Kaiser Permanente Georgia 1

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ISSUE 3 VOLUME 11 JUNE 2017

FormularyUpdate

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A PUBL ICAT ION OF THE GEORGIA PHARMACY AND THERAPEUT ICS (P&T) COMMITTEE . The Formulary Update contains information regarding formulary additions, deletions, exclusions, brief descriptions of products, and current drug related news. It also lists items to be discussed at upcoming P&T meetings. Please refer to the web site http://kpnet.kp.org:81/ga/healthcare/formularies.html or providers.kp.org for the full KP GA Drug Formulary. If you have Lexi-Comp PDA access to the KPGA Online Formulary, remember to sync your device for the most current information.

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Formulary Additions

At A Glance

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Netupitant and palonosetron (Akynzeo) added to the Commercial formulary effective June 30, 3017. Akynzeo is the first oral fixed combination of a NK-1 antagonist and a 5-HT3 antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Palonosetron prevents nausea and vomiting during the actue phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Akynzeo is a recommended option in combination with dexamethasone for patients receiving moderately and highly emetogenic chemotherapy in the National Comprehensive Cancer Network (NCCN) antiemesis guidelines and the American Society of Clinical Oncology (ASCO) antiemesis guidelines. Akynzeo is the preferred NK-1 based medication for Kaiser Permanente.

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uPcoming Formulary items

An important aspect of the formulary process is the involvement of all practitioners. Please contact your P&T Committee representative or your clinical service chief by July 15, 2017 if you wish to comment on any of the medications, class reviews, or other agenda items under consideration. To make formulary addition requests, you must submit a Formulary Additions/Deletions Form and Conflict of Interest Form to Drug Information Services or call (404) 949-5331.

Formulary Additions, Continued Doxepin oral concentrate solution 10 mg/ml added to the Commercial

Formulary effective June 30, 2017. Doxepin was originally approved by the FDA in 1969 for the treatment of depression and/or anxiety, depression and/or anxiety associated with alcoholism or with organic disease, and psychotic depressive disorders with associated anxiety. Currently, generic doxepin (10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg) is available on the KPGA Commercial formulary. In 2010, the FDA approved doxepin (Silenor®) 3 mg and 6 mg for the treatment of insomnia characterized by difficulty with sleep maintenance. The American Geriatrics Society 2015 updated Beers criteria advises to avoid doses of > 6 mg/day in patients 65 years and older to avoid high anticholinergic, and sedating side effects. The addition of doxepin 10 mg/ml concentrate solution to the KPGA Commercial formulary will provide a safer dose alternative for elderly patients as recommended by the 2015 Beers criteria and reduce the utilization of high risk medications in older patients.

Updated Beers Criteria: http://onlinelibrary.wiley.com/doi/10.1111/jgs.13702/epdf

Tacrolimus 0.03% and 0.1% Ointment added to the Commercial Formulary effective June 30, 2017. Tacrolimus is a topical calcineurin inhibitor indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in immunocompetent patients not responsive to conventional therapy or when conventional therapy is not appropriate. Currently, topical pimecrolimus (Elidel) 1% cream is on the KPGA Commercial Formulary. Both topical calcineurin inhibitors carry a boxed warning due to the association of these products and rare cases of malignancy (including skin and lymphoma). Therefore, these products are recommended for short-term and intermittent treatment using the minimum amount necessary for the control of symptoms and only on involved areas. Topical calcineurin agents are considered second-line therapies in the treatment of AD , and should be limited to patients who have failed treatment with other medications. The addition of tacrolimus ointment to the Commerical Formulary will provide an additional therapy with an alternative vehicle for use in AD. The step therapy requirement will also be removed for tacrolimus for ACA plans.

Ixazomib (Ninlaro) added to the Commercial Formulary effective June 30, 2017. Ixazomib is the first commericially available oral proteasome inhibitor (PI) approved for the treatment of patients with relapsed/refractory multiple myeloma as part of an oral triplet regimen, which includes an immunomodulatory drug and a corticosteroid. Ixazomib in combination with lenalidomide and dexamethasone has shown to have significantly prolonged progression-free survival (PFS) over lenalidomide and dexamethasone alone. The most frequently reported adverse reactions (>20%) in the Ninlaro based regimen were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, vomiting, back pain and peripheral edema. The National Comprehensive Cancer Network (NCCN) includes Ixazomib plus lenalidomide + dexamethasone as a Category 1 recommendation on the list of preferred regimens for patients with previously treated multiple myeloma.

