initiative, “Improving Asthma ControlLearning Collaborative.” This initiative will support state Medicaid and CHIPbeneficiaries and will focus on improving asthma control. Dr. Albertson noted thereare two parts to the initiative: 1) a series of four webinars that began in October2019 for discussing concepts and tools for asthma control and 2) an affinityworkgroup to begin in March 2020 to take action.

Dr. Albertson motioned to recommend the DUR program and Medi-Cal MCPsparticipate in this action-oriented affinity group in designing and implementing QIprojects related to improving asthma control in California. The motion wasseconded.

c. Recap of morning action items – Dr. Orozco read the Board action items from themorning session. There was no discussion and no edits were made to the listed actionitems.

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d. Health Plan Presentations by CenCal Health: Adam Horn, PharmD [Clinical Pharmacist]provided an overview of the following two educational intervention programs:

i. Asthma Population Health Project –In 2018, only 60.72% of Santa Barbara Countyand 61.67% of San Luis Obispo County had an asthma medication ratio (AMR) of <0.5. Dr. Horn stated that CenCal Health set a goal to reach 67% by December 31,2019, and he summarized the following five steps CenCal Health took to addressdecreasing asthma medication adherence:

1. A TeleVox campaign, which was a member-directed outreach to remindtargeted members of the importance of asthma control in order to reduceexacerbations and emergency department (ED) visits;

2. Retrospective DUR letter about AMR that targeted members ages 5-85years old with 4 or more asthma medication prescriptions over a 12-monthperiod and an AMR < 0.6;

3. An Asthma Action Plan Education brochure for members, which waspresented at a provider webinar and also published to CenCal Health’sNovember 2019 Provider Bulletin;

4. Annual asthma training for providers with continuing education creditsoffered for attendees; and

5. The Asthma Home Health Promotoras program, in which community healthworkers offered in-home educational visits to high-risk members identifiedby high ED visits and low AMR.

Dr. Horn reported the results of this five-step program far exceeded the goal they had originally set. He shared that in 2019, Santa Barbara County had increased to 91.46% with an AMR of < 0.5 and San Luis Obispo County increased to 92.75%. He also noted that CenCal Health surpassed the 95th percentile benchmark for all Medicaid plans in the United States.

Dr. Albertson asked if there was a corresponding reduction in ED visits or hospitalizations. Dr. Horn said he was not sure and would have to check with the quality department. Dr. Khurana asked for more details on the TeleVox campaign. Dr. Horn said they were just automated telephone calls that reminded members about the importance of keeping asthma controlled.

Dr. Shost questioned if the Global Initiative for Asthma (GINA) guidelines will have an impact on the program. Dr. Horn believed the GINA guidelines were influencing the results as providers were beginning to adopt the guidelines at the time the program was in operation. Dr. Shost asked if the provider webinar taught the GINA guidelines. Dr. Horn said it did not, as the webinar content had already been defined prior to the guidelines. Dr. Albertson noted that the guidelines have been controversial, and some providers are reluctant to follow the guidelines.

Dr. Leung asked Dr. Horn what he thought was the biggest driver of the change in the AMR rate. Dr. Horn stated he thought it was likely due to a decrease in the use of rescue inhalers, especially during the summer months. Dr. Leung reported that he has been providing academic detailing on the GINA guidelines in general and cautions providers on overuse of albuterol and tries to ensure that all patients have an inhaled corticosteroid (ICS) available. Dr. Leung stated that feedback he is getting from providers is that they are receiving questions from pharmacies regarding as needed use of long-acting β2 adrenergic receptor agonists (LABAs) for ICS/LABA combination medications.

Dr. Lee noted she was impressed with the remarkable jump in AMR rates and asked if there were any financial incentives for providers. Dr. Horn said there was a financial incentive similar to the pay-for-performance incentives already in place for providers. Dr. Siao asked if they encountered any issues with quantity limits due to GINA guidelines recommending use of ICS for both controller medication and as PRN. Dr. Horn said the limits are open and unrestricted, although they do have a preferred ICS/LABA. Dr. Siao asked if they had looked at overall costs and if they

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have increased at all as a result of improved adherence and increased use of medications. Dr. Horn stated that he hasn’t looked at this. Ms. Chan asked Dr. Horn for feedback on which training he thought was most useful. Dr. Horn stated the letter writing had the largest impact due to the reach and the seminar by the allergist was very well received. Dr. Horn noted that the multi-pronged approach seemed to provide the greatest overall benefit.

ii. Opioid-Benzodiazepine Edit and Provider Outreach – Dr. Horn stated that the goalof this campaign was to deter overutilization of opioids and to update utilizationmanagement measures. Dr. Horn provided an overview of six phases CenCalHealth used when implementing safety edits and gave a detailed timeline thatoutlined each phase, including when quantity limits were added or updated andwhen edits were implemented. Dr. Horn then discussed the benzodiazepine-opioidconcurrent use safety edit and described that it is a point of sale soft edit thatidentifies any overlap use of opioids and benzodiazepines. Dr. Horn provided agraph that displayed the impact of the edit on claims and members who did and didnot receive subsequent approval. Dr. Horn summarized a provider outreachcampaign that targeted providers who prescribed high-dose benzodiazepines orprescribed concomitant opioids and benzodiazepines. Dr. Horn noted the provideroutreach letter included information on the opioid-benzodiazepine edit,benzodiazepine tapering instructions, and contact information to a pharmacist whocould discuss benzodiazepine treatment in further detail. Dr. Horn indicated that asa result of the campaign, there was a decrease in opioid utilization, milligramsprescribed, and concomitant use of opioids and benzodiazepines. Dr. Hornconcluded by sharing the top provider responses, including the provider is in theprocess of tapering down, the provider will discuss tapering at next visit, and theprovider asking for tapering guidance.

e. DUR Annual Report to CMSi. FFY 2018: State Comparison Summary – Ms. Chan stated that there are two state

comparison summaries available on the Centers for Medicare & Medicaid Services(CMS) website, the National Medicaid Fee-For-Service (FFS) 2018 Drug UtilizationReview (DUR) and the National Medicaid Managed Care Organization (MCO) 2018Drug Utilization Review (DUR). Ms. Chan then provided a summary of the MCOstate comparison summary, focusing on areas relevant to SUPPORT Actrequirements.

ii. FFY 2019: Fee-for-Service Draft Report – Ms. Chan provided a brief overview of theannual report covering the Medi-Cal fee-for-service program for FFY 2019. Ms.Chan indicated CMS has not yet released the final FFY 2019 survey questionnaireand this draft is based on the 2018 questionnaire. An amended version might bepresented to the DUR board in May as appropriate. Ms. Chan also encouragedmanaged care plan to use the fee-for-service report as a model or guide forcompleting their report.

iii. FFY 2019: Fee-for-Service Additional Data – Ms. Fingado presented data for FFY2019 that she thought the Board might find useful but was not required by CMS as apart of the FFY 2019 annual report. Data reported included fee-for-service pharmacyutilization by age group, the top 20 drug therapeutic categories by utilizingbeneficiaries, the top 20 drugs by utilizing beneficiaries, and trends over time ingeneric utilization, generic expenditures, and DUR cost-savings estimates.

f. UCSF Updatei. Prospective DUR: Fee-for-Service

• Review of DUR Alerts for New Generic Code Numbers (GCNs) in 4Q2019(October – December 2019): At each Board meeting, a list of new GCNadditions with prospective DUR alerts turned on other than DD, ER, and PG areprovided to the Board for review. At this meeting, the Board reviewed the alertprofiles for the following drugs:o ACETAMINOPHEN – Ingredient Duplication (ID), High Dose (HD)o ALBUTEROL SULFATE – Therapeutic Duplication (TD), Ingredient

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Duplication (ID), High Dose (HD), Low Dose (LD) o AMLODIPINE BESYLATE/CELECOXIB – Drug-Disease (MC), Therapeutic

Duplication (TD), Late Refill (LR), Ingredient Duplication (ID), High Dose(HD), Low Dose (LD)

o ASENAPINE – Drug-Disease (MC), Therapeutic Duplication (TD), Late Refill(LR), Additive Toxicity (AT), Ingredient Duplication (ID), High Dose (HD),Low Dose (LD)

o DICLOFENAC SODIUM/LIDOCAINE – Drug-Allergy (DA), Drug-Disease(MC), Therapeutic Duplication (TD), Ingredient Duplication (ID), High Dose(HD), Low Dose (LD)

o DICLOFENAC/MENTHOL/TAPE – Drug-Allergy (DA), Drug-Disease (MC),Therapeutic Duplication (TD), Ingredient Duplication (ID), High Dose (HD),Low Dose (LD)

o DIGOXIN – Therapeutic Duplication (TD), Late Refill (LR), IngredientDuplication (ID), High Dose (HD), Low Dose (LD)

o DIVALPROEX SODIUM – Drug-Allergy (DA), Late Refill (LR), IngredientDuplication (ID), High Dose (HD), Low Dose (LD)

o DULOXETINE HCL – Therapeutic Duplication (TD), Late Refill (LR),Ingredient Duplication (ID), Drug-Age (PA), High Dose (HD), Low Dose (LD)

o GABAPENTIN/LIDOCAINE – Drug-Allergy (DA), Late Refill (LR), AdditiveToxicity (AT), Ingredient Duplication (ID), High Dose (HD), Low Dose (LD)

o SODIUM/POTAS/CHLORIDE/DEXTROSE – High Dose (HD), Low Dose(LD)

o TESTOSTERONE UNDECANOATE – Drug-Allergy (DA), TherapeuticDuplication (TD), Late Refill (LR), Ingredient Duplication (ID), High Dose(HD), Low Dose (LD)

There were no questions or objections to these alert profile recommendations. There was no further discussion.

ii. DUR Educational Outreach to Providers• Update: GINA Guidelines Letter – Ms. Fingado provided a mailing update

regarding the educational outreach letter focused on the GINA guidelines. Shereported that a total of 346 letters were mailed to prescribers between January16, 2020, and January 30, 2020, regarding Medi-Cal fee-for-servicebeneficiaries in their practice with paid claims for short-acting β2-agonists(SABAs) alone and a diagnosis of asthma. Beneficiaries were excluded from themailing if they had medical claims for a condition that may complicate asthmatreatment. Each prescriber was sent a letter that included the names andbirthdates of the identified patient(s) in their practice, the Medi-Cal DUR alert onthe GINA guidelines, and a provider survey. Ms. Fingado noted that finaloutcomes would be presented at the Board meeting in May of 2021 andreminded the group that the primary outcome is the percentage of continuouslyeligible beneficiaries with paid claims for SABAs alone within the 12 monthsfollowing the mailing and the secondary outcome is the percentage ofcontinuously eligible beneficiaries with paid claims for inhaled corticosteroid(ICS) treatment within 12 months following the mailing. Ms. Fingado noted thatthe final response rate and undeliverable rate (within 90 days of mailing) wouldbe reported at that time as well. Ms. Fingado reported that some of the surveysreturned thus far have noted they prescribed rescue medications in theemergency department. Ms. Fingado suggested that the Board might want toconsider excluding certain provider types like emergency medicine specialists inthe future to maximize impact of the letters. There were no objections from theBoard. She also asked if the Board thought it was worthwhile to follow-up withproviders who indicate on their survey that they have prescribed controllermedications to let them know there are no paid claims for these medications inthe claims database. The Board suggested a complete profile might helpproviders see what is being picked up from pharmacies and what is not. AshleyTeijelo, PharmD (Community Health Group) commented on the webinar thatproviders could be notified for return to shelf medications. There were no

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objections from the Board to follow-up with providers via telephone or by sending full patient pharmacy profiles, as needed.

• Update: Gabapentin Letter – Ms. Fingado provided a mailing update regardingthe educational outreach letter focused on gabapentin. She reported that a totalof 150 letters were mailed on January 30, 2020, to the top 150 prescribers ofgabapentin (by total paid claims) in the Medi-Cal program. Ms. Fingado notedthat while these prescribers represented only 1.8% of all prescriber ofgabapentin, they were responsible for over 10% of all prescriptions ofgabapentin. Each prescriber was sent a letter that included the Medi-Cal DURbulletin on gabapentin and a provider survey. Ms. Fingado noted that thedecision was made to send an additional letter to address patient-specificconcomitant use of gabapentin and opioids, with special attention on thosegabapentin claims as moderate (> 900 mg) or high (>1800 mg) average dailydose of gabapentin. She stated that final outcomes would be presented at theBoard meeting in May of 2021 and reminded the group that the primary outcomeis the provider-specific total paid claims for gabapentin within the 12 monthsfollowing the mailing and the secondary outcome is the total initial paid claimsfor gabapentin (100-day look back period) within 12 months following themailing. Ms. Fingado noted that the final response rate and undeliverable rate(within 90 days of mailing) would be reported at that time as well.

• Update: Additive Toxicity Letter – Ms. Fingado provided a mailing updateregarding the repeat of the educational outreach letter focused on additivetoxicity alerts. She reported that a total of 73 letters were mailed on January 30,2020, representing 29 Medi-Cal fee-for-service beneficiaries that generated anadditive toxicity (AT) alert with pharmacist override in December 2019. Ms.Fingado noted that each of these beneficiaries had at least one paid claim forboth an opioid and benzodiazepine, as well as paid claims for at least twoadditional central nervous system (CNS) depressants. Beneficiaries wereexcluded from the mailing if they had paid claims from skilled nursing facilities(SNFs), intermediate care facilities (ICFs), home health, and/or hospice practicelocations or diagnostic codes indicating palliative care, or treatment for cancer orsickle-cell anemia. Each prescriber was sent a letter that included the updatedMedi-Cal DUR bulletin regarding the AT alert, a handout on naloxone, patientprofile(s), and provider surveys. Ms. Fingado stated that final outcomes wouldbe presented at the Board meeting in November of 2020 and reminded thegroup that the primary outcome is the total number of continuously eligiblebeneficiaries without active paid claims for both opioids and benzodiazepineswithin the 6 months following the mailing and the secondary outcome is the totalnumber of continuously eligible beneficiaries with a paid claim for naloxonewithin the 6 months following the mailing. Ms. Fingado noted that the finalresponse rate and undeliverable rate (within 90 days of mailing) would bereported at that time as well.

• Ms. Fingado shared the list of approved educational outreach topics and Dr.Wong suggested adding an educational outreach topic related to the AmericanCollege of Rheumatology 2020 guidelines for the management of reproductivehealth in rheumatic and skeletal diseases. There were no objections to this, andDr. Wong said he would share the reference as soon as it was available.

iii. Retrospective DUR• Global Quarterly: 3Q2019 (July – September 2019) – Ms. Fingado presented

the Global Quarterly Medi-Cal DUR report for 3Q2019. This quarterly reportcontains all pharmacy utilization data for the Medi-Cal program. Utilization dataare presented in aggregate, and then stratified by FFS or MCP enrollment statusand the following population aid code groups:o Affordable Care Act (ACA)o Optional Targeted Low-income Children (OTLIC)

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o Seniors and Persons with Disabilities (SPD)o All other aid codes not categorized as ACA, OTLIC, or SPD (OTHER)

The Board recommended no changes to the report template and there were no questions or discussion.

• FFS Quarterly Report: 4Q2019 (October – December 2019) – Ms. Fingadopresented the Medi-Cal fee-for-service quarterly DUR report for the 4th quarter of2019, which includes both prospective and retrospective DUR data. Thisquarterly report contains fee-for-service pharmacy utilization data presented inaggregate, and then stratified by Medi-Cal FFS enrollees only and by Medi-Calmanaged care plan (MCP) enrollees only. This report includes all carved-outdrugs processed through the FFS program. Ms. Fingado noted that 15% ofeligible Medi-Cal FFS enrollees had a paid claim through the Medi-Cal fee-for-service program, compared with only 2% of Medi-Cal MCP enrollees. Ms.Fingado also pointed out that among all Medi-Cal beneficiaries with a paid claimthrough the Medi-Cal fee-for-service program in 2019 Q4, 61% were FFSenrollees and 40% were MCP enrollees (numbers add up to slightly more than100% due to < 1% of beneficiaries being enrolled in both programs during thequarter). In addition, Ms. Fingado reported continued significant increases in theuse of NALOXONE and BUPRENORPHINE HCL/NALOXONE HCL in the MCPpopulation during 2019 Q4 when compared to the prior-year quarter. This ismost likely due to Assembly Bill 2760 (Wood, Chapter 324), which was effectivethe first day of 2019 Q1.

• Quarterly Evaluation Report: 4Q2019 (October – December 2019) – Ms.Fingado shared that quarterly evaluation reports have replaced the biennialreport, which was due to be presented in February 2021. Ms. Fingado stated thebiennial report had become too dense and the timing between the publication ofthe original article and the biennial evaluation was variable, between two andfour years, depending on publication date. Ms. Fingado noted that with the newquarterly evaluation report, reviews will now be completed two years after thequarter the original article was published. She stated that Board meetings during2020 would include two quarters of articles and Board meetings during 2021and beyond would review the articles published in the quarter two years prior.Ms. Fingado then presented a summary of the report published in the 4th quarterof 2019, which covered the following educational article published during the 1st

quarter of 2017:o Improving the Quality of Care: Risks Associated with Use of

Fluoroquinolones – February 2017

Ms. Fingado stated the original article found that within the Medi-Cal fee-for-service population, approximately two-thirds (n = 33,483; 68%) of fluoroquinolone use from December 1, 2015, through November 30, 2016, appeared to be potentially inappropriate based on the new FDA recommendations, with 5,102 beneficiaries (10%) having a primary or secondary diagnosis of acute bacterial exacerbation of chronic bronchitis, a total of 9,165 beneficiaries (19%) with acute sinusitis, and 19,306 beneficiaries (39%) with an uncomplicated urinary-tract infection (UTI). Ms. Fingado noted the purpose of the evaluation report was to review current fluoroquinolone use in the Medi-Cal fee-for-service population and review relevant safety information and clinical recommendations for fluoroquinolones in order to determine if there have been any changes in use since the original DUR bulletin was published in February 2017. The same inclusion and exclusion criteria were used as listed in the methods for the original DUR bulletin and potentially inappropriate fluoroquinolone use was calculated among the same selected demographic groups that had significant findings in the original article.

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Ms. Fingado reported that the results showed a 40% decrease in the total number of Medi-Cal fee-for-service beneficiaries identified with at least one paid claim for a fluoroquinolone during the measurement year. Ms. Fingado noted that the eligible Medi-Cal fee-for-service population during this same time period decreased by only 10%, so the use of fluoroquinolone medications decreased beyond what would be expected from a simple decrease in the eligible population. In addition, Ms. Fingado reported an overall decrease in potentially inappropriate use of fluoroquinolones among the study population by 11%. Ms. Fingado highlighted the percentage of female beneficiaries in the study population with potentially inappropriate use of fluoroquinolones during the measurement year showed the lowest improvement (a decrease from 71% to 61%). She noted these numbers are most likely impacted by the greater use of fluoroquinolones to treat uncomplicated UTI in this population.

Ms. Fingado also shared that since the publication of the original DUR article, the DUR program has published the following two additional alerts related to FDA safety concerns regarding fluoroquinolones:

o Drug Safety Communication: Adverse Effects from FluoroquinoloneAntibiotics published in July 2018

o Drug Safety Communication: Updated Adverse Effects fromFluoroquinolones published in March 2019.

Ms. Fingado asked the Board to consider whether there was value in repeating the educational outreach letter to top prescribers of fluoroquinolones, with the inclusion of the two additional safety alerts published by the DUR program. Dr. Dryjanski asked if the days’ supply was reviewed. Ms. Fingado stated that it was not reviewed. Dr. Stafford noted he continues to be surprised by how often fluoroquinolones are used for UTIs and asked if there were certain areas of the state where this was more problematic. Ms. Fingado reported Los Angeles County was an outlier at the time of the original DUR bulletin.

Dr. Albertson asked if there could be a proposal to focus on UTIs only. Dr. Stafford agreed that if there was going to be an area of follow-up, this might be an area of focus. Ms. Fingado reported that the previous educational outreach on this topic only looked at the top prescribers overall, not by diagnosis. Ms. Fingado agreed this would be important, as although potentially inappropriate use is decreasing, it remains highest in the UTI group. Dr. Paulson suggested adding recommendations for alternatives to fluoroquinolones in the letter. Dr. Leung stated that penicillin allergy was also an issue for prescribing considerations. Ms. Fingado noted these patients were excluded from the analysis, although we could add information about this in the letter. Dr. Paulson suggested that nursing home patients should be targeted for educational outreach as well. Dr. Paulson motioned to recommend another educational outreach letter focused on UTIs to also include an updated fluoroquinolones bulletin. The motion was seconded. There was no further discussion. The motion passed.

AYE: Albertson, Blatt, Dryjanski, Leung, McBride, Mowers, Paulson, Stafford, Walker, and Wong NAY: None ABSTAIN: None ABSENT: Dhanvanthari, Liu, and Stebbins

ACTION ITEM: The DUR Board recommendations to revise the bulletin on fluoroquinolones with current data and updated suggestions for alternative treatments and complete educational outreach to prescribers with a focus on urinary tract infections (UTIs) will be submitted to DHCS.

iv. Review of DUR Publications presented by Dr. Lynch

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• Bulletin (December 2019): Gabapentin – Dr. Lynch let the Board know that theDUR educational bulletin entitled, “Improving the Quality of Care: RisksAssociated with Use of Gabapentin,” published in December 2019.

• Updated Bulletin (January 2020): Additive Toxicity – Dr. Lynch let the Boardknow that updates to Table 2 in the DUR educational alert entitled, “ProDURUpdate: Additive Toxicity Alert Now Focused Only On CNS Depressants,”published in January 2020.

• Discussion/Recommendations for Future Educational Bulletins – The calendarfor future DUR educational bulletins was reviewed.

Dr. Paulson suggested publishing an educational bulletin with recommendationsfor tapering of benzodiazepines and opioids. Dr. Paulson stated the CenCalHealth letter was a good place to start and could also develop educationaloutreach letters on this topic to be sent out twice per year. The motion wasseconded. There was no further discussion. The motion passed.

AYE: Albertson, Blatt, Dryjanski, Leung, McBride, Mowers, Paulson, Stafford, and Walker NAY: None ABSTAIN: None ABSENT: Dhanvanthari, Liu, Stebbins, and Wong

ACTION ITEM: The DUR Board recommendations to publish an educational bulletin on tapering of benzodiazepines and opioids and complete biannual educational outreach letters to prescribers on this topic will be submitted to DHCS.

Dr. Leung asked if there are educational bulletins that align with the Core Set measures. Ms. Fingado stated that before the Global Board there were bulletins that aligned with all of the relevant Core Set measures. However, Ms. Fingado noted there are now many new measures and others could be revisited again. Dr. Leung explained that the childhood measures are difficult to look at, but health plans are held accountable for these measures. Dr. Leung suggested considering an educational bulletin on strategies to increase these childhood measures, perhaps starting with the immunization measures. Ms. Fingado noted that there is another group running the data for these measures and that maybe the focus of the bulletin could be on ways to improve. Dr. Leung shared they have a quality team doing academic detailing about well child visits, timing of immunizations, and trying improving performance around those measures. Ms. Fingado noted the California Department of Public Health (CDPH) Immunization Department has several webinars and resources available on these topics and she could review these resources for inclusion in the bulletin. The motion was seconded. There was no further discussion. The motion passed.

AYE: Albertson, Blatt, Dryjanski, Leung, McBride, Mowers, Paulson, Stafford, and Walker NAY: None ABSTAIN: None ABSENT: Dhanvanthari, Liu, Stebbins, and Wong

ACTION ITEM: The DUR Board recommendation to publish an educational bulletin on strategies to increase the childhood immunization quality measures will be submitted to DHCS.

g. Recap of today’s action items – Dr. Orozco gave a brief verbal update on the threeaction items in the afternoon session. There were no edits or additional discussion.

h. Looking ahead: Call for future meeting agenda – Ms. Chan stated that she welcomesrecommendations from the Board for speakers. Possible presentations for May includethe Health Plan of San Joaquin describing their opioid initiative and DHCS ManagedCare Quality and Monitoring Division giving an overview of Medi-Cal managed care planquality improvement projects.

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6) PUBLICCOMMENTS

• There were no public comments.

7) CONSENTAGENDA

• The next Board meeting will be held from 9:30 a.m. to 3:00 p.m. on May 19, 2020, in theDHCS 1st Floor Conference Room located at 1700 K Street, Sacramento, CA 95814.

8) ADJOURNMENT • The meeting was adjourned at 2:28 p.m.

Action Items Ownership

Post the November 19, 2019, Board meeting minutes to the DUR website. Amanda The DUR Board recommendation to conduct a retrospective DUR review of psychotropic use over time by class among Medi-Cal beneficiaries 18 years of age or younger from October 1, 2013, to September 30, 2014 through calendar years 2015-2019, stratifying by prescriber specialty and foster care status (if possible) will be submitted to DHCS.

Amanda/Shal

The DUR Board recommendations to revise the bulletin on fluoroquinolones with current data and updated suggestions for alternative treatments and complete educational outreach to prescribers with a focus on urinary tract infections (UTIs) will be submitted to DHCS.

Amanda/Shal

The DUR Board recommendations to publish an educational bulletin on tapering of benzodiazepines and opioids and complete biannual educational outreach letters to prescribers on this topic will be submitted to DHCS.

Amanda/Shal

The DUR Board recommendation to publish an educational bulletin on strategies to increase the childhood immunization quality measures will be submitted to DHCS. Amanda/Shal

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Board Action Items from February 25, 2020

• Conduct a retrospective DUR review of psychotropic use over time byclass among Medi-Cal beneficiaries 18 years of age or younger, stratifyingby prescriber specialty and foster care status (if possible).o Approved. This review will be presented at the September 2020 Board

meeting.• Revise the bulletin on fluoroquinolones and complete educational

outreach to prescribers with a focus on urinary tract infections (UTIs).o Revised bulletin has published and outreach proposal to be discussed today.

• Publish an educational bulletin on tapering of benzodiazepines andopioids and complete biannual educational outreach on this topic.o Approved and added to queue.

• Publish an educational bulletin on strategies to increase the childhoodimmunization quality measures.o Approved. Will be incorporated into the upcoming immunization bulletin

(scheduled for publication in September 2020).

