Kaiser Permanente Georgia 1

u Formulary Removals . . . . . . . . . . . 1

I S S U E 4 V O L U M E 13 A U G U S T

Formulary Update

uNational Medicare Part D Formulary . . . . . . . . . . . . . . . . . . . . 3

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.

uOther Updates. . . . . . . . . . . . . . . 4,5

Formulary Removals

At A Glance

uAdditions to QRM . . . . . . . . . . . .2

uQRM Updates . . . . . . . . . . . . . . . . . . 4

The following medications will be removed from the Commercial Formulary effective September 25, 2019:

• Hydrocortisone acetate suppositories (Anucort-HC): Hydrocortisone acetate suppositories will be removed from the KPGA Commercial Formulary and shifted to OTC alternatives and hydrocortisone 2.5% cream. Shifting utilization to hydrocortisone 2.5% cream will have a quarterly savings of approximately $70,000.

• Ibrutinib (Imbruvica) 140mg, 240mg tablets: Ibrutinib is an irreversible Bruton’s tyrosine kinase inhibitor that is used for multiple indications, including mantle cell lymphoma and chronic lymphocytic leukemia, etc. The strengths available at KPGA are 70mg and 140mg capsules and 140mg, 280mg, 420mg, and 560mg tablets. The 140mg and 280mg tablets will be removed from formulary due to higher cost.

W r i t t e n b y : L u n a S o u f i , P h a r m D a n d K a r a n P a t e l , P h a r m D E d i t e d b y : M i c h e l l e R o g e r s , P h a r m D

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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 October 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 have been recently approved:

• Zulresso (brexanolone): A GABA-A receptor positive modulator which is indicated forthe treatment of postpartum depression (PPD) in adults. Brexanolone is administeredvia continuous infusion over a span of 60 hours in an inpatient infusion setting. Themedication has a Risk Evaluation and Mitigation Strategy (REMS) due to the risk ofexcessive sedation and sudden loss of consciousness.

• Vyndaqel (tafamidis meglumine)/ Vyndamax (tafamidis): A transthyretin stabilizerindicated for the treatment of the cardiomyopathy of wild type or hereditarytransthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality andcardiovascular-related hospitalizations. The medication was approved by the FDAin 2019 as a 20mg capsule (Vyndaquel) and as a 61 mg capsule (Vyndamax). Tafamidismeglumine and tafamidis are not substitutable on a per mg basis.

• Zolgensma (onasemnogene abeparvovec-xioi): An adeno-associated virus vector-based gene therapy which is indicated for the treatment of pediatric patients less than2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutation in the SMN1gene. The medication is a one-time treatment and is administered via continuousinfusion over 60 minutes in an infusion clinic.

ETSP Guidelines as well as pipeline candidates can be found here: https://sites.sp.kp.org/teams/npps/sitepages/home.aspx

Additions to QRM (Prior Authorization)• Doptelet (avatrombopag) is indicated for the treatment of thrombocytopenia in adult

patients with chronic liver disease who are scheduled to undergo a procedure. Al-though avatrombopag showed a significant reduction in the need for platelet trans-fusions versus placebo, over 30% of patients treated with high-dose avatrombopagin Phase 3 clinical trials still required a platelet transfusion or rescue procedure forbleeding. QRM Criteria are pending.

• Mulpleta (lusutrombopag) is the second FDA-approved pharmacotherapy indicatedfor the treatment of thrombocytopenia (TCP) in adults with chronic liver diseasescheduled to undergo a procedure. Due to the variability in bleeding risk for pro-cedures performed, the degree of benefit a patient may experience with use oflusutrombopag is uncertain. Therefore, it may be reasonable to monitor patientsundergoing low bleeding risk procedures instead of prophylactically treating patientswith lusutrombopag. QRM Criteria are pending.

• Qbrexza (Glycopyrronium) topical wipes are indicated for the treatment of primaryaxillary hyperhidrosis in adults and pediatric patients 9 years of age and older. Thecost of Qbrexza is $555 for a 30 day supply. Drysol (Aluminum 20%), and OTC optionsare other medications used for the same indication available at a much lower costthan Qbrexza. The addition of Qbrexza to QRM criteria will ensure appropriate andcost-effective medications are utilized before choosing Qbrexza. QRM Criteria arepending.

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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

Sayta Jayanthi, MDHospitalist

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.

Intial Tier Placements-Recently launched and approved medicationsMedication Name Tier Implementation Date

GALCANEZUMAB-GNLMSUBCUTANEOUS SOLN PREFILLED SYR 100 MG/ML (EMGALITY)

Specialty Tier 5 6/7/2019

AMIFAMPRIDINE TAB 10 MG (RUZURGI) Specialty Tier 5 6/7/2019

CISPLATIN IV FOR INJ 50 MG Specialty Tier 5 6/5/2019

FULVESTRANT INJ 250 MG/5ML Specialty Tier 5 5/31/2019

ALPELISIB TAB THERAPY PACK 200 MG, 250 MG, 300 MG DAILY DOSE (PIQRAY)

Specialty Tier 5 5/31/2019

PENICILLAMINE CAPS 250 MG Specialty Tier 5 5/31/2019

TEZACAFTOR-IVACAFTOR 50-75 MG & IVACAFTOR 75 MG TAB TBPK (SYMDEKO)

Specialty Tier 5 6/26/2019

MEPOLIZUMAB SUBCUTANEOUSSOLUTION AUTO-INJECTOR , PREF SYRINGE 100 MG/ML (NUCALA)

Specialty Tier 5 6/12/2019

POLATUZUMAB VEDOTIN-PIIQ FOR IVSOLUTION 140 MG (POLIVY)

Specialty Tier 5 6/12/2019

SELINEXOR TAB THERAPY PACK 20 MG (60 MG, 80 MG, 100 MG ONCE WEEKLY, 80 MG TWICE WEEKLY) (XPOVIO)

Specialty Tier 5 7/10/2019

TIOPRONIN DELAYED RELEASE TABS 100 MG, 300 MG (THIOLA EC)

Specialty Tier 5 7/10/2019

ICATIBANT ACETATE INJ 30 MG/3ML Specialty Tier 5 7/17/2019

TRASTUZUMAB-ANNS FOR IV SOLN 420 MG (KANJINTI)

Specialty Tier 5 7/23/2019

BEVACIZUMAB-AWWB IV SOLN 100 MG/4ML, 400 MG/16ML (FOR INFUSION) (MVASI)

Specialty Tier 5 7/23/2019

POSACONAZOLE SUSP 40 MG/ML Specialty Tier 5 7/24/2019

POSACONAZOLE TAB DELAYEDRELEASE 100 MG

Specialty Tier 5 7/24/2019

DAROLUTAMIDE TAB 300 MG (NUBEQA) Specialty Tier 5 8/1/2019

Departmental Floor Stock ChangesMedication Department

Azithromycin 250 mg tabs OBGYN/PEDS

Injectable prochlorperazine ACC/CDU Pyxis

Nifedipine 10mg IR OBGYN

Kaiser Permanente Georgia 4

Class Review

October 2019:

Medication Class ReviewsLaxatives

Antidiarrheals

AntacidsUlcer drugs

Medical DevicesAntidotes

Cardiotonics

Estrogens

Contraceptives, OralProgestinsOxytocics

Vaginal ProductsChemicals

Medications Not Added to the Formulary• Nuzyra (omadacycline) is a tetracycline antibiotic indicated for the treatment of community

acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI) Review of omadacycline data does not offer any advantages over current therapies for the treatment of ABSSSI or CABP. Although studies have shown omadacycline (Nuzyra) is noninferior to existing options recommended by the guidelines, the drug has not shown superiority. The cost of omadacycline is significantly more expensive than IV or oral linezolid/ moxifloxacin. Moreover, both linezolid and moxifloxacin are available as generics. Therefore, making omadacycline non-formulary will allow for the use of clinically appropriate and cost-effective therapies for the treatment of ABSSSI or CABP. Step therapy restriction will be applied to all applicable open benefits.

• Lokelma (sodium zirconium cyclosilicate) is a treatment for patients with hyperkalemia. Sodium zirconium cyclosilicate is an inorganic cation exchanger that has high affinity for potassium ions in the lumen of the GI tract resulting in fecal elimination of potassium. Sodium zirconium cyclosilicate has not been shown to be more efficacious than sodium polystyrene sulfonate but costs signficantly more. Although sodium zirconium cyclosilicate’s mechanism of action may suggest it has a safer side effect profile, there are no comparative or long-term safety data to indicate that sodium zirconium cyclosilicate is safer than sodium polystyrene sulfonate. Step therapy restriction will be applied to all applicable open benefits.

Non-Formulary Cost ConsiderationsNon-Formulary Medication Preferred Alternatives Clinical Pearls

Hydrocortisone acetate suppositories

OTC Alternatives:• Phenylephrine HCL 0.25%, cocoa

butter 88.44% suppositories • Benzocaine 20% ointment • Dibucaine 1% ointment • Lidocaine 5% cream (Anecream)• Fiber Supplements

RX Alternative:• Hydrocortisone 2.5% cream

• The cost of hydrocortisone acetate sup-positories are approximately 14 times more expensive than hydrocortisone 2.5% cream.

• The cost of hydrocortisone acetate sup-positories range between 6 to 32 times more expensive than OTC alternatives.

• Hydrocortisone 2.5% cream can be ap-plied using rectal tip applicator or finger cot

Lokelma (sodium zirco-nium cyclosilicate)

Veltassa (patiromer)

• Sodium polystyrene sulfonate powder for reconstitution (SPS)

• Lokelma is approximately 4 to 15 times more expensive than SPS

• Veltassa is approximately 6 to 23 times the cost of SPS and 1.5 times more than Lokelma.

• If 15 gm/day of Lokelma is required and there is a documented intolerance to SPS - Veltassa is a more cost-effective alternative

Changes to QRM Criteria• Symdeko (Tezacaftor/Ivacaftor): Updated QRM criteria to include ages 6 and older

• Acthar Gel (corticotropin): Changed QRM criteria to nephrotic syndrome

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

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In the News....New Boxed Warning issued for Xeljanz

On July 26, 2019, the U.S. Food and Drug Administration (FDA) issued a new Boxed Warning about tofacitinib (Xeljanz, Xeljanz XR) which is used for ulcerative colitis (UC) and rheumatoid arthritis (RA). The Boxed Warning states an increased risk of blood clots and death when taking 10 mg twice daily. The 10 mg twice daily dose of tofacitinib is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and for long-term use in limited situations. While the increased risks of blood clots and death were seen in patients taking this dose for RA, may also apply to those taking tofacitinib for ulcerative colitis. The updated warning can be found on FDA.gov.1 In addition, the approved use of tafacitinib for ulcerative colitis will be limited to certain patients who have an inadequate response or who are intolerant to TNF blockers.2 The FDA approved these changes, including adding the most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with RA that examined a lower and this higher dose of tofactinib.

1. The U.S. Food and Drug Administration. FDA approves Boxed Warning about increased risk of blood clots and death withhigher doses of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR). FDA Drug Safety Communication.July 26, 2019. https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/xeljanz-xeljanz-xr-tofaci-tinib-drug-safety-communication-due-increased-risk-blood-clots-and-death. Accessed August 29, 2019.

2. Xeljanz. [package insert]. New York, NY. Pfizer Inc; 2019.

Rare Occurrence of Serious Liver Injury with Use of Hepatitis C Medications

The FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C in patients with mod-erate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. All these medicines contain a hepatitis C virus (HCV) protease inhibitor and are not indicated for use in patients with moderate to severe liver impairment. In most patients, symptoms resolved or new onset worsening of liver function improved after stopping the medicine. These medicines are safe and effective in patients with no or mild liver impairment. For Kaiser Permanente, these medications are not considered preferred or first line therapies.

Health care professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing informa-tion for patients without liver impairment or with mild liver impairment (Child-Pugh A). Assess severity of liver disease at baseline and closely monitor for signs and symptoms of worsening liver function such as increases in liver enzymes, jaun-dice, ascites, encephalopathy, and variceal hemorrhage. Assessment of baseline liver disease and close monitoring are especially important in those with pre-existing significant liver problems or risk factors, such as hepatocellular carcinoma or alcohol abuse, which can also contribute to clinical worsening of liver function or liver failure during treatment. Discontinue these medicines in patients who develop signs and symptoms of liver decompensation or as clinically indicated. The complete FDA Safety Communication can be accessed here: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and