Kaiser Permanente Georgia 1

u Formulary Additions . . . . . . . . . 1,2

I S S U E 3 V O L U M E 12 J U N E 2018

FormularyUpdate

uNational Medicare Part D Formulary . . . . . . . . . . . . . . . . . . . . 3,4

A P U B L I C AT I O N O F T H E G E O R G I A P H A R M A C Y A N D T H E R A P E U T I C S ( P & T ) C O M M I T T E E . 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.

uOther Updates. . . . . . . . . . . . . . . . . 5

Formulary Additions

At A Glance

uAdditions to QRM . . . . . . . . . . . . 2 uQRM Updates . . . . . . . . . . . . . . . . . 3 uFloorstock changes. . . . . . . . . . . . . 3

The following medications were added to the Commercial Formulary effective June 6, 2018:• Biktarvy (Bictegravir/emtricitabine/tenofovir alafenamide) is indicated as a

complete regimen for the treatment of HIV-1 in adults. It is the first co-formulated integrase strand transfer inhibitor (INSTI)-based regimen that does not contain a pharmacokinetic booster and contains the alafenamide prodrug of tenofovir, TAF. Thus, it may provide clinical advantages in comparison to other boosted antiretrovial regimens ( e.g. Genvoya, Stribild) that have greater potential for drug-drug interactions. In addition, TAF offers potential safety advantages, including lower risk of renal toxicity and bone mineral density changes.

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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 20th, 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.

The following medications will be added to the Commercial Formulary effective July 5, 2018:

• Cimduo (Lamivudine/tenofovir disoproxil) is a dual fixed dose combination of the nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) lamivudine (3TC) and tenofovir disoproxil (TDF) indicated in combination with other anti-retrovirals for the treatment of HIV-1 infection in adult and pediatric patients weighing > 35 kg. 3TC is structurally related to FTC (emtricitabine) and they are considered pharmacologically equivalent and clinically interchangeable by the World Health Organization. The cost of Cimduo is 40% lower than the fixed dose combination Truvada. This drug has been added to the brand adjudicated to generic list. Therefore, Cimduo allows patients to have a lower cost option for the treatment of HIV. Cimduo has not yet been studied in HIV-1 pre-exposure prophylaxis (PrEP), so is not approved for use in PrEP.

• Diclofenac 1% topical gel is a non-steroidal anti-inflammatory drug (NSAID) formulated for direct application to a painful site for the relief of pain due to osteoarthritis. Topical diclofenac has the potential to limit systemic adverse events by minimizing systemic concentrations of diclofenac compared to oral administration. The addition of diclofenac topical gel provides a safe, non-opioid option for osteoarthritis with less systemic absorption and GI risks.

The following oral contraceptives will be added to the Commercial Formulary effective July 5, 2018:

• Jolessa (levonorgestrel-ethinyl estradiol)-generic for Seasonale• Drosperinone-ethinyl estradiol 3-0.02 mg -generic for Yaz• Drospirenone-ethinyl estradiol 3-0.03 mg- generic for Yasmin• Tri-Lo Sprintec (norgestimate-ethinyl estradiol)- generic for Ortho Tri-Cyclen Lo

Interregional Practice Recommendations

The Emerging Therapeutics Strategy (ETS) Program is a centralized effort that applies our evidence-based model to develop interregional practice recommendations with KP physician specialists, coordinates KP HeathConnect clinical content for decision support, and monitors outcomes to measure uptake of the clinical and strategy recommendations. Through the collaboration of Pharmacy, Permanente physicians, and Federation partners, the ETS Program offers a unified approach in the provision and management of specialty drugs, to help ensure that our members derive the greatest value from these products.

New Interregional Practice Recommendations have been approved for the following ETS Program Medications:

• Hemlibra (emicizumab-kxwh) is a bispecific factor IXa and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Guidelines can be found here: https://sites.sp.kp.org/teams/npps/sitepages/home.aspx

Formulary Additions, Con’t• Symfi (Efavirez, lamivudine/tenofovir disoproxil) is indicated as a complete regimen for the

treatment of HIV-1 infection in adult and pediatric patients weighing > 40 kg. This drug is therapeutically similar to the branded combination product Atripla. The wholesale acquisition cost (WAC) of Symfi is 40% lower than Atripla. This drug has been added to the brand adjudicated to generic list. Therefore, Symfi allows patients to have a lower cost option for the treatment of HIV.

