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u Formulary Additions . . . . . . . . . . . . . . 1

I S S U E 2 V O L U M E 14 APR I L

Formulary Update

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 http://providers.kaiserpermanente.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.

At A Glance

uAdditions To QRM . . . . . . . . . . . . . . . 2 uQRM Updates. . . . . . . . . . . . . . . . . . . 3

Other Updates. . . . . . . . . . . . . . . . . . 5

National Medicare Part D Formulary . . . . . . . . . . . . . . . . . . . . . . . 4

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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 June 1, 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.

Interregional Practice RecommendationsThe 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 HealthConnect 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.

The following IR Practice recommendations/revisions have been recently approved:

• Oxbryta (Voxelotor): An HbS polymerization inhibitor that reversibly binds to Hb andstabilizes the oxygenated Hb state. It is indicated for the treatment of sickle cell disease inadults and pediatric patients aged 12 years and older.

• Endari (L-Glutamine): An amino acid indicated to reduce the acute complications of sickle celldisease in adult and pediatric patients 5 years of age and older. IR Practice recommendationsrevised to include: (1) Health Connect messaging that initial and follow-up smartphraseassessment templates have been developed for clinician documentation and (2) alternativetherapy additions of Crizanlizumab-tmca (Adakveo) and Voxelotor (Oxbryta) to treat patientswith sickle cell disease.

ETSP Guidelines as well as pipeline candidates can be found here: https://secure.sp.kp.org/teams/emergingtsc/SitePages/Home.aspx. Please note: Newly marketed medications requiring ETSP review will also receive prior authorization (PA) review. These medications will not be eligible for consideration of drug benefit coverage until completion of drug specific ESTP and PA criteria review processes.

Additions to QRM (Prior Authorization)Effective 5.13.20:

• Afrezza (insulin-oral inhalation) is indicated for the treatment of diabetes mellitus(type 1 or type 2) to improve glycemic control. (Non-preferred medication, numerous formulary alternatives available)

• Auvi-Q (epinephrine) is indicated for the treatment of type I allergic reactions, including anaphylactic reactions. (Non-preferred medication delivery device, considerAdrenaclick [epinephrine injection] as preferred alternative medication)

• Diacomit (stiripentol) is indicated as adjunctive treatment of refractory generalized tonic-clonic seizures in conjunction with clobazam and valproic acid (off-label) in patients ≥2 years with Dravet syndrome.

• Northera (droxidopa) is indicated for the treatment of orthostatic dizziness, light-headedness, or the “feeling that you are about to black out” in adults with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

• Rozylytrek (entrectinib) is indicated for the treatment of metastatic non-small cell lung cancer in adults whose tumors are ROS1-positive; treatment of solid tumors in adult and pediatric patients ≥12 years of age that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or have no satisfactory alternative therapy.

• Vitrakvi (larotrectinib) is indicated for treatment of solid tumors (in adult and pediatric patients) that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatment.

• Elmiron (pentosan polysulfate) is indicated for relief of bladder pain or discomfort due to interstitial cystitis.

• Otezla (apremilast) is indicated for treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; treatment of active psoriatic arthritis; treatment of oral ulcers associated with Behçet disease.

• Vascepa (icosapent ethyl) is indicated for cardiovascular risk reduction with mild hypertriglyceridemia; as an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia.

Effective 8.12.20:

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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, BCPSClinical Pharmacy

Gary Beals, RPhExecutive Director, Pharmacy Operations

Karen Bolden, RN, BSNClinical Services

Hector Clarke, PharmD, BCOP Ambulatory Pharmacy

Alyssa Dayton, MDObstetrics and Gynecology

Pierson Gladney, MD Hematology/Oncology

Patrick Hall, MDAdult Primary Care

Craig Kaplan, MDAdult Primary Care

Amy Levine, MDPediatrics

Sophie Lukashok, MDInfectious Disease

Felecia Martin, PharmDPharmacy/Geriatrics

Shayne Mixon, PharmDPharmacy Operations

Jay Polokoff, MDPediatrics

Rachel Robins, MDHospitalist

Jennifer Rodriguez, MDBehavioral Health

Designated Alternates:Jacqueline Anglade, MD Obstetrics and Gynecology

Lesia Jackson, RNClinical Services

Satya Jayanthi, MDHospitalist

QRM Updates• Asthma Biologics:

o Cinqair (reslizumab)- updated trial medication to Fasenra (benralizumab)[KPGA’s preferred interleukin-5 antagonist] and Dupixent (dupilumab).

o Fasenra (benralizumab)- updated age criteria to ≥12 years of age; changed dosage/administration and monitoring for patient/caregiver administration.

o Nucala (mepolizumab)- updated age criteria to ≥6 years of age; age criteria of ≥12 years of age and trial medication added for severe asthma w/an eosinophilic phenotype; changed dosage/administration and monitoring for patient/caregiver administration.

o Dupixent (dupilumab)- updated trial medication to KPGA preferred Fasenra(benralizumab) [KPGA’s preferred interleukin-5 antagonist].

• Dupixent (dupilumab)- updated with addition of BSA >10% for atopic dermatitis and minimum 2 week duration for topical therapies.

• GLP-1 receptor agonists- updated with addition of Rybelsus (semiglutide) as preferred GLP-1 receptor agonist medication; addition of criteria for members with ASCVD.

• Humira (adalimumab) and Inflectra (infliximab)- updated criteria to include the diagnosis of hidradentitis suppurativa.

• Remicade (infliximab)- updated to allow for Remicade coverage in pediatric patients ≤ 18 years of age.

• SGLT-2 and DPP-4 inhibitors- updated to align with recent update to KP DM National Clinical Practice Guidelines.

• Xyrem (sodium oxybate)-includes clarification when to confirm a patient is negative for succinic semialdehyde dehydrogenase; addition of indication for excessive daytime sleepiness; removal of atomoxetine as a trial medication.

Prior Authorization criteria can be found here: http://kpnet.kp.org:81/ga/healthcare/docs/drug restrictedMedications.pdf

Medications Not Added to the Formulary• Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) is a three-drug

combination indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine, lamivudine, or tenofovir disoproxil fumarate. Delstrigo joins an increasingly crowded market of single-tablet, complete regimens for the treatment of HIV-1 infection. Factors that lead to non-formulary status include co-formulation with TDF instead of TAF (the latter of which has been associated with less bone/renal toxicity), indications currently limited to adults, the lack of safety data in pregnancy, and DHHS treatment guidelines that recommend integrase strand transfer inhibitor (INSTI)-based regimens for initial therapy in most patients with HIV.

• Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. Although doravirine is proven efficacious and well-tolerated, studies demonstrate the noninferiority of doravirine to both efavirenz (EFV) and darunavir/ritonavir (DRV/r) when taken in combination with two NRTIs and switching to DOR/3TC/TDF was noninferior to continuing prior baseline regimens with respect to maintaining virologic suppression.

• Pretomanid is an antimycobacterial drug that kills actively replicating Mycobacterium tuberculosis by inhibiting mycolic acid biosynthesis, blocking cell wall production. It is indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant, or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Prescribing of this medication is restricted to Infectious Disease and Pulmonology specialists.

• Xenleta (lefamulin) is pleuromutilin that inhibits bacterial protein synthesis through interactions with the A- and P-sites of the peptidyl transferase center (PTC) of the rRNA 50S subunit, indicated for the treatment of adults with CABP caused by susceptible microorganisms. Lefamulin demonstrated non-inferiority in comparison to moxifloxacin for the treatment of community-acquired bacterial pneumonia; and IV and oral formulations may facilitate oral step down. The cost of lefamulin is significantly higher than currently available generic treatment options.

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Class Review

June 2020:

Medication Class ReviewsAndrogen/Anabolic

Anorectal

Antidiabetics

AntiemeticsAntineoplastics

Corticosteroids

Dietary Products/Dietary Management Products

Digestive aids AgentsGastrointestinal Agents -

Misc

Gout Agents

Ophthalmic Agents

Pharmaceutical AdjuvantsThyroid

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 rec-ommendations through consensus building in order to maintain one National MPD Formulary for Kaiser Permanente.

