Formulary. Update. At A Glance. Formulary Additions ISSUE 4 VOLUME 11 AUGUST 2017

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1 ISSUE 4 VOLUME 11 AUGUST 2017 u Formulary Additions unew Criteria Restricted Medications ,3 umedications not added to the Formulary unational Medicare Part D Formulary uclinical Update Formulary Update At A Glance Formulary Additions A PUBLICATION OF THE GEORGIA PHARMACY AND THERAPEUTICS (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 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. Advair Diskus (fluticasone/salmeterol) 250/50 mcg and 500/50 mcg will be added to the Commercial Formulary effective August 25th, Advair Diskus is a combined corticosteroid (ICS) and long-acting beta2-agonist (LABA) inhaler used for asthma and chronic obstructive pulmonary disease. Dulera (mometasone/formoterol) is currently the preferred agent on the KPGA Commercial Formulary, however, it will be removed from the KPGA formulary effective Jan 1, 2018 as a result of the contracted price for Advair Diskus becoming significantly lower than Dulera by the end of the year. There is a National Kaiser Permanente initiative to switch patients from Dulera to Advair Diskus. Conversion from Dulera to Advair Diskus will be based on the standing order below. Studies have shown that Dulera and Advair Diskus are similar in safety and efficacy. Kaiser Permanente Georgia 1

2 Formulary Additions, Continued The following changes to the KPGA formulary are as follows: Upcoming Formulary Items Advair Diskus 250/50 mcg and 500/50 mcg will be added to the Commercial Formulary effective August 25, Step therapy will be removed from Advair Diskus on the QHP Formulary for the 250/50 mcg and 500/50 mcg strengths effective August 25, Dulera will be removed from the Commercial Formulary effective January 1st, Step therapy will be added back to Dulera on the QHP Formulary effective January 1st, The lowest strength of Advair Diskus (100/50 mcg) will remain non-formulary on the Commercial Formulary and non-preferred tier 4 with step therapy on the QHP Formulary. Advair HFA will remain non-formulary on the KPGA Formulary Standing Order: Dulera to Advair Diskus Dulera Equivalent To Advair Diskus Dulera 100/5 mcg two inhalations twice daily Dulera 200/5mcg two inhalations twice daily Advair Diskus 250/50 mcg one inhalation twice daily Advair Diskus 500/50 mcg one inhalation twice daily 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 September 15, 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) New Criteria Restricted Medications (QRM) Criteria restricted medications require review by Quality Resource Management (QRM) prior to coverage. The prior authorization process and criteria apply to all formularies except the Medicare Part D Formulary. A complete listing of prior authorization medications and their corresponding criteria is available on the intranet under Healthcare Delivery/Guides & References/Formularies/Criteria Restricted (QRM) Medications. The following medications will be added to the list of Criteria Restricted Medications (QRM): Insulin Degludec/Liraglutide (Xultophy) -Class: Antidiabetic -Mechanism of Action: GLP-1 Receptor Agonist with Long Acting Insulin -Indication: Improve glycemic control in adult patients with T2DM Insulin Glargine/Lixesenatide (Soliqua) -Class: Antidiabetic -Mechanism of Action: GLP-1 Receptor Agonist with Long Acting Insulin -Indication: Improve glycemic control in adult patients with T2DM Miltefosine (Impavido) -Class: Antiparasitic Agent -Mechanism of Action: Exact mechanism unknown -Indication: Visceral, cutaneous, and mucosal leishmaniasis 2 Kaiser Permanente Georgia

3 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, RPh Director of Pharmacy Karen Bolden, RN, BSN Clinical Services Alyssa Dayton, MD Obstetrics and Gynecology Carole Gardner, MD Geriatric Medicine David Jones, MD Pediatrics Craig Kaplan, MD Adult Primary Care George Kawamura, MD Adult Primary Care Amy Levine, MD Pediatrics Felecia Martin, PharmD Pharmacy/Geriatrics Shayne Mixon, PharmD Pharmacy Operations Rachel Robins, MD Hospitalist Jennifer Rodriguez, MD Behavioral Health Designated Alternates: Jacqueline Anglade, MD Obstetrics and Gynecology Lesia Jackson, RN Clinical Services New Criteria Restricted Medications (QRM), Continued Ixekizumab (Taltz) -Class: Monoclonal antibody (humanized interleukin-17a antagonist) -Mechanism of Action: Inhibits the release of proinflammatory cytokines -Indication: Adults with moderate-to-severe plaque psoriasis -Effective Date: September 27, 2017 Ustekinumab (Stelara) -Class: Monoclonal antibody (human interleukin-12 and -23 antagonist) -Mechanism of Action: Binds to and interferes with proinflammatory cytokines -Indication: Moderate to severe plaque psoriasis, active psoriatic arthritis, alone or in combination with methotrexate, and moderately to severely active Crohn s disease (CD) Teriparatide (Forteo) -Class: Parathyroid -Mechanism of Action: Parathyroid hormone analog -Indication: Treatment of postmenopausal women with osteoporosis at high risk for fracture, increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture Interferon beta-1 a (Rebif) -Class: Interferon beta -Mechanism of Action: Alters expression and response to surface antigens -Indication: Relapsing forms of multiple sclerosis Changes to QRM Criteria Glatiramer Acetate (Glatopa): Criteria now include addressing use in females of child bearing potential (12-50 years of age) with intent to conceive within the next 1 year Medications Reviewed, but not added to the Formulary: Eucrisa (Crisaborole) is a topical phosphodiesterase 4 (PDE-4 ) inhibitor indicated for mild to moderate atopic dermatitis. This medication is a third line agent for the treatment of atopic dermatitis after topical steroids and calcineurin inhibitors. Crisaborole is currently on the non-preferred tier (Tier 4) of the National MPD formulary. Isentress HD (Raltegravir) is an antiviral medication for HIV patients that are treatmentnaïve or virologically suppressed on an initial regimen of raltegravir (Isentress) 400mg twice daily. Due to the differences in the indication compared to Isentress 400 and lower-cost formulary alternatives, this medication will not be added to the Commercial Formulary. Decision pending for National MPD Formulary. Kaiser Permanente Georgia 3