1

MCP: ___________________________________________________________________________

Name of DUR representative: ___________________________ ___ ___

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GLOBAL MEDI-CAL DRUG USE REVIEW BOARD February 25, 2020 BOARD MEETING MCP ACTIONS

Attended meeting? Yes No

Reminders

• MCPs are required to ensure representation and participation at Global Medi-Cal DUR Boardmeetings, either in-person or via webinar. Refer to the Global Medi-Cal DUR Board bylaws forthe attendance requirements for Global Medi-Cal DUR Board members

• MCPs are required to have a process for distribution of provider education programs andmaterials developed by Global Medi-Cal DUR Board to their providers

Summary of Required Actions

I. Educational Bulletins: MCP to have a process for distribution of provider educationprograms and materials developed by Global DUR Board to their providers via establishedmechanisms.

Required dissemination of DUR educational bulletins and alerts

Description Mechanism of dissemination

Date of Dissemination

December 2019 Bulletin: Improving the Quality of Care: Risks Associated with Use of Gabapentin

This document contains both information and form fields. To read information, use the Down Arrow from a form field.

2

22Summary of Global Medi-Cal DUR Board Activities

(not required to document on the Annual Report to CMS)

1. Review 2019 Board Accomplishments

Actions:a. Review at MCP’s P&T/DUR Committeeb. Share individual MCP’s success with DUR Board at future meetings

2. Review Board Goals and Priorities

Actions:a. Review board goals and priority areas at MCPs P&T/DUR Committeeb. Submit innovative practices on priority areas MCPs has worked on and share lessons learnedc. Consider presenting best practices at future DUR board meetings

3. Review Health Plan Presentation by Alameda Alliance for Health: Opioid Stewardship

Actions:a. Identify any gaps of care, and assess whether your MCP will adopt any improvement strategies

presentedb. Identify strategies for tapering opioids and benzodiazepinesc. Review role of pain specialist and oncologist specialist in pain management

4. Review Health Plan Presentation by CenCal Health: Asthma Population Health Project

Actions:a. Assess the five-step strategies presented by CenCal Health to improve medication adherence,

noting the results far exceeded expectationsb. Consider other measures such as hospitailziation rates, besides asthma medication ratio (AMR) to

measure success

5. Review Health Plan Presentation by CenCal Health: Opioid-Benzodiazepine Edit and ProviderOutreach

Action:a. If the MCP has similar concurrent use of opioids and benzodiazepine edit in place, consider

performing a DUR to assess outcome

6. Review Board Actions and Recommendations from the February 25, 2020 DUR Board Meeting(see “Action Items” found in the last section of the meeting minutes).

Actions:a. Discuss the actions and recommendations at the MCP’s P&T/DUR meeting.b. Consider offering feedback at future DUR board meetings

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CMS DUR Annual Report FFY 2019

MCO Survey

Pauline Chan, R.Ph., MBA

May 19, 2020

Overview

• 42 CFR 438.3 (s)(4) and (5) require that each Medicaid managedcare organization (MCO) must operate a drug utilization review(DUR) program, and must

– Meet the requirements described in 1927 (g) of the SocialSecurity Act (the Act)

– Submit an annual report

• Reporting period is by federal fiscal year

• FFY 2019 covers the period of October 1, 2018 to September 30,2019

FFY 2019 MCO Survey (cont.)

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FFY 2019 MCO Survey

• Answering the MCO Survey questions and returning the survey andattachments will constitute compliance with the aforementionedstatutory and regulatory requirements

• FFY 2019 MCO survey topics:

– Nature and scope of the prospective and retrospective DUR

– Summary of interventions

– Assessment of the education program

– DUR board activities

– DUR program’s impact on quality of care

• Review Topics:

– Non-capitated or “carved out” drugs survey questions

– Innovative Practices Narrative• Focus topics

– Executive Reports• Includes FFY 2020 goals

• Program oversights and initiatives

– DUR program’s impact on quality of care

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Non-Capitated Drug Categories (Carved Out)

• Selected HIV/AIDS/Hepatitis B treatment drugs

• Selected alcohol and heroin detoxification and dependencytreatment drugs

• Selected coagulation factors; and

• Selected drugs used to treat psychiatric conditions (includingantipsychotics and MAO inhibitors)

Note: Individual health plans may be exempted from specific category or categories of the carved out drugs

Buprenorphine, Naloxone, Buprenorphine/Naloxone Combinations and Methadone for Opioid Use Disorder

1. For plans with non-capitated (carved out) drugs, Fee For Service(FFS) sets the total mg per day limits on the use of buprenorphineand buprenorphine/naloxone combination drugs at maximum offour dosage units per day, regardless of strength

2. No limit on the allowable length of the treatment

3. Does not require maximum mg per day allowable be reduced aftera set period of time

4. Has at least one preferred buprenorphine/naloxone combinationproduct available without prior authorization

5. Currently does not have edits in place to monitor opioids beingused concurrently with MAT

Buprenorphine, Naloxone, Buprenorphine/Naloxone Combinations and Methadone for Opioid Use Disorder (cont.)

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6. Has at least one naloxone opioid overdose product

available without prior authorization

7. No limit on the allowable length of the treatment

8. Has at least one naloxone opioid overdose product

available without prior authorization

9. California Medical Board/State Board of Pharmacy/Medi-Cal allowpharmacists to furnish naloxone

Antipsychotics

1. Currently no restrictions in place to limit the quantity ofantipsychotics.

Restrictions other than quantity limits:

a. An approved Treatment Authorization Request is required forany antipsychotic medication for all Medi-Cal beneficiaries 0-17years of age

b. An approved Treatment Authorization Request is also requiredfor beneficiaries residing in skilled nursing facilities (SNFs)

Antipsychotics (cont.)

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2. Monitors the appropriate use of antipsychotics in children

a. includes all children

b. monitoring criteria includes– child’s age

– dosage

– indication

– polypharmacy

c. Monitoring goals include reducing polypharmacy and

improve compliance with dosing guidelines and annual

metabolic risk assessment

Innovative Practices

• Discuss development of innovative practices during the past year

• Describe in detailed narrative innovative practices that:

– Improve the program

– Improve optimal use of prescription drugs

– Have helped to control costs

• Topics suggested by CMS:• Disease management

• Academic detailing

• Automated prior authorizations

• Continuing education programs

• Health plan best practices

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Executive Report

• A brief overview of your DUR program:

– FFY 2019 program highlights

– Includes objectives, tools and outcomes of initiativesaccomplished

– Goals for 2020

– Includes program oversight and initiatives

Questions?

Global Medi-Cal DUR Board Meeting 05-19-2020

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Update on Actions Item from November 19, 2019 Board Meeting

Action Items: • Apply for participation in an action-oriented affinity group

related to improving asthma control in California• Review the process for both FFS and MCP patients to

obtain a SGLT2 inhibitor or a GLP1-RA– Identify potential barriers– Identify ways to mitigate such barriers

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Pharmacy Update Topics: Medi-Cal Rx

H.R. 6

Ivana Thompson, PharmD Pharmacy Benefits Division

May 19, 2020

DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 2

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Global Medi-Cal DUR Updates: Q1 2020

Amanda R. Fingado, MPH Senior Epidemiologist/Statistician Department of Clinical Pharmacy

Shal Lynch, PharmD, CGP Health Sciences Associate Clinical Professor Department of Clinical Pharmacy

Topics for Discussion

▪ Publications- March 2020: Montelukast Alert- April 2020: Ranitidine Alert- April 2020: Updated Fluoroquinolones Bulletin

▪ Educational Outreach- Final Outcomes: MEDD 2019- Outcomes: Montelukast- Outcomes: Ranitidine- Proposal: Fluoroquinolones and UTI

DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 3

Topics for Discussion (cont.)

DUR Publications – 2020Q1 (1/1/20 – 3/31/20) 4

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▪ Fee-for-Service Prospective DUR: New GCNs Q1 2020▪ Retrospective DUR:

- Global Quarterly Report: 4Q2019 (October – December 2019)- Global Annual Report: 2019 (January – December 2019)- FFS Quarterly Report: 1Q2020 (January – March 2020)- Evaluation Report: 1Q2020 (January – March 2020)- Hepatitis C Virus (HCV) Drugs: Calendar Year 2019- Beers Criteria Drugs: Calendar Year 2019

DUR Publications

March 2020: Alert ▪ Drug Safety Communication: Mental Health Side Effects from Montelukast

April 2020: Alert ▪ Drug Safety Communication: Withdrawal of All Ranitidine Products

April 2020: Bulletin ▪ Improving Quality of Care: Update of Risks Associated with Use of

Fluoroquinolones

DUR Publications – 2020Q1 (1/1/20 – 3/31/20) 5

DUR Publications – 2020Q1 (1/1/20 – 3/31/20) 6

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Future Topics: Alerts

Alerts: - Updated ACR guidelines for the Management of Reproductive Health in

Rheumatic and Musculoskeletal Diseases (in progress for May 2020publication)

- Updated ADA opioid guidelines to dentists- Updated ACOG guidelines for postpartum pain- Updated NAMS guidelines for hormone replacement therapy- California Upgrades Immunization Registry to CAIR2

Future Topics: Bulletins

Bulletins: - Antihyperglycemic medications (for summer 2020 publication)- Annual immunization update, with childhood immunization rate

improvement strategies included (for September 2020 publication)- Managing pain in population with comorbid mental health conditions- Pharmacist furnishing of naloxone- Pharmacist furnishing of hormonal contraception- Hypertension medication adherence- Benzodiazepine/Opioid tapering

1

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 7

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 8

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Board questions/recommendations?

Background: MEDD – 2019

Background: ▪ In 2016, DUR program sent letters/profiles to 134 prescribers of

155 beneficiaries with individual paid claims > 120 mg MEDD▪ Outcomes:

- Response rate 23% with 97% rating info as “useful” or “very useful”- 40% of beneficiaries ↓ total days with cumulative MEDD > 120 mg- 20% of beneficiaries ≥1 paid claim for MAT

▪ In November 2017 the Board recommended repeat of mailing

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 9

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 10

35

Objectives: MEDD – 2019

▪ To improve the quality of pain treatment among non-cancer,non-hospice Medi-Cal fee-for-service beneficiaries atincreased risk of opioid overdose.

Methods: MEDD – 2019

▪ Inclusion criteria:- Medi-Cal FFS beneficiaries with at least 1 paid claim > 120 mg

MEDD since January 1, 2019▪ Exclusion criteria:

- Practice locations including SNF, ICF, home health, hospice- Diagnostic codes indicating palliative care or cancer treatment

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 11

Methods: MEDD – 2019 (cont.)

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 12

36

▪ Study population included 87 continuously-eligible Medi-CalFFS beneficiaries with at least 1 paid claim > 120 mg MEDDsince January 1, 2019- 26 (31%) had a paid claim for naloxone since January 1, 2019- Furnished by pharmacists (n = 9) and ordered by prescribers (n =

17)▪ Letters included patient profiles, updated Medi-Cal DUR

MEDD article, naloxone handout, and provider surveys▪ Letters mailed to 85 prescribers on April 26, 2019

Final Primary Outcome: MEDD – 2019

▪ Response rate = 19% and undeliverable mail rate = 6%▪ Primary:

- The percentage of the continuously-eligible study population(n=68; 78%) with a paid claim exceeding > 120 mg MEDD in the6-month period following the mailing of the intervention letter:▪ 62% (n = 42)

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 13

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 14

▪ Secondary:

Final Secondary Outcomes (cont.)

37

Final Secondary Outcomes: MEDD – 2019

▪ Secondary:- Percentage of continuously-eligible population (n=68)

▪ Receiving prescription opioid medication as part of a narcotic withdrawaltreatment plan in the 6-month period following the mailing: 53% (n = 36)- Either buprenorphine only or no opioids at all after 12 months: 32% (n = 22)

▪ With hospital or emergency department visits due to opioid overdose inthe 6-month period following the mailing: 3%

▪ With a paid claim for take-home naloxone in the 6-month periodfollowing the mailing of the intervention letter: 11 additional beneficiaries(24 had received before letter, so 35 total or 51% after letter)

- Total days with cumulative MEDD > 120 mg in the 6-month periodprior to the mailing compared to the number of days withcumulative MEDD > 120 mg in the 6-month period following themailing, by beneficiary (in the continuously-eligible population):▪ Average days pre-intervention = 147.4 ± 22.6 days▪ Average days post-intervention = 104.4 ± 30.8 days▪ Days were calculated up to a maximum of 180 days, per beneficiary▪ A decrease was observed in 38 (68%) beneficiaries

2

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 15

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 16

38

Board questions/recommendations?

Background: Montelukast Letter

▪ In March 2020, the FDA added a Boxed Warning to theprescribing information for montelukast due to reports ofserious mental health side effects associated with use.

▪ Recommendation includes prescribing montelukast only forpatients who cannot tolerate or are not being treated effectivelywith other allergy medications.

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 17

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 18

39

Objective/Methods: Montelukast Letter

▪ Objective- To inform health care providers of the possible risks associated with

use of montelukast▪ Methods

- The top 223 prescribers of montelukast (by number of FFS patientsprescribed montelukast in 2020) were sent a letter on April 24, 2020▪ Included the Medi-Cal DUR alert on montelukast and a provider survey▪ Each prescriber had ≥ 5 patients prescribed montelukast in 2020 (3% of

prescribers representing 26% of all patients)

Outcomes: Montelukast Letter

▪ Outcomes (to be presented at the September 2021 meeting):- Primary: % of continuously-eligible patients with paid claims for

montelukast treatment within 12 months following the mailing- Secondary: % of continuously-eligible patients with paid claims for

montelukast and concomitant diagnosis codes indicating mentalhealth side effects within 12 months following the mailing

▪ Provider response rate and returned mail rate (within 90 days ofthe mailing) will be reported

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 19

3

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 20

40

Board questions/recommendations?

Background: Ranitidine Letter

▪ On April 1, 2020, the FDA requested an immediatemanufacturer’s market withdrawal of ranitidine in the U.S.

▪ Ranitidine will not be available for prescriptions or OTC use.▪ FDA testing results showed levels of a compound called N-

nitrosodimethylamine (NDMA) may increase to unacceptablelevels over time and when stored at higher than roomtemperature- NDMA has not been found in famotidine, cimetidine, esomeprazole,

lansoprazole, or omeprazole.

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 21

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 22

41

Objectives: Ranitidine Letter

▪ Objectives- To inform health care providers about the immediate withdrawal of

ranitidine from the US market- To offer health care providers alternate treatment options, including

no treatment (when indicated)

Methods: Ranitidine Letter

▪ Methods- Paid claims for ranitidine were reviewed for any ranitidine

prescriptions active beyond April 1, 2020▪ Example: Claim on 3/15/20 for a 90 days’ supply

- A total of 597 prescribers (representing 706 patients) were sent aletter on May 8, 2020

- Letters included patient name/DOB and ranitidine claims data, theMedi-Cal DUR alert on the ranitidine, and provider survey

4

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 23

42

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 24

Outcomes: Ranitidine Letter

▪ Outcomes (to be presented at the February 2021 meeting):- Primary: % of continuously-eligible patients with no paid claims for

alternative medications within 6 months following the mailing- Secondary: % of continuously-eligible patients with paid claims for the

following treatments within 6 months following the mailing:▪ Histamine-2 blockers▪ Proton-pump inhibitors

▪ Provider response rate and returned mail rate (within 90 days ofthe mailing) will also be reported

Board questions/recommendations?

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 25

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 26

43

Proposal: Fluoroquinolones/UTI Letter

▪ Fluoroquinolones should not be prescribed to community-dwelling patients who have other treatment options foruncomplicated UTI, as the risks outweigh the benefits

▪ A 2019 review of paid claims for fluoroquinolones found 34% offluoroquinolones in the Medi-Cal fee-for-service program wereprescribed for uncomplicated UTI

▪ The 2017 fluoroquinolones bulletin was updated to includethese recent data and two additional drug safetycommunications

Objectives: Fluoroquinolones/UTI Letter

▪ Objectives- To inform health care providers about the risks associated with

fluoroquinolones- To offer health care providers alternate treatment options for

uncomplicated UTI

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 27

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 28

44

Methods: Fluoroquinolones/UTI Letter

▪ Methods- The top prescribers by total number of community-dwelling FFS

patients prescribed fluoroquinolones for an uncomplicated UTIsince January 1, 2020 will be included in the study population

- Prescribers will receive letter including the Medi-Cal DUR bulletinon fluoroquinolones and a provider survey

Outcomes: Fluoroquinolones/UTI Letter

▪ Outcomes (to be presented at the February 2021 meeting):- Primary: Total fluoroquinolones prescribed to community-dwelling

patients for uncomplicated UTI within 6 months following the mailing- Secondary: Total trimethoprim/sulfamethoxazole and nitrofurantoin

monohydrate/macrocrystals prescribed to community-dwelling patientsfor uncomplicated UTI within 6 months following the mailing

▪ Provider response rate and returned mail rate (within 90 days ofthe mailing) will also be reported

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 29

19

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 30

45

Board questions/recommendations?

Future Educational Outreach Topics

DUR Educational Outreach to Pharmacies/Providers ▪ Oseltamivir or zanamivir paid claims + influenza vaccine▪ Statin use with cardiovascular disease▪ Chronic use of PPIs▪ Chronic use of temazepam/zolpidem▪ Tapering of opioids/buprenorphine

5

DUR Educational Outreach Updates – 2020Q1 (1/1/20 – 3/31/20) 31

Prospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 32

46

Board questions/recommendations?

New GCN Alert Profiles

Background ▪ Each week new Generic Code Numbers (GCNs) are added▪ Overutilization (ER), Drug-Pregnancy (PG) and Drug-Drug

Interactions (DD) alerts are automatically turned on for allnew GCNs

▪ New GCNs are reviewed weekly for additional alerts▪ New GCNs with alerts turned on other than ER, PG, and DD

are provided at each Board meeting for review

6

Prospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 33

New GCN Alert Profiles (cont.)

Prospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 34

47

Table 1. New GCNs for Existing DUR Target Drugs: Q1 2020 Drug Description Alerts Turned on

DIAZEPAM AT, HD, LD

DICLOFENAC/SILICONE, ADHESIVE DA, MC, TD, ID, HD, LD

EMPAGLIFLOZ/LINAGLIP/METFORMIN MC, TD, HD, LD

ESTRADIOL MC

IBUPROFEN DA, MC, TD, ID, HD, LD

LUMATEPERONE TOSYLATE MC, TD, LR, AT, ID, HD, LO

METFORMIN HCL MC, TD, HD, LD

OMEPRAZOLE/AMOXICILURIFABUTIN DA, TD, ID, HD, LD

SOD.POT CHLO/SOD CIT/RICE/WHEY MC, TD, ID, HD, LD

SOD.POT CHLOR/SOD CIT/RICE SYR MC, TD, ID, HD, LD

TRAMADOL HCL MC, TD, AT, ID, HD, LO

DA Drug-Allergy

MC Drug-Disease

TD Therapeutic Duplication

LR Late Refill

AT Additive Toxicity

ID lngredient Duplication

PA Drug-Age

HD High Dose

LD Low Dose

Board questions/recommendations?

7

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 35

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 36

48

Global Quarterly Report: 4Q2019

▪ Across all population aid code groups, the vast majority ofutilizing beneficiaries are MCP enrollees (range from 98% ofOTLIC to 88% of OTHER)

▪ Total utilizing beneficiaries and total paid claims decreasedacross all age groups for both FFS and MCP enrollees,except for the 13 – 18 year age group in the MCP population

▪ Hydrocodone/acetaminophen posted a 1% decrease in totalpercentage of utilizing beneficiaries with a paid claim and a20% decrease in total paid claims vs. 4Q2018

Board questions/recommendations?

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 37

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 38

49

Global Annual Report

▪ When calendar year 2018 data were presented last year, theBoard asked for more frequent (quarterly) reports

▪ Two quarterly reports are presented at each Board meeting- FFS (all drugs processed through FFS program)- Global (all drugs processed through both FFS and MCP)

▪ Does the Board still have interest in a global annual report?- FFS annual presented each year at February Board meeting- Keep in mind reports may change starting in 2021 (Medi-Cal Rx)

Global Annual Report: Calendar Year 2019

▪ Only 19% of eligible FFS enrollees had a paid pharmacyclaim vs. 45% of eligible MCP enrollees

▪ FFS enrollees were 26% of eligible beneficiaries, 12% ofutilizing beneficiaries, and 6% of total paid claims

▪ 2% decrease from 2018 in utilizing beneficiaries and totalpaid claims

▪ MCP enrollees had a greater percentage of utilizingbeneficiaries across almost all of the top 20 drug therapeuticcategories and top 20 drugs

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 39

8

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 40

50

Board questions/recommendations?

FFS Quarterly Report: 1Q2020

▪ 15% of eligible Medi-Cal FFS enrollees had a paid claim throughthe FFSprogram vs. 2% of eligible Medi-Cal MCP enrollees

▪ Among FFS enrollees, there was a 49% increase in averagepaid claims per day and a 48% increase in total utilizingbeneficiaries with a paid claim in comparison to last year forOSELTAMIVIR PHOSPHATE primarily driven by a spike inutilization during January 2020 corresponding with an increasein reporting of ILI in California throughout January

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 41

9

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 42

51

Board questions/recommendations?

Reminder: Quarterly Evaluation Reports

▪ Quarterly evaluation reports have replaced the biennial reportdue to be presented in February 2021

▪ Biennial report too dense, timing between original article andbiennial evaluation was variable

▪ Evaluations will now be completed two years after the quarterthe original article was published- Board meetings during 2020 will include two quarters of articles- Board meetings during 2021 and beyond will include one quarter

Retrospective DUR Updates – – 2020Q1 (1/1/20 – 3/31/20) 43

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 44

52

Quarterly Evaluation Report: 1Q2020

▪ Six articles to evaluate from 2Q2017 and 3Q2017:- Improving the Quality of Care: Overutilization of Proton Pump Inhibitors – April 2017- Alert: Medi-Cal Expands Access to Adult Immunizations in Pharmacies – April 2017- Drug Safety Communication: Risks of Codeine and Tramadol Use in Children – May

2017 - Clinical Review: Drug-Induced QT Interval Prolongation – August 2017- 2017 Immunization Updates: Influenza, HepA, Meningococcal, HPV, Adult Vaccines –

September 2017- Alert: Online Report to the Vaccine Adverse Event Reporting System (VAERS) –

September 2017

PPI Evaluation: Purpose

▪ Review proton pump inhibitor use in the Medi-Cal fee-for-service population

▪ Review relevant safety information and clinicalrecommendations for proton pump inhibitors in order todetermine if there have been any changes since theoriginal DUR bulletin was published in April 2017

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 45

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 46

53

PPI Evaluation: Study Population

▪ Same inclusion/exclusion criteria as the published article- At least one paid claim for a PPI through the Medi-Cal FFS

program between 3/1/19 and 2/29/20 (the measurement year)- Continuous exclusive eligibility in the FFS program during the

measurement year

PPI Evaluation: Data Criteria

▪ Any beneficiary with the following ICD-10-CM diagnosis codesduring the measurement year or the year prior to the measurementyear was coded as a potentially appropriate use of a PPI:- H. pylori infection (B96.81)- Zollinger-Ellison Syndrome (E16.4)- GERD (K21.0 and K21.9)- Esophagitis (K20.0 – K20.9)- Barrett’s esophagus (K22.7)- Gastric, duodenal, and peptic ulcers (K25.0 – K25.9, K26.0 – K26.9, K27.0 – K27.9)- GI hemorrhage (K92.2)

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 47

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 48

PPI Evaluation: Results (cont.)

54

PPI Evaluation: Results

Medi-Cal fee-for-service population Article data:

1101/15 – 10/31/16

Evaluation data:

03/01/19 – 02/29/20

% change

Beneficiaries identified with at least one paid claim for a PPI during the measurement year that met inclusion/ exclusion criteria 23,921 37,139 55%

Percentage of study population with a PPI treatment duration for ≤ 90 days during the measurement year 61% 62% 1%

Percentage of study population with a PPI treatment duration for ≥ 300 days during the measurement year (long-term use) 13% 15% 2%

Percentage of study population with potentially inappropriate use of PPIs during the measurement year 77% 67% -10%

Percentage of beneficiaries with long-term use with potentially inappropriate use of PPIs during the measurement year 75% 52% -23%

Percentage of beneficiaries with long-term use with a break of 30 days or more without a PPI during the measurement year 15% 20% 5%

Figure 1. Utilization of Proton Pump Inhibitors and H2-receptor Antagonists (with dates of service between November 1, 2016, and February 29, 2020)

otal

Util

izin

g B

enef

icia

ries

20,000 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000

T 2,000 0

Nov

-16

Dec

-16

Jan-

17

Feb-

17

Mar

-17

Apr

-17

May

-17

Jun-

17

Jul-1

7 A

ug-1

7 S

ep-1

7 O

ct-1

7 N

ov-1

7 D

ec-1

7 Ja

n-18

Fe

b-18

M

ar-1

8 A

pr-1

8 M

ay-1

8 Ju

n-18

Ju

l-18

Aug

-18

Sep

-18

Oct

-18

Nov

-18

Dec

-18

Jan-

19

Feb-

19

Mar

-19

Apr

-19

May

-19

Jun-

19

Jul-1

9 A

ug-1

9 S

ep-1

9 O

ct-1

9 N

ov-1

9 D

ec-1

9 Ja

n-20

Fe

b-20

HISTAMINE H2-RECEPTOR INHIBITORS PROTON-PUMP INHIBITORS

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 49

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 50

55

PPI Evaluation: Analysis

▪ PPI use in the Medi-Cal FFS population increased by 55%- Beginning of increase corresponds to omeprazole added to CDL

May 1, 2019- Long-term use increased by only 2%, but could increase if new

starts end up with long-term use▪ 67% may be using PPIs inappropriately▪ Patients without clear indications for PPI use should be

reevaluated at each refill, with consideration given tosupervised tapering

PPI Evaluation: Recommendations

▪ Research/Policy Recommendation:- Continue to monitor overutilization of proton pump inhibitors in

the Medi-Cal population, especially those beneficiaries whostarted on omeprazole in May 2019.

▪ Board Recommendation:- Consider educational outreach letter to top prescribers of PPIs

that includes strategies for tapering PPIs.

10

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 51

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 52

56

Board questions/recommendations?

Adult Immunization Evaluation: Purpose

▪ Review the policies regarding adult immunizations inpharmacies since the publication of the original articleand describe any relevant updates.

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 53

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 54

57

Adult Immunization Evaluation: Analysis

▪ Expanded access to adult immunizations as a pharmacybenefit continues to be Medi-Cal policy.

▪ There have been no additional updates to this policysince the original article was published in April 2017.

Adult Immunization: Recommendations

▪ Research/Policy Recommendations:- Continue to monitor adult immunizations in pharmacies since

expanded access was implemented.- Continue to collaborate with Immunization Branch on educational

efforts that may need additional promotion.

▪ Board Recommendation:- Consider reviewing adult immunization rates in the pharmacy by

region, to aid in focused education and outreach efforts.

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 55

11

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 56

58

Board questions/recommendations?

Codeine/Tramadol Evaluation: Purpose

▪ Review the FDA safety communications on codeine andtramadol since the publication of the original article anddescribe any relevant updates.

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 57

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 58

59

Codeine/Tramadol Evaluation: Updates

▪ Since the publication of this educational article, the DURprogram has published one additional alert related toFDA safety concerns regarding codeine:- Drug Safety Communication: New Age Limit for Opioid Cough

and Cold Medicines published in July 2018▪ In 2019, educational outreach letters were sent to prescribers

of tramadol and/or codeine to patients < 18 years of age inthe Medi-Cal FFS program during a 6-month time period- Results to be presented at the November 2020 Board meeting

Codeine/Tramadol Evaluation: Analysis

▪ A third of the prescribers in the mailings were dentists▪ More than half of the prescribers with more than one

patient listed in the mailings were dentists▪ A recent study found that more than one-half of opioid

prescriptions written by dentists exceed the 3-day supplyrecommended by the CDC in its 2016 guidelines foracute dental pain management

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 59

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 60

12

60

Codeine/Tramadol: Recommendations

▪ Research/Policy Recommendations:- Continue to monitor research and FDA communications

regarding opioid medications.- Evaluate the use of opioid medications among the Medi-Cal

population 18 years of age or younger.▪ Board Recommendation:

- Discuss prioritizing an educational article highlighting suggestedguidelines from professional dental organizations for acute painmanagement in children and adolescents, as well as adults.

Board questions/recommendations?

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 61

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 62

61

QT Prolongation Evaluation: Purpose

▪ Review use of QT-prolonging medications in the Medi-Cal FFS population with at least one medical claimdiagnostic code for schizophrenia and/or bipolar disorder

▪ Review relevant safety information and clinicalrecommendations for avoiding drug-induced QTprolongation in this population to determine if there havebeen any changes in use since the original DUR bulletinwas published in August 2017

QT Prolongation: Study Population

▪ Same inclusion/exclusion criteria as the published article- Continuous, exclusive eligibility in the FFS program during the

measurement year (1/1/19 – 12/31/19)- At least one paid medical claim with either schizophrenia or

bipolar disorder listed as a diagnosis code in either themeasurement year or the year prior to the measurement year

- Age between 18 and 64 years of age throughout the duration ofthe measurement year

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 63

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 64

62

QT Prolongation: Data Criteria

▪ Known TdP risk study population included beneficiaries with at leastone paid claim for either chlorpromazine, haloperidol, pimozide, orthioridazine- Paid pharmacy claims for non-antipsychotic medications classified as

known TdP risk were also reviewed during the measurement year- Diagnostic codes for concomitant medical conditions that may cause QT

prolongation and potential adverse cardiac events that may beassociated with QT prolongation were reviewed (followed the detailedmethods outlined in the original article)

QT Prolongation Evaluation: Results

Medi-Cal fee-for-service study population Article data:

4/01/16 – 3/31/17

Evaluation data:

01/01/19 – 12/31/19

Percent change

Beneficiaries that met inclusion/exclusion criteria with at least one paid claim for an antipsychotic medication with known TdP risk during the measurement year 5,654 1,929 -66%

Percentage of these beneficiaries with at least one paid claim for additional non-antipsychotic medications with known TdP risk during the measurement year 49% 19% -30%

Percentage of these beneficiaries with at least 12 paid claims for additional non-antipsychotic medications with known TdP risk during the measurement year 19% <1% -19%

Percentage of these beneficiaries with at least one paid medical claim with a condition that may cause QT prolongation during the measurement year 12% 28% 16%

Percentage of these beneficiaries with at least one paid medical claim for an ECG during the measurement year 10% 25% 15%

Percentage of these beneficiaries with at least one paid medical claim indicating a potential adverse cardiac event during the measurement year 2% 9% 7%

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 65

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63

QT Prolongation Evaluation: Analysis

▪ 66% decrease in the number of Medi-Cal FFS beneficiarieswith a diagnosis of schizophrenia and/or bipolar disorder withpaid claims for antipsychotic medications with known TdP risk

▪ Potential adverse cardiac events increased from 2% to 9% inthe current study population, with the most frequent adverseevent being long QT syndrome

▪ 76% of the beneficiaries in the current study population werealso in the original study population three years ago,suggesting adherence and treatment benefit

QT Prolongation: Recommendations

▪ Research/Policy Recommendation:- Continue to monitor use of antipsychotic medications in the Medi-

Cal population.- Continue to follow evidence-based guidelines and

recommendations for ECG monitoring in patients onantipsychotics with a risk of QT prolongation.

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 67

13

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 68

64

Board questions/recommendations?

Immunization Evaluation: Purpose

▪ Review updates to the ACIP recommendations andpolicies for influenza, HepA, meningococcal disease,HPV, and adult immunizations since the original articlewas published in September 2017

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 69

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 70

65

Immunization Evaluation: Updates

▪ There have been updates in ACIP recommendations forinfluenza, HepA, and HPV since the original article

▪ A 2018 evaluation reviewed adult immunization practicelocation data for 2017 calendar year and found that adultimmunization rates across all Medi-Cal beneficiaries inthe pharmacy setting remain low, ranging from 4.5% forinfluenza to 0.1% for HPV.

Adult Immunizations in the Pharmacy

Vaccine

2018 Evaluation

Data 01/01/17-

12/31/17

2020 Evaluation

Data 01/01/19 -

12/31/19

Percent change

Percent change in Total Utilizing

Beneficiaries

Hepatitis A 2.8% 7.4% 4.6% -21.9% Hepatitis B 1.3% 3.1% 1.8% 9.4% HPV 0.1% 1.5% 1.4% -7.0% Influenza 4.5% 4.7% 0.2% 18.1% Meningococcal ACWY 0.6% 3.9% 3.4% -55.9% Meningococcal B 0.1% 1.5% 1.5% -43.2%

MMR 4.1% 7.9% 3.8% 13.3%

fe,ymo�l 2.8% 4.4% 1.6% 1.8%

lQQe 3.1% 3.3% 0.1% 4.4% Varicella 1.6% 4.4% 2.8% -20.0% Zoster 2.2% 9.5% 7.2% 10.5%

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 71

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 72

66

Immunization Evaluation: Analysis

▪ For all vaccines, the % of adult vaccinations in thepharmacy increased from 2017 to 2019, ranging from anincrease of 0.1% (TDaP) to an increase of 7.2% (zoster).

▪ There were decreases in total utilizing beneficiaries forHepA, HPV, MenACWY, MenB, and varicella- May be due to increases in utilizing beneficiaries in 2018 analysis

as a result of guideline changes (MenACWY, MenB, HPV,varicella) or outbreak mitigation (HepA, MenACWY, MenB) justprior to or during 2017

Immunization: Recommendations

▪ Research/Policy Recommendations:- Continue to follow updates to immunization regulations/legislation.- Continue to work with the CDPH on annual summaries of

immunization guidelines, products, and/or research

▪ Board Recommendation:- Discuss the value in including immunization strategies for adults in

the upcoming bulletin (along with strategies for children andadolescents).

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 73

14

Retrospective DUR Updates – 2019Q4 (10/1/19 – 12/31/19) 74

67

Board questions/recommendations?

VAERS Evaluation: Purpose

▪ Review any updates with regards to VAERS since theoriginal DUR alert was published in September 2017.

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 75

Retrospective DUR Updates – 2020Q1 (1/1/20 – 3/31/20) 76

68

VAERS Evaluation: Analysis

▪ The original VAERS reporting form was phased out afterDecember 2017.

▪ There have been no additional updates to the reportingsystem.

VAERS Evaluation: Recommendation

▪ Research/Policy Recommendation:- Continue to monitor CDC and FDA communications regarding

vaccine safety.

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Board questions/recommendations?

HCV Drugs - Background

▪ More than 3 million people in the United States are living withhepatitis C virus (HCV) infection- ~17,000 new HCV cases each year (estimate only half are reported)- 75%–85% of newly infected persons develop chronic HCV infection

▪ Without treatment, chronic HCV infection can lead to serious liverproblems

▪ HCV-related deaths in the US continue to increase

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HCV Drugs - Background (cont.)

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▪ Treatment options for HCV infection have been evolvingcontinuously since the introduction of HCV protease inhibitortherapies in 2011- Within Medi-Cal fee-for-service, all drugs except ribavirn are covered

with an approved Treatment Authorization Request (TAR)- In March 2020, DHCS revised its

Treatment Policy for the Management of Chronic Hepatitis C

HCV Drugs - Objective

▪ To evaluate the utilization of drugs used to treat HCV infection,including an assessment of potential HCV reinfection andretreatment in the Medi-Cal fee-for-service population.

In November 2016 the DUR Board recommended this evaluation be conducted on an annual basis. Previous reports covered FFS-only data in FFY 2016, FFY 2017, and FFY 2018.

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HCV Drugs - Methods

▪ Paid claims for all HCV medications with dates of servicebetween October 1, 2018 and September 30, 2019 werereviewed for all Medi-Cal beneficiaries

▪ During this measurement year, a total of 9,577 beneficiaries wereidentified as having a paid claim for an HCV medication, for atotal number of 24,317 paid claims- A total of 603 FFS enrollees and 9,110 MCP enrollees (136 were

enrolled in both programs during FFY 2019)- 603 FFS enrollees is up from 496 FFS enrollees in FFY 2018

HCV Drugs – Utilization Data FFY 2019

Drug Total FFS Total MCP DACLATASVIR < 20 < 20 ELBASVIR/GRAZOPREVIR < 20 249 GLECAPREVIR/PIBRENTASVIR 397 6,317 LEDIPASVIR/SOFOSBUVIR 54 131 PEGINTERFERON ALFA-2A < 20 28 PEGINTERFERON ALFA-2B < 20 < 20 RIBAVIRIN 20 204 SOFOSBUVIR < 20 < 20 SOFOSBUVIR/VELPATASVIR 113 2,016 SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR < 20 155

Some beneficiaries may be on more than one medication.

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HCV Drugs – Discussion

▪ In comparison with FFY 2018 there was increased use ofglecaprevir/pibrentasvir and sofosbuvir/velpatasvir

▪ All beneficiaries are required to have a baseline HCV-RNA leveland comprehensive metabolic panel before initiating treatment

▪ Analytical limitations include lack of clinical/TAR data▪ Prescribing trends remain in line with guidelines▪ Very limited evidence of retreatment over time (< 20

beneficiaries)

HCV Drugs – Recommended Action

▪ Given that pharmacy and medical claims data continue toshow use of these drugs follow clinical guidelines, discuss theappropriate frequency for reviewing HCV drug utilization- All HCV drugs require TAR review- Within a four-year review of claims data, there is no evidence of

problematic reinfection/retreatment

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Beers Criteria Drugs - Background

Board questions/recommendations?

▪ May 2019 DUR Board Meeting Action Item recommended aretrospective DUR review:- To identify the total number of Medi-Cal beneficiaries age 65 years

and older not eligible for Medicare (FFS and MCP)- To review literature for the typical cutoff age for Beers list

interventions- To analyze paid claims for these drugs

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Beers Criteria Drugs - Methods

▪ Inclusion/Exclusion Criteria:- Medi-Cal beneficiaries (FFS and MCP enrollees)- 65 years of age or older (almost every review had 65 years as cutoff)- Not dually-eligible for Medicare

▪ Measurement year was calendar year 2019 (1/1/19-12/31/19)▪ Drugs identified using the most recent NDC list from the “Use of

High-risk Medications in Older Adults (DAE)” HEDIS measure

2019 Population Summary

Beneficiaries 65 years of age and older

Total Utilizing Beneficiaries

Total Paid Claims

All FFS 140,913 (16%) 767,519 (8%) All MCP 757,487 (84%) 8,958,477 (92%) FFS non-duals 29,047 (13%) 229,240 (5%) MCP non-duals 202,732 (87%) 4,570,508 (95%) FFS (DAE drugs only) 28,308 (17%) 50,471(15%) MCP (DAE drugs only) 140,393 (83%) 291,002 (85%) FFS non-duals (DAE drugs only) 5,472 (12%) 8,060 (7%) MCP non-duals (DAE drugs only) 41,993 (88%) 100,048 (93%)

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2019 Population Summary (cont.)

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▪ FFS non-duals with a paid claim for a DAE represent 4% ofall FFS beneficiaries 65+ years of age- 19% of all FFS non-duals

▪ MCP non-duals with a paid claim for a DAE represent 6% ofall MCP beneficiaries 65+ years of age- 21% of all MCP non-duals

Top 20 DAE Drugs: FFS

Drug Total Utilizing Beneficiaries

KETOROLAC TROMETHAMINE 826 MECLIZINE HCL 704 PROMETHAZINE/DEXTROMETHORPHAN 579 NITROFURANTOIN MONOHYD/M-CRYST 558 HYDROXYZINE HCL 350 DIPHENHYDRAMINE HCL 332 GLYBURIDE 217 AMITRIPTYLINE HCL 202 DIGOXIN 195 PROMETHAZINE HCL 142

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Top 20 DAE Drugs: MCP

Drug Total Utilizing Beneficiaries

MECLIZINE HCL* 6,161 PROMETHAZINE/DEXTROMETHORPHAN* 5,317 NITROFURANTOIN MONOHYD/M-CRYST* 3,625 CYCLOBENZAPRINE HCL 2,853 KETOROLAC TROMETHAMINE* 2,681 HYDROXYZINE HCL* 2,566 DIPHENHYDRAMINE HCL* 2,482 ZOLPIDEM TARTRATE 1,804 PROMETHAZINE HCL* 1,367 AMITRIPTYLINE HCL* 1,264 * Also in FFS Top 10

Beers Criteria Drugs – Discussion

▪ Rate with at least one high-risk medication (19% FFS and 21%MCP) is slightly higher than national averages for Medicarebeneficiaries- 2018 Medicare HMO rate: 14.6%- 2018 Medicare PPO rate: 13.5%

▪ Opportunities for educational outreach- The non-dual 65+ population has not been the focus of any outreach- Cough/cold/allergy medicines could be one area with high impact

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Beers Criteria Drugs - Recommendations

Suggested Board actions: ▪ Discuss whether further evaluation using the DDE/DAE

HEDIS measures for 2020 would be useful in the non-dualpopulation 65 years of age or older- Could focus on certain drugs/drug classes- Could stratify by plan to see whether there are certain plans that

are doing a better job reducing the use of these high-risk drugs- Could be the basis for educational article and/or provider

outreach

Board questions/recommendations?

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Future Topics

▪ Annual review of drugs added to the Medi-Cal List of ContractDrugs (ongoing, presented each November)

▪ Psychotropic use over time by children and adolescents▪ Opioid prescribing by dentists▪ NSAIDs▪ Pharmacist furnishing of hormonal contraceptives▪ Assessment of opioid use and mortality (stratified by gender)▪ Antipsychotic polypharmacy in adults

Future Topics: Adult Core Set Measures

▪ Antidepressant Medication Management (AMM-AD)▪ Concurrent Use of Opioids and Benzodiazepines (COB-AD)▪ Contraceptive Care – Postpartum Women Ages 21–44 (CCP-AD)▪ Flu Vaccinations for Adults Ages 18–64 (FVA-AD)▪ Use of Opioids at High Dosage in Persons Without Cancer (OHD-AD)▪ Adherence to Antipsychotic Medications for Individuals with

Schizophrenia (SAA-AD)▪ Diabetes Screening for People With Schizophrenia or Bipolar Disorder

Who Are Using Antipsychotic Medications (SSD-AD)

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Future Topics: Child Core Set Measures

▪ Follow-Up Care for Children Prescribed Attention-Deficit/HyperactivityDisorder (ADHD) Medication (ADD-CH)

▪ Asthma Medication Ratio: Ages 5–18 (AMR-CH)▪ Contraceptive Care – Postpartum Women Ages 15–20 (CCP-CH)▪ Childhood Immunization Status (CIS-CH)▪ Immunizations for Adolescents (IMA-CH)

Board questions/recommendations?

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QUARTERLY SUMMARY GLOBAL MEDI-CAL DRUG USE REVIEW

REPORT PERIOD: 4th QUARTER 2019 (OCTOBER – DECEMBER 2019) Executive Summary

The Global DUR quarterly report provides information on retrospective drug utilization for all paid pharmacy claims for beneficiaries in the Medi-Cal program. For this report, the retrospective data cover the fourth quarter of 2019 (2019 Q4).

In 2019 Q4, approximately 32% of eligible Medi-Cal enrollees had a paid pharmacy claim through the Medi-Cal program, including 15% of eligible Medi-Cal fee-for-service enrollees and 34% of Medi-Cal managed care plan (MCP) enrollees (Table 1.1). Among all Medi-Cal beneficiaries with a paid claim through the Medi-Cal program in 2019 Q4, 9% were FFS enrollees and 85% were MCP enrollees. When data from 2019 Q4 were compared to the prior year (2018 Q4), data from 2019 Q4 showed a 3% decrease in total eligible beneficiaries, a 4% decreased in total utilizing beneficiaries, and a 5% decrease in total paid pharmacy claims.

When beneficiaries eligible for Medi-Cal were stratified by population aid code group (Tables 1.2 – 1.5), 29% were Affordable Care Act (ACA), 11% were Optional Targeted Low Income Children (OTLIC), and 16% were Seniors and Persons with Disabilities (SPD). Within the population aid code groups, the vast majority of utilizing beneficiaries were MCP enrollees, including 93% of the ACA population, 98% of the OTLIC population, 90% of the SPD population, and 88% of the remaining (OTHER) population. These tables also include the total number of beneficiaries that were continuously-eligible within each population aid code group. Continuous eligibility is plan-specific and is measured for 2019 Q4 from October 1, 2019 – December 1, 2019.

As shown in Tables 2.1 – 2.3, there was a decrease in total utilizing beneficiaries and total paid claims across all age groups for both FFS and MCP enrollees in comparison to the prior-year quarter, except for the 13 – 18 year age group in the MCP population. Within this group, both total utilizing beneficiaries and total paid claims increased by 2% in comparison to 2019 Q4.

The greatest decrease in total utilizing beneficiaries and total paid claims within the top 20 drug therapeutic categories by total utilizing beneficiaries (Table 3) was seen in the OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS drug therapeutic category, which posted a 1% decrease in total percentage of utilizing beneficiaries with a paid claim and a 20% decrease in total paid claims in comparison to the prior-year quarter. Similar results are shown on Table 5, where HYDROCODONE/ACETAMINOPHEN also posted a 1% decrease in total percentage of utilizing beneficiaries with a paid claim and a 20% decrease in total paid claims in comparison to the prior-year quarter.

Tables 4.1 – 4.4 show the top 20 drug therapeutic categories by total continuously-eligible utilizing beneficiaries in 2019 Q4, stratified by population aid code group and Tables 6.1 – 6.4 show the top 20 drugs by total continuously-eligible utilizing beneficiaries in 2019 Q4, stratified by population aid code group. Within each of these tables, the mean days’ supply per utilizing beneficiary is shown for both FFS and MCP enrollees.

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Tables 1.1-1.5. Summary of Global Medi-Cal Pharmacy Utilization.

Table 1.1 shows pharmacy utilization in the Medi-Cal program, including the percent change from the prior-year quarter. Beneficiaries with enrollments in both FFS and MCP during the quarter may be counted twice (represents 0.5% of utilizing beneficiaries). Tables 1.2-1.5 show pharmacy utilization in the Medi-Cal program, stratified by population aid code group.

Table 1: Global Medi-Cal Pharmacy Utilization Measures for the Entire Medi-Cal Population

Category Current Quarter 2019 Q4

Prior-Year Quarter 2018 Q4

% Change from Prior Year

Total Eligible Beneficiaries 15,372,324 15,802,041 -2.7%Total Utilizing Beneficiaries 4,968,889 5,191,689 -4.3%Total Paid Rx Claims 27,024,296 28,313,422 -4.6%Average Paid Rx Claims per Eligible Beneficiary 1.76 1.79 -1.9%Average Paid Rx Claims per Utilizing Beneficiary 5.44 5.45 -0.3%Fee-for-Service Enrollees

Total Eligible Beneficiaries 3,035,124 3,188,808 -4.8%Total Utilizing Beneficiaries 442,078 454,209 -2.7%Total Paid Rx Claims 1,593,876 1,631,380 -2.3%Average Paid Rx Claims per Eligible Beneficiary 0.53 0.51 2.7% Average Paid Rx Claims per Utilizing Beneficiary 3.61 3.59 0.4%

Managed Care Plan Enrollees Total Eligible Beneficiaries 12,507,537 12,811,411 -2.4%Total Utilizing Beneficiaries 4,235,044 4,344,686 -2.5%Total Paid Rx Claims 23,836,934 24,994,428 -4.6%Average Paid Rx Claims per Eligible Beneficiary 1.91 1.95 -2.3%Average Paid Rx Claims per Utilizing Beneficiary 5.63 5.75 -2.2%

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Table 1.2 shows pharmacy utilization within the Affordable Care Act (ACA) population, which consists of the following Adult Expansion aid codes: M1, M2, L1, and 7U. Continuous eligibility is plan-specific and is measured from October 1, 2019 – December 1, 2019.

Among the ACA population, 57% of FFS enrollees and 78% of MCP enrollees were continuously-eligible within the same plan during 2019 Q4.

Table 1.2: Global Medi-Cal Pharmacy Utilization Measures for the ACA Population

Category Current Quarter 2019 Q4

Prior-Year Quarter 2018 Q4

% Change from Prior Year

Total Eligible Beneficiaries 4,482,516 4,612,243 -2.9%Total Utilizing Beneficiaries 1,570,931 1,602,709 -2.0%Total Paid Rx Claims 9,952,605 10,422,495 -4.7%Average Paid Rx Claims per Eligible Beneficiary 2.22 2.26 -1.8%Average Paid Rx Claims per Utilizing Beneficiary 6.34 6.50 -2.6%Continuously-Eligible Total Eligible Beneficiaries 3,533,235 3,666,727 -3.6%Continuously-Eligible Total Utilizing Beneficiaries 889,324 938,707 -5.3%Continuously-Eligible Total Paid Rx Claims 6,055,188 6,408,852 -5.5%Fee-for-Service Enrollees

Total Eligible Beneficiaries 901,906 943,709 -4.6%Total Utilizing Beneficiaries 117,197 117,205 0.0% Total Paid Rx Claims 465,250 463,787 0.3% Average Paid Rx Claims per Eligible Beneficiary 0.52 0.49 4.7% Average Paid Rx Claims per Utilizing Beneficiary 3.97 3.96 0.3% Continuously-Eligible Total Eligible Beneficiaries 517,861 553,478 -6.4%Continuously-Eligible Total Utilizing Beneficiaries 44,856 44,067 1.8% Continuously-Eligible Total Paid Rx Claims 123,291 120,313 2.5%

Managed Care Plan Enrollees Total Eligible Beneficiaries 3,712,737 3,806,238 -2.5%Total Utilizing Beneficiaries 1,467,593 1,500,275 -2.2%Total Paid Rx Claims 9,487,355 9,958,673 -5.0%Average Paid Rx Claims per Eligible Beneficiary 2.56 2.62 -2.4%Average Paid Rx Claims per Utilizing Beneficiary 6.46 6.64 -2.7%Continuously-Eligible Total Eligible Beneficiaries 2,880,667 2,968,126 -2.9%Continuously-Eligible Total Utilizing Beneficiaries 816,998 863,858 -5.4%Continuously-Eligible Total Paid Rx Claims 2,885,213 3,058359 -5.7%

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Table 1.3 shows pharmacy utilization within the Optional Targeted Low Income Children (OTLIC) population consists of the following OTLIC aid codes: 2P, 2R, 2S, 2T, 2U, 5C, 5D, E2, E5, E6, E7, H1, H2, H3, H4, H5, M5, T0, T1, T2, T3, T4, T5, T6, T7, T8, and T9. Continuous eligibility is plan-specific and is measured from October 1, 2019 – December 1, 2019.

Among the OTLIC population, 34% of FFS enrollees and 78% of MCP enrollees were continuously-eligible within the same plan during 2019 Q4.

Table 1.3: Global Medi-Cal Pharmacy Utilization Measures for the OTLIC Population

Category Current Quarter 2019 Q4

Prior-Year Quarter 2018 Q4

% Change from Prior Year

Total Eligible Beneficiaries 1,619,046 1,633,021 -0.9%Total Utilizing Beneficiaries 354,526 344,782 2.8% Total Paid Rx Claims 976,791 942,536 3.5% Average Paid Rx Claims per Eligible Beneficiary 0.60 0.58 4.3% Average Paid Rx Claims per Utilizing Beneficiary 2.76 2.73 0.8% Continuously-Eligible Total Eligible Beneficiaries 1,272,389 1,279,082 -0.5%Continuously-Eligible Total Utilizing Beneficiaries 154,768 152,658 1.4% Continuously-Eligible Total Paid Rx Claims 623,085 597,101 4.4% Fee-for-Service Enrollees

Total Eligible Beneficiaries 113,937 114,281 -0.3%Total Utilizing Beneficiaries 7,265 6,820 6.1% Total Paid Rx Claims 16,932 15,158 10.5% Average Paid Rx Claims per Eligible Beneficiary 0.15 0.13 10.8% Average Paid Rx Claims per Utilizing Beneficiary 2.33 2.22 4.6% Continuously-Eligible Total Eligible Beneficiaries 39,101 40,190 -2.7%Continuously-Eligible Total Utilizing Beneficiaries 2,246 2,055 9.3% Continuously-Eligible Total Paid Rx Claims 4,404 3,861 14.1%

Managed Care Plan Enrollees Total Eligible Beneficiaries 1,539,933 1,552,897 -0.8%Total Utilizing Beneficiaries 347,937 338,653 2.7% Total Paid Rx Claims 959,859 927,373 3.4% Average Paid Rx Claims per Eligible Beneficiary 0.62 0.60 4.2% Average Paid Rx Claims per Utilizing Beneficiary 2.76 2.74 0.7% Continuously-Eligible Total Eligible Beneficiaries 1,196,432 1,201,614 -0.4%Continuously-Eligible Total Utilizing Beneficiaries 149,515 147,552 1.3% Continuously-Eligible Total Paid Rx Claims 307,356 294,896 4.2%

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Table 1.4 shows pharmacy utilization within the Seniors and Persons with Disabilities (SPD) population, which consists of the following SPD aid codes: 10, 13, 14, 16, 17, 1E, 1H, 20, 23, 24, 26, 27, 2E, 2H, 36, 60, 63, 64, 66, 67, 6A, 6C, 6E, 6G, 6H, 6J, 6N, 6P, 6R, 6V, 6W, 6X, 6Y, C1, C2, C3, C4, C7, C8, D2, D3, D4, D5, D6, and D7. Continuous eligibility is plan-specific and is measured from October 1, 2019 – December 1, 2019.

Among the SPD population, 74% of FFS enrollees and 82% of MCP enrollees were continuously-eligible within the same plan during 2019 Q4.

Table 1.4: Global Medi-Cal Pharmacy Utilization Measures for the SPD Population

Category Current Quarter 2019 Q4

Prior-Year Quarter 2018 Q4

% Change from Prior Year

Total Eligible Beneficiaries 2,453,651 2,496,848 -1.7% Total Utilizing Beneficiaries 885,499 947,502 -6.5% Total Paid Rx Claims 7,330,540 7,973,618 -8.1% Average Paid Rx Claims per Eligible Beneficiary 2.99 3.19 -6.5% Average Paid Rx Claims per Utilizing Beneficiary 8.28 8.42 -1.6% Continuously-Eligible Total Eligible Beneficiaries 2,049,734 2,088,741 -1.9% Continuously-Eligible Total Utilizing Beneficiaries 567,777 620,261 -8.5% Continuously-Eligible Total Paid Rx Claims 4,587,116 4,974,335 -7.8% Fee-for-Service Enrollees

Total Eligible Beneficiaries 511,621 525,295 -2.6% Total Utilizing Beneficiaries 94,416 101,644 -7.1% Total Paid Rx Claims 444,341 482,336 -7.9% Average Paid Rx Claims per Eligible Beneficiary 0.87 0.92 -5.4% Average Paid Rx Claims per Utilizing Beneficiary 4.71 4.75 -0.8% Continuously-Eligible Total Eligible Beneficiaries 380,789 391,215 -2.7% Continuously-Eligible Total Utilizing Beneficiaries 49,898 53,068 -6.0% Continuously-Eligible Total Paid Rx Claims 135,510 142,518 -4.9%

Managed Care Plan Enrollees Total Eligible Beneficiaries 1,978,287 2,007,577 -1.5% Total Utilizing Beneficiaries 795,653 850,730 -6.5% Total Paid Rx Claims 6,886,199 7,491,037 -8.1% Average Paid Rx Claims per Eligible Beneficiary 3.48 3.73 -6.7% Average Paid Rx Claims per Utilizing Beneficiary 8.65 8.81 -1.7% Continuously-Eligible Total Eligible Beneficiaries 1,621,797 1,648,446 -1.6% Continuously-Eligible Total Utilizing Beneficiaries 509,373 556,971 -8.5% Continuously-Eligible Total Paid Rx Claims 2,156,229 2,339,205 -7.8%

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Table 1.5 shows pharmacy utilization within the Other Populations (OTHER) population, which consists of all aid codes not categorized under ACA, OTLIC, or SPD. Continuous eligibility is plan-specific and is measured from October 1, 2019 – December 1, 2019.

Among the OTHER population, 57% of FFS enrollees and 78% of MCP enrollees were continuously-eligible within the same plan during 2019 Q4.

Table 1.5: Global Medi-Cal Pharmacy Utilization Measures for the OTHER Population

Category Current Quarter 2019 Q4

Prior-Year Quarter 2018 Q4

% Change from Prior Year

Total Eligible Beneficiaries 6,812,422 7,087,512 -4.0%Total Utilizing Beneficiaries 1,866,202 1,905,452 -2.1%Total Paid Rx Claims 7,161,607 7,279,591 -1.7%Average Paid Rx Claims per Eligible Beneficiary 1.05 1.03 2.3% Average Paid Rx Claims per Utilizing Beneficiary 3.84 3.82 0.5% Continuously-Eligible Total Eligible Beneficiaries 5,332,400 5,577,308 -4.4%Continuously-Eligible Total Utilizing Beneficiaries 886,299 913,342 -3.0%Continuously-Eligible Total Paid Rx Claims 4,446,500 4,480,815 -0.8%Fee-for-Service Enrollees

Total Eligible Beneficiaries 1,541,107 1,642,802 -6.6%Total Utilizing Beneficiaries 224,640 230,014 -2.4%Total Paid Rx Claims 660,635 662,976 -0.4%Average Paid Rx Claims per Eligible Beneficiary 0.43 0.40 5.9% Average Paid Rx Claims per Utilizing Beneficiary 2.94 2.88 2.0% Continuously-Eligible Total Eligible Beneficiaries 882,300 962,718 -8.4%Continuously-Eligible Total Utilizing Beneficiaries 81,618 82,065 -0.5%Continuously-Eligible Total Paid Rx Claims 177,539 173,758 2.2%

Managed Care Plan Enrollees Total Eligible Beneficiaries 5,451,088 5,635,320 -3.4%Total Utilizing Beneficiaries 1,650,898 1,685,394 -2.1%Total Paid Rx Claims 6,500,972 6,616,518 -1.8%Average Paid Rx Claims per Eligible Beneficiary 1.19 1.17 1.6% Average Paid Rx Claims per Utilizing Beneficiary 3.94 3.93 0.3% Continuously-Eligible Total Eligible Beneficiaries 4,265,571 4,416,613 -3.4%Continuously-Eligible Total Utilizing Beneficiaries 778,359 802,880 -3.1%Continuously-Eligible Total Paid Rx Claims 2,035,938 2,053,528 -0.9%

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Table 2.1 – 2.3. Pharmacy Utilization by Age Group in the Medi-Cal Population.

These tables present pharmacy utilization data in the Medi-Cal program broken out by age group, including the percent change from the prior-year quarter. Beneficiaries with enrollments in both FFS and MCP during the quarter may be counted in both Table 2.2 and Table 2.3, as enrollment status may change.

Table 2.1: Pharmacy Utilization by Age Group for the Entire Medi-Cal Population

Age Group (years)

Current Quarter

2019 Q4 Total Paid Claims

Prior-Year Quarter

2018 Q4 Total Paid Claims

% Change from

Prior Year

Current Quarter 2019 Q4

Total Utilizing Beneficiaries

Prior-Year Quarter 2018 Q4

Total Utilizing Beneficiaries

% Change from

Prior Year

0 – 12 3,499,907 3,740,250 -6.4% 1,181,987 1,261,799 -6.3%13 – 18 1,484,582 1,509,209 -1.6% 454,481 466,280 -2.5%19 – 39 5,694,641 5,906,638 -3.6% 1,285,221 1,330,182 -3.4%40 – 64 13,966,931 14,716,231 -5.1% 1,615,190 1,679,481 -3.8%65+ 2,378,235 2,441,091 -2.6% 432,010 453,944 -4.8%Total* 27,024,296 28,313,419 -4.6% 4,968,889 5,191,686 -4.3%* Unknowns represent less than 1% of total

Table 2.2: Pharmacy Utilization by Age Group for the Medi-Cal FFS Population Only

Age Group (years)

Current Quarter

2019 Q4 Total Paid Claims

Prior-Year Quarter

2018 Q4 Total Paid Claims

% Change from

Prior Year

Current Quarter 2019 Q4

Total Utilizing Beneficiaries

Prior-Year Quarter 2018 Q4

Total Utilizing Beneficiaries

% Change from

Prior Year

0 – 12 171,168 180,511 -5.2% 64,906 68,055 -4.6%13 – 18 92,581 93,870 -1.4% 24,370 24,478 -0.4%19 – 39 452,692 463,866 -2.4% 144,118 149,808 -3.8%40 – 64 691,684 699,118 -1.1% 148,806 148,812 0.0% 65+ 185,751 194,014 -4.3% 59,878 63,055 -5.0%Total* 1,593,876 1,631,380 -2.3% 442,078 454,209 -2.7%* Unknowns represent less than 1% of total

Table 2.3: Pharmacy Utilization by Age Group for the Medi-Cal MCP Population Only

Age Group (years)

Current Quarter

2019 Q4 Total Paid Claims

Prior-Year Quarter

2018 Q4 Total Paid Claims

% Change from

Prior Year

Current Quarter 2019 Q4

Total Utilizing Beneficiaries

Prior-Year Quarter 2018 Q4

Total Utilizing Beneficiaries

% Change from

Prior Year

0 – 12 2,624,571 2,635,895 -0.4% 916,330 926,320 -1.1%13 – 18 1,248,927 1,226,620 1.8% 391,178 385,349 1.5% 19 – 39 5,045,996 5,237,003 -3.7% 1,115,439 1,143,287 -2.4%40 – 64 12,789,257 13,645,311 -6.3% 1,452,814 1,505,926 -3.5%65+ 2,128,183 2,249,599 -5.4% 359,283 383,804 -6.4%Total* 23,836,934 24,994,428 -4.6% 4,235,044 4,344,686 -2.5%* Unknowns represent less than 1% of total

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Table 3. Top 20 Drug Therapeutic Categories in the Medi-Cal Population.

This table presents the top 20 drug therapeutic categories in the Medi-Cal program, by total utilizing beneficiaries. The current quarter is compared to the prior-year quarter in order to illustrate changes in utilization for these drugs. The prior-year quarter ranking of the drug therapeutic category is listed for reference.

Table 3: Top 20 Drug Therapeutic Categories by Total Utilizing Beneficiaries for the Entire Medi-Cal Population

Rank

Last Year Rank Drug Therapeutic Category Description

Current Quarter

2019 Q4 Total Paid Claims

% Change from Prior

Year

Current Quarter

2019 Q4 Total Utilizing

Beneficiaries

% Utilizing Beneficiaries with a Paid

Claim

% Change from Prior

Year

1 1 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 1,459,200 -5.6% 1,140,140 23.0% -0.3%

2 2 PENICILLIN ANTIBIOTICS 806,622 -6.2% 742,973 15.0% -0.3%3 3 BETA-ADRENERGIC AGENTS, INHALED,

SHORT ACTING 790,797 -6.9% 527,063 10.6% -0.3%4 4 ANTIHISTAMINES - 2ND GENERATION 742,786 -4.0% 496,750 10.0% 0.2% 5 5 ANTIHYPERLIPIDEMIC-HMGCOA

REDUCTASE INHIB(STATINS) 919,232 -2.1% 490,461 9.9% 0.5% 6 6 ANTICONVULSANTS 921,160 -1.5% 416,276 8.4% 0.3% 7 8 PLATELET AGGREGATION INHIBITORS 692,603 -6.8% 370,561 7.5% -0.1%8 16 VITAMIN D PREPARATIONS 605,516 7.3% 334,881 6.7% 0.8% 9 10 ANTIHYPERTENSIVES, ACE INHIBITORS 627,090 -7.7% 329,576 6.6% 0.0%

10 12 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 671,532 -1.2% 322,330 6.5% 0.2%

11 7 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 513,849 -20.4% 316,930 6.4% -1.4%

12 11 TOPICAL ANTI-INFLAMMATORY STEROIDAL 395,467 -3.8% 316,519 6.4% 0.1%

13 13 PROTON-PUMP INHIBITORS 565,436 -4.7% 315,678 6.4% 0.1% 14 9 MACROLIDE ANTIBIOTICS 335,378 -10.8% 311,329 6.3% -0.5%15 14 LAXATIVES AND CATHARTICS 442,511 -6.0% 299,713 6.0% -0.1%16 17 ANTIHYPERGLYCEMIC, BIGUANIDE TYPE 558,106 -5.2% 297,430 6.0% 0.1% 17 15 ANALGESIC/ANTIPYRETICS,NON-

SALICYLATE 342,476 -5.2% 296,145 6.0% 0.0% 18 20 GLUCOCORTICOIDS 341,494 -1.6% 279,066 5.6% 0.1% 19 18 NASAL ANTI-INFLAMMATORY STEROIDS 371,869 -3.2% 277,916 5.6% 0.1% 20 19 ANTIHISTAMINES - 1ST GENERATION 381,524 -6.3% 268,828 5.4% -0.1%

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Tables 4.1 – 4.4. Top 20 Drug Therapeutic Categories in the Continuosly-Eligible Medi-Cal Population by Population Aid Code Group, Stratified by Program.

These tables present the top 20 drug therapeutic categories in the Medi-Cal program by total continuously-eligible utilizing beneficiaries from each population aid code group, stratified by Medi-Cal program. Mean days’ supply per utilizing beneficiary is included for reference. Continuous eligibility is plan-specific and is measured from October 1, 2019 – December 1, 2019.

Table 4.1 presents the top 20 drug therapeutic categories in the Affordable Care Act (ACA) population, which consists of the following Adult Expansion aid codes: M1, M2, L1, and 7U.

Table 4.1: Top 20 Drug Therapeutic Categories by Total Continuously-Eligible ACA Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Therapeutic Category Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries FFS MCP All Medi-Cal % FFS % MCP

1 ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) 59 53 142,600 11.9% 16.4%

2 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 17 30 138,486 16.4% 15.5%

3 ANTICONVULSANTS 39 42 98,664 10.3% 11.1% 4 ANTIHYPERTENSIVES, ACE INHIBITORS 58 54 94,417 10.5% 10.7%

5 ANTIHYPERGLYCEMIC, BIGUANIDE TYPE 58 54 85,970 9.8% 9.7%

6 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 41 42 82,938 6.7% 9.4%

7 PROTON-PUMP INHIBITORS 42 48 77,622 6.9% 8.9% 8 CALCIUM CHANNEL BLOCKING AGENTS 54 51 67,826 6.3% 7.7% 9 VITAMIN D PREPARATIONS 53 47 61,684 1.3% 7.4% 10 PLATELET AGGREGATION INHIBITORS 59 53 60,726 3.6% 7.1% 11 BETA-ADRENERGIC BLOCKING AGENTS 52 49 58,551 4.7% 6.7% 12 ANTIHISTAMINES - 2ND GENERATION 42 39 56,712 3.2% 6.6%

13 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 26 29 56,658 5.2% 6.4%

14 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 8 24 54,420 5.2% 6.2%

15 INSULINS 41 41 53,849 6.6% 6.1% 16 BLOOD SUGAR DIAGNOSTICS 31 48 50,176 0.0% 6.0%

17 ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST 59 53 47,660 3.6% 5.5%

18 THYROID HORMONES 58 51 47,003 4.1% 5.4% 19 PENICILLIN ANTIBIOTICS 9 18 46,980 6.6% 5.2% 20 THIAZIDE AND RELATED DIURETICS 58 56 43,685 4.0% 5.0%

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Table 4.2 presents the top 20 drug therapeutic categories in the Optional Targeted Low Income Children (OTLIC) population, which consists of the following OTLIC aid codes: 2P, 2R, 2S, 2T, 2U, 5C, 5D, E2, E5, E6, E7, H1, H2, H3, H4, H5, M5, T0, T1, T2, T3, T4, T5, T6, T7, T8, and T9.

Table 4.2: Top 20 Drug Therapeutic Categories by Total Continuously-Eligible OTLIC Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Therapeutic Category Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries FFS MCP All Medi-Cal % FFS % MCP

1 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 9 25 28,176 16.3% 18.2%

2 PENICILLIN ANTIBIOTICS 10 17 24,926 19.8% 16.0%

3 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 24 33 19,871 14.1% 12.8%

4 ANTIHISTAMINES - 2ND GENERATION 31 37 19,646 7.6% 12.8%

5 ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 7 24 10,613 7.7% 6.8%

6 NASAL ANTI-INFLAMMATORY STEROIDS 36 44 9,897 5.3% 6.5% 7 MACROLIDE ANTIBIOTICS 6 26 9,157 6.3% 5.9%

8 TOPICAL ANTI-INFLAMMATORY STEROIDAL 19 29 8,143 4.2% 5.3%

9 ANTIVIRALS, GENERAL 6 20 8,083 6.5% 5.2% 10 GLUCOCORTICOIDS, ORALLY INHALED 35 44 8,048 4.3% 5.2% 11 ANTIEMETIC/ANTIVERTIGO AGENTS 5 14 7,683 4.9% 5.0% 12 GLUCOCORTICOIDS 9 27 7,262 6.1% 4.7%

13 LEUKOTRIENE RECEPTOR ANTAGONISTS 37 40 6,487 3.8% 4.2%

14 TOPICAL ANTIBIOTICS 25 29 6,480 1.4% 4.2%

15 NON-OPIOID ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB. 11 44 5,937 4.1% 3.8%

16 ANTIHISTAMINES - 1ST GENERATION 20 29 5,896 3.5% 3.8%

17 NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST 5 24 5,285 0.0% 3.4%

18 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 37 43 5,173 4.5% 3.3%

19 CEPHALOSPORIN ANTIBIOTICS - 1ST GENERATION 9 22 4,855 3.7% 3.1%

20 CONTRACEPTIVES,ORAL 60 61 4,477 1.6% 2.9%

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Table 4.3 presents the top 20 drug therapeutic categories in the Seniors and Persons with Disabilities (SPD) population, which consists of the following SPD aid codes: 10, 13, 14, 16, 17, 1E, 1H, 20, 23, 24, 26, 27, 2E, 2H, 36, 60, 63, 64, 66, 67, 6A, 6C, 6E, 6G, 6H, 6J, 6N, 6P, 6R, 6V, 6W, 6X, 6Y, C1, C2, C3, C4, C7, C8, D2, D3, D4, D5, D6, and D7.

Table 4.3: Top 20 Drug Therapeutic Categories by Total Continuously-Eligible SPD Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Therapeutic Category Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries FFS MCP All Medi-Cal % FFS % MCP

1 PLATELET AGGREGATION INHIBITORS 60 48 108,323 21.0% 19.0% 2 ANTICONVULSANTS 38 46 102,410 15.2% 18.3% 3 VITAMIN D PREPARATIONS 44 42 84,683 4.1% 16.1%

4 ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) 47 52 82,190 5.5% 15.3%

5 LAXATIVES AND CATHARTICS 40 35 64,505 14.9% 11.1%

6 ANTIPSYCHOTIC,ATYPICAL,DOPAMINE, SEROTONIN ANTAGNST 38 39 61,797 6.3% 11.3%

7 ANTIHISTAMINES - 2ND GENERATION 44 40 57,229 14.0% 9.8%

8 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 24 35 50,993 2.5% 9.6%

9 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 39 45 48,879 3.7% 9.1%

10 PROTON-PUMP INHIBITORS 40 48 48,214 4.1% 8.9% 11 CALCIUM CHANNEL BLOCKING AGENTS 47 52 46,479 3.4% 8.6% 12 ANTIHYPERTENSIVES, ACE INHIBITORS 49 54 45,759 3.4% 8.5% 13 CALCIUM REPLACEMENT 58 41 41,364 6.3% 7.5% 14 BETA-ADRENERGIC BLOCKING AGENTS 43 49 39,919 3.1% 7.4%

15 ANTIHYPERGLYCEMIC, BIGUANIDE TYPE 49 53 39,251 2.6% 7.3%

16 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 27 36 37,443 3.3% 6.9%

17 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 17 33 34,819 1.9% 6.6%

18 BLOOD SUGAR DIAGNOSTICS 25 46 32,505 0.0% 6.3% 19 INSULINS 36 43 29,960 3.0% 5.5% 20 ANTIHISTAMINES - 1ST GENERATION 30 37 29,837 4.6% 5.3%

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Table 4.4 presents the top 20 drug therapeutic categories in the Other Populations (OTHER) population, which consists of all aid codes not categorized under ACA, OTLIC, or SPD.

Table 4.4: Top 20 Drug Therapeutic Categories by Total Continuously-Eligible OTHER Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Therapeutic Category Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries FFS MCP All Medi-Cal % FFS % MCP

1 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 13 31 177,923 18.0% 20.4%

2 PENICILLIN ANTIBIOTICS 9 21 114,299 9.8% 13.2%

3 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 21 37 85,274 6.8% 9.9%

4 ANTIHISTAMINES - 2ND GENERATION 35 41 75,959 4.3% 9.1%

5 ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 9 30 59,280 3.8% 6.8%

6 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 35 49 46,167 4.8% 5.3%

7 ANTICONVULSANTS 34 49 45,530 5.0% 5.2% 8 MACROLIDE ANTIBIOTICS 6 31 42,563 3.9% 4.9%

9 TOPICAL ANTI-INFLAMMATORY STEROIDAL 20 32 41,446 3.3% 4.8%

10 ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) 59 57 41,386 4.3% 4.8%

11 ANTIEMETIC/ANTIVERTIGO AGENTS 7 20 41,266 4.2% 4.7% 12 GLUCOCORTICOIDS 10 36 40,790 3.6% 4.7% 13 NASAL ANTI-INFLAMMATORY STEROIDS 36 45 38,270 2.5% 4.6% 14 ANTIHISTAMINES - 1ST GENERATION 19 35 36,265 3.0% 4.2% 15 PROTON-PUMP INHIBITORS 39 51 35,816 3.4% 4.2%

16 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 5 29 35,674 3.9% 4.1%

17 ANTIVIRALS, GENERAL 9 29 35,053 3.4% 4.0% 18 CONTRACEPTIVES,ORAL 59 70 33,559 4.3% 3.8%

19 ANTIHYPERGLYCEMIC, BIGUANIDE TYPE 52 58 33,557 5.1% 3.7%

20 VITAMIN D PREPARATIONS 51 50 32,966 0.9% 4.0%

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Table 5. Top 20 Drugs in the Medi-Cal Population. This table presents the top 20 drugs in the Medi-Cal program, by total utilizing beneficiaries. The current quarter is compared to the prior-year quarter in order to illustrate changes in utilization for these drugs. The prior-year quarter ranking of each drug is listed for reference.

Table 5: Top 20 Drugs by Total Utilizing Beneficiaries for the Entire Medi-Cal Population

Rank

Last Year Rank Drug Description

Current Quarter 2019 Q4 Total Paid Claims

% Change from Prior Year

Current Quarter 2019 Q4 Total

Utilizing Beneficiaries

% Utilizing Beneficiaries with a Paid

Claim

% Change from Prior

Year 1 1 IBUPROFEN 1,113,196 -5.1% 904,900 18.2% -0.2%2 2 AMOXICILLIN 610,011 -6.1% 559,192 11.3% -0.2%3 3 ALBUTEROL SULFATE 803,584 -7.3% 540,566 10.9% -0.4%4 4 LORATADINE 523,194 -7.2% 349,363 7.0% -0.1%5 5 ASPIRIN 637,260 -7.8% 344,244 6.9% -0.2%

FLUTICASONE PROPIONATE 6 7 452,052 4.4% 329,890 6.6% 0.5%

7 10 ATORVASTATIN CALCIUM 608,085 7.0% 327,056 6.6% 0.8%

8 9 METFORMIN HCL 558,106 -5.2% 297,430 6.0% 0.1% 9 6 AZITHROMYCIN 318,267 -10.9% 296,926 6.0% -0.5%

10 8 ACETAMINOPHEN 342,489 296,155 6.0% -5.2% 0.0% 11 12 LISINOPRIL 482,335 -5.4% 252,508 5.1% 0.1%

12 11 HYDROCODONE/ ACETAMINOPHEN 376,890 -20.4% 223,751 4.5% -0.9%

13 16 AMLODIPINE BESYLATE 407,286 -1.8% 213,089 4.3% 0.2%

14 14 OMEPRAZOLE 380,217 -6.2% 212,564 4.3% 0.0%

15 13 PROMETHAZINE/ DEXTROMETHORPHAN 235,776 -10.8% 211,834 4.3% -0.3%

16 17 GABAPENTIN 425,922 -0.7% 208,466 4.2% 0.2%

17 19 CHOLECALCIFEROL (VITAMIN D3) 353,068 9.8% 201,890 4.1% 0.6%

18 15 BLOOD SUGAR DIAGNOSTIC 353,949 -5.1% 201,377 4.1% 0.0%

19 18 CEPHALEXIN 205,651 -5.0% 191,180 3.9% 0.0%

20 21 LEVOTHYROXINE SODIUM 345,604 -4.2% 167,664 3.4% 0.1%

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Tables 6.1 – 6.4. Top 20 Drugs in the Medi-Cal Population, by Population Aid Code Group and Program.

These tables present utilization of the top 20 drugs in the Medi-Cal program by total continuously-eligible utilizing beneficiaries from each population aid code group, stratified by Medi-Cal program. Mean days’ supply per utilizing beneficiary is included for reference. Continuous eligibility is plan-specific and is measured from October 1, 2019 – December 1, 2019.

Table 6.1 presents the top 20 drugs in the Affordable Care Act (ACA) population, which consists of the following Adult Expansion aid codes: M1, M2, L1, and 7U.

Table 6.1: Top 20 Drugs by Total Continuously-Eligible ACA Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries FFS MCP All Medi-Cal % FFS % MCP

1 ATORVASTATIN CALCIUM 58 56 100,548 8.8% 11.5% 2 IBUPROFEN 14 28 89,650 12.3% 9.9% 3 METFORMIN HCL 58 58 85,971 9.8% 9.7% 4 LISINOPRIL 57 59 75,109 8.5% 8.5% 5 AMLODIPINE BESYLATE 54 54 59,682 5.4% 6.8% 6 GABAPENTIN 38 46 57,004 5.3% 6.5% 7 ALBUTEROL SULFATE 26 33 56,662 5.2% 6.4% 8 OMEPRAZOLE 42 49 53,779 3.2% 6.3% 9 ASPIRIN 62 56 52,606 2.7% 6.2% 10 BLOOD SUGAR DIAGNOSTIC 53 52 50,175 0.0% 6.0% 11 LEVOTHYROXINE SODIUM 58 57 45,112 4.0% 5.2% 12 LOSARTAN POTASSIUM 59 57 43,852 3.3% 5.1% 13 FLUTICASONE PROPIONATE 38 42 41,424 2.7% 4.8% 14 HYDROCODONE/ACETAMINOPHEN 7 28 40,296 3.8% 4.6% 15 HYDROCHLOROTHIAZIDE 58 60 38,279 3.5% 4.4% 16 LORATADINE 43 44 38,030 2.3% 4.4% 17 CHOLECALCIFEROL (VITAMIN D3) 39 48 35,707 0.0% 4.3% 18 AMOXICILLIN 9 22 30,100 4.3% 3.3% 19 INSULIN GLARGINE,HUM.REC.ANLOG 42 47 29,467 3.5% 3.3% 20 LANCETS 65 60 28,205 0.0% 3.4%

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Table 6.2 presents the top 20 drugs in the Optional Targeted Low Income Children (OTLIC) population, which consists of the following OTLIC aid codes: 2P, 2R, 2S, 2T, 2U, 5C, 5D, E2, E5, E6, E7, H1, H2, H3, H4, H5, M5, T0, T1, T2, T3, T4, T5, T6, T7, T8, and T9.

Table 6.2: Top 20 Drugs by Total Continuously-Eligible OTLIC Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries FFS MCP All Medi-Cal % FFS % MCP

1 IBUPROFEN 8 25 26,942 15.7% 17.4% 2 AMOXICILLIN 10 18 20,382 15.9% 13.1% 3 ALBUTEROL SULFATE 23 33 20,369 14.3% 13.1% 4 FLUTICASONE PROPIONATE 35 43 13,621 7.7% 8.9% 5 LORATADINE 30 38 12,179 6.1% 7.9% 6 ACETAMINOPHEN 7 24 10,619 7.7% 6.8% 7 AZITHROMYCIN 5 26 9,008 6.0% 5.8% 8 OSELTAMIVIR PHOSPHATE 5 21 7,615 6.2% 4.9% 9 CETIRIZINE HCL 37 36 7,235 1.5% 4.8% 10 MONTELUKAST SODIUM 37 40 6,484 3.8% 4.2% 11 PROMETHAZINE/DEXTROMETHORPHAN 11 44 5,932 4.1% 3.8% 12 ONDANSETRON 4 14 5,628 3.3% 3.6% 13 CEPHALEXIN 9 22 4,842 3.7% 3.1%

14 BROMPHENIRAMINE/ PSEUDOEPHED/DM 5 22 4,134 0.0% 2.7%

15 AMOXICILLIN/POTASSIUM CLAV 10 11 3,817 3.7% 2.4% 16 TRIAMCINOLONE ACETONIDE 17 30 3,726 1.8% 2.4% 17 BENZOYL PEROXIDE 31 37 3,366 0.6% 2.2% 18 CLINDAMYCIN PHOSPHATE 34 35 3,350 0.6% 2.2% 19 HYDROCORTISONE 21 27 3,256 2.0% 2.1% 20 DIPHENHYDRAMINE HCL 18 27 3,152 1.8% 2.0%

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Table 6.3 presents the top 20 drugs in the Seniors and Persons with Disabilities (SPD) population, which consists of the following SPD aid codes: 10, 13, 14, 16, 17, 1E, 1H, 20, 23, 24, 26, 27, 2E, 2H, 36, 60, 63, 64, 66, 67, 6A, 6C, 6E, 6G, 6H, 6J, 6N, 6P, 6R, 6V, 6W, 6X, 6Y, C1, C2, C3, C4, C7, C8, D2, D3, D4, D5, D6, and D7.

Table 6.3: Top 20 Drugs by Total Continuously-Eligible SPD Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries FFS MCP All Medi-Cal % FFS % MCP

1 ASPIRIN 60 48 101,884 20.9% 17.8% 2 ATORVASTATIN CALCIUM 46 52 55,431 3.8% 10.3% 3 CHOLECALCIFEROL (VITAMIN D3) 38 42 48,768 0.5% 9.5% 4 LORATADINE 45 42 42,785 12.2% 7.1% 5 DOCUSATE SODIUM 41 38 41,050 13.3% 6.7% 6 GABAPENTIN 37 45 39,954 3.1% 7.4% 7 AMLODIPINE BESYLATE 47 52 39,510 2.9% 7.3% 8 METFORMIN HCL 49 53 39,251 2.6% 7.3% 9 ALBUTEROL SULFATE 26 37 36,880 3.0% 6.8% 10 ERGOCALCIFEROL (VITAMIN D2) 45 41 34,747 3.5% 6.4% 11 LISINOPRIL 48 56 33,772 2.4% 6.3% 12 BLOOD SUGAR DIAGNOSTIC 25 46 32,500 0.0% 6.3% 13 OMEPRAZOLE 32 46 30,730 1.4% 5.9% 14 IBUPROFEN 18 31 29,144 1.7% 5.5% 15 HYDROCODONE/ACETAMINOPHEN 17 34 26,535 1.4% 5.0% 16 FERROUS SULFATE 47 45 26,021 7.5% 4.3% 17 LEVOTHYROXINE SODIUM 43 52 25,741 3.0% 4.7% 18 LOSARTAN POTASSIUM 53 55 25,508 1.3% 4.8% 19 FOLIC ACID 45 43 25,108 8.1% 4.1% 20 TRAZODONE HCL 37 43 20,698 1.5% 3.9%

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Table 6.4 presents the top 20 drugs in the Other Populations (OTHER) population, which consists of all aid codes not categorized under ACA, OTLIC, or SPD.

Table 6.4: Top 20 Drug by Total Continuously-Eligible OTHER Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Description

Current Quarter 2019 Q4 Mean Days’ Supply per

Utilizing Beneficiary Total Continuously-Eligible

Utilizing Beneficiaries

FFS MCP All Medi-Cal %

FFS % MCP 1 IBUPROFEN 11 30 153,283 15.8% 17.5% 2 AMOXICILLIN 9 23 91,037 7.3% 10.6% 3 ALBUTEROL SULFATE 21 37 88,132 7.0% 10.3% 4 ACETAMINOPHEN 9 30 59,341 3.8% 6.8% 5 FLUTICASONE PROPIONATE 36 45 50,234 3.5% 6.0% 6 LORATADINE 34 42 49,266 3.4% 5.9% 7 AZITHROMYCIN 5 32 40,945 3.6% 4.7% 8 METFORMIN HCL 52 58 33,557 5.1% 3.7% 9 ATORVASTATIN CALCIUM 58 57 29,478 3.1% 3.4% 10 OSELTAMIVIR PHOSPHATE 5 29 27,545 2.5% 3.2% 11 CEPHALEXIN 9 27 27,103 3.7% 3.0% 12 FERROUS SULFATE 56 54 26,961 4.9% 2.8% 13 LISINOPRIL 56 60 26,293 3.4% 3.0% 14 HYDROCODONE/ACETAMINOPHEN 5 31 26,055 2.8% 3.0% 15 ONDANSETRON 5 18 25,599 2.1% 3.0% 16 CETIRIZINE HCL 37 39 25,543 0.9% 3.1% 17 OMEPRAZOLE 37 49 25,471 1.9% 3.0% 18 PROMETHAZINE/DEXTROMETHORPHAN 10 50 23,793 1.9% 2.8% 19 LEVOTHYROXINE SODIUM 54 58 23,205 2.5% 2.7% 20 MONTELUKAST SODIUM 37 41 22,559 1.7% 2.7%

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ANNUAL SUMMARY GLOBAL MEDI-CAL DRUG USE REVIEW

CALENDAR YEAR 2019 (JANUARY – DECEMBER 2019) Executive Summary

The Global DUR annual report provides information on retrospective drug utilization for all pharmacy claims processed by Medi-Cal. For this report, the retrospective data cover the calendar year of 2019.

Table 1 provides a summary of pharmacy utilization during calendar year 2019 for the entire Medi-Cal program, as well as stratified by beneficiaries enrolled in Medi-Cal fee-for-service (FFS) and Medi-Cal managed care plans (MCPs). In 2019, only 18.7% of eligible Medi-Cal FFS enrollees had a paid pharmacy claim, compared with 44.8% of Medi-Cal MCP enrollees. Of note, beneficiaries may have enrollments in both Medi-Cal fee-for-service FFS and MCP during the year and therefore may be counted twice in the stratified data given in Table 1. Among all Medi-Cal beneficiaries with a paid pharmacy claim through the Medi-Cal program in 2019, only 11.7% were FFS enrollees and 90.5% were MCP enrollees (numbers add up to more than 100% due to 2.2% of beneficiaries being enrolled in both programs during 2019).

In 2019, FFS enrollees were approximately 25.5% of eligible Medi-Cal beneficiaries, 11.7% of utilizing beneficiaries, and 6.2% of total paid pharmacy claims. For 2019, the MCP enrollees have a higher average number of paid pharmacy claims per eligible beneficiary than the FFS enrollees (4.58 vs. 0.97) and a higher average number of paid pharmacy claims per utilizing beneficiary (5.20 vs. 10.20), which may help explain the higher percentage of paid pharmacy claims by MCP enrollees.

As shown in Table 2, total utilizing beneficiaries decreased among all age groups from the prior year (2018), with a 2.0% decrease in overall utilizing beneficiaries and a 1.8% decrease in total paid claims.

In this report, two tables highlight utilization among the top 20 drug therapeutic drug categories (Table 3) and top 20 drugs (Table 5) among all Medi-Cal beneficiaries, in comparison to the prior year. Two additional tables show the top 20 drug therapeutic drug categories (Table 4) and top 20 drugs (Table 6) along with the corresponding overall percentages within the FFS and MCP enrollee populations.

Table 4 suggests a greater percentage of utilizing beneficiaries in the MCP population had paid claims for all of the top 20 drug therapeutic categories than in the FFS population except for CEPHALOSPORINS ANTIBIOTICS – 1ST GENERATION, which was equal between the two programs (both utilized by 6.5% of the utilizing beneficiaries).

Similarly, Table 6 suggests a greater percentage of utilizing beneficiaries in the MCP population had paid claims for 15 out of the top 20 drugs. Drugs with a greater percentage of utilizing beneficiaries in the FFS population included: HYDROCODONE/ACETAMINOPHEN (5.8% vs. 5.7%), METFORMIN HCL (4.7% vs. 4.2%), and FERROUS SULFATE (6.0% vs. 3.5%). Two drugs were equal between the two programs: ASPIRIN (both at 4.9%) and CEPHALEXIN (both at 6.5%).

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Table 1. Summary of Global Medi-Cal Pharmacy Utilization.This table shows pharmacy utilization in the Medi-Cal program, including the percent change from the prior year. Beneficiaries with enrollments in both FFS and MCP during the year may be counted twice (represents 2.2% of utilizing beneficiaries).

Table 1: Pharmacy Utilization Measures for the Entire Medi-Cal Population

Category Current Year 2019

Prior Year 2018

% Change from Prior Year

Total Eligible Beneficiaries 26,527,829 27,175,467 -2.4%Total Utilizing Beneficiaries 10,818,817 11,043,577 -2.0%Total Paid Rx Claims 106,538,995 108,439,368 -1.8%Average Paid Rx Claims per Eligible Beneficiary 4.02 3.99 0.7% Average Paid Rx Claims per Utilizing Beneficiary 9.65 9.82 0.3% Fee-for-Service Enrollees

Total Eligible Beneficiaries 6,775,800 7,011,567 -3.4%Total Utilizing Beneficiaries 1,267,903 1,328,232 -4.5%Total Paid Rx Claims 6,597,565 6,849,844 -3.7%Average Paid Rx Claims per Eligible Beneficiary 0.97 0.98 -0.3%Average Paid Rx Claims per Utilizing Beneficiary 5.20 5.16 0.9%

Managed Care Plan Enrollees Total Eligible Beneficiaries 21,831,125 22,358,680 -2.4%Total Utilizing Beneficiaries 9,791,034 9,959,736 -1.7%Total Paid Rx Claims 99,900,955 101,504,871 -1.6%Average Paid Rx Claims per Eligible Beneficiary 4.58 4.54 0.8% Average Paid Rx Claims per Utilizing Beneficiary 10.20 10.19 0.1%

Table 2. Pharmacy Utilization by Age Group in the Medi-Cal Population. This table presents pharmacy utilization data in the Medi-Cal program, broken out by age group, including the percent change from the prior year.

Table 2: Pharmacy Utilization by Age Group for the Entire Medi-Cal Population Age

Group (years)

Current Year 2019 Total

Paid Claims

Prior Year 2018 Total

Paid Claims

% Change from

Prior Year

Current Year 2019 Total Utilizing Beneficiaries

Prior Year 2018 Total Utilizing Beneficiaries

% Change from

Prior Year 0 – 12 11,555,036 12,017,485 -3.9% 2,647,210 2,764,607 -4.3%13 – 18 5,560,622 5,457,369 1.9% 1,079,891 1,081,958 -0.2%19 – 39 22,928,084 23,053,548 -0.5% 2,984,594 3,028,723 -1.5%40 – 64 56,764,689 58,192,291 -2.5% 3,220,317 3,274,296 -1.7%65+ 9,730,563 9,718,655 0.1% 886,804 893,983 -0.8%Total* 106,538,995 108,439,368 -1.8% 10,818,817 11,043,577 -2.0%* Unknowns represent less than 1% of total

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Table 3. Top 20 Drug Therapeutic Categories in the Medi-Cal Population. This table presents utilization of the top 20 drug therapeutic categories in the Medi-Cal program, by total utilizing beneficiaries. The current year is compared to the prior year in order to illustrate changes in utilization for these drugs. The prior year ranking of the drug therapeutic category is listed for reference.

Table 3: Top 20 Drug Therapeutic Categories by Total Utilizing Beneficiaries for the Entire Medi-Cal Population

Rank

Last Year Rank Drug Therapeutic Category Description

Current Year 2019 Total

Paid Claims

% Change from Prior

Year

Current Year 2019 Total Utilizing

Beneficiaries

% Utilizing Beneficiaries with a Paid

Claim

% Change Total Utilizing Beneficiaries

Prior Year

1 1 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 5,335,993 -3.3% 2,970,661 27.5% -0.2%

2 2 PENICILLIN ANTIBIOTICS 2,552,221 -4.5% 2,013,353 18.6% -0.4%

3 3 ANTIHISTAMINES - 2ND GENERATION 3,025,837 2.1% 1,206,837 11.2% 0.6%

4 4 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 2,826,506 -1.9% 1,121,169 10.4% -0.1%

5 6 TOPICAL ANTI-INFLAMMATORY STEROIDAL 1,688,647 -1.1% 1,044,619 9.7% 0.2%

6 5 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 2,103,393 -17.2% 911,433 8.4% -1.6%

7 7 LAXATIVES AND CATHARTICS 1,838,354 -2.4% 859,285 7.9% 0.1%

8 9 ANTIEMETIC/ANTIVERTIGO AGENTS 1,153,536 2.1% 802,870 7.4% 0.3%

9 8 MACROLIDE ANTIBIOTICS 983,491 -6.2% 790,915 7.3% -0.3%10 13 GLUCOCORTICOIDS 1,169,822 1.7% 766,519 7.1% 0.3%

11 12 ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) 3,764,994 -0.7% 765,212 7.1% 0.2%

12 11 ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 1,139,373 -1.6% 759,908 7.0% 0.1%

13 10 ANTIHISTAMINES - 1ST GENERATION 1,485,880 -3.9% 739,076 6.8% -0.1%

14 14 CEPHALOSPORIN ANTIBIOTICS - 1ST GENERATION 865,607 -2.0% 717,633 6.6% 0.0%

15 15 ANTICONVULSANTS 3,789,062 0.7% 699,701 6.5% 0.2%

16 16 NASAL ANTI-INFLAMMATORY STEROIDS 1,472,435 2.7% 695,141 6.4% 0.3%

17 19 VITAMIN D PREPARATIONS 2,521,537 8.8% 660,243 6.1% 0.7% 18 17 PROTON-PUMP INHIBITORS 2,310,634 -2.8% 640,087 5.9% 0.1%

19 20 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 2,751,685 0.7% 574,514 5.3% 0.1%

20 18 PLATELET AGGREGATION INHIBITORS 2,789,241 -7.1% 573,266 5.3% -0.2%

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Table 4. Top 20 Drug Therapeutic Categories in the Medi-Cal Population, by Program. This table presents utilization of the top 20 drug therapeutic categories in the Medi-Cal program, by total utilizing beneficiaries stratified by Medi-Cal program.

Table 4: Top 20 Drug Therapeutic Categories by Total Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Drug Therapeutic Category Description

Current Year 2019 Total Paid Claims Total Utilizing Beneficiaries

All Medi-Cal

% FFS

% MCP

All Medi-Cal % FFS % MCP

1 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 5,335,993 5.9% 5.0% 2,970,661 23.1% 27.6%

2 PENICILLIN ANTIBIOTICS 2,552,221 3.0% 2.4% 2,013,353 13.2% 18.9% 3 ANTIHISTAMINES - 2ND GENERATION 3,025,837 2.5% 2.9% 1,206,837 5.9% 11.6%

4 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 2,826,506 2.5% 2.7% 1,121,169 6.9% 10.7%

5 TOPICAL ANTI-INFLAMMATORY STEROIDAL 1,688,647 1.3% 1.6% 1,044,619 5.2% 10.1%

6 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 2,103,393 2.1% 2.0% 911,433 8.1% 8.3%

7 LAXATIVES AND CATHARTICS 1,838,354 2.5% 1.7% 859,285 5.9% 8.1% 8 ANTIEMETIC/ANTIVERTIGO AGENTS 1,153,536 1.6% 1.0% 802,870 6.5% 7.4% 9 MACROLIDE ANTIBIOTICS 983,491 1.1% 0.9% 790,915 4.8% 7.5% 10 GLUCOCORTICOIDS 1,169,822 1.3% 1.1% 766,519 4.8% 7.3%

ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) 11 3,764,994 2.8% 3.6% 765,212 5.6% 7.3%

12 ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 1,139,373 0.8% 1.1% 759,908 3.8% 7.4%

13 ANTIHISTAMINES - 1ST GENERATION 1,485,880 1.6% 1.4% 739,076 4.7% 7.0%

14 CEPHALOSPORIN ANTIBIOTICS - 1ST GENERATION 865,607 1.4% 0.8% 717,633 6.5% 6.5%

15 ANTICONVULSANTS 3,789,062 4.3% 3.5% 699,701 6.1% 6.6% 16 NASAL ANTI-INFLAMMATORY STEROIDS 1,472,435 0.6% 1.4% 695,141 2.2% 6.8% 17 VITAMIN D PREPARATIONS 2,521,537 0.4% 2.5% 660,243 1.0% 6.6% 18 PROTON-PUMP INHIBITORS 2,310,634 1.6% 2.2% 640,087 3.9% 6.1%

19 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 2,751,685 2.3% 2.6% 574,514 4.2% 5.5%

20 PLATELET AGGREGATION INHIBITORS 2,789,241 3.0% 2.6% 573,266 5.2% 5.3%

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Table 5. Top 20 Drugs in the Medi-Cal Population. This table presents utilization of the top 20 drugs in the Medi-Cal program, by total utilizing beneficiaries. The current year is compared to the prior year in order to illustrate changes in utilization for these drugs. The prior year ranking of each drug is listed for reference.

Table 5: Top 20 Drugs by Total Utilizing Beneficiaries for the Entire Medi-Cal Population

Rank

Last Year Rank Drug Description

Current Year 2019 Total Paid

Claims % Change from

Prior Year

Current Year 2019 Total Utilizing

Beneficiaries

% Utilizing Beneficiaries with a Paid

Claim

% Change Total Utilizing Beneficiaries

Prior Year 1 1 IBUPROFEN 3,924,022 -2.8% 2,325,981 21.5% -0.1%2 2 AMOXICILLIN 1,896,979 -4.9% 1,453,427 13.4% -0.4%3 3 ALBUTEROL SULFATE 2,850,546 -2.3% 1,149,583 10.6% -0.1%4 4 LORATADINE 2,084,198 -2.3% 817,797 7.6% 0.1%

5 7 FLUTICASONE PROPIONATE 1,777,645 8.3% 802,394 7.4% 0.6%

6 6 ACETAMINOPHEN 1,140,144 -1.6% 760,579 7.0% 0.1% 7 5 AZITHROMYCIN 916,453 -6.3% 739,441 6.8% -0.3%8 9 CEPHALEXIN 859,867 -2.1% 714,198 6.6% 0.0%

9 8 HYDROCODONE/ ACETAMINOPHEN 1,554,379 -16.8% 623,061 5.8% -1.0%

10 10 ASPIRIN 2,562,039 -8.2% 537,590 5.0% -0.2%

11 12 ATORVASTATIN CALCIUM 2,510,635 8.1% 517,826 4.8% 0.5%

12 13 TRIAMCINOLONE ACETONIDE 755,306 -1.3% 465,849 4.3% 0.1%

13 11 PROMETHAZINE/ DEXTROMETHORPHAN 612,223 -8.1% 458,649 4.2% -0.2%

14 14 METFORMIN HCL 2,295,517 -3.0% 451,355 4.2% 0.1%

15 15 AMOXICILLIN/ POTASSIUM CLAV 507,817 0.0% 434,559 4.0% 0.1%

16 16 OMEPRAZOLE 1,560,307 -3.6% 430,697 4.0% 0.1% 17 23 ONDANSETRON 531,402 6.5% 414,531 3.8% 0.3% 18 17 FERROUS SULFATE 1,053,897 -3.6% 410,455 3.8% -0.1%19 20 PREDNISONE 696,584 2.0% 408,896 3.8% 0.1% 20 21 HYDROCORTISONE 595,988 0.2% 398,637 3.7% 0.1%

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Table 6. Top 20 Drugs in the Medi-Cal Population, by Program. This table presents utilization of the top 20 drug therapeutic categories in the Medi-Cal program, by total utilizing beneficiaries stratified by Medi-Cal program.

Table 6: Top 20 Drugs by Total Utilizing Beneficiaries for the Entire Medi-Cal Population, by Program

Rank Medi-Cal

Current Year 2019

Total Paid Claims Total Utilizing Beneficiaries

Medi-Cal % FFS % MCP Medi-Cal % FFS % MCP 1 IBUPROFEN 3,924,022 4.8% 3.6% 2,325,981 19.2% 21.5% 2 AMOXICILLIN 1,896,979 2.1% 1.8% 1,453,427 9.0% 13.8% 3 ALBUTEROL SULFATE 2,850,546 2.5% 2.7% 1,149,583 7.1% 11.0% 4 LORATADINE 2,084,198 2.3% 1.9% 817,797 5.2% 7.7% 5 FLUTICASONE PROPIONATE 1,777,645 0.9% 1.7% 802,394 3.0% 7.9% 6 ACETAMINOPHEN 1,140,144 0.8% 1.1% 760,579 3.8% 7.4% 7 AZITHROMYCIN 916,453 1.0% 0.9% 739,441 4.4% 7.0% 8 CEPHALEXIN 859,867 1.4% 0.8% 714,198 6.5% 6.5%

9 HYDROCODONE/ ACETAMINOPHEN 1,554,379 1.5% 1.5% 623,061 5.8% 5.7%

10 ASPIRIN 2,562,039 2.8% 2.4% 537,590 4.9% 4.9% 11 ATORVASTATIN CALCIUM 2,510,635 2.0% 2.4% 517,826 4.1% 4.9% 12 TRIAMCINOLONE ACETONIDE 755,306 0.6% 0.7% 465,849 2.3% 4.5%

13 PROMETHAZINE/ DEXTROMETHORPHAN 612,223 0.8% 0.6% 458,649 3.1% 4.3%

14 METFORMIN HCL 2,295,517 2.4% 2.1% 451,355 4.7% 4.2%

15 AMOXICILLIN/ POTASSIUM CLAV 507,817 0.7% 0.5% 434,559 3.1% 4.1%

16 OMEPRAZOLE 1,560,307 0.3% 1.5% 430,697 1.2% 4.3% 17 ONDANSETRON 531,402 0.5% 0.5% 414,531 2.5% 3.9% 18 FERROUS SULFATE 1,053,897 2.1% 0.9% 410,455 6.0% 3.5% 19 PREDNISONE 696,584 0.9% 0.6% 408,896 3.4% 3.8% 20 HYDROCORTISONE 595,988 0.6% 0.6% 398,637 2.3% 3.8%

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QUARTERLY SUMMARY MEDI-CAL FEE-FOR-SERVICE PROGRAM DRUG USE REVIEW

REPORT PERIOD: 1st QUARTER 2020 (JANUARY – MARCH 2020)

Executive Summary

The DUR quarterly report provides information on both prospective and retrospective drug utilization for all claims processed by the Medi-Cal Fee-for-Service (FFS) program, including the carved-out drug claims for the Medi-Cal Managed Care Plans (MCPs). For this quarterly report, the prospective and retrospective data cover the first quarter of 2020 (2020 Q1). All tables can be found in Appendix A and definitions of selected terms can be found in Appendix B.

Prospective DUR As shown in Table 1.1, in comparison to the prior quarter (2019 Q4), in 2020 Q1 overall drug claims, DUR drug claims, total DUR alerts, total alert overrides, and total alert cancels all increased. A comparison between 2020 Q1 and 2019 Q4 showed very little change among the summary of alert transactions by therapeutic problem (Table 1.2) and among the top 10 drugs for each of the 12 prospective DUR alerts (Tables 2.1-2.12).

Retrospective DUR In 2020 Q1, approximately 15% of eligible Medi-Cal FFS enrollees had a paid claim through the Medi-Cal fee-for-service program, compared with only 2% of Medi-Cal MCP enrollees (Table 3.2 and Table 3.3). Among all Medi-Cal beneficiaries with a paid claim through the Medi-Cal fee-for-service program in 2020 Q1, 62% were FFS enrollees and 39% were MCP enrollees (numbers add up to slightly more than 100% due to < 1% of beneficiaries being enrolled in both programs during the quarter).

As shown in Tables 4.1 – 4.3, there was an across-the-board increase in utilizing beneficiaries and paid claims processed by the FFS aprogram in comparison to the prior-year quarter except within the 65 years of age or older age group, where there was a decrease in utilizing beneficiaries and paid claims processed by the FFS program observed in both the FFS and MCP populations.

A review of the top 20 drug therapeutic categories in the FFS population (Table 5.2) by percentage of utilizing beneficiaries with a paid claim showed a 30% increase in average paid claims per day and a 31% increase in total utilizing beneficiaries with a paid claim in comparison to last year for ANTIVIRALS, GENERAL. Similarly, a review of the top 20 drugs in the FFS population (Table 5.2) by percentage of utilizing beneficiaries with a paid claim showed a 49% increase in average paid claims per day and a 48% increase in total utilizing beneficiaries with a paid claim in comparison to last year for OSELTAMIVIR PHOSPHATE. This increase was primarily driven by a spike in utilization during January 2020, which corresponded to an increase in reports of influenza-like illness in California.

Table 6.3 shows a decrease in the use of NALOXONE in the MCP population during 2020 Q1 when compared to the prior-year quarter, the first decrease since the passage of Assembly Bill 2760 (Wood, Chapter 324), which was effective the first day of 2019 Q1.

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Appendix A: Prospective and Retrospective DUR Tables

Tables 1.1-1.2. Summary of Prospective DUR Alert Transactions in the Medi-Cal Fee-for-Service Program. Table 1.1 provides summary level data (by volume) on pharmacy claims and DUR alert activities, including data and percent change from the prior quarter. Alerts are generated after adjudication of drug claims which exceed or otherwise fall outside of certain prescribed parameters. Please see Appendix B for definitions of terms used in this DUR report.

Table 1.1: Summary of Alert Transactions

Category

Current Quarter 2020 Q1

(Jan – Mar 2020)

Prior Quarter 2019 Q4

(Oct – Dec 2020)

% Change from Prior

Quarter

Prior-Year Quarter 2019 Q1

(Jan – Mar 2019)

% Change from

Prior-Year Quarter

Drug Claims 8,012,907 7,649,437 4.8% 8,000,439 0.2% DUR Drug Claims 3,743,106 3,628,850 3.1% 3,753,849 -0.3%Total Alerts 1,082,025 1,056,097 2.5% 1,054,056 2.7% Total Alert Overrides 691,686 673,242 2.7% 680,252 1.7% Total Alert Cancels 198 197 0.5% 276 -28.3%

Note: Drug claims receiving multiple alerts can be adjudicated by pharmacists by responding to only one conflict code, followed by an intervention code and outcome code. The remaining alerts on the claim cannot be tracked as they are overridden by the pharmacist’s response to a single alert. For example, a single claim can generate up to eight different alerts, but the pharmacist can override all eight alerts by choosing to override only one alert. In addition, the number of cancelled alerts may be underrepresented due to the system’s inability to capture claims that were not adjudicated.

Table 1.2 provides a summary of the number of drug claims and alerts generated for each therapeutic problem type (sorted by alert frequency). Total alerts not adjudicated may be overrepresented, as claims with multiple alerts that have been adjudicated under one alert will show up as not adjudicated for the remaining alerts.

Table 1.2: Summary of Alert Transactions by Therapeutic Problem Type – 2020 Q1

Therapeutic Problem Type Total Alerts

Total Alert Over-rides

% Alert Over-rides

Total Alert

Cancels % Alert Cancels

Total Alerts

Not Adjud-icated

% Alerts

Not Adjud-icated

Therapeutic Duplication (TD) 324,284 249,049 76.8% 32 0.0% 75,203 23.2% Early Refill (ER) 309,448 108,106 34.9% 93 0.0% 201,249 65.0% Ingredient Duplication (ID) 225,708 167,274 74.1% 22 0.0% 58,412 25.9% Late Refill (LR) 102,194 81,022 79.3% 23 0.0% 21,149 20.7% Total High Dose (HD) 45,638 29,828 65.4% 13 0.0% 15,797 34.6% Additive Toxicity (AT) 39,638 32,037 80.8% 2 0.0% 7,599 19.2% Drug-Pregnancy (PG) 17,924 12,515 69.8% 2 0.0% 5,407 30.2% Total Low Dose (LD) 11,206 7,511 67.0% 0 0.0% 3,695 33.0% Drug-Drug (DD) 3,364 2,460 73.1% 1 0.0% 903 26.8% Drug-Disease (MC) 2,243 1,635 72.9% 0 0.0% 608 27.1% Drug-Age (PA) 262 179 68.3% 0 0.0% 83 31.7% Drug-Allergy (DA) 116 70 60.3% 0 0.0% 46 39.7%

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Tables 2.1-2.12. Prospective DUR Alert Transactions by Therapeutic Problem Type in the Medi-Cal Fee-for-Service Program. Each of the following tables provides greater detail of each of the 12 DUR alerts with the top 10 drugs generating each respective alert. For each of the top 10 drugs, data are provided for the total number of adjudicated alerts, alert overrides, alert cancels, paid claims, and the percentage of paid claims with alert overrides. Tables are listed in order of DUR alert priority, which is determined by the DUR Board.

Table 2.1: Top 10 Drugs by Therapeutic Problem Type – Drug-Allergy (DA) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 PHENYTOIN SODIUM EXTENDED 53 53 0 1,415 3.7% 2 PHENYTOIN 16 16 0 587 2.7% 3 AMOXICILLIN 8 8 0 35,378 0.0% 4 MORPHINE SULFATE 8 8 0 997 0.8% 5 OXYCODONE HCL/ACETAMINOPHEN 6 6 0 3,150 0.2% 6 OXYCODONE HCL 5 5 0 3,733 0.1% 7 ZIPRASIDONE HCL 5 5 0 14,939 0.0% 8 IBUPROFEN 4 4 0 81,822 0.0% 9 SULFAMETHOXAZOLE/TRIMETHOPRIM 4 4 0 11,276 0.0%

10 AMOXICILLIN/POTASSIUM CLAV 3 3 0 12,865 0.0%

Table 2.2: Top 10 Drugs by Therapeutic Problem Type – Drug-Pregnancy (PG) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 IBUPROFEN 11,535 11,534 1 81,822 14.1% 2 NORETHINDRONE 2,023 2,023 0 3,207 63.1% 3 MISOPROSTOL 451 450 1 518 87.1% 4 NAPROXEN 328 328 0 11,268 2.9% 5 METHYLERGONOVINE MALEATE 235 235 0 126 186.5% 6 METHIMAZOLE 114 114 0 1,398 8.2% 7 LISINOPRIL 113 113 0 32,318 0.3% 8 INDOMETHACIN 107 107 0 677 15.8% 9 PROPRANOLOL HCL 94 94 0 4,292 2.2%

10 ULIPRISTAL ACETATE 90 90 0 132 68.2%

Table 2.3: Top 10 Drugs by Therapeutic Problem Type – Drug-Disease (MC) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 POTASSIUM CHLORIDE 405 405 0 2,912 13.9% 2 METFORMIN HCL 266 266 0 41,596 0.6% 3 HALOPERIDOL 246 246 0 19,132 1.3% 4 PROPRANOLOL HCL 130 130 0 4,292 3.0% 5 METOPROLOL TARTRATE 75 75 0 6,148 1.2% 6 CARBAMAZEPINE 52 52 0 2,426 2.1% 7 METOPROLOL SUCCINATE 51 51 0 6,743 0.8% 8 NORETHINDRONE-E.ESTRADIOL-IRON 51 51 0 3,013 1.7% 9 DILTIAZEM HCL 48 48 0 1,383 3.5%

10 NORGESTIMATE-ETHINYL ESTRADIOL 46 46 0 3,315 1.4%

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Table 2.4: Top 10 Drugs by Therapeutic Problem Type – Drug-Drug Interaction (DD) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 GEMFIBROZIL 338 338 0 1,812 18.7% 2 ATORVASTATIN CALCIUM 256 256 0 34,388 0.7% 3 SIMVASTATIN 185 185 0 7,310 2.5% 4 HYDROXYCHLOROQUINE SULFATE 170 170 0 1,635 10.4%

5 BUPRENORPHINE HCL/ NALOXONE HCL 164 164 0 48,726 0.3%

6 AMLODIPINE BESYLATE 136 136 0 22,811 0.6% 7 AZITHROMYCIN 112 111 1 21,783 0.5% 8 NALTREXONE HCL 66 66 0 9,312 0.7% 9 PIOGLITAZONE HCL 51 51 0 2,669 1.9%

10 ELVITEG/COB/EMTRI/TENOF ALAFEN 48 48 0 7,702 0.6%

Table 2.5: Top 10 Drugs by Therapeutic Problem Type – Therapeutic Duplication (TD) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 QUETIAPINE FUMARATE 39,861 39,859 2 140,187 28.4% 2 OLANZAPINE 28,986 28,983 3 84,476 34.3% 3 ARIPIPRAZOLE 21,701 21,700 1 108,901 19.9% 4 RISPERIDONE 21,119 21,118 1 80,791 26.1% 5 LURASIDONE HCL 13,425 13,425 0 41,528 32.3% 6 CLOZAPINE 13,356 13,355 1 22,477 59.4% 7 HALOPERIDOL 12,611 12,611 0 19,132 65.9% 8 PALIPERIDONE PALMITATE 7,915 7,910 5 20,226 39.1% 9 CHLORPROMAZINE HCL 5,593 5,593 0 6,087 91.9%

10 ZIPRASIDONE HCL 5,084 5,084 0 14,939 34.0%

Table 2.6: Top 10 Drugs by Therapeutic Problem Type – Overutilization (ER) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 QUETIAPINE FUMARATE 8,987 8,984 3 140,187 6.4% 2 ARIPIPRAZOLE 6,289 6,282 7 108,901 5.8% 3 OLANZAPINE 5,001 4,999 2 84,476 5.9% 4 RISPERIDONE 4,614 4,608 6 80,791 5.7% 5 BENZTROPINE MESYLATE 3,695 3,694 1 53,092 7.0% 6 BICTEGRAV/EMTRICIT/TENOFOV ALA 3,644 3,643 1 22,687 16.1% 7 LURASIDONE HCL 3,362 3,362 0 41,528 8.1% 8 LITHIUM CARBONATE 2,778 2,776 2 29,215 9.5% 9 METFORMIN HCL 2,292 2,289 3 41,596 5.5%

10 BUPRENORPHINE HCL/ NALOXONE HCL 2,269 2,269 0 48,726 4.7%

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Table 2.7: Top 10 Drugs by Therapeutic Problem Type – Underutilization (LR) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 QUETIAPINE FUMARATE 12,531 12,527 4 140,187 8.9% 2 ARIPIPRAZOLE 12,527 12,524 3 108,901 11.5% 3 RISPERIDONE 7,757 7,756 1 80,791 9.6% 4 OLANZAPINE 7,629 7,627 2 84,476 9.0% 5 BENZTROPINE MESYLATE 5,587 5,586 1 53,092 10.5% 6 LURASIDONE HCL 5,115 5,111 4 41,528 12.3% 7 LITHIUM CARBONATE 3,661 3,660 1 29,215 12.5% 8 ATORVASTATIN CALCIUM 3,384 3,383 1 34,388 9.8% 9 LEVOTHYROXINE SODIUM 2,426 2,426 0 23,200 10.5%

10 GABAPENTIN 2,278 2,277 1 23,231 9.8%

Table 2.8: Top 10 Drugs by Therapeutic Problem Type – Additive Toxicity (AT) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 GABAPENTIN 2,247 2,247 0 23,231 9.7% 2 LITHIUM CARBONATE 1,601 1,601 0 29,215 5.5% 3 BACLOFEN 1,286 1,285 1 12,209 10.5% 4 LORAZEPAM 1,238 1,238 0 6,188 20.0% 5 QUETIAPINE FUMARATE 1,236 1,236 0 140,187 0.9% 6 CLONAZEPAM 1,052 1,052 0 5,536 19.0% 7 HYDROCODONE/ACETAMINOPHEN 1,049 1,049 0 20,722 5.1% 8 ARIPIPRAZOLE 683 683 0 108,901 0.6% 9 BUSPIRONE HCL 666 666 0 3,683 18.1%

10 TRAZODONE HCL 644 644 0 10,740 6.0%

Table 2.9: Top 10 Drugs by Therapeutic Problem Type – Ingredient Duplication (ID) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 QUETIAPINE FUMARATE 28,565 28,561 4 140,187 20.4% 2 OLANZAPINE 15,858 15,856 2 84,476 18.8% 3 ARIPIPRAZOLE 11,806 11,804 2 108,901 10.8% 4 RISPERIDONE 10,983 10,982 1 80,791 13.6% 5 ALBUTEROL SULFATE 9,531 9,529 2 52,708 18.1% 6 CLOZAPINE 6,708 6,707 1 22,477 29.8% 7 LURASIDONE HCL 6,381 6,380 1 41,528 15.4% 8 LEVOTHYROXINE SODIUM 3,024 3,024 0 23,200 13.0% 9 ZIPRASIDONE HCL 2,747 2,747 0 14,939 18.4%

10 BENZTROPINE MESYLATE 2,199 2,198 1 53,092 4.1%

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Table 2.10: Top 10 Drugs by Therapeutic Problem Type – Drug-Age (PA) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 AMITRIPTYLINE HCL 134 134 0 2,867 4.7% 2 DOXEPIN HCL 15 15 0 374 4.0% 3 ACETAMINOPHEN WITH CODEINE 8 8 0 4,611 0.2% 4 CODEINE PHOSPHATE/GUAIFENESIN 7 7 0 4,100 0.2% 5 QUETIAPINE FUMARATE 6 6 0 140,187 0.0% 6 AZITHROMYCIN 3 3 0 21,783 0.0% 7 BENZTROPINE MESYLATE 3 3 0 53,092 0.0% 8 LURASIDONE HCL 3 3 0 41,528 0.0% 9 MYCOPHENOLATE MOFETIL 3 3 0 2,551 0.1%

10 OLANZAPINE 3 3 0 84,476 0.0%

Table 2.11: Top 10 Drugs by Therapeutic Problem Type – High Dose (HD) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 OLANZAPINE 7,557 7,556 1 84,476 8.9% 2 IBUPROFEN 2,409 2,407 2 81,822 2.9% 3 RISPERIDONE 2,052 2,052 0 80,791 2.5% 4 QUETIAPINE FUMARATE 1,298 1,298 0 140,187 0.9% 5 AMOXICILLIN 1,251 1,251 0 35,378 3.5% 6 AMOXICILLIN/POTASSIUM CLAV 1,075 1,075 0 12,865 8.4% 7 GABAPENTIN 1,037 1,036 1 23,231 4.5% 8 ALBUTEROL SULFATE 603 599 4 52,708 1.1% 9 HYDROCODONE/ACETAMINOPHEN 590 590 0 20,722 2.8%

10 PROMETHAZINE/ DEXTROMETHORPHAN 551 551 0 18,396 3.0%

Table 2.12: Top 10 Drugs by Therapeutic Problem Type – Low Dose (LD) – 2020 Q1

Rank Drug Generic Name/Ingredient Name

Total Adjudicated

Alerts Total Alert Overrides

Total Alert Cancels

Total Paid

Claims

% of Paid Claims

with Alert Overrides

1 AZITHROMYCIN 919 919 0 21,783 4.2% 2 DIVALPROEX SODIUM 717 717 0 9,952 7.2% 3 ERYTHROMYCIN ETHYLSUCCINATE 495 495 0 1,532 32.3% 4 DULOXETINE HCL 468 468 0 4,097 11.4% 5 AMOXICILLIN/POTASSIUM CLAV 403 403 0 12,865 3.1% 6 BUPROPION HCL 296 296 0 5,527 5.4% 7 ALBUTEROL SULFATE 288 288 0 52,708 0.5% 8 AMOXICILLIN 235 235 0 35,378 0.7% 9 SULFAMETHOXAZOLE/TRIMETHOPRIM 188 188 0 11,276 1.7%

10 AMLODIPINE BESYLATE 148 148 0 22,811 0.6%

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Tables 3.1-3.3. Summary of Medi-Cal Fee-for-Service Pharmacy Utilization.These tables shows pharmacy utilization in the Medi-Cal Fee-for-Service program, including the percent change from the prior quarter and prior-year quarter. Beneficiaries with enrollments in both FFS and MCP during the quarter may be counted in both Table 3.2 and Table 3.3, as enrollment status may change.

Table 3.1: Fee-for-Service Pharmacy Utilization Measures for the Entire Medi-Cal Population

Category

Current Quarter 2020 Q1

Prior Quarter 2019 Q4

Prior-Year Quarter 2019 Q1

% Change from Prior

Quarter

% Change from Prior-

Year Quarter Total Eligible Beneficiaries 14,845,571 15,173,050 15,380,806 -2.2% -3.5%Total Utilizing Beneficiaries 732,023 710,986 747,969 3.0% -2.1%Total Paid Rx Claims 2,560,191 2,469,273 2,566,921 3.7% -0.3%Average Paid Rx Claims per Eligible Beneficiary 0.17 0.16 0.17 6.0% 3.3% Average Paid Rx Claims per Utilizing Beneficiary 3.50 3.47 3.43 0.7% 1.9%

Table 3.2: Fee-for-Service Pharmacy Utilization Measures for the Medi-Cal FFS Population Only

Category

Current Quarter

2020 Q1 Prior Quarter

2019 Q4

Prior-Year Quarter 2019 Q1

% Change from Prior

Quarter

% Change from Prior-

Year Quarter Total Eligible Beneficiaries 2,999,514 3,054,486 3,181,746 -1.8% -5.7%Total Utilizing Beneficiaries 451,025 433,878 466,949 4.0% -3.4%Total Paid Rx Claims 1,628,138 1,560,450 1,654,232 4.3% -1.6%Average Paid Rx Claims per Eligible Beneficiary 0.54 0.51 0.52 6.2% 4.4% Average Paid Rx Claims per Utilizing Beneficiary 3.61 3.60 3.54 0.4% 1.9%

Table 3.3: Fee-for-Service Pharmacy Utilization Measures for the Medi-Cal MCP Population Only

Category

Current Quarter 2020 Q1

Prior Quarter 2019 Q4

Prior-Year Quarter 2019 Q1

% Change from Prior

Quarter

% Change from Prior-

Year Quarter

Total Eligible Beneficiaries 12,286,132 12,509,074 12,600,342 -1.8% -2.5%Total Utilizing Beneficiaries 286,357 282,827 286,828 1.2% -0.2%Total Paid Rx Claims 932,053 914,089 919,921 2.0% 1.3% Average Paid Rx Claims per Eligible Beneficiary 0.08 0.07 0.07 3.8% 3.9% Average Paid Rx Claims per Utilizing Beneficiary 3.25 3.23 3.21 0.7% 1.5%

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Tables 4.1-4.3. Fee-for-Service Pharmacy Utilization by Age Group in the Medi-Cal Population. These tables present pharmacy utilization data in the Medi-Cal Fee-for-Service program, broken out by age group, including the percent change from the prior quarter and prior-year quarter. Beneficiaries with enrollments in both FFS and MCP during the quarter may be counted in both Table 4.2 and Table 4.3, as enrollment status may change.

Table 4.1: Fee-for-Service Pharmacy Utilization by Age Group for the Entire Medi-Cal Population Age

Group (years)

Current Quarter 2020 Q1

Total Paid Claims

% Change from Prior

Quarter

% Change from Prior-

Year Quarter

Current Quarter Total Utilizing Beneficiaries

% Change from Prior

Quarter

% Change from Prior-

Year Quarter 0 – 12 265,302 10.3% -8.5% 85,499 8.4% -10.8%13 – 18 173,809 5.9% 0.1% 44,693 3.5% -2.7%19 – 39 808,961 3.4% 1.4% 253,066 2.3% -0.7%40 – 64 1,119,745 2.9% 1.0% 286,070 2.7% -0.1%65+ 192,373 -0.8% -2.4% 62,694 -0.4% -3.5%Total* 2,560,191 3.7% -0.3% 732,023 3.0% -2.1%

Table 4.2: Fee-for-Service Pharmacy Utilization by Age Group for the Medi-Cal FFS Population Only Age

Group (years)

Current Quarter 2020 Q1

Total Paid Claims

% Change from Prior

Quarter

% Change from Prior-

Year Quarter

Current Quarter Total Utilizing Beneficiaries

% Change from Prior

Quarter

% Change from Prior-

Year Quarter 0 – 12 183,346 13.8% -8.7% 68,349 11.1% -10.5%13 – 18 96,931 7.8% 0.1% 25,340 5.8% -2.4%19 – 39 459,001 3.3% -1.9% 145,253 2.3% -4.0%40 – 64 706,911 3.8% 0.9% 153,136 4.1% 0.9% 65+ 181,948 -1.0% -3.2% 58,946 -0.5% -4.2%Total* 1,628,138 4.3% -1.6% 451,025 4.0% -3.4%

Table 4.3: Fee-for-Service Pharmacy Utilization by Age Group for the Medi-Cal MCP Population Only Age

Group (years)

Current Quarter 2020 Q1

Total Paid Claims

% Change from Prior

Quarter

% Change from Prior-

Year Quarter

Current Quarter Total Utilizing Beneficiaries

% Change from Prior

Quarter

% Change from Prior-

Year Quarter 0 – 12 81,956 2.9% -8.7% 17,477 -1.3% -12.3%13 – 18 76,878 3.5% -0.3% 19,606 0.6% -3.5%19 – 39 349,960 2.9% 5.1% 110,497 2.0% 4.0% 40 – 64 412,834 0.8% 0.5% 134,967 1.1% -1.3%65+ 10,425 -0.1% 9.4% 3,810 -0.6% 7.7% Total* 932,053 2.0% 1.3% 286,357 1.2% -0.2%* Unknowns represent less than 1% of total

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Tables 5.1-5.3. Top 20 Fee-for-Service Drug Therapeutic Categories in the Medi-Cal Population. These tables present utilization of the top 20 drug therapeutic categories in the Medi-Cal Fee-for-Service program, by total utilizing beneficiaries. The current quarter is compared to the prior quarter and prior-year quarter in order to illustrate changes in utilization and reimbursement dollars paid to pharmacies for these top utilized drugs. The prior-year quarter ranking of the drug therapeutic category is listed for reference.

Table 5.1: Top 20 Fee-for-Service Drug Therapeutic Categories by Total Utilizing Beneficiaries for the Entire Medi-Cal Population

Rank

Last Year Rank Drug Therapeutic Category Description

Current Quarter 2020 Q1

Total Paid

Claims

% Change

from Prior

Quarter

% Change

from Prior-Year

Quarter

Current Quarter

Total Utilizing Benefici-

aries

% Utilizing Benefici-

aries with a Paid

Claim

% Change Total

Utilizing Benefici-

aries from Prior

Quarter

% Change Utilizing

Total Utilizing Benefici-

aries Prior- Year

Quarter

1 1 ANTIPSYCHOTIC,ATYPICAL,DOPAMINE ,SEROTONIN ANTAGNST 414,104 0.9% 1.3% 155,841 21.3% 1.0% -0.7%

2 2 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 98,178 5.7% -6.4% 85,736 11.7% 5.4% -6.8%

3 4 ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED 115,933 2.4% 6.2% 49,937 6.8% 1.8% 3.9%

4 3 PENICILLIN ANTIBIOTICS 51,792 13.9% -12.1% 48,120 6.6% 14.3% -11.8%5 5 ANTICONVULSANTS 80,517 -1.0% -4.6% 38,289 5.2% 0.8% -3.6%

6 6 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 52,855 23.8% 5.3% 37,311 5.1% 26.9% 3.9%

7 13 ANTIHISTAMINES - 2ND GENERATION 48,153 10.8% 20.6% 34,061 4.7% 16.0% 22.8%

8 8 ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) 46,071 4.1% 2.2% 31,957 4.4% 7.1% 5.1%

9 7 PLATELET AGGREGATION INHIBITORS 45,464 -0.7% -8.8% 31,220 4.3% -0.3% -10.1%

10 9 ANTIHYPERTENSIVES, ACE INHIBITORS 42,627 5.1% -2.1% 28,847 3.9% 5.6% -0.8%

11 14 ANTIHYPERGLYCEMIC, BIGUANIDE TYPE 41,574 7.0% 1.7% 28,626 3.9% 7.9% 3.8%

12 10 INSULINS 51,114 4.2% -1.4% 27,332 3.7% 2.6% -2.9%13 11 LAXATIVES AND CATHARTICS 40,259 -2.4% -3.8% 26,439 3.6% -1.8% -5.9%14 15 IRON REPLACEMENT 33,738 2.0% -6.0% 25,187 3.4% 1.9% -7.8%15 16 ANTIEMETIC/ANTIVERTIGO AGENTS 27,712 1.1% 0.1% 24,095 3.3% 0.9% -0.1%

16 12 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 28,428 -6.1% -16.0% 23,391 3.2% -7.1% -15.8%

17 29 PROTON-PUMP INHIBITORS 34,023 6.6% 36.8% 22,767 3.1% 6.4% 45.0%

18 18 ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC 57,437 -1.1% -2.3% 22,487 3.1% -0.7% -3.5%

19 19 MACROLIDE ANTIBIOTICS 24,364 24.7% -4.8% 21,726 3.0% 27.4% -4.2%

20 22 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 36,855 2.9% -0.5% 20,759 2.8% 3.7% -1.2%

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Table 5.2: Top 20 Fee-for-Service Drug Therapeutic Categories by Total Utilizing Beneficiaries for the Medi-Cal FFS Population Only

Rank

Last Year Rank Drug Therapeutic Category Description

Current Quarter 2020 Q1

Total Paid

Claims

% Change

from Prior

Quarter

% Change

from Prior-Year

Quarter

Current Quarter

Total Utilizing Benefici-

aries

% Utilizing Benefici-

aries with a Paid

Claim

% Change Total

Utilizing Benefici-

aries from Prior

Quarter

% Change Utilizing

Total Utilizing Benefici-

aries Prior- Year

Quarter

1 1 NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE ANALGESICS 96,909 5.8% -6.4% 84,743 18.8% 5.4% -6.8%

2 2 PENICILLIN ANTIBIOTICS 50,890 14.1% -12.0% 47,450 10.5% 14.5% -11.7%

3 4 BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING 49,611 24.6% 6.1% 35,787 7.9% 27.7% 4.8%

4 9 ANTIHISTAMINES - 2ND GENERATION 47,154 11.0% 20.9% 33,546 7.4% 16.3% 23.2% 5 5 ANTICONVULSANTS 66,364 -1.2% -3.9% 32,634 7.2% 1.2% -2.3%

6 6 ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) 45,614 4.1% 2.2% 31,661 7.0% 7.2% 5.1%

7 3 PLATELET AGGREGATION INHIBITORS 44,589 -0.6% -9.0% 30,710 6.8% -0.3% -10.2%

8 12 ANTIHYPERGLYCEMIC, BIGUANIDE TYPE 39,292 6.9% 1.9% 27,485 6.1% 8.1% 4.1%

9 8 ANTIHYPERTENSIVES, ACE INHIBITORS 39,573 5.2% -1.8% 27,340 6.1% 5.9% -0.2%

10 10 LAXATIVES AND CATHARTICS 38,234 -2.7% -3.7% 25,200 5.6% -2.0% -5.7%11 11 IRON REPLACEMENT 32,808 1.9% -5.9% 24,633 5.5% 1.8% -7.8%12 13 ANTIEMETIC/ANTIVERTIGO AGENTS 26,684 1.1% 0.2% 23,330 5.2% 0.9% 0.0%

13 7 OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS 28,083 -5.8% -15.9% 23,095 5.1% -6.8% -15.7%

14 27 PROTON-PUMP INHIBITORS 32,264 6.9% 40.3% 21,867 4.9% 6.6% 48.2% 15 14 MACROLIDE ANTIBIOTICS 23,518 26.4% -3.9% 21,286 4.7% 28.2% -3.8%

16 16 SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 36,496 3.2% -0.4% 20,517 4.6% 4.0% -1.1%

17 26 ANTIVIRALS, GENERAL 22,425 94.3% 29.7% 19,498 4.3% 105.6% 31.0% 18 17 GLUCOCORTICOIDS 23,284 13.3% -5.7% 19,147 4.3% 14.2% -6.7%

19 15 CEPHALOSPORIN ANTIBIOTICS - 1ST GENERATION 20,301 -4.8% -10.4% 19,087 4.2% -5.1% -10.4%

20 18 PRENATAL VITAMIN PREPARATIONS 21,115 4.7% -2.6% 18,610 4.1% 4.9% -4.4%

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Table 5.3: Top 20 Fee-for-Service Drug Therapeutic Categories by Total Utilizing Beneficiaries for the Medi-Cal MCP Population Only

Rank

Last Year Rank Drug Therapeutic Category Description

Current Quarter 2020 Q1

Total Paid

Claims

% Change

from Prior

Quarter

% Change

from Prior-Year

Quarter

Current Quarter

Total Utilizing Benefici-

aries

% Utilizing Benefici-

aries with a Paid

Claim

% Change Total

Utilizing Benefici-

aries from Prior

Quarter

% Change Utilizing

Total Utilizing Benefici-

aries Prior- Year

Quarter

1 1 ANTIPSYCHOTIC,ATYPICAL,DOPAMINE ,SEROTONIN ANTAGNST 379,460 1.1% 1.9% 143,114 50.0% 1.0% -0.3%

2 2 ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED 107,518 2.4% 6.7% 46,312 16.2% 1.6% 4.2%

3 4 ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC 52,757 -1.0% -1.7% 20,667 7.2% -0.7% -3.0%

4 3 OPIOID ANTAGONISTS 22,574 10.2% -9.7% 18,040 6.3% 9.6% -16.9%

5 5 OPIOID WITHDRAWAL THERAPY AGENTS, OPIOID-TYPE 54,347 5.1% 22.8% 17,535 6.1% 7.6% 25.8%

6 9 ARV-NUCLEOSIDE,NUCLEOTIDE RTI,INTEGRASE INHIBITORS 27,152 5.8% 23.5% 11,332 4.0% 4.2% 20.5%

7 6 BIPOLAR DISORDER DRUGS 26,967 0.4% 0.2% 10,998 3.8% -0.5% -2.4% 8 7 INSULINS 20,549 5.9% -3.3% 9,830 3.4% 0.5% -7.7%

9 8 ANTIVIRALS, HIV-SPEC, NUCLEOSIDE-NUCLEOTIDE ANALOG 16,994 -1.9% -18.6% 8,580 3.0% -3.3% -14.0%

10 10 ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES 22,244 0.3% 3.7% 8,459 3.0% 1.0% -1.3%

11 11 ANTICONVULSANTS 14,333 0.1% -7.5% 5,845 2.0% -1.1% -10.1% 12 12 ANTIPSYCHOTICS,PHENOTHIAZINES 11,211 -1.6% -4.0% 4,102 1.4% -0.9% -6.6%

13 13 ANTIVIRALS,HIV-1 INTEGRASE STRAND TRANSFER INHIBTR 8,169 -4.4% -18.8% 3,554 1.2% -5.5% -19.0%

14 15 OPIOID ANALGESICS 6,898 5.0% 21.5% 3,330 1.2% 2.8% 15.3% 15 22 ANTI-ALCOHOLIC PREPARATIONS 5,369 4.6% 100.0% 2,924 1.0% 6.3% 108.9%

16 14 ANTIRETROVIRAL-NRTIS AND INTEGRASE INHIBITORS COMB 7,029 -4.7% -19.8% 2,893 1.0% -6.9% -21.2%

17 19 HEPATITIS B TREATMENT AGENTS 5,165 2.4% -10.3% 2,293 0.8% 3.6% -10.9%

18 16 ARTV NUCLEOSIDE,NUCLEOTIDE,NON-NUCLEOSIDE RTI COMB

5,064 -5.3% 34.7% 2,120 0.7% -6.7% 29.1%

19 17 ANTICONVULSANT - BENZODIAZEPINE TYPE 4,591 5.6% -23.2% 1,973 0.7% 4.0% -25.5%

20 20 AGENTS TO TREAT HYPOGLYCEMIA (HYPERGLYCEMICS) 2,373 -3.3% 3.1% 1,921 0.7% -3.0% -3.8%

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Tables 6.1-6.3. Top 20 Fee-for-Service Drugs in the Medi-Cal Population. These tables present the utilization of the top 20 drugs in the Medi-Cal Fee-for-Service program, by total utilizing beneficiaries. The current quarter is compared to the prior quarter and prior-year quarter in order to illustrate changes in utilization for these drugs. The prior-year quarter ranking of each drug is listed for reference.

Table 6.1: Top 20 Fee-for-Service Drugs by Total Utilizing Beneficiaries for the Entire Medi-Cal Population

Rank

Last Year Rank Drug Description

Current Quarter 2020 Q1

Total Paid

Claims

% Change from Prior

Quarter

% Change from

Prior-Year Quarter

Current Quarter

Total Utilizing Benefici-

aries

% Utilizing Benefici- aries with

a Paid Claim

% Change Total

Utilizing Benefici-

aries from Prior

Quarter

% Change Utilizing

Total Utilizing Benefici-

aries Prior-Year

Quarter 1 1 IBUPROFEN 81,789 7.6% -6.2% 72,141 9.9% 7.2% -6.6%2 2 QUETIAPINE FUMARATE 140,161 1.5% 0.8% 53,246 7.3% 1.6% -0.8%3 3 ARIPIPRAZOLE 108,877 2.4% 5.6% 46,707 6.4% 1.7% 3.1% 4 5 ALBUTEROL SULFATE 52,482 24.4% 5.0% 37,584 5.1% 27.4% 3.2% 5 4 AMOXICILLIN 35,360 12.6% -15.0% 32,689 4.5% 12.8% -14.7%6 7 RISPERIDONE 80,761 0.2% -0.5% 32,020 4.4% 0.4% -2.6%7 8 OLANZAPINE 84,442 2.2% 3.8% 31,974 4.4% 1.8% 2.5% 8 6 ASPIRIN 41,986 -1.4% -10.9% 29,032 4.0% -1.1% -12.2%9 9 METFORMIN HCL 41,574 7.0% 1.7% 28,626 3.9% 7.9% 3.8%

10 11 LORATADINE 38,525 8.2% -0.5% 26,919 3.7% 13.5% -0.8%11 10 FERROUS SULFATE 33,641 2.0% -5.9% 25,145 3.4% 1.9% -7.8%12 16 ATORVASTATIN CALCIUM 34,348 5.5% 8.8% 23,666 3.2% 8.4% 11.8% 13 12 DOCUSATE SODIUM 34,287 -3.9% -5.4% 22,765 3.1% -3.7% -7.9%14 13 LISINOPRIL 32,282 5.7% -0.7% 22,387 3.1% 6.2% 0.8% 15 15 BENZTROPINE MESYLATE 53,087 -1.2% -2.4% 20,773 2.8% -1.0% -3.6%16 17 AZITHROMYCIN 21,527 29.1% -3.9% 19,957 2.7% 30.0% -4.0%17 14 CEPHALEXIN 20,558 -4.9% -10.6% 19,350 2.7% -5.1% -10.5%

18 33 FLUTICASONE PROPIONATE 23,757 23.1% 61.4% 19,002 2.6% 25.9% 62.9%

19 20 LURASIDONE HCL 41,525 1.6% 1.6% 17,073 2.3% 0.0% -1.1%

20 18 HYDROCODONE/ ACETAMINOPHEN 20,676 -6.7% -14.5% 16,918 2.3% -8.0% -14.8%

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Table 6.2: Top 20 Fee-for-Service Drugs by Total Utilizing Beneficiaries for the Medi-Cal FFS Population Only

Rank

Last Year Rank Drug Description

Current Quarter 2020 Q1

Total Paid

Claims

% Change from Prior

Quarter

% Change from

Prior-Year Quarter

Current Quarter

Total Utilizing Benefici-

aries

% Utilizing Benefici- aries with

a Paid Claim

% Change Total

Utilizing Benefici-

aries from Prior

Quarter

% Change Utilizing

Total Utilizing Benefici-

aries Prior-Year

Quarter 1 1 IBUPROFEN 80,905 7.7% -6.2% 71,392 15.8% 7.3% -6.5%2 3 ALBUTEROL SULFATE 49,869 25.0% 5.4% 36,378 8.1% 28.0% 3.7% 3 2 AMOXICILLIN 34,841 12.7% -14.9% 32,296 7.2% 12.9% -14.6%4 4 ASPIRIN 41,181 -1.4% -11.0% 28,561 6.3% -1.1% -12.3%5 7 METFORMIN HCL 39,292 6.9% 1.9% 27,485 6.1% 8.1% 4.1% 6 5 LORATADINE 38,074 8.4% -0.4% 26,668 5.9% 13.7% -0.7%7 6 FERROUS SULFATE 32,773 1.8% -5.9% 24,615 5.5% 1.8% -7.8%8 11 ATORVASTATIN CALCIUM 33,991 5.5% 8.8% 23,441 5.2% 8.5% 11.9% 9 8 DOCUSATE SODIUM 33,880 -3.9% -5.5% 22,466 5.0% -3.7% -7.9%

10 9 LISINOPRIL 31,266 5.8% -0.4% 21,839 4.8% 6.3% 1.1% 11 12 AZITHROMYCIN 21,239 29.8% -3.7% 19,732 4.4% 30.3% -3.9%12 10 CEPHALEXIN 20,226 -4.8% -10.4% 19,064 4.2% -5.1% -10.4%

13 23 FLUTICASONE PROPIONATE 22,760 24.0% 65.0% 18,397 4.1% 26.7% 66.5%

14 13 HYDROCODONE/ ACETAMINOPHEN 20,403 -6.4% -14.3% 16,674 3.7% -7.7% -14.6%

15 14 PROMETHAZINE/ DEXTROMETHORPHAN 18,343 36.0% -3.2% 16,165 3.6% 34.8% -4.7%

16 16 PRENATAL VITAMINS NO.95 17,066 3.7% 3.5% 15,113 3.4% 4.0% 2.1% 17 18 AMLODIPINE BESYLATE 22,313 5.1% 3.9% 14,859 3.3% 7.5% 5.4% 18 27 OSELTAMIVIR PHOSPHATE 15,963 211.3% 49.3% 14,801 3.3% 207.0% 48.0% 19 15 ACETAMINOPHEN 15,376 19.6% -11.3% 14,298 3.2% 18.9% -11.7%20 19 PREDNISONE 16,669 15.6% -1.4% 13,689 3.0% 17.2% -2.0%

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Table 6.3: Top 20 Fee-for-Service Drugs by Total Utilizing Beneficiaries for the Medi-Cal MCP Population Only

Rank

Last Year Rank Drug Description

Current Quarter 2020 Q1

Total Paid

Claims

% Change from Prior

Quarter

% Change from

Prior-Year Quarter

Current Quarter

Total Utilizing Benefici-

aries

% Utilizing Benefici- aries with

a Paid Claim

% Change Total

Utilizing Benefici-

aries from Prior

Quarter

% Change Utilizing

Total Utilizing Benefici-

aries Prior-Year

Quarter 1 1 QUETIAPINE FUMARATE 129,597 1.7% 1.5% 49,223 17.2% 1.7% -0.2%2 2 ARIPIPRAZOLE 100,687 2.3% 6.1% 43,182 15.1% 1.5% 3.5% 3 4 OLANZAPINE 76,418 2.5% 4.7% 28,883 10.1% 2.0% 3.0% 4 3 RISPERIDONE 72,243 0.4% 0.3% 28,676 10.0% 0.3% -2.3%5 5 BENZTROPINE MESYLATE 48,860 -1.1% -1.8% 19,134 6.7% -0.9% -3.2%6 7 LURASIDONE HCL 39,167 1.6% 1.8% 16,090 5.6% -0.2% -1.0%

7 8 BUPRENORPHINE HCL/ NALOXONE HCL 44,920 4.1% 20.5% 13,788 4.8% 6.3% 22.3%

8 6 NALOXONE HCL 14,136 10.8% -25.5% 13,032 4.6% 10.2% -27.6%9 9 LITHIUM CARBONATE 26,712 0.6% 0.5% 10,879 3.8% -0.4% -2.3%

10 14 BICTEGRAV/EMTRICIT/ TENOFOV ALA 19,894 11.3% 72.5% 8,261 2.9% 9.5% 67.5%

11 10 PALIPERIDONE PALMITATE 19,184 -1.4% 4.5% 8,184 2.9% -0.2% 2.9% 12 11 HALOPERIDOL 17,508 1.2% 6.4% 6,546 2.3% 1.3% 0.4% 13 13 ZIPRASIDONE HCL 13,917 -1.0% -5.0% 5,103 1.8% -1.6% -6.2%14 19 NALTREXONE HCL 8,438 9.1% 40.2% 5,008 1.8% 8.1% 35.6%

15 12 EMTRICITABINE/ TENOFOVIR (TDF) 8,377 -15.4% -29.7% 4,798 1.7% -13.3% -22.4%

16 15 INSULIN LISPRO 9,040 5.1% -0.7% 4,064 1.4% -0.7% -5.4%

17 18 EMTRICITABINE/ TENOFOV ALAFENAM 8,611 16.3% -3.7% 3,779 1.3% 13.3% -0.2%

18 17 INSULIN GLARGINE, HUM.REC.ANLOG 7,199 6.1% -4.1% 3,747 1.3% 0.9% -8.2%

19 23 BUPRENORPHINE HCL 9,182 5.9% 22.5% 3,588 1.3% 7.4% 23.5% 20 22 CLOZAPINE 19,907 -0.6% 8.3% 3,515 1.2% 0.8% 5.0%

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APPENDIX B: Definition of terms.

Adjudicate: To pay or deny drug claims after evaluating the claim for coverage requirements

Beneficiary: A person who has been determined eligible for Medi-Cal, as according to the California Code of Regulations 50024

Eligible beneficiary: A Medi-Cal beneficiary that qualifies for drug benefits

Quarter: One fourth, ¼, 25% or .25 of a year measured in months.

Reimbursement: The reimbursement paid to Medi-Cal pharmacy providers for legend and nonlegend drugs dispensed to Medi-Cal Fee-for-Service (FFS) beneficiaries. Reimbursement is determined in accordance with CA Welfare and Institutions Code Section 14105.45(b)(1).

Drug therapeutic category: Drug therapeutic categories are grouping of drugs at various hierarchy levels and characteristics that may be similar in chemical structure, pharmacological effect, clinical use, indications, and/or other characteristics of drug products.

Utilizing beneficiary: A Medi-Cal beneficiary with at least one prescription filled during the measurement period

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MEDI-CAL DRUG USE REVIEW (DUR) PROGRAM QUARTERLY EVALUATION REPORT – 1st Quarter 2020

The purpose of the educational intervention component of DUR is to improve the quality and cost-effectiveness of prescribing and dispensing practices for Medi-Cal beneficiaries. Educational interventions include ongoing dissemination of clinically important information through the Medi-Cal provider bulletin process.

DUR educational articles are published in provider bulletins and posted on the DUR: Educational Articles page on the DUR website. Two years after publication, each article is reviewed again in a systematic way in order to evaluate any change over time. These evaluations are conducted quarterly and use the following template:

• Background• Purpose• Data Criteria and Findings• Analysis• Limitations• Research/Policy Recommendations• Clinical Recommendations• Board Recommendations

Many factors may influence the prescribing and dispensing practices of Medi-Cal providers, making it difficult to accurately measure the full impact of the educational articles. Such factors may include, but are not limited to, the following:

• Changes and updates to treatment guidelines and recommendations• Beneficiary expectations and requests and healthcare habits and behavior• Direct-to-consumer advertising• Provider training and experience• Anecdotal experience• Provider resistance• Extent of readership• Exposure to multiple sources of continuing education

The purpose of DUR educational articles is to apprise Medi-Cal providers and pharmacies of current treatment guidelines and recommendations on drugs, disease states, and medical conditions. These articles contain valuable information that is effective when used as a part of an overall campaign to disseminate timely and needed information to providers and pharmacies.

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The following recommendations may help to improve accessibility, reach, and interest of educational articles to the Medi-Cal provider and pharmacy community:

• Continue to distribute articles through normal publication channels, butalso send articles separate and independent from the bulletin, in order toincrease visibility.

• Distribute article links to medical and pharmaceuticalorganizations/associations for distribution to their members or publicationsin journals and/or bulletins.

• Encourage prescribers and pharmacists to sign up for distribution of DURarticles via the Medi-Cal Subscription Service (MCSS).

• Facilitate continuing medical education (CME) and/or continuing education(CE) opportunities to prescribers and pharmacists related to article content

• Incorporate case studies into articles.• Package articles with other collateral materials for distribution through

various media channels such as posters, postcard mailings and flyers thathighlight the recommendations of each article.

• Disseminate shorter educational alerts that highlight relevant andimportant topics that can be published with greater frequency.

• When appropriate, disseminate lay versions of articles to beneficiaries topromote physician uptake and set beneficiary expectations.

• Continue to support the direct link between articles and retrospective DUReducational outreach to prescribers and pharmacists.

• Increase understanding of prospective DUR alert methodology, by usingarticles to focus on drug therapy problems that are frequently overriddenat the pharmacy level.

• Include patient-specific profiles for educational outreach where the primaryobjective is an improvement in the quality of care.

• Use provider-specific profiles for educational outreach where the primaryobjective is an improvement in the quality of prescribing.

• Use pharmacy-specific profiles for educational outreach where the primaryobjective is an improvement in the quality of dispensing.

This quarterly evaluation report provides a detailed evaluation of the following DUR educational articles published during the 2nd and 3rd quarters of 2018:

• Improving the Quality of Care: Overutilization of Proton Pump Inhibitors –April 2017

• Alert: Medi-Cal Expands Access to Adult Immunizations in Pharmacies –April 2017

• Drug Safety Communication: Risks of Codeine and Tramadol Use inChildren – May 2017

• Clinical Review: Drug-Induced QT Interval Prolongation – August 2017• 2017 Immunization Updates: Influenza, HepA, Meningococcal, HPV, Adult

Vaccines – September 2017• Alert: Online Report to the Vaccine Adverse Event Reporting System

(VAERS) – September 2017

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Evaluation of Educational Articles

Improving the Quality of Care: Overutilization of Proton Pump Inhibitors – April 2017

• Background: Proton pump inhibitors (PPIs) are typically used to reducegastric acid and are one of the most commonly prescribed medications in theUnited States. However, an estimated 25% to 70% of these prescriptionshave no appropriate indication for PPIs. Treatment with PPIs often continueswell beyond recommended guidelines, and there is increasing data showingthat PPIs are associated with a number of adverse effects. Current evidencenow suggests PPI use may be associated with an increased risk of both acuteand chronic kidney disease, hypomagnesemia, Clostridium difficile infection,osteoporotic fractures, and dementia. Within the Medi-Cal fee-for-servicepopulation, 77% of beneficiaries with a paid claim for a PPI betweenNovember 1, 2015, and October 31, 2016, had no indication for potentiallyappropriate use of PPI therapy and 85% of long-term users showed noattempt at tapering off PPIs during a one-year period.

• Purpose: The purpose of this evaluation is to 1) review proton pump inhibitoruse in the Medi-Cal fee-for-service population and 2) review relevant safetyinformation and clinical recommendations for proton pump inhibitors in orderto determine if there have been any changes since the original DUR bulletinwas published in April 2017.

• Data Criteria and Findings: For this evaluation, the sameinclusion/exclusion criteria as the published article were followed.Beneficiaries had to have continuous eligibility in the Medi-Cal Fee-for-Service program for the duration of the measurement year (March 1, 2019,through February 29, 2020) and at least one paid claim for a PPI.

In order to determine the appropriateness of prescribing PPIs, all availablemedical claims data were reviewed during both the measurement year andthe year prior to the measurement year. Any beneficiary with one of thefollowing primary or secondary ICD-10-CM diagnosis codes within that two-year timeframe was coded as a potentially appropriate use of a PPI:

o H. pylori infection (B96.81)o Zollinger-Ellison Syndrome (E16.4)o GERD (K21.0 and K21.9)o Esophagitis (K20.0 – K20.9)o Barrett’s esophagus (K22.7)o Gastric, duodenal, and peptic ulcers (K25.0 – K25.9, K26.0 –

K26.9, K27.0 – K27.9)o GI hemorrhage (K92.2)

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Demographic characteristics, including gender, age, race/ethnicity, and geographic region of residence, were reviewed for all beneficiaries in the study population.

Medi-Cal fee-for-service population Article data:

1101/15 – 10/31/16

Evaluation data: 03/01/19 – 02/29/20

Percent change

Beneficiaries identified with at least one paid claim for a PPI during the measurement year that met inclusion/ exclusion criteria

23,921 37,139 55%

Percentage of study population with a PPI treatment duration for ≤ 90 days during the measurement year

61% 62% 1%

Percentage of study population with a PPI treatment duration for ≥ 300 days during the measurement year (long-term use)

13% 15% 2%

Percentage of study population with potentially inappropriate use of PPIs during the measurement year

77% 67% -10%

Percentage of beneficiaries with long-term use with potentially inappropriate use of PPIs during the measurement year

75% 52% -23%

Percentage of beneficiaries with long-term use with a break of 30 days or more without a PPI during the measurement year

15% 20% 5%

An additional review was conducted in order to assess total utilizing beneficiaries of both PPIs and H2-receptor antagonists over time since the original article.

Figure 1. Utilization of Proton Pump Inhibitors and H2-receptor Antagonists (with dates of service between November 1, 2016, and February 29, 2020)

0

5,000

10,000

15,000

20,000

Nov

-16

Jan-

17

Mar

-17

May

-17

Jul-1

7

Sep

-17

Nov

-17

Jan-

18

Mar

-18

May

-18

Jul-1

8

Sep

-18

Nov

-18

Jan-

19

Mar

-19

May

-19

Jul-1

9

Sep

-19

Nov

-19

Jan-

20

Tota

l Util

izin

g B

enef

icia

ries

HISTAMINE H2-RECEPTOR INHIBITORS PROTON-PUMP INHIBITORS

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• Analysis: The results from the evaluation of proton pump inhibitors show thatoverall PPI use in the Medi-Cal fee-for-service population has increased by55% since the original article was published. As shown in Figure 1, thisincrease is due to a combination of the addition of new utilizing PPIbeneficiaries as well as some switching of beneficiaries from H2-receptorantagonists to PPIs. As shown in Figure 1, the beginning of this increaseduse corresponds to omeprazole being added to the Medi-Cal List of ContractDrugs, effective May 1, 2019.

While total beneficiaries with a paid claim for a PPI increased by 55%, thosewith long-term PPI use (treatment duration for ≥ 300 days during themeasurement year) increased by only 2%. This is most likely due to thetiming of the increase in beneficiaries who started PPIs after May 2019, asthey would not have time to complete 300 or more days of treatment duringthe measurement year, which ended on February 29, 2020.

The study population with potentially inappropriate use of PPIs during themeasurement year decreased by 10% and among beneficiaries with long-term use of PPIs, the potentially inappropriate use of PPIs during themeasurement year decreased by 23%. While this is a positive trend, thesedata show that 67% of beneficiaries (of a much larger study population) maybe using PPIs inappropriately.

Patients who lack a clear indication for appropriate use of PPI therapy shouldbe reevaluated at each prescription refill in order to determine if PPI therapycan be safely discontinued or if an alternative treatment regimen may beneeded. By supervised tapering of PPIs, a substantial number of patientstreated with PPIs without a clear indication can discontinue PPIs or lower thedose of PPI therapy, reducing their long-term risk of adverse events.

An article published in Current Gastroenterology Reports in 2008 outlinedevidence-based strategies for discontinuation of PPIs that may minimizesymptom recurrence. Future work in this study population could identifypredictors of PPI tapering difficulty and address them as part of the overalltapering strategy.

• Limitations: These data only include paid pharmacy claims and do notinclude over-the-counter medications in which beneficiaries did not have aprescription through the Medi-Cal fee-for-service program. In addition, theoriginal article did not specify dual-eligibility in the Medicare program in theexclusion criteria. For this evaluation report we did exclude dual-eligiblebeneficiaries, in order to ensure we had complete medical and pharmacyclaims data for the duration of the measurement year and the number ofexclusions was nominal (less than 1% of the total study population).

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• Research/Policy Recommendations:1. Continue to monitor overutilization of proton pump inhibitors in the Medi-

Cal population, especially those beneficiaries who began takingomeprazole in May 2019 and may end up with long-term use of PPIs as aresult.

• Clinical Recommendations:1. Encourage non-pharmacologic/lifestyle management as first-line

treatments for GERD symptoms.2. Periodically consider tapering PPIs in patients receiving prolonged therapy

using evidence-based strategies in order to minimize symptomrecurrence.

3. Prescribe PPIs only for clearly documented indications and for theshortest duration possible.

4. Exercise caution in the elderly and in patients with other risk factors for C.difficile infection or bone fractures.

5. Recommend reevaluating PPI indications at transitions of care as anopportunity to eliminate unnecessary therapy.

6. Recommend antacids or H2-receptor antagonists as needed forbreakthrough symptoms after PPI discontinuation.

7. For patients requiring long-term PPI therapy or high doses of PPIs, followrecommended monitoring guidelines for serum creatinine and magnesiumlevels.

• Board Recommendations:1. Consider educational outreach letter to top prescribers of PPIs that

includes strategies for tapering PPIs.

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Alert: Medi-Cal Expands Access to Adult Immunizations in Pharmacies – April 2017

• Background: This alert informed providers that the Medi-Cal Fee-for-ServiceList of Contract Drugs now includes all adult immunizations recommended bythe Advisory Committee on Immunization Practices (ACIP) as a pharmacybenefit. Medi-Cal also expanded their Presumptive Eligibility for PregnantWomen (PE4PW) program to offer a full range of influenza vaccine products,as well as Tdap (tetanus, diphtheria toxoids, and acellular pertussis)immunizations to pregnant women at in-network pharmacies.

• Purpose: The purpose of this evaluation is to review the policies regardingadult immunizations in pharmacies since the publication of the original articleand to describe any relevant updates.

• Data Criteria and Findings: There have been no additional updates to thispolicy since the original article was published in April 2017.

• Analysis: Expanded access to adult immunizations as a pharmacy benefitcontinues to be Medi-Cal policy. Pharmacies need to enroll in the CaliforniaImmunization Registry (CAIR2) in order to submit vaccination information andpharmacists need to enroll in order to view immunization records. Pharmacystaff may also request a user role to look up patients, review administereddoses, add or edit patient information, and/or run reports. Pharmacistscontinue to serve as advocates for immunization as educators (encouragingpatients to be immunized), facilitators (hosting sites for immunization), and asimmunizers, following state regulations and Medi-Cal policies.

• Limitations: None.

• Research/Policy Recommendations:1. Continue to monitor adult immunizations in pharmacies since expanded

access was implemented.2. Continue to collaborate with Immunization Branch on educational efforts

that may need additional promotion.

• Clinical Recommendation:1. Pharmacy regulations require that pharmacists notify the primary care

provider and prenatal care provider, if applicable and known, aboutimmunizations administered to their patients and report immunizationsadministered into the state or regional immunization registry within 14days of administration.

• Board Recommendation:1. Consider reviewing adult immunization rates by region, in order to allow

for focused education and outreach efforts.

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Drug Safety Communication: Risks of Codeine and Tramadol Use in Children – May 2017

• Background: Codeine is approved to treat pain and cough, and tramadol isapproved to treat pain. These medicines carry serious risks, including slowedor difficult breathing and death, which appear to be a greater risk in childrenyounger than 12 years of age. On April 20, 2017, the United States Food andDrug Administration (FDA) announced they are restricting the use of codeineand tramadol medicines in children. They are also recommending against theuse of codeine and tramadol medicines in breastfeeding mothers due topossible harm to their infants.

• Purpose: The purpose of this evaluation is to review the FDA safetycommunications on codeine and tramadol since the publication of the originalarticle and to describe any relevant updates.

• Data Criteria and Findings: Since the publication of this educational article,the DUR program has published one additional alert related to FDA safetyconcerns regarding codeine:

o Drug Safety Communication: New Age Limit for Opioid Cough andCold Medicines published in July 2018

This alert followed the January 11, 2018, announcement that the U.S. Food and Drug Administration (FDA) was requiring safety labeling changes for prescription cough and cold medicines containing codeine to limit use to adults 18 years of age and older because the risks outweigh the benefits in children younger than 18 years of age.

In July and August of 2019, educational outreach letters were sent to all prescribers of tramadol (44 prescribers) and/or codeine (313 prescribers) to patients < 18 years of age in the Medi-Cal fee-for-service program during a 6-month time period. The objective for these mailings was the following:

o To inform health care providers and patients of the serious risksattributed to prescribing codeine or tramadol to patients <18 years

The primary outcome for the mailings is the total continuously-eligible beneficiaries < 18 years of age with a paid claim for codeine or tramadol within the 12 months following the mailing. The results are still pending and will be presented at the DUR Board meeting in November 2020.

• Analysis: Although the results of the primary outcome from the educationaloutreach letters are still pending, there was an interesting finding whenreviewing the prescriber specialty of those receiving the letters. Over a third ofthe prescribers in the mailings were dentists and over half of the prescriberswith more than one patient listed in the mailings were dentists. A review ofAmerican Academy of Pediatric Dentistry (AAPD) guidelines for pain state

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that for acute pain management in children and adolescents, opioids are not to be used as first-line therapy due to the risks outweighing the benefits in this population. A study published in February of 2020 in the American Journal of Preventive Medicine found that more than one-half of opioid prescriptions written by dentists exceed the 3-day supply recommended by the Centers for Disease Control and Prevention (CDC) in its 2016 guidelines for acute dental pain management, suggesting dental pain management may need to be addressed as an educational topic in the near future.

• Limitations: None.

• Research/Policy Recommendations:1. Continue to monitor research and FDA communications regarding opioid

medications.2. Evaluate the use of opioid medications among the Medi-Cal population 18

years of age or younger.

• Clinical Recommendations:1. Be aware that tramadol and single-ingredient codeine medicines are FDA-

approved only for use in adults.2. Consider over-the-counter (OTC) or other FDA-approved prescription

medicines for pain management in children younger than 12 years of ageand in adolescents younger than 18 years of age, especially those withcertain genetic factors, obesity, or obstructive sleep apnea and otherbreathing problems.

3. Treatment for cough may not be necessary, as cough is often secondaryto infection, not serious, and usually will get better on its own.

4. Avoid OTC cough and cold medications for children less than 2 years ofage because of the risk of serious, life-threatening adverse events.

5. Avoid the use of codeine and tramadol medicines in breastfeedingmothers due to possible harm to their infants.

• Board Recommendation:1. Discuss prioritizing an educational alert or bulletin highlighting the

suggested guidelines from professional dental organizations for acute painmanagement in children and adolescents, as well as adults.

o Consider a repeat mailing targeted to dentists who prescribedcodeine and tramadol to children and adolescents during a 6-monthperiod.

o Consider a mailing targeted to dentists who prescribed opioids toadults at quantities that exceeded those recommended in theguidelines.

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Clinical Review: Drug-Induced QT Interval Prolongation – August 2017

• Background: Changes in the electrical activity that control contraction of thecells of the heart muscle can lead to a condition in which there is anabnormally long QT interval on the ECG, that may result in a rare, butpotentially fatal, ventricular arrhythmia known as torsades de pointes (TdP)The QT interval can be prolonged due to an inherited condition known ascongenital long QT syndrome (LQTS). It can also be an acquired conditioncaused by medical conditions including cardiac disease or electrolyteimbalances, and most commonly drug induced. Even though drug-inducedTdP is a relatively rare event, sudden cardiac death and TdP due to drug-induced QT interval prolongation are top reasons that prompt the U.S. FDA toremove drugs from the U.S. market.

Among continuously eligible Medi-Cal fee-for-service beneficiaries between18 and 64 years of age with a medical claim diagnostic code of schizophreniaand/or bipolar disorder, a total of 8% (n = 5,654) had at least one paid claimfor an antipsychotic medication with a known TdP risk during themeasurement year (April 1, 2016, through March 31, 2017). Almost half of thestudy population with at least one paid claim for a QT-prolongingantipsychotic medication during the measurement year had at least one paidclaim for an additional, non-antipsychotic medication categorized as a knownTdP risk (azithromycin was the most common). Within the cohort with at leastone paid claim for an antipsychotic medication with known TdP risk, 49% alsohad a paid claim for another non-antipsychotic medication with a known TdPrisk, 12% had at least one medical condition that may cause QT prolongation,and only 10% of this group had a paid claim for an ECG during this same timeperiod. This study focused on beneficiaries with a diagnosis of schizophreniaand/or bipolar disorder because antipsychotic medications are recommendedas first-line treatments for these conditions, and the benefits of treatmentoften outweigh the risks.

• Purpose: The purpose of this evaluation is to 1) review use of QT-prolongingmedications in the Medi-Cal fee-for-service population with at least onemedical claim diagnostic code for schizophrenia and/or bipolar disorder and2) review relevant safety information and clinical recommendations foravoiding drug-induced QT prolongation in this population to determine if therehave been any changes in use since the original DUR bulletin was publishedin August 2017.

• Data Criteria and Findings: For this evaluation, the sameinclusion/exclusion criteria as the published article were followed:• Inclusion criteria:

o Continuous eligibility in the Medi-Cal Fee-for-Service programbetween January 1, 2019 and December 31, 2019 (themeasurement year).

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o At least one paid medical claim with either schizophrenia or bipolardisorder listed as a primary or secondary ICD-10-CM diagnosiscode in the measurement year or the year prior to themeasurement year.

o Age between 18 and 64 years of age throughout the duration of themeasurement year.

• Exclusion criteria:o Dual-eligibility in the Medicare program.

Demographic characteristics, including gender, age, race/ethnicity, and geographic region of residence, were reviewed for all beneficiaries in the study population. In addition, paid pharmacy claims for all antipsychotic medications during the measurement year were reviewed for each individual beneficiary and the cohort was stratified into the following five subgroups:

o Known TdP risk: The beneficiary had at least one paid claim foreither chlorpromazine, haloperidol, pimozide, or thioridazine.

o Possible TdP risk: The beneficiary had at least one paid claim foreither aripiprazole, asenapine, clozapine, iloperidone, paliperidone,perphenazine, pimavanserin, or risperidone.

o Conditional TdP risk: The beneficiary had at least one paid claim foreither olanzapine, quetiapine, or ziprasidone.

o Other: The beneficiary had at least one paid claim for anantipsychotic medication; however the medication has not beenclassified as having a known, possible, or conditional TdP risk (asof March 31, 2020).

o None: The beneficiary had no paid claims for any antipsychoticmedication during the measurement year. In cases wherebeneficiaries had paid claims for multiple antipsychotic medications,subgroups were assigned based on the antipsychotic medicationwith the greatest risk (if any).

In cases where beneficiaries had paid claims for multiple antipsychotic medications, subgroups were assigned based on the antipsychotic medication with the greatest risk (if any).

As the risk of QT prolongation may increase with the use of multiple QT-prolonging medications, paid pharmacy claims for any non-antipsychotic medications classified as having known TdP risk were also reviewed for the study population during the measurement year.

Diagnostic codes for concomitant medical conditions that may cause QT prolongation and potential adverse cardiac events that may be associated with QT prolongation followed the methods outlined in the original article.

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Medi-Cal fee-for-service study population Article data:

4/01/16 – 3/31/17

Evaluation data: 01/01/19 – 12/31/19

Percent change

Beneficiaries that met inclusion/exclusion criteria with at least one paid claim for an antipsychotic medication with known TdP risk during the measurement year

5,654 1,929 -66%

Percentage of these beneficiaries with at least one paid claim for additional non-antipsychotic medications with known TdP risk during the measurement year

49% 19% -30%

Percentage of these beneficiaries with at least 12 paid claims for additional non-antipsychotic medications with known TdP risk during the measurement year

19% <1% -19%

Percentage of these beneficiaries with at least one paid medical claim with a condition that may cause QT prolongation during the measurement year

12% 28% 16%

Percentage of these beneficiaries with at least one paid medical claim for an ECG during the measurement year

10% 25% 15%

Percentage of these beneficiaries with at least one paid medical claim indicating a potential adverse cardiac event during the measurement year

2% 9% 7%

• Analysis: The results from the evaluation show a significant reduction (adecrease of 66%) in the number of Medi-Cal fee-for-service beneficiaries witha diagnosis of schizophrenia and/or bipolar disorder that have a paid claim foran antipsychotic medication with known TdP risk during the measurementyear. These drugs are all first-generation antipsychotic medications, whichhave been decreasing in utilization over time.

Within this population, approximately 19% had a paid claim for an additionalmedication with known TdP risk during the measurement year, which is downfrom 49% in the original analysis. In addition, there were less than 10beneficiaries (< 1%) with at least 12 paid claims for medications with knownTdP risk during the measurement year.

While 28% of this population had at least one medical condition that maycause QT prolongation (up from 12% in the original analysis), the overallnumber of beneficiaries in this group remained constant, due to the smallersample size in the evaluation study population. A review of the two cohortsfound that 76% of the beneficiaries in the current study population were also

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included in the original study population three years ago, which may indicate that these conditions are constant over time and not increasing, as the raw numbers may indicate. Similarly, the total number of beneficiaries (n = 480; 25%) of the current study population with an ECG during the measurement year closely approximates the total number of beneficiaries (n = 540; 10%) that had a paid claim for an ECG during the original analysis.

As expected, during a single measurement year, the incidence rate for potential adverse cardiac events was low but did increase from 2% to 9% in the current study population, with the most frequent adverse event being long QT syndrome.

Overall, the current study population remained relatively stable from the original analysis, with 76% of beneficiaries appearing in the analysis from the original study. This may indicate that this cohort is adherent and having treatment success with their antipsychotic medication regimen, and QT prolongation may be being monitored and mitigated by fewer paid claims for other drugs with known TdP risk in this population.

• Limitations: Due to the limitations inherent in claims data, causality ofadverse events cannot be determined and there are no QT intervalmeasurements available to provide objective outcome measures.

• Research/Policy Recommendations:1. Continue to monitor use of antipsychotic medications in the Medi-Cal

population.2. Continue to follow evidence-based guidelines and recommendations for

ECG monitoring in patients on antipsychotics with a risk of QTprolongation.

• Clinical Recommendations:1. Assess risk for QT interval prolongation for every patient who is about to

begin taking a QT-prolonging medication.2. Avoid QT-prolonging medications in elderly patients, patients with pre-

existing heart disease, history of ventricular arrhythmias, or with metabolicabnormalities such as hypokalemia, except for cases in which the benefitsof treatment clearly outweigh the risks.

3. Avoid concomitant administration of drugs that inhibit the cytochromeP450, especially imidazole antifungals, macrolide antibiotics, or drugs thatcause electrolyte disturbance in patients taking QT-prolongingmedications. Grapefruit juice should also be avoided, due to similarinhibition of cytochrome P450 enzymes.

4. Discuss the risks of QT-prolonging medications and pay careful attentionto potential electrolyte loss caused by diarrhea, vomiting, profusesweating, undernourishment, diuretic therapy, alcohol and/or drug use,and eating disorders in patients at high risk for QT interval prolongation.

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5. In patients with a diagnosis of schizophrenia and/or bipolar disorder whohave either concomitant medical conditions that may cause QTprolongation or risk factors for drug-induced TdP, the selection of anantipsychotic medication should include an ECG assessment of the QTinterval and evaluation of the risk profile of all potential first-line treatmentoptions.

6. Before and after starting a new QT-prolonging medication, considerwhether an ECG is indicated based on both the potential of the medicationto cause QT prolongation and individual risk factors for the patient (forexample, personal history of QT prolongation, potential for druginteractions). Consider checking a source such as the CredibleMedswebsite to review the potential of medications to result in QT-prolongation.Expert opinion should be sought before starting QT-prolongingmedications if the patient has a prolonged QTc at baseline (>450 ms inmen and >470 ms in women in the absence of interventricular conductiondefects). Regular ECG monitoring is recommended for patients at highrisk for QT interval prolongation and those taking additional concomitantQT-prolonging medications.

7. Routine monitoring of electrolytes is recommended for patients who startQT-prolonging medications, especially for patients taking concomitantmedications that may cause hypokalemia or hypomagnesemia.

8. If the ECG shows signs of impending TdP development, treatment optionsmay include immediately discontinuing the QT-prolonging drug, replacingpotassium, administering intravenous magnesium, considering temporarypacing to prevent bradycardia and long pauses, and transferring thepatient to a hospital unit with the highest level of ECG monitoringsurveillance where immediate defibrillation is available.

9. If drug-induced QT interval prolongation has occurred, a careful review ofthe patient’s personal and family history should be obtained in order toidentify the possibility of a congenital LQTS. Where congenital LQTS issuspected, ECG screening is recommended for all of the patient’s first-degree relatives.

• Board Recommendations:1. None.

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2017 Immunization Updates: Influenza, HepA, Meningococcal, HPV, Adult Vaccines – September 2017

• Background: Starting in 2014, the California Medi-Cal Drug Use Reviewprogram began consolidating updates in immunization guidelines, products,and/or research into an annual summary. The 2017 summary includedinfluenza, hepatitis A (HepA), meningococcal disease, human papillomavirus(HPV), and adult immunizations.

• Purpose: The purpose of this evaluation is to review updates to the ACIPrecommendations and policies for influenza, HepA, meningococcal disease,HPV, and adult immunizations since the original article was published inSeptember 2017.

• Data Criteria and Findings:

1. Influenza vaccine: During both the 2014 – 2015 and 2015 – 2016influenza seasons, ACIP recommended the use of live attenuatedinfluenza vaccine (LAIV) for healthy children aged two through eight yearswithout contraindications or precautions to the vaccine. Due to loweffectiveness in the United States during those seasons, thisrecommendation was reversed for both the 2016 – 2017 and 2017 – 2018seasons. However, starting with the 2018 – 2019 season, quadrivalentLAIV (LAIV4) has again been an available option.

2. Hepatitis A vaccine: On February 21, 2018, ACIP updated theirrecommendations for both HepA virus postexposure prophylaxis (PEP)and HepA virus preexposure prophylaxis for international travel.

For PEP, ACIP now recommends administration of the HepA vaccine to allpersons 1 year of age or older. Among persons 40 years of age or older,immune globulin (IG) may be administered in addition to HepA vaccine,depending on the provider’s risk assessment (the dosage of IG has beenupdated to 0.1 mL/kg). ACIP determined that HepA vaccine for PEPprovides advantages over IG, including induction of active immunity,longer duration of protection, ease of administration, and greateracceptability and availability.

The updated recommendation for HepA virus prexposure prophylaxis forinternational travel states that HepA vaccine should now be administeredto infants between 6 and 11 months of age, traveling to countries whereinprotection against HepA virus is recommended. However, the travel-related dose for infants between 6 and 11 months of age should not becounted toward the routine 2-dose HepA vaccination series, and the 2-dose series should still be initiated once an infant reaches 12 months ofage according to the routine, age-appropriate vaccination schedule. All

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other recommendations for preexposure protection against the HepA virus for travelers younger than 6 months of age and travelers 12 months of age or older remain unchanged, except for the updated dosage of IG (0.1 mL/kg).

In addition, in light of large outbreaks in California and other states, on October 24, 2018, ACIP recommended routine immunization against the HepA virus for all persons 1 year of age or older experiencing homelessness. Routine vaccination consists of a 2-dose schedule or a 3-dose schedule when combined hepatitis A and B vaccine is administered. Concern about loss to follow-up before HepA vaccine series completion should not be a deterrent to initiating the series, as a single dose of HepA vaccine can provide personal protection and contribute to herd immunity, although long-term protection might be suboptimal.

3. Meningococcal vaccine: There have not been any updates to therecommendations for meningococcal vaccine since the original article waspublished in September 2017.

4. Human papillomavirus (HPV) vaccine: Routine vaccination against HPV isnow recommended at 11 or 12 years of age in order to prevent new HPVinfections and HPV-associated disease; however, vaccination can beadministered starting at 9 years of age.

In June 2019, ACIP recommended catch-up HPV vaccination for allpersons 26 years of age or younger. ACIP did not recommend catch-upvaccination for all adults 27 through 45 years of age but recognized thatsome persons who are not adequately vaccinated might be at risk for newHPV infection and might benefit from vaccination in this age range;therefore, ACIP recommended shared clinical decision making regardingpotential HPV vaccination for this population. HPV vaccines are notlicensed for use in adults 46 years of age or older. Routinerecommendations for HPV vaccination of adolescents have not changed.

5. Adult immunizations: Due to similar requirements across the entire adultMedi-Cal population, the analysis from the original article was repeatedand expanded to include all Medi-Cal beneficiaries (fee-for-service andthose in a managed care plan). The measurement period included allmedical and pharmacy claims with dates of service between January 1,2017, and December 31, 2017.

For reference, Medi-Cal beneficiaries with at least one dose of a vaccinethat requires multiple doses during the time frame were included in theanalysis, not just those beneficiaries who completed the series. Any Medi-Cal beneficiary receiving the hepatitis A and B combination vaccine wascounted among both the hepatitis A and hepatitis B totals. Vaccines that

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averaged <10 immunizations in the pharmacy during this time frame (for example, rabies) were excluded due to data confidentiality issues.

This analysis found that adult immunization rates across all Medi-Cal beneficiaries in the pharmacy setting remain low, ranging from 4.5% for influenza to 0.1% for HPV. There were much lower rates of pharmacy administration of vaccines across the entire Medi-Cal population, in comparison with the analysis in the original article that just looked at Medi-Cal fee-for-service beneficiaries.

Using the same methodology from the 2017 analysis described above, this evaluation was repeated for adult immunizations with dates of service between January 1, 2019, and December 31, 2019, in order to determine if there have been any changes over time.

Table 1. Percentage of Medi-Cal beneficiaries between 19 and 64 Years of Age with vaccine location as the pharmacy

Vaccine

2018 Evaluation

Data 01/01/17 – 12/31/17

2020 Evaluation

Data 01/01/19 – 12/31/19

Percent change

Percent change in Total Utilizing

Beneficiaries

Hepatitis A 2.8% 7.4% 4.6% -21.9%

Hepatitis B 1.3% 3.1% 1.8% 9.4%

HPV 0.1% 1.5% 1.4% -7.0%

Influenza 4.5% 4.7% 0.2% 18.1%

Meningococcal ACWY 0.6% 3.9% 3.4% -55.9%

Meningococcal B 0.1% 1.5% 1.5% -43.2%

MMR 4.1% 7.9% 3.8% 13.3%

Peumococcal 2.8% 4.4% 1.6% 1.8%

TDaP 3.1% 3.3% 0.1% 4.4%

Varicella 1.6% 4.4% 2.8% -20.0%

Zoster 2.2% 9.5% 7.2% 10.5%

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• Analysis: For all vaccines, the percentage of adult vaccinations taking placein the pharmacy increased from 2017 to 2019, ranging from an increase of0.1% (TDaP) to an increase of 7.2% (zoster). While this increase invaccination in the pharmacy setting from 2017 to 2019 is promising, it stillrepresents a small percentage of adult immunizations and providesopportunity for areas of expansion.

A number of factors may account for the continued difference in pharmacyadministration of adult immunizations. MCPs often have pay-for-performancemetrics tied to immunizations, which may provide greater incentives tomedical providers for administering vaccines in the medical setting. Otherfactors may include continuity-of-care issues, lower reimbursement in thepharmacy setting, pharmacy-specific rules regarding pharmacy administrationof immunizations, lack of training in the pharmacy setting, and timeconstraints for administration. Future work in this area could try to identifypotential barriers and facilitators to adult immunizations, including stratifyingby specific vaccines, geographic regions, and/or MCPs, in order to targetspecific areas for improvement.

The percent change in total utilizing beneficiaries from 2017 to 2019 was alsoincluded in the table, for reference. While the majority of vaccinations saw anincrease in the adult population, there were decreases in total utilizingbeneficiaries for HepA, HPV, MenACWY, MenB, and varicella. For the mostpart, these vaccines may have had increases in utilizing beneficiaries in 2017as a result of changes in ACIP or CDPH guidelines (MenACWY, MenB, HPV,varicella) or outbreak mitigation (HepA, MenACWY, MenB) just prior to orduring the 2017 calendar year.

• Limitations: The original article included adults 18 years of age through 64years of age in the analysis of adult vaccine practice location. However, it wasdetermined after publication that the California Vaccines for Children (VFC)program covers vaccinations for those beneficiaries who are 18 years of age,so the updated analysis excluded this population and reflects only adults 19years age through 64 years of age that are not dually-eligible for Medicare.

• Research/Policy Recommendations:1. Continue to follow updates to immunization regulations and legislation.2. Continue to work with the CDPH on annual summaries of immunization

guidelines, products, and/or research to ensure the highest priorityinformation gets promoted through as many channels as possible.

3. Develop targeted DUR educational outreach to providers and pharmacies,as needed, to promote vaccination according to CDC guidelines.

4. Closely monitor surveillance reports for vaccine-preventable diseasesthrough the CDPH website.

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5. Identify potential barriers and facilitators to adult and childhood immunizations, including stratifying by specific vaccines, geographic regions, and/or MCPs, in order to target specific areas for improvement.

• Clinical Recommendations: 1. All prescribers and pharmacies should review immunization status and

other evidence of immunity to vaccine-preventable diseases for all patients.

2. All health care providers should routinely encourage annual influenza vaccine for all patients 6 months of age and older.

3. All health care providers should feel comfortable addressing myths about vaccines and vaccine-preventable diseases.

• Board Recommendation: 1. Discuss the value in including immunization strategies for adults in the

upcoming bulletin. Strategies for children and adolescents will be included, but perhaps there is value in including strategies for all ages.

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Alert: Online Report to the Vaccine Adverse Event Reporting System (VAERS) – September 2017

• Background: The Vaccine Adverse Event Reporting System (VAERS), co-managed by the Centers for Disease Control and Prevention (CDC) and theU.S. Food and Drug Administration (FDA), is the national post-marketingsafety monitoring system that accepts reports about adverse events thatoccur after administration of licensed vaccines in the U.S. On June 30, 2017,CDC and FDA implemented a revised reporting form and a new process forsubmitting reports electronically to VAERS, through the VAERS 2.0 onlinereporting tool.

• Purpose: The purpose of this evaluation is to review if there were anyupdates with regards to VAERS since the original DUR alert was published inSeptember 2017.

• Data Criteria and Findings: The original VAERS reporting form was phasedout after December 2017. There have been no additional updates to thereporting system.

• Analysis: VAERS is a passive reporting system, relying on individuals tosend in reports of their experiences to CDC and FDA. VAERS is not designedto determine if a vaccine caused a health problem, but is especially useful fordetecting unusual or unexpected patterns of adverse event reporting thatmight indicate a possible safety problem with a vaccine.

• Limitations: None.

• Research/Policy Recommendation:1. Continue to monitor CDC and FDA communications regarding vaccine

safety.

• Clinical Recommendations:1. Healthcare providers are required by law to report to VAERS:

a. Any adverse event listed in the VAERS Table of Reportable EventsFollowing Vaccination that occurs within the specified time periodafter vaccination

b. An adverse event listed by the vaccine manufacturer as acontraindication to further doses of the vaccine

2. Healthcare providers are strongly encouraged to report:a. Any adverse event that occurs after the administration of a vaccine

licensed in the United States, whether or not it is clear that avaccine caused the adverse event

b. Vaccine administration errors

• Board Recommendations: None.