New Criteria Restricted Medications (QRM)The following medications will be criteria restricted and subject to QRM review:

• Ocrelizumab (Ocrevus)• Class: Anti-CD20 monoclonal antibody• Mechanism of Action: Recombinant humanized IgG monoclonal antibody

directed against B-cells which express the cell surface antigen CD20• Indication: Treatment of adult patients with relapsing or primary progressive

forms of multiple sclerosis (MS).• Dupilumab (Dupixent)

• Class: Interleukin-4 (IL-4) receptor antagonist• Mechanism of Action: Inhibits IL-4 and IL-13 cytokine-induced responses,

including the release of proinflammatory cytokines, chemokines and IgE.Indication: Treatment of adult patients with moderate to severe atopicdermatitis whose disease is not adequately controlled with topicalprescription therapies or when those therapies are not advisable.

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Questions and concerns?

If you have any questions or concerns, please contact any of

the following P&T Committee members and designated

alternates:

P&T Chair:Carole Gardner, MD

P&T Committee Members:Debbi Baker, PharmD, BCPS

Clinical Pharmacy

Gary Beals, RPhDirector of Pharmacy

Karen Bolden, RN, BSNClinical Services

Alyssa Dayton, MDObstetrics and Gynecology

Carole Gardner, MDElder Care

David Jones, MDPediatrics

Craig Kaplan, MDAmbulatory Medicine

George Kawamura, MDAmbulatory Medicine

Amy Levine, MDPediatrics

Felecia Martin, PharmDPharmacy/Geriatrics

Shayne Mixon, PharmDPharmacy Operations

Rachel Robins, MDHospitalist

Jennifer Rodriguez, MDBehavioral Health

Designated Alternates:Jacqueline Anglade, MD

Obstetrics and Gynecology

Lesia Jackson, RNClinical Services

New Criteria Restricted Medications (QRM)Eluxadoline (Viberzi)-Effective September 30, 2017

• Class: Gastrointestinal Agent, Miscellaneous• Mechanism of Action: Mixed mu-opioid receptor agonist, delta opioid

receptor antagonist, and kappa opioid receptor agonist which acts locallyto reduce abdominal pain and diarrhea in patients with Irritable BowelSyndrome with diarrhea (IBS-D).

• Indication: Treatment of IBS-D in adults.

Changes to Criteria Restricted MedicationsDenosumab (Prolia)

• Includes correcting hypocalcemia prior to treatment and a baseline dentalexam as new criteria for approval.

• Allows Oncologists to prescribe in addition to Endocrinologists andRheumatologists

• Revised criteria to include documentation if clinical trial of IV bisphosphonatenot advisable or clinical barrier to trialing IV bisphosphonate.

National Medicare Part D FormularyKaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T Committee reviews drugs and decides on tier status. The National Medicare Part D Pharmacy and Therapeutics Committee is charged with reconciling regional differences in MPD Formulary recommendations through consensus building in order to maintain one National MPD Formulary for Kaiser Permanente.

Medication Name TierImplementation

Date

ustekinumab 45 mg/0.5 ml Injection (Stelara) 5 4/17/2017

pirfenidone 267 mg, 801 mg tablets (Esbriet) 5 4/19/2017

thiotepa 15 mg, 100 mg injection (Tepadina) 5 4/21/2017

niraparib tosylate 100 mg capsules (Zejula)** 5 4/25/2017

brigatinib 30 mg tablets (Alunbrig) 5 5/1/2017

durvalumab 120 mg/2.4 ml, 500 mg/10 ml injection (Imfinzi)** 5 5/2/2017

midostaurin 25 mg capsules (Rydapt)** 5 5/2/2017

abaloparatide 3120 mcg/1.56 ml subcutaneous injection (Tymlos)

5 5/2/2017

abiraterone acetate 500 mg tablets (Zytiga)** 5 5/2/2017

Ribociclib 200 m tablets/letrozole 2.5 mg tablets therapy pack (Kisqali 200, Kisqali 400, Kisqali 600)**

5 5/10/2017

trastuzumab 150 mg injection (Herceptin) 5 5/12/2017

abatacept 87.5 mg/0.7ml, 50 mg/0.4 ml injection (Orencia) 5 5/19/2017

edaravone 30 mg/100 ml injection (Radicava) 5 5/19/2017

rucaparib 250 mg tablets (Rubraca)** 5 5/22/2017

sarilumab 150 mg/1.14 ml, 200 mg/1.14 ml injection (Kevzara) 5 5/25/2017

methotrexate 2.5 mg/ml oral solution (Xatmep) 5 5/26/2017

**Protected Class

Intial Tier placements-Recently launched and approved Medications

Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine

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class review

August 2017:

Medication class Reviews

Endocrine and Metabolic agents-Misc

Analgesics-Non-narcotic

Analgesics-Opioids

Analgesics-Anti-inflammatory

Vitamins

Mutlivitamins

Minerals/Electrolytes

Hematopoietic Agents

Anticoagulants

Hemostatics

Otics

Mouth/throat/dental

Antiseptics & Disinfectants

Diagnostic Products

Skeletal Muscle Relaxants

Facts & Comparisons® has launched a new platform on Clinical Library

Medical Office Floorstock Additions

Approved medications will be added to the electronic floorstock ordering forms on the intranet.

Medication Department

Morphine 4 mg/ml Southwood Urgent Care

Sweet Ease

Azithromycin 250 mg tablets

Azithromycin 1 gm packets

Famotidine 20 mg tablets

Misoprostol 200 mcg UD tablets Procedure Suite Pyxis for OB D&C Hemorrhage kit medicationsMethergine IM 0.2 mg

Vasopressin Kit (100 units/250 or 500 ml NS)

Oxytocin IV Kit (2-4 vials w/500 ml LR)

Hemabate 250 mcg/ml ampules

Noteworthy NewsThe Quantity Limit for Hepatitis C Medications (14 days x 2, then 28 day supply) has

been increased to a 28-day supply for the following medications:

• Epclusa• Harvoni• Sovaldi• Technivie• Zepatier

Effective June 30, 2017

Found on the KP Clinical Library: http://fco.factsandcomparisons.com/action/home?siteid=2

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Non-Formulary Cost ConsiderationsClass Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls

Gastrointestinal Agents,

Miscellaneous

• Viberzi 100 mg BID or 75 mgBID

• OTC Imodium A-D 4mg afterfirst loose stool then 2mgafter each subsequent loosestool

• Diphenoxylate/Atropine2.5/0.025mg 2T QID

• Diphenoxylate/Atropine2.5/0.025mg/5ml 10ml QID

• Cholestyramine 4g 1-6 timesDAILY

• Xifaxan 550mg TID x 14d 0RFNF

• Alosetron 0.5mg BID NF

• Viberzi Rx is approximately 500X thecost of OTC Imodium

• Viberzi Rx is approximately 15X thecost of Diphenoxylate/Atropine

• Viberzi Rx is approximately 16X thecost of Cholestyramine

• Xifaxan is dosed for 14 days only (maybe redosed up to 2 times)

• Alosetron is only indicated for use inwomen with IBS-D

Tricyclic Antidepressants

• Silenor 3 mg or 6 mg QHS

• Doxepin oral concentratesolution 3- 6 mg QHS

• Zolpidem 5-10mg QHS• Trazodone 50-100mg QHS• Temazepam 15-30mg QHS• Zaleplon 5-10mg QHS• Eszopiclone 1-3mg QHS NF• Ambien CR 6.25-12.5mg QHS

NF

• Avoid Benzodiazepines and Non-Benzodiazepine hypnotics in theelderly. 2015 Updated Beers crite-ria: http://onlinelibrary.wiley.com/doi/10.1111/jgs.13702/epdf

• Silenor Rx is approximately 300X thecost of doxepin oral concentratesolution.

FDA Drug Safety Communication:Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may

be linked to an increased risk of bladder cancer.

http://www.fda.gov/Drugs/DrugSafety/ucm519616.htm

FDA Dug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in

young children and pregnant women.http://www.fda.gov/Drugs/DrugSafety/

ucm532356.htm

FDA REQUESTS REMOVAL OF OPANA ER FOR RISKS RELATED TO ABUSE

The FDA has requested that Endo Pharmaceuticals remove its opioid pain medication, Opana ER, from the market. The FDA’s decsion is based on a review of postmarketing data that has shown a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of Opana ER has been associated with a serious outbreak of HIV and Hepatitis C, and cases of thrombotic microangiopathy. The FDA has determined the benefits of reformulated Opana ER no longer outweigh the risks.

Opana ER (oxymorphone hydrochloride extended-release) was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Endo replaced the original formulation of Opana ER with the new formulation in 2012. The reformulated product is designed with physiochemical proper-ties intended to make the drug resistant to physical and chemical manipulation for abuse by snorting and injecting. Although the reformulated product was approved, the FDA determined that the drug did not meet the agency’s standards for being considered abuse-deterrent and therefore declined Endo’s request to include a description of abuse-deterrant properties in the product label-ing.

Several other related opioids are on the FDA’s radar including, generic oxymorphone extended release and generic oxymorphone immediate release. The Agency is currently assessing the available data on abuse patterns for these two drugs.

Opana ER (Brand and generic) is currently not on the KPGA Commercial Formulary and both the brand and generic ER products are on the Specialty Tier requiring step therapy for ACA plans.

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm562401.htm

Clinical Updates