Initial Tier Placements-Recently launched and approved medications

Medication Tier Effective Date

teriparatide 620 mcg/2.48 mL injection 5 3/24/2020

thiotepa 100 mg injection (generic) 5 3/23/2020

cenobamate 50 mg, 100 mg, 150 mg, 200 mg tablets; 50/100, 50/200, 150/200 titration packs (Xcopri)

5 3/23/2020

trastuzumab-pkrb 150 mg, 420 mg injection (Herzuma) 5 3/16/2020

rimegepant sulfate 75 mg disintegrating tablets (Nurtec ODT) 5 3/9/2020

isatuximab-irfc 100 mg/5 mL, 500 mg/25 mL injection (Sarclisa) 5 3/9/2020

palbociclib 75 mg, 100 mg, 125 mg tablets (Ibrance) 5 3/9/2020

cysteamine bitartrate 75 mg, 300 mg delayed release granules packet (Procysbi)

5 2/19/2020

trastuzumab-qyyp 420 mg injection (Trazimera) 5 2/18/2020

etoposide phosphate 100 mg injection (Etopophos) 5 2/18/2020

peanut allergen powder level 1-10 capsules, level 1 initial dose escalation capsules, level 11 initial and maintenance capsules (Palforzia)

5 2/17/2020

cefiderocol sulfate tosylate 1 gm injection (Fetroja) 5 2/17/2020

tazemetostat Hbr 200 mg tablets (Tazverik) 5 1/28/2020

rituximab-pvvr 100 mg/10 mL, 500 mg/50 mL injection (Ruxience) 5 1/27/2020

teprotumumab-trbw 500 mg injection (Tepezza) 5 1/24/2020

generic-calcipotriene/betamethasone dipropionate 0.005-0.064% suspension

5 1/20/2020

lumateperone tosylate 42 mg capsules (Caplyta) 5 1/17/2020

imipenem-cilastatin-relebactam 500 mg-500 mg-250 mg injection (Recarbrio)

5 1/13/2020

isotretinoin micronized 8 mg, 16 mg, 24 mg, 32 mg capsules (Absorica LD)

5 1/6/2020

bevacizumab-bvzr 100 mg/4 mL, 400 mg/16 mL injection (Zirabev) 5 1/6/2020

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In the News....

EPIDIOLEX® Oral Solution De-Scheduled by DEA

On April 6, 2020, Greenwich (GW) pharmaceuticals announced in a press release that the United States Drug Enforcement Administration (DEA) has de-scheduled Epidiolex, making it no longer a controlled substance under the federal Controlled Substances Act (CSA). Prior to this notification, the drug was listed under Schedule V of the CSA. Schedule V drugs are defined as substances or chemicals with a lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Epidiolex is a cannabidiol oral solution, indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients ≥2 years of age. Although federal controlled-substance restrictions for Epidiolex have been removed, the medication remains a controlled substance in several states. The company is now in the process of implementing the de-scheduling change at the state level to allow providers the ability to write prescriptions for up to 1 year and allow transfers between pharmacies for dispensing. Once changes cascade down to the the state level, physicians will be able to prescribe Epidiolex without the restrictions imposed by state prescription drug monitoring programs.

1. Greenwich Pharmaceuticals. GW Pharmaceuticals plc and Its U.S. Subsidiary Greenwich Biosciences, Inc. Announce ThatEPIDIOLEX® (cannabidiol) Oral Solution Has Been Descheduled And Is No Longer A Controlled Substance. Press Release. http://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-plc-and-its-us-subsidiary-greenwich-1. Accessed May5, 2020.

2. Epidiolex. [package insert]. Carlsbad, CA, Greenwich Biosciences, Inc; 20183. United States Drug Enforcement Administration. Drug Scheduling. https://www.dea.gov/drug-scheduling. Accessed May 5,

2020