• Rosuvastatin is a high intensity statin option for patients unable to tolerate other statins due to muscle aches or myalgia. Since rosuvastatin is not significantly eliminated by CYP450 enzymes, it has a low potential for drug-drug interactions. Atorvastatin will remain the KPGA preferred statin.

• Ezetimibe is a cholesterol inhibtor indicated for the treatment of hypercholesterolemia. it is recommended in combination with a statin for high-risk individuals with ASCVD or for those who cannot tolerate statin therapy.

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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, MDGeriatric Medicine

Jay Polokoff, MDPediatrics

Craig Kaplan, MDAdult Primary Care

George Kawamura, MDAdult Primary Care

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

Additions to QRM

Departmental Floorstock AdditionsMedication Department

Magnesium Oxide 400 mg tabletsChlorothiazide 250 mg tabletsMetolazone 2.5 mg tabletsPotassium 20 meq tablets

Cardiology

Makena 1.25 gm/5 ml OB/GYN

Ceftriaxone 1 gm vials Pulmonology

Medicare Part DKaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T Com-mittee 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 Formu-lary for Kaiser Permanente.

The following medications were reviewed at the June P&T Meeting for Medicare Part D coverage:

1. Copanlisib (Aliqopa) intravenous: Specialty Tier 52. Durvalumab (Imfinzi) intravenous: Specialty Tier 5

2018 Tier changes

• Retacrit Inj 40000 Unit -downtier to Tier 4• Zenpep Cap 3000, 15000 Unit- Tier 3 Placement• Palonosetron Inj 0.25/2 ml-downtier to Tier 4

Changes to QRM Criteria• Asthma monoclonal antibodies (Nucala, Cinqair, Xolair): Updated to include our formulary

ICS/LABA (Advair Diskus) and risk of malignancy included in Cinqair criteria.• Harvoni: Criteria changed for 8 weeks of therapy course• Kalydeco: Monitoring parameters moved to criteria for initial and continued approval.

Please see full QRM guidelines here: http://kpnet.kp.org:81/ga/healthcare/docs/drug/restrict-edMedications.pdf

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Class Review

August 2018:

Medication Class ReviewsEndocrine and Metabolic

Agents-misc

Analgesics- Non-Narcotic

Analgesics-OpioidsAnalgesics-Antiinflammatory

;dH VitaminsoticsMulti-vitamins

Minerals & Electrolytes

Hematopoietic AgentsAnticoagulants

HemostaticsOtic

Mouth/throat/dentalAntiseptics & Disinfectants

Diagnostic ProductsSkeletal Muscle Relaxants

Medicare Part D, Con’tIntial Tier Placements-Recently launched and approved medications

Medication Name Tier Implementation Dateertugliflozin and metformin 2.5-500 mg, 2.5-1000 mg, 7.5-500 mg, 7.5-1000 mg tablets (Segluromet)

Non-Preferred

Tier 42/1/2018

ertugliflozin and sitagliptin 5 -100 mg, 15-100 mg tablets (Stelujan)

Non-Preferred

Tier 42/1/2018

ertugliflozin 5 mg, 15 mg tablets (Steglatro) Non-

Preferred Tier 4

2/1/2018

bictegravir-emtricitabine-tenofovir alagenamide 50mg/200mg/25 mg tablets (Biktarvy)**

Non-Preferred

Tier 42/7/2018

nilotinib 50 mg capsules Specialty Tier 5 3/28/2018

ranibizumab 0.3 mg, 0.5 mg injection (Lucentis) Specialty Tier 5 3/29/2018

efavirenz, lamivudine and tenofovir disoproxil fumarate 400 mg, 300 mg, 300 mg tablets (Symfi lo)**

Non-preferred Brand Tier

4

4/5/2018

burosumab-twza 10 mg/ml, 20 mg/ml, 30 mg/ml injection (Crysvita)

Specialty Tier 5 4/24/2018

adalimumab 10 mg/0.1 ml, 20 mg/0.2 ml, 40 mg/0.4 ml (Humira)adalimumab 40 mg/0.4 ml pen-injector kit (Humira)adalimumab 80 mg/0.8 ml injection; 80 mg/0.8 ml,80 mg/0.8 ml & 40 mg/0.4 ml injection kit (Humira Pediatric Crohn’s)

Specialty Tier 5 4/25/2018

tolvaptan 45 mg/15 mg, 60 mg/30 mg, 90 mg/30 mg chew-able tablets (Jynarque)

Specialty Tier 5 4/26/2018

fosnetupitant and palonosetron 235 mg; 0.25 mg injection (Akynzeo)

Non-preferred

Tier 44/26/2018

fostamatinib disodium 100 mg, 150 mg tablets (Tavalisse) Specialty Tier 5 5/11/2018

sarilumab 150 mg/1.14 ml, 200 mg/1.14 ml injection (Kev-zara)

Specialty Tier 5 5/25/2018

epoetin alfa-epbx 2000 units/ml, 3000 units/ml, 4000 units/ml, 10,000 units/ml injection (Retacrit)

Non-Preferred

Tier 45/25/2018

ibalizumab-uiyk 150 mg/ml injection (Trogarzo)** Specialty Tier 5 Pending

**Protected Class

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Drugs Not Added to the FormularyVerzenio (abemaciclib):• Treatment in combination with fulvestrant for the treatment of women with hormone receptor (HR) positive, human epidermal growth

factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

• Monotherapy for the treatment of adult patients with HR positive, HER2 negative advanced or metastatic breast cancer with diseaseprogression following endocrine therapy and prior chemotherapy in the metastatic setting.

• In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women withHR-positive, HER2-negative advanced or metastatic breast cancer

Calquence (acalabrutinib): Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

Symfi-Lo (efavirenz 400 mg, lamivudine, and tenofovir disoproxil): Treament of HIV-1 infection in adult and pediatric patients weighing > 35 kg.

Standing Order for Oxybutnin to TrospiumOxybutnin is an antimuscarinic agent indicated for the treatment of overactive bladder. Trospium provides comparable efficacy at the therapeutically equivalent doses listed below. However, trospium is more preferred in older adults due to structural differences resulting in lower lipophilicity and central nervous system side effects such as cognitive impairment.

Inclusions: Patients aged 64 years and older without previous trial of trospium.

Coming soon......Effective 8/31/2018, prescriptions for Lyrica (pregabalin) [all strengths] will have a quantity limit of 60 capsules per month. Lyrica is currently one of KPGA’s top utilized, non-preferred drugs by cost despite its non-formulary satus. Lyrica is FDA-approved for the management of neuropathic pain (NP) associated with diabetic perhipheral neuropathy (DPN), NP associated with spinal cord injury, postherpetic neuralgia, fibromyalgia, and adjunctive therapy for adult patients with partial onset seizures. Note: Does not apply to QHP Plans for 2018.

Approximately 40% of KPGA’s total utilization exceeds two capsules per day per patient, although most indications can be managed with twice daily dosing. An exception process to request higher quantities per month for those patients who fail twice daily dosing will be available for prescribers.

Product DiscontinuationTeva has discontinued manufacturing of estropipate tablets ( 0.75 mg, 1.5 mg, and 3 mg) and is exiting the market. The supply of the 3 mg tablets has been depleted at the manufacturer and wholesaler levels. Estropipate 0.75 mg and 1.5 mg tablets are still available from the wholesaler however limited supply is available.

As alternatives are considered: First, determine if hormone therapy is still needed. Hormone therapy should be used for the shortest duration possible and generally within 10 years of menopause. Patients with clinical ASCVD or ASCVD risk > 10% should generally not be started or continued on hormone therapy.

For vasomotor symptoms, consider preferred estradiol oral/patch, ring or cream

For vaginal/vulvar atrophy, consider preferred local vaginal estrogen (Estradiol vaginal cream (generic for Estrace), Yuvafem tablets (generic for Vagifem) or Estring).