4 Medicare Part D Kaiser 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. Class Review Intial Tier placements-recently launched and approved Medications Medication Name Tier Implementation Date Aripiprazole Lauroxil 1064mg/3.9 ml injection (Aristada) Aripiprazole lauroxil 882 mg/3.2 ml injection (Aristada) Treprostinil diolamine 5 mg CR tablets (Orenitram) Dronabinol 5 mg/ml solution (Syndros) Brodalumab 210 mg/1.5 ml subcutaneous injections (Siliq) Deferasirox 90 mg, 180 mg, 360 mg granules packet (Jadenu Sprinkles) Rituximab 1400 mg/23400 units/11.7 ml; 1600 mg/26800 units/13.4 ml injections (Rituxan Hycela) ** C1 esterase inhibitor (human) 2000 unit; 3000 unit injection (Haegarda) Guselkumab 100 mg/ml injection (Tremfya) Neratinib maleate 40 mg tablets (Nerlynx)** ** Protected class 6/9/2017 7/4/2017 6/16/2017 6/20/2017 6/22/2017 6/26/2017 6/27/2017 7/14/2017 7/18/2017 7/19/2017 October 2017: Medication Class Reviews Laxatives Antidiarrheals Antacids Ulcer Medications Medical Devices Antidotes Cardiotonics Estrogens Contraceptives, oral Progestins Oxytocics Vaginal Products Chemicals Noteworthy News Glaxo Smith Kline (GSK) has made the decision to discontinue further marketing of Tanzeum (Albiglutide). Albiglutide is a GLP-1A receptor agonist for the treatment of Type 2 Diabetes. GSK expects commercial supply to be depleted by July 2018 allowing for sufficient time to transition existing patients. Currently, albiglutide is a criteria-restricted (QRM) Medication that requires review prior to dispensing at KPGA. Kaiser Permanente Georgia 4

5 Non-Formulary Cost Considerations Class Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls Atopic Dermatitis (Eczema)-Topical Eucrisa (Crisaborole) Betamethasone Val 0.1 % Cream Mometasone 0.1% Ointment/ Cream Triamcinolone 0.1% Ointment/ Cream Tacrolimus Ointment 0.1%, 0.03% Elidel (Pimecrolimus) 1% Cream Eucrisa costs approximately X the cost of topical corticosteroids. Eucrisa costs approximately X the cost of topical calcineurin inhibitors Use of Eucrisa should only be considered in patients with an intolerance, inadequate response or loss of response to topical steroids and topical calcineurin inhibitors Antiretroviral Agents Isentress HD (Raltegravir) 600 mg Genvoya (Elvitegravir, cobistat, Emtricitabine, tenofovir alafenamide) Isentress (Raltegravir) 400 mg + Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tivicay (Dolutegravir) + Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) The once daily preferred formulary agent, Genvoya, is the more costeffective antiretroviral for HIV. Isentress HD, Isentress and Tivicay all must be taken in combination with other antiretroviral agents for the treatment of HIV Infection. Genvoya can be taken once daily as monotherapy. Clinical Updates Two new medications to treat Hepatitis C virus (HCV) have been approved by the FDA- Vosevi approved on July 18th, 2017 and Mavyret approved on August 3rd, According to the Centers for Disease Control and Prevention (CDC), approximately 2.7 to 3.9 million people in the United States have HCV, a viral disease that causes inflammation of the liver and can lead to diminished liver function or liver failure. Early diagnosis and treatment of chronic HCV can prevent liver damage. Vosevi, (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) is used to treat adults with chronic HCV genotypes 1-6 without cirrhosis or with mild cirrhosis. Vosevi is the first treatment approved for patients who have tried advanced treatment and haven t been cured. The recommended dose is one tablet, every day with food, for twelve weeks. The safety and efficacy of Vosevi was evaluated in two Phase 3 clinical trials that enrolled approximately 750 adults without cirrhosis or with mild cirrhosis. Results of both trials demonstrated that 96-97% of patients who received Vosevi had no virus detected in the blood 12 weeks after finishing treatment. The most common adverse reactions in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Mavyret (glecaprevir and pibrentasvir) is the first approved treatment to be used for eight weeks and is indicated for all HCV genotypes 1-6 in adults without cirrhosis who have not been previously treated. Mavyret is also approved for adult patients with HCV genotype 1 infection who have already undergone treatment with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor and for patients with moderate to severe kidney disease including those on dialysis. This drug combo needs to be taken as three pills once a day. The safety and efficacy of Mavyret was evaluated in a clinical trial which enrolled approximately 2,300 adults with genotype 1-6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that % of patients who received Mavyret for 8, 12 or 16 weeks duration showed no virus detected in the blood 12 weeks after finishing treatment. Treatment duration with Mavyret differs depending on treatment history, viral genotype, and cirrhosis status. The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea. Kaiser Permanente Georgia 5