Kaiser Permanente Georgia 1

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

I S S U E 5 V O L U M E 12 O C TO B E R 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.

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Formulary Additions

At A Glance

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

The following medications will be added to the Commercial Formulary effective October 31, 2018:• Tetracycline capsules: The American College of Gastroenterology recommends a combi-

nation of bismuth, tetracycline, metronidazole, and a PPI for 10 to 14 days as a first line regimen for the treatment of H. pylori. Tetracycline capsules are once again available and therefore individual agents for H. pylori should be prescribed. Please discontinue prescribing Pylera, a pre-packaged 10 day product containing bismuth subcitrate potas-sium, tetracycline, and metronidazole, which costs more than 12 times the individual components when used conmitantly with omeprazole for H. Pylori treatment and is non-formulary at Kaiser Georgia.

2 Kaiser Permanente Georgia

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 November 23rd, 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 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:

• Epidiolex (Cannabidiol)- Indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome in patients 2 years of age and older.

• Palynziq (Pegvaliase)- Indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concnetrations greater than 600 micromol/L on existing management.

• Crysvita (Burosumab-twza)-Clinically administered subcutaneous injection for the treatment of X-linked hypophosphatemia (SLH) in adult and pediatric patients 1 year of age and older.

• Endari (Glutamine)- Indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years and older.

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

Additions to QRM (Prior Authorization)Effective October 31, 2018:1. Epidiolex (Cannabidiol)- First medication to be approved by the FDA that contains a

purified drug substance derived from the Cannabis sativa plant, more commonly known as marijuana. Cannabidiol does not cause the intoxication or euphoria that comes from tetrahydrocannadinol (THC) the primary psychoactive component of marijuana. Cannabidiol is FDA-approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients age 2 years and older. While cannabidiol add-on therapy has been shown to be more effective than placebo in reducing the frequencies of treatment-resistant seizures in patients with these rare and severe forms of epilepsy, there are no active comparative trials available to determine if CBD has an advantage compared to other FDA-approved anti-epileptic drugs (AEDs).

2. Palnziq (Pegvaliase-pqpz)-Novel enzyme therapy for adults with phenylketonuria (PKU) who have uncontrolled blood phenylalanine (Phe) concentrations greater than 600 micromol/L on existing management. It is given as a subcutaneous injection once daily. Sapropterin (Kuvan) is the only other pharmacologic treatment approved to reduce blood Phe levels, but is administered orally. Sapropterin must be used in conjunction with a Phe-restricted diet and only 25-50% of patients are estimated to be sapropterin-responsive. As a phenylalanine-metabolizing enzyme, pegvaliase-pqpz does not require a Phe-restricted diet to be effective.

Formulary Additions, Con’t• Potassium Chloride 20 meq microencapsulated tablets (Klor Con): The cost of potassium chloride

20 meq packets has increased to 15 x the cost of 20 meq Klor Con tablets. The microencapsulated tablet can be made into an aqueous suspension as easily as the packets for patients with difficulty swallowing the tablets. Replacing the packets with the tablets will be a significant cost savings to the organization. The packets will be removed from the Commercial Formulary 12-31-18. Patients currently using the packets will be sent letters and converted to the tablets. In addition, an alternative message in KPHC will be developed to direct prescribing to Klor Con 20 meq tablets. The steps for making an aqueous suspension include the following: 1) Place whole tablet in approximately 4 oz of water 2) Allow 2 minutes for the tablet to disintegrate 3) Stir for ~30 seconds 4) Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw 5) Add another one fluid ounce of water, swirl, and consume immediately 6) Then, add an additional one fluid ounce of water, swirl, and consume immediately.

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, 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 (Prior Authorization), Con’t.

Departmental Floorstock AdditionsMedication Department

Phenol Swabs, Ampho B-chlorampheni-col-sulfadiazine powder

ENT

Duoneb Pulmonary, Peds, Adult Primary Care, ACC/CDU, Urgent Care

Pilocarpine 4% Ophthalmology

Amiodarone premix bags 150 mg/100 cc, 360 mg/200 ml

ACC/CDU

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.

New Medications-Protected Class:• lusutrombopag 3 mg tablets (Mulpleta)-FDA approved for treatment of thrombocytope-

nia in adult patients with chronic liver disease who are scheduled to undergo a procedure.• mogamulizumab-kpkc 20 mg/5 mL injection (Poteligeo) – FDA approved for treatment in

adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

• ivosidenib 250 mg tablets (Tibsovo) – FDA approved for treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible IDH1 muta-tion as detected by an FDA-approved test.

• aripiprazole lauroxil 675 mg extended-release injection (Aristada Initio) – FDA approved for treatment in combination with oral aripiprazole, is indicated for the initiation of aripip-razole lauroxil when used for the treatment of schizophrenia in adults.

Changes to QRM Criteria• Multiple Sclerosis Medications- Multiple changes including high risk features table.• Growth Hormone- Multiple changes made to align with newest guidelines and streamline

for more efficient review• Xolair- Chronic idiopathic urticaria section: Removed trial of antiinflammatory and immuno-

suppressant agents to align with newest National KP Guidelines• Zepatier- Changed criteria to indicate this is a non-preferred medication for KPGA

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

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Class Review

December 2018:

Medication Class ReviewsVaccines

Antihistamines

Nasal Agents-Systemic & Topical

Respiratory Agents-misc.Antianginal

Beta Blockers

Calcium Channel Blockers

AntiarrhythmicsAntihypertensives

DiureticsVasopressors

AntihyperlipidemicsCardiovascular agents-misc.

Medicare Part D, Con’tNew Medications-Protected Class:

• risperidone 90 mg, 120 mg extended-release injectable suspension (Perseris) – FDA ap-proved for treatment of schizophrenia in adults.

Intial Tier Placements-Recently launched and approved medications

Medication Name Tier Implementation Date

dalfampridine 10 mg tablets (generic) Specialty Tier 5 9/12/2018

filgrastim-aafi 300 mcg/0.5 mL, 480 mcg/0.8 mL injection (Nivestym)

Specialty Tier 5 9/7/2018

lanadelumab-flyo 150 mg/mL injection (Takhzyro)** Specialty Tier 5 8/29/2018

pasireotide pamoate 10 mg, 30 mg injection (Signifor LAR) Specialty Tier 5 8/27/2018

mogamulizumab-kpkc 20 mg/5 mL injection (Poteligeo) Specialty Tier 5 8/24/2018

adapalene 0.1% solution (generic) Specialty Tier 5 8/21/2018

tildrakizumab-asmn 100 mg/mL injection (Ilumya) Specialty Tier 5 8/21/2018

lenvatinib 4 mg, 12 mg therapy pack/capsules (Len-vima)**

Specialty Tier 5 8/21/2018

lusutrombopag 3 mg tablets (Mulpleta) Specialty Tier 5 8/22/2018

patisiran 10 mg/5 mL injection (Onpattro) Specialty Tier 5 8/15/2018

risperidone 90 mg, 120 mg injection (Perseris)** Specialty Tier 5 8/15/2018

migalastat 123 mg capsules (Galafold) Specialty Tier 5 8/15/2018

lumacaftor/ivacaftor 100/125 mg, 150 mg/188 granules packets (Orkambi)

Specialty Tier 5 8/14/2015

tadalafil 20 mg tablets (generic Adcirca) Specialty Tier 5 8/13/2018

carfilzomib 10 mg injection (Kyprolis) Specialty Tier 5 8/10/2018

ibalizumab-uiyk 150 mg/mL injection (Trogarzo)** Non-Preferred Tier 4 Pending

secnidazole 2 gm oral granule (Solosec) Non-Preferred Tier 4 Pending

macimorelin 0.5 mg solution (Macrilen) Non-Preferred Tier 4 Pending

** Protected Class

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New Standing Order

**Biktarvy® is the preferred alternative due to the better safety profile. Patients unwilling to switch to Biktarvy® will be switched to Symfi®.

In the News. . .

Insulin can now be used in patients with Commercial Drivers LicensesThe U.S. Department of Transportation, Federal Motor Carrier Safety Administration (FMCSA) has issued a new rule permitting individuals on a stable insulin regimen to operate commercial vehicles in interstate commerce. Previously, individuals with insulin-treated diabetes mellitus were prohibited from driving commercial motor vehicles unless they obtained an exemption from FMC-SA. Visit http://www.diabetes.org/newsroom/press-releases/2018/advocacy-commercial-drivers-final-rule.html to learn more.

The FDA has expanded the approval of Gardasil 9, the human papillomavirus (HPV) vaccine, to include men and women ages 27 to 45. The CDC estimates that HPV vaccination can prevent more than 90% of HPV-related cancers, which most commonly include those of the cervix and oropharynx, as well as penile, anal, vaginal, and vulvar cancers.

In all, an estimated 31,000 new HPV-related cases are diagnosed in the U.S. each year. In women, roughly 12,000 new cervical can-cer cases are diagnosed each year and 4,000 die from the disease. In 2014, the agