Idaho Medicaid Drug Utilization Review Program

19 April 2012

Follow-up to Previous ReviewsCitalopram High Dose

Transdermal Testosterone Intervention

Colchicine DUR

Ketorolac DUR

2

Citalopram High Dose DURFDA Drug Safety Communication: Abnormal

heart rhythms associated with high doses of Celexa (citalopram hydrobromide)On August 24, 2011, the Food and Drug

Administration (FDA) released a Safety Announcement addressing the high dose of citalopram and potential adverse effects it can have on the heart. The maximum daily dose is now recommended to be 40 mg per day when it was previously 60 mg per day.

A review of Idaho Medicaid Recipients showed that during the previous 3 months 234 recipients had received doses greater than 40 mg per day.

3

Citalopram High Dose DURLetters were sent out about 235 patients on

10/6/2011 to 186 prescribers with a list of their patients along with the FDA Safety Announcement and Survey Response Form. (see Letter and Announcement in Packet)

As of 4/11/2012, 60 responses have been received (32% response rate) 1 additional response since last DUR Meeting

4

Citalopram High Dose DUR: Response Detail as of 4/11/2012Note that providers may choose more than

one selection per response. Will use this information for care of future patients

29 Reviewed info and have modified or plan to modify treatment

28 Found Info clinically useful and plan to monitor patients

22 Reviewed info and do not believe adjustment is necessary

19 Will change dose

19 Very useful to my practice

18 Extremely useful to my practice

15 Somewhat useful to my practice

10 Not useful to my practice

6

5

Citalopram High Dose DUR: Response Detail as of 4/11/2012

Note that providers may choose more than one selection per response.

Previously saw this patient, but no longer in my care5

Attempted to modify the therapy, but the patient response was not favorable5

Will discontinue medication3

Patient is under my care, but I am not prescriber for this med2

I am not the provider for this patient1 6

Citalopram High Dose DUR:Response Detail as of 4/11/2012 (one additional comment from last meeting)

“Pt is no longer on this. It was changed to Effexor when she was hospitalized, thanks.”

7

Citalopram High Dose DURRecommendations

Decrease the maximum daily dose to the FDA recommended 40mg.

Require a quantity override Prior Authorization for any claims with a dose greater than 40mg per day.

8

Citalopram High Dose DUR2 patients currently receiving 60mg daily

Both times pharmacy overrode with: TD – Therapeutic Duplication M0 – Prescriber consulted 1G – Filled, prescriber approval

Idaho Medicaid Pharmacy Clinical Call Center has been receiving PA requests for 60mg stating patient is stable on current regimen with no mention of awareness of the new FDA Safety announcement. These requests are being denied.

Example of recent PA request (see packet)9

Citalopram High Dose DUROn March 28, 2012 the FDA sent out a revised

Drug Safety Communication with updated recommendations: Recognition that although citalopram use should be avoided, if

possible, in patients with certain conditions because of the risk of QT prolongation, ECG monitoring and/or electrolyte monitoring is recommended if citalopram must be used in such patients.

Patients with congenital long QT syndrome are at particular risk of Torsade de Pointes, ventricular tachycardia, and sudden death when given drugs that prolong the QT interval.  Nevertheless, the labeling recommendation for patients with congenital long QT syndrome has been changed from “contraindicated” to “not recommended,” because it is recognized that there may be some patients with this condition who could benefit from a low dose of citalopram and who lack viable alternatives.

The maximum recommended dose of citalopram is 20 mg per day for patients over the age of 60.

Citalopram is recommended to be discontinued in patients who are found to have persistent QTc measurements greater than 500 ms.

10

Citalopram High Dose DURReport ran looking at data from 1/1/2012 to

3/25/2012 and there were 76 recipients receiving 40mg of citalopram daily who were over the age of 60.

Should a new RetroDur activity be done on this patient population?

11

Transdermal Testosterone InterventionThe Idaho Medicaid Pharmacy and

Therapeutics Committee recommended that therapeutic criteria be set up on this class of medication including testosterone levels as part of the criteria.

RetroDur activity was completed and new criteria was implemented based on these recommendations.

12

Transdermal Testosterone Intervention48 prescribers with 52 recipients were identified

and letters along with the educational handout and PA form were sent out to the prescribers. (see packet)

As of 4/11/2012, 24 completed PA forms (46%) were sent in and 1 returned saying they were not the prescriber.

As of 4/11/2012, 3 new PA requests have come in which were not part of the DUR Intervention.

18 out of the 27 PA requests (67%) were approved.

5 recipients are no longer on therapy22 recipients will have claim deny on next fill at

pharmacy.

13

Colchicine DURHistorical Perspective

In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled “Marketed Unapproved Drugs-Compliance Policy Guide (CPG)”. Notice that any illegally marketed product is subject to FDA

enforcement at any time Clarified that the FDA intends to use a risk-based approach to

enforcementJuly 29, 2009: Colcrys® approved for Familial

Mediterranean Fever (FMF)July 30, 2009: Colcrys® approved for Acute Gout FlaresOctober 16, 2009: Colcrys® approved for Chronic Gout

14

Colchicine DUROctober 1, 2010: FDA sent out a notice that it

intends to initiate enforcement action against any marketed and listed unapproved single-ingredient oral colchicine product that is manufactured on or after November 15, 2010, or that is shipped on or after December 30, 2010. May 2010 May 2011Colcrys® No Rx’s 8 Rx’s

$241.82/46 tabs

colchicine 42 Rx’s (7 different NDCs)

$23.25/46 tabs

No Rx’s

15

Therapeutic Criteria for Colcrys®

1. Acute Gout• Contra-indication and/or failure to NSAIDS or

corticosteroids

2. Chronic Gout• Adjunct to allopurinol AND contra-indication

or failure to NSAIDS

16

Utilization OverviewDate Number of

RecipientsNumber of Claims

4/1/11-6/30/11

Colcrys® 16 29

1/1/12-3/31/12

Colcrys® 15 23

Colcrys’® Utilization

17

Therapeutic Criteria for Colcrys®The Idaho Medicaid Pharmacy &

Therapeutics Committee has recommended that no PA be required for acute cases.

Pharmacies do have the ability to use a 3 day emergency override if the prescription falls under the appropriate criteria.

18

Ketorolac DURHistorical Perspective:

Discovered that in the drug profiles the Maximum Quantity was set at 10 tablets per day.

The Maximum Quantity was immediately changed to 4 tablets per day as recommended by the package insert.

Report was generated to see how many patients have actually received doses higher than the recommended amount and based on this report it was felt that a Retrospective DUR would be appropriate.

19

Ketorolac DURMaximum quantity per day reduced from 10

to 4 tablets on 5/24/2011Utilization Overview:

DUR letter sent on 6/20/2011 to 9 prescribers3 patient profiles provided in packet to

review

Date Span Total # of claims

Total # of claims >4 per day

2/23/11-5/23/11 ketorolac 249 395/24/11-8/24/11 ketorolac 213 01/1/12-3/31/12 ketorolac 239 0

20

Current Interventions/Outcomes StudiesP&T Committee Narcotic Analgesic

StudiesOphthalmic Antibiotic/Steroid

CombinationsAtopic DermatitisSenator Grassley LetterProtease inhibitors and statinsSynagis 2010-2011 Season

21

Narcotic Patterns of Use in Chronic Non-Malignant Pain

Intermittent Report

22

Profile ReviewGenerated profiles for the top 150 recipients by total

narcotic claim count from the recipients who had at least one narcotic claim in each of the 24 months of the period ending December 2011

Time Period: May 1, 2011 through December 31, 2011

Evaluated thus far 90. Cancer Diagnosis found in 3.All profiles were hand reviewed by Idaho Medicaid

PharmacistsDiagnoses were hand searched from electronic

records since medical diagnosis codes were unavailable in RetroDUR database

23

Review FocusYears of opioid use Number of different opioids usedDaily morphine equivalentsNumber of different prescribersOther concurrent potentially addictive drugsDiagnosis or indication for chronic opioid useAverage days between refillsHistory of abuse diagnosisCurrently in lock-in program?Additional opioid use outside of Medicaid

24

Length of Time for Continuous Opioid Use

1 2 3 4 5 6 7 8 9 10 11 120

2

4

6

8

10

12

14

16

18

20

Number of Years on Opioids

Years

Number of Participants

Records only back to 1998

Average = 9.8 years

25

Number of Different Opioids

26

Includes different drugs or dosage formsMay or may not be concurrent, but over course of therapy

1 2 3 4 5 60

5

10

15

20

25

30

35

Number of Different Opioids

Number of Partic-ipants

Average = 2.6

Daily Morphine Equivalents

27

Lowest = 10 mgHighest = 1080 mg

0-99100 - 199200-299300-399400-499500-599600-699700-799800-899900-999

1000-1100

0 5 10 15 20 25 30 35

Daily Morphine Equivalents

Number of Participants

Daily Morphine Equivalents

(mg)

Average= 202 mg equivalents

Number of Prescribers per Participant

28

1 2 3 4 5 6 70

5

10

15

20

25

30

35

40

45

50

Number of Prescribers

Participants

Average number of prescribers per participants is 2

29

18

2457

11

171 2 2

1

Other Concurrent Potentially Addictive DrugsNone

Benzodiazepines Only (up to 3)

Muscle relaxants only

Sedative Hypnotics Only

Benzodiazepines plus muscle relaxants

Benzodiazepines plus sedative hypnotics

Sedative Hypnotics plus muscle re-laxants

Benzodiazepines plus a stimulant

Benzodiazapines plus a stimulant plus a sedative hypnotic

Benzodiazepines plus muscle relaxants plus sedative hypnotics

For this count temazepam was classified as a sedative hypnotic and di-azepam as a benzodiazepine

Diagnosis/IndicationsDiagnosis Number of Participants

(incidence)

lumbago: unspecified disorder of back; back pain 62

chronic pain; chronic pain syndrome; other chronic pain 58

intevertebral disc disorder; lumbar disc degeneration; cervical disc degeneration; cervicalgia; sciatica; disc degeneration; spondylosis

29

knee injury; shoulder injury; pain in limb; lower leg pain; neck injury; hip and thigh injury; wrist injury 29

hand joint pain; osteoarthritis; rheumatoid arthritis; pain in joint of ankle and foot; ankylosing spondylitis; other disorders of synovium tendon and bursa

28

headache; migraine 6

disorders of muscle ligament and fascia; other disease of bone and cartilage; myalgia 5

abdominal pain, generalized pain 4

multiple sclerosis 3

peripheral neuropathy; diabetic peripheral neuropathy 2

Unknown 2

Most patients had multiples diagnoses

30

Average Days Prior to Refill

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 160

5

10

15

20

25

30

35

40

45

Average Days Prior to Refill

Participants

31

Other Information GatheredNumber on Medicaid Pharmacy Lock-In

3 currently on lock-in1 previously on lock-in, released 1/2011

Non-Medicaid Opioid FillsFrom Board of Pharmacy Reports 30 of the 87 patients had fills not paid for by

MedicaidExtra number of doses ranged from 2 to 1719

32

Summary of Narcotic Study- 187 of the top 150 were evaluated for time

period of 5/2011 through 12/2011The average patient evaluated had been

receiving narcotic analgesics f0r 9.8 yearsEach patient was on an average of 2.6

different narcotic analgesicsDaily total morphine equivalents ranged from

10 mg to 1080 mg with average being 202 mgThe patients saw an average of 2 different

prescribers for their narcotic prescriptions33

Summary - 2Most patients were on concurrent potentially

addictive drugsMost common were benzodiazepines with or

without muscle relaxants or sedative hypnoticsThe most common diagnoses were

lumbago/back pain and chronic pain syndrome

Three patients were currently on pharmacy lock-in

34 % of the patients had opioid prescriptions paid outside of Medicaid pharmacy benefit with extra doses up to 1719 for the 8 month period

34

Next Steps

35

Ophthalmic Antibiotic/Steroid CombinationsThe P&T Committee requested a DUR to evaluate

whether the prescribing physicians were specialists (ophthalmologists), primary care, or ER prescribers. Also included in the review will be the age of the recipients.

36

Ophthalmic Antibiotic/Steroid CombinationsOphthalmic Antibiotic/Steroid Combinations

by Provider Type (see packet)

Ophthalmic Antibiotic/Steroid Combo Claims 1/1/2011 – 3/19/2012

Age Range Recipients Claims0 – 9 yrs old 540 62110 – 18 yrs old 443 478> 18 yrs old 471 619Totals 1454 1718

37

Ophthalmic Antibiotic/Steroid Combinations

Ophthalmic Antibiotic/Steroid ProductsGSN

Brand Generic Form

# of claims

7986 Tobradex tobra/dex Susp 783

48547

Maxitrol neo/polymyx b/dex Susp 423

48546

Maxitrol neo/polymyx b/dex Oint 202

7985 Tobradex tobra/dex Oint 121

58620

Zylet tobra/lotepred Susp 84

7964 Cortisporin neo/polymyx b/hc Susp 77

66617

Tobradex tobra/dex Susp 23

48543

Cortisporin neo/bacitrac zn/polymyx b/hc

Oint 4

7985 Pred-G gent/prednisolone Susp 1

38

Next Steps

39

Atopic DermatitisThe P&T Committee requested a DUR on this drug

class to include patterns of use, presence or absence of step up therapy from steroids, specialty of prescribers and geographic region differences of prescribing patterns. The DUR should include an educational piece on risks of these agents compared to risks from steroids since many practitioners seem to be using these agents to spare patients from steroid exposure.

40

Atopic DermatitisAtopic Dermatitis (AD) is a chronic relapsing,

pruritic, inflammatory skin condition that most commonly affects children.60-65% of patients develop AD before age 185-90% of patients have developed signs of

their disease by age 5.Lifetime prevalence is estimated between 10-

20% in children and 1-3% in adults.It is estimated that close to $2.6 billion is spent

yearly on the disease in the United States.

41

Atopic DermatitisThe cause of AD appears to be a result of

interactions between genetics, environment, skin barrier defects, and the immune system.

AD persists on average 4.4 years in children and 18.2 years in adults.The disease typically improves as children get

older; however, up to 40% does not and recurs into adulthood.

Triggers may include aeroallergens, climate, emotional stress, hormones, food, irritants, and microbes.

42

Atopic DermatitisTreatment

Emollients are considered mainstay of maintenance therapy

Topical corticosteroids are the standard of care which other treatments are compared and are considered first-line treatments for flare-ups. Local side effects include striae, atrophy, and telangiectasia. Systemic side effects including hypothalamic-pituitary-

adrenal axis suppression, reduced linear growth in children, and bone density changes in adults are the most worrisome. There is no conclusive evidence that appropriately used topical steroids cause significant systemic adverse effects.

Topical corticosteroids should be used for the shortest duration possible to control the flare-up.

43

Atopic DermatitisTreatment

Sedating antihistamines are useful when patients have sleep disturbances and concomitant allergic conditions.

Antibiotics should be reserved for patients with acutely infected lesions.

Topical calcineurin inhibitors should be second-line treatments for flare-ups and maintenance. Local side effects include skin burning and irritation.

Patients should also be counseled on proper sun protection. Black Box Warning – discussed on next slide

44

Atopic Dermatitis

45

Atopic DermatitisIn March 2010, the FDA issued a public health

advisory about the potential cancer risk associated with the use of Elidel (pimecrolimus) and Protopic (tacrolimus) products applied to the skin.This was based off of information from animal studies,

case reports in a small amount of patients, and how the drugs work. The FDA recommends that healthcare providers, patients,

and caregivers consider the following: Use these products only as second-line agents as short

term and intermittent treatment. Avoid the use in children under the age of 2. Use for a short period of time, not continuously. Children and adults with a weakened or compromised

immune system should not use these products. Use the minimum amount of the products needed to

control the patient’s symptoms. 46

Atopic DermatitisReferences

http://www.aad.org/skin-conditions/dermatology-a-to-z/atopic-dermatitis. Retrieved March 22, 2012.

Hanifin, J.M., Cooper, K.D., Ho, V.C., Kang, S., et al. Guidelines of care for atopic dermatitis. Journal of the American Academy of Dermatology. 2004;50:391-404.

Peterson, J.D., Chan, L.S., A Comprehensive Management Guide for Atopic Dermatitis. Dermatology Nursing. 2006;18(6):531-542.

Buys, L.M., Treatment Options for Atopic Dermatitis. Am Fam Physician. 2007;Feb 15;75(4):523-528.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153525.htm. Retrieved March 16, 2012.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153941.htm. Retrieved March 16, 2012.

Elidel [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp.; July 2010.

Protopic [package insert]. Deerfield, IL; Astellas Pharma US, Inc.; November 2011.

47

Atopic DermatitisTopical Immunomodulators 2011 Table (see

packet)

Topical Immunomodulators 2011 Sorted by City Table (see packet)

48

Atopic DermatitisRegion Map Region # of

prescribers

# of 2011 claims for topical immunomodulators

1 17 382 23 683 30 904 55 1865 30 906 29 1107 40 187Out of State

18 31

None noted

2 1049

Atopic Dermatitis

Claims Data from 2011Brand Strength Form

# of Recipients

Age Range

# of Paid Claims

Protopic 0.03% Oint.

76 0 – 71 125

Protopic 0.1% Oint. 39 2 – 60 90Elidel 1% Cream 348 2 – 67 595Totals 463 0-71 810

50

Atopic Dermatitis# of recipients with calcineurin inhibitor claims

# of claims per age group

2150

194

112

< 2 yrs old2 - 6 yrs old7 - 15 yrs old>= 16 yrs old

2236

363209

< 2 yrs old2 - 6 yrs old7 - 15 yrs old>= 16 yrs old

51

Atopic Dermatitis

Claims Data from 2011# of

RecipientsAge

Range# of Paid Claims

Corticosteroid Totals

299 0 – 71 1,661

52

Atopic Dermatitis# of recipients of calcineurin inhibitors with previous corticosteroids

# of claims per age group of corticosteroids

2104

128

65< 2 yrs old2 - 6 yrs old7 - 15 yrs old>= 16 yrs old

18503

744

396

< 2 yrs old2 - 6 yrs old7 -15 yrs old>= 16 yrs old

53

Next Steps

54

55

Grassley Letter 2010Premise

Federal and State governments spend $317 billion annually on Medicaid programs

As ranking member of Senate Committee on Finance he is obligated to ensure that taxpayer dollars are appropriately spent on federal health care

Medicaid suffers from systemic weaknesses that lead to fraud, waste, and abuse resulting in higher costs and less health care to those who are in need

Purpose of letter: request information on outliers, how Idaho monitors and actions taken

56

2010 Drugs In ReviewAbilifyGeodonSeroquelZyprexaRisperdalOxyContinRoxicodoneXanax

57

Data RequestedList of top ten Medicaid prescribers for listed

drugsFor each prescriber

His/her prescriber identifierNumber of prescriptions written per drug per

yearTotal amount billed to Medicaid per drug,

separated for each yearNote: no information requested on number of

Medicaid eligibles or total number of prescriptions for each drug

58

ResultsSee Handout number 1Reported from Medicaid data unit, no

pharmacy input

59

Grassley Letter January 23, 2012Premise

Follow-up from previous letterPain management and mental health drugs have

addictive properties and potential for fraud and abuse by prescribers and patients is extremely high

High prescribing rates of mental health drugsPain management clinics are hotbeds for black

market painkillersAmerican people pay the price for over-

prescription, abuse, and fraud60

His Extensive Review of our Data

Concern about oversight and enforcement of Medicaid abuse in our state

The data we provided is “ quite shocking”The top prescriber of OxyContin wrote nearly

double the amount of scripts of next provider and 8 times more than another top 10 prescriber

Antipsychotic top prescribers wrote double or triple the others in the top 10

61

Responses to Questions 1 and 21. What action, if any, has your agency taken with respect to the

prescribers identified to the Committee?A. No action has been taken.

2. If there has been no action taken with respect to these prescribers, please explain why not.

A. The number of prescriptions written by these prescribers only shows that these prescribers have relatively higher prescribing of these specific agents compared to other prescribers. It does not necessarily indicate overprescribing or inappropriate prescribing. These numbers must be looked at in context of several factors including total prescriptions for a particular drug in Medicaid overall and the patient mix seen by the specific prescriber. Specialists for mental health or pain management will have more of those patients using those drugs than general practitioners. Almost all of prescribers in both the mental health and pain classes of medication seen here have the majority if not all of their patients fitting that category.

62

Responses to Questions 3 and 43. Please identify which of the providers identified to the

Committee remain eligible to bill the Medicaid Program.A. All of the providers except for O0391, PA 724, M5597,

CNS15A and MD00046330 remain eligible to bill the Idaho Medicaid Program. M5597 is incarcerated for Medicaid billing fraud (not related to drug prescribing) and all of the others listed above have left the state.

4. Please provide the 2010 and 2011 numbers for the top prescribers of these same drugs.

A. Attached. Please note that the analysis for 2010 and 2011 includes Risperdal Consta, generic Roxicodone (oxycodone), and generic Xanax (alprazolam) which were not included in the 2008 and 2009 report.

63

Results See Handout #2

64

Responses to Questions 5 and 65. Has each of these prescribers been cross-checked

for complaints or misconduct with the state medical board or the National Practitioner Data Bank? If not, do you plan to do so?A. Our claims adjudication system does use the

National Data Bank for prescribers and no irregularities have come to our attention. We have not checked with the state medical board and would not do so unless we determined that prescribing was inappropriate.

6. Have any of the prescribers identified to this Committee been referred to your state medical board? A. Not by Idaho Medicaid.

65

Responses to Questions 7 and 87. Is there any system set up in you state to identify and

monitor excessive prescription writing? If not, why not?

A. This would come under the responsibility of the state board of pharmacy and resources would have to be designated and funded.

8. Have you received any training or guidance from the Centers for Medicare and Medicaid Studies to help identify potential issues with prescription drugs?

A. No

66

Responses to Questions 9 and 109. Does your state maintain a database of all prescribed controlled-

substance? If so, what entities have access to it?A. Idaho does have a prescription monitoring program. The program is

overseen by the Idaho Board of Pharmacy. Information is available to prescribers, pharmacies, and law enforcement. Idaho Medicaid has this information available for review of participants and providers. The Medicaid Pharmacy Program uses this information for its lock-in program.

10. Does your state have any point-of-sale restrictions related to maximum units, prior authorization, therapeutic duplication, or early refill?A. Yes. All individual medications in the Idaho Medicaid drug database have

been reviewed and have hard edits on dose/day and maximum units per month as well as age restrictions. We have over 100 drugs requiring prior authorization for preferred drug status, therapeutic use, age, and/ or quantity. We utilize point of sale prospective drug utilization review edits for therapeutic duplication and early refill. 67

Response to Question 1111. Were any of these top ten prescribers identified in the federal-

mandated Drug Utilization Review or CMS-base retrospective reviews?A. The Idaho Medicaid Drug Utilization Review Board has looked at or is

currently looking at appropriate use of both narcotic analgesics and atypical antipsychotics. In these reviews, we identify specific patients so if one of those patients identified had one of these prescribers as their prescriber they would have received an educational intervention.

In 2010 the Board looked at the following:

Narcotic use studies looking at multiple short or long-acting agents in one patient.

Narcotic use study identifying patients receiving continuous narcotic pain treatment with short acting agents without addition of long-acting agents.  

Narcotic use study of continued opioid use with dependency and/or abuse diagnosis.

68

Response to Question 11 (cont.)

Currently the DUR Board is doing a very detailed study on narcotic analgesics that includes the following data. If deemed necessary, they will also use information from the Board of Pharmacy Prescription Drug Monitoring Program, legal/arrest databases and hospital discharge medication records.Patient Profiling

Number of patients on monthly (chronic) narcotics Number of different agents used by individual patients Total (cumulative) monthly doses of all concurrent narcotics Number of prescribers per patient Analysis of multiple scripts from multiple providers Other addictive drugs prescribed concurrently Diagnosis/indication for narcotic use and data backing that diagnosis Patients with no relevant diagnosis for medication Evaluation for evidence of illicit drug use Relationships of long-acting narcotic use and break through narcotics use (lack of long acting

and/or break through narcotics given continuously) Hospital and ER admissions for overdose Prescription fill history, including early refills

 

69

Response to Question 11 (cont)Provider Profiling• Prescribing pattern for non-pain clinic prescribers

Currently the DUR Board is working with the Program Integrity unit to look at use of injectable atypical antipsychotics and ensuring what is paid for by Medicaid is actually administered.

The Pharmacy and Therapeutics Committee is also instituting appropriate use guidelines for atypical antipsychotics which will involve prior authorization review of those prescriptions not meeting the guideline criteria.

70

Response to Questions #1212. Does your state have any programs in place to educate

providers about the prescription of antipsychotics to children and adolescents? A. The Idaho Medicaid Pharmacy program utilizes an Academic

Detailing (Educational Outreach) program to meet one on one with high use prescribers of mental health medication. The Medicaid pharmacy program is also participating in a project with other areas of Health and Welfare and various community organizations to improve the use of psychotropic drugs in Foster kids. It is anticipated that this will include appropriate consent for treatment, prior authorization when necessary and a set up of red flags to identify potential inappropriate prescribing.  

71

Protease inhibitors and statinsOn March 1, 2012 the U.S. Food and Drug

Administration (FDA) issued a safety communication in regards to interactions between protease inhibitors and statins. (see packet)

Idaho had one patient on both a protease inhibitor and a statin. His course of Incivek will be complete soon and he has been non-compliant on his lovastatin (fills 9/11/11, 10/10/11, and 1/6/12) so it was decided not to send any correspondence to the prescriber.

72

Impact of using the 2009 revised American Academy of Pediatrics (AAP) recommendations for infants with gestational age between 32 to 35 weeks. The AAP Committee on Infectious Disease updated the

recommendations for the use of palivizumab for the prevention of respiratory syncytial virus infections August 2009

2006 Red Book Recommendations

2009 Red Book Recommendations

32-35 weeks gestation 32 weeks, 0 days - 34 weeks, 6 days

Less than 6 months of age at the start of the RSV season

Less than 3 months of age at the start of the RSV season

Receive 5 doses for prophylaxis per season

Receive prophylaxis until 90 days of age or a maximum of 3 doses

Must have 2 of 5 risk factors Either of 2 specific risk factors73

2006 Red Book Risk Factors

2009 Red Book Risk Factors

Child care attendance Child care attendance with infants and young toddlers

School aged siblings Sibling(s) less than 5 years of age

Exposure to environmental air pollutantsCongenital abnormalities of the airwaysSevere neuromuscular disease

74

Information from the American Academy of Pediatrics regarding update to previous recommendations. Optimal balance of benefit and cost from this expensive

intervention. Based on the availability of additional data regarding

seasonality of RSV disease as well as the limitations in available data on risk factors for identifying children at increased risk of serious RSV lower respiratory tract disease.

Cost Considerations of immunoprophylaxis with 5 monthly doses of palivizumab is an effective, though costly, intervention that reduces hospitalization rates by 39% to 82% among high-risk infants. The primary benefit of immunoprophylaxis is a decrease in the rate of RSV-associated hospitalization. No prospective, randomized clinical trial has demonstrated a significant decrease in the rate of mortality attributable to RSV or in the rate of recurrent wheezing following RSV infection among infants who receive prophylaxis. Economic analyses fail to demonstrate overall savings in health care dollars because of the high cost if all at risk infants receive prophylaxis.

75

Incidence of RSV Hospitalization by Treatment Group per prescribing information MedImmune revision date July 2010

Trial Placebo SynagisDifferenc

e Between Groups

Relative Reductio

np-Value

Trial 1Impact-RSV

N 500 1002

Hospitalization

53 (10.6%)

48 (4.8%) 5.8% 55% <0.001

Trial 2 CHD

N 648 639

Hospitalization

63 (9.7%)

34 (5.3%) 4.4% 45% 0.003

76

History of Synagis Season Prior Authorization Requests

Total Requests Received

Percentage Denied

2007 452 31%

2008 509 30%

2009 472 35%

2010 445 39%

Criteria change did not cause fewer prior authorization request submissions.

77

Review Criteria: Specifically looked at 56 infants between 32

weeks, 0 days to 35 weeks gestational age and < 6 months chronological age as of December 1, 2010.

Filtered denials based on infants that met criteria per the previous 2006 Red Book recommendations but did not met criteria per the updated 2009 Red Book recommendations.

78

Case studies: One infant was hospitalized Baby 1: DOB 11/3/2010 with the gestational age

box 32-34 weeks, 6 days checked. No other information was provided as well as no discharge summary. The electronic claims profile was not indicative of any risk factors. RSV positive with hospitalization February 2011.

Using either the 2006 or the 2009 Red Book recommendations the infant would not have met criteria because no risk factors were provided.

79

Two infants were RSV positive without hospitalizationBaby 2 and 3: Twins with DOB 8/7/2010 with

gestational age checked 32-34 weeks, 6 days. Synagis denied because infants > 90 days old upon start of RSV season using 12/1/2010. RSV positive 3/2/11 and 3/8/11 without hospital or emergency department admission.

80

The following Infants were neither hospitalized nor RSV positive:

Requests Received

Gestational Age

5 32 weeks23 32-34weeks , 6

days4 33 weeks2 33-35 weeks12 34 weeks10 35 weeks

81

Summary445 prior authorizations received and 56 of

those did not meet criteria using the new AAP guidelines (13%).

Only one of the 56 infants was RSV positive with hospitalization. There was no information submitted and nothing in the electronic claims profile indicative of high risk.

Impact of implementing the new AAP guidelines continues to not be significant.

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Proposed Studies for Next Quarter:P&T Committee Narcotic Analgesic StudiesLeukotrienes vs. inhaled corticosteroids in

children with asthmaUse of Psychotropic Medications in Foster

Children Use of Lupron

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P&T Committee Narcotic Analgesic StudiesCommittee Recommendation for Drug

Utilization Review of Narcotic Analgesics The Committee recommended a comprehensive drug

utilization review of short and long-acting narcotics. This was based on concern over the misuse/abuse of these agents that is not addressed through the preferred drug list. Components of the proposed review are outlined below.

 Patient ProfilingNumber of patients on monthly (chronic) narcoticsNumber of different agents used by individual

patients Total (cumulative) monthly doses of all concurrent

narcoticsNumber of prescribers per patientAnalysis of multiple scripts from multiple providers

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P&T Committee Narcotic Analgesic StudiesPatient Profiling Continued

Other addictive drugs prescribed concurrentlyDiagnosis/indication for narcotic use and data

backing that diagnosisPatients with no relevant diagnosis for medicationEvaluation for evidence of illicit drug useRelationships of long-acting narcotic use and

breakthrough narcotics use (lack of long acting and/or breakthrough narcotics given continuously)

Hospital and ER admissions for overdosePrescription fill history, including early refills

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P&T Committee Narcotic Analgesic StudiesProvider Profiling

Prescribing pattern for non-pain clinic prescribers

They also suggested utilizing several data sources outside Medicaid including outlier reports from the Board of Pharmacy Prescription Drug Monitoring Program, legal/arrest databases and hospital discharge medication records.

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P&T Committee Narcotic Analgesic Studies

Possible policy changes suggested for consideration after collection and analysis of the data Restriction of prescriptions to prescribers and

pharmacies within Idaho state borders Stricter refill policies (90% rather than current 75%

threshold) Expansion of lock-in program

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Leukotrienes vs. inhaled corticosteroids in children with asthmaNumber of recipients < 18 years of age with

paid claim for leukotriene:

Number of recipients < 18 years of age with paid claim for inhaled corticosteroid:

Date # of recipients7/1/2011 – 9/30/2011 3,3691/1/2012 – 3/31/2012 3,059

Date # of recipients7/1/2011 – 9/30/2011 1,5951/1/2012 – 3/31/2012 2,156

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Use of Psychotropic Medications in Foster Children The U.S. Government Accountability Office

released the results from a study that they performed examining the rates of psychotropic medications for foster and nonfoster children in 2008.

It was determined that HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions.

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Use of Psychotropic Medications in Foster ChildrenMedication Classes included in the report

ADHD drugsAnti-anxietyAnticonvulsantAntidepressantsAnti-enuretic (just desmopressin acetate) Antiparkinson Antipsychotics Combination anti-anxiety and antidepressant Hypnotic Mood stabilizer (just lithium)Sleep aid (just melatonin) 

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Use of Psychotropic Medications in Foster ChildrenPercentage of children (0-17 years old) prescribed psychotropic Medications in named State and year

Foster Children Nonfoster children Ratio of foster to nonfoster children

Florida 2008 22.0% 8.2% 2.7

Massachusetts 2008 39.1% 10.2% 3.8

Michigan 2008 21.0% 7.9% 2.7

Oregon 2008 19.7% 4.8% 4.1

Texas 2008 32.2% 7.1% 4.5

Idaho 2008 38.8% 14.8% 2.6

Idaho 2011 42.9% 14.8% 2.9

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Psychotropic Medication Use in Foster Children

4/2012 Update

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AACAP1 Practice Parameter on the Use of Psychotropic Medication in Children and Adolescents1. Assessment2. Development of a treatment and monitoring

plan3. Psychoeducation and assent/consent4. Implementation of the treatment and

monitoring plan5. Management of complex pharmacological

interventions including medication discontinuation

1 Journal of American Academy of Child and Adolescent Psychiatry 48:9; September 2009 93

Areas For Idaho Medicaid Pharmacy Program to Assist1. Education of prescribers on the medications – extension of

Academic Detailing program2. Educational information on the medications for persons

giving consent3. Provide medication profiles to case workers4. Set up guidelines with red flag systems5. Develop protocols for monitoring medications6. Develop and provide simple medication guides for foster

parents7. Data

1. Baseline2. Trending 3. Monitoring the impact of the interventions

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Guidelines, Prior Authorization, and Red FlagsPrior Authorization

Diagnosis per P&T recommendations Evidence-based indications for age

Age and Quantity per evidence-based informationRed Flags

RetroDUR evaluation of patients meeting red flagsQuarterly interventionsTransition to timely alerts (ProDUR) and possible

hard edits requiring prior authorization

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Possible Red FlagsTexas

Five (5) or more psychotropic medications prescribed concomitantly

Two (2) or more concomitant antidepressantsTwo (2) or more concomitant antipsychotic medications

(actual PA on 3rd)Two (2) or more concomitant stimulant medications (long-

acting plus an immediate release of same chemical entity not considered concomitant)

Three (3) or more concomitant mood stabilizer medicationsPsychotropic polypharmacy ( 2 or more agents) for a given

mental disorder prescribed before utilizing psychotropic monotherapy

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Texas Red Flags - continuedAdditionally

Diagnosis, age, and dose limitations similar to what Idaho does presently

Require specialty training for diagnosis other than ADHD, uncomplicated anxiety disorders or uncomplicated depression

*Medication overlap and cross-titration ok when switching psychotropics

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Possible Other Red Tags• Two (2) or more concomitant anti-anxiety agents• Two (2) or more concomitant sedative/hypnotic

agentsSplit into separate interventions for 1 Vs 2

prescribers for duplicate therapy for antidepressants, stimulants, atypical antipsychotics, anti-anxiety agents, sedative/hypnotics

98

Next Steps

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Prospective DUR ReportHistory Errors:

• DD – drug-to-drug• PG – drug to pregnancy• TD – therapeutic

duplication• ER – early refill• MC – drug-to-disease

Non-History Errors:• PA – drug-to-age• HD – high dose• LD – low dose• SX – drug-to-gender

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Prospective DUR ReportIdaho Medicaid ProgramProDUR Message Report

March-12 

ProDUR ProDUR Message MessageMessage Severity Count Amount

Drug To Drug 1 2,272 $457,602.00  2 14,784 $2,549,305.71  3 65,365 $11,032,658.53

9 3 $22.47Drug To Gender 1 116 $25,224.88  2 53 $1,287.90Drug To Known Disease 1 64,935 $19,679,895.85  2 242,066 $45,599,264.18  3 289,788 $55,585,891.88Drug To Pregnancy 1 101 $3,180.77  2 23 $429.52  A 3 $70.69  B 131 $55,749.15  C 256 $21,660.28  D 36 $2,146.06  X 41 $863.47Duplicate Therapy 0 120,392 $26,014,904.40Min Max 0 37,330 $7,045,362.22Too Soon Clinical 0 22,684 $4,678,290.51ALL   860,379 $172,753,810.47               Total Number of Claims with Messages 218,822              Average ProDUR Message Per Claim            3.93 

101

DUR Winter NewsletterCopy of Fall Newsletter in packetBrainstorm for new topics (Prescriber

emails???)

102

Annual American Drug Utilization Review Society (ADURS) Meeting

February 23-25, 2012Scottsdale, Arizona

103

ADURS 2012Representatives were present from

43 states

State Medicaid employees

Drug Utilization Review personnel

104

ADURS 201214 hours of Continuing Education

Hepatitis C Update“Less Abusable” OpioidsNew DrugsPipeline DrugsCMS UpdateIs it a “Drug” ?

105

ADURS 2012

Round Table – Oral report by representative from each state on DUR projects done in the past year plus challenges and successes.

106

ADURS 2012Round Table Report

Atypical antipsychoticsRequire psychiatrist to be prescriber for (a)

children less than 6 years or (b) children less than 18 years.

Signed consent form (by parents or guardians).

Baseline metabolic monitoring (blood glucose, HgbA1c, lipid panel) and then routinely thereafter.

Letters sent to prescribers of patients less than 16 years old who are receiving two or more atypicals concurrently .

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ADURS 2012Round Table Report

Suboxone TherapyMaximum daily dose of 16mg with enforced

reduction to 8mg after 3-6 months.Automatic lock-in to one pharmacy.Approvals for only three months at a time,

requiring documentation of patient’s attendance at counseling sessions and negative urine drug screen for renewal.

Limiting approval to two years per lifetime.

108

ADURS 2012Round Table Report

Polypharmacy – Patients receiving more than 15 medications per month for at least 3 consecutive months.

Methadone – No other opioids are allowed without prior authorization

Topical Immunomodulators – Requires trial and failure of TWO topical corticosteroids first. Quantity is limited to one tube per 90 days.

109

ADURS 2012Round Table Report

Pain Therapy – Require pain specialist review of any non-cancer patient receiving more than 1000 mg/day of morphine equivalents.

Controlled Substances – Refills not allowed until 100% of time has elapsed (pharmacy can override for weekends/holidays to allow early refill by a few days).

Twice daily PPI not approved unless patient has first tried and failed once daily PPI plus a bedtime H-2 blocker.

110

Medicaid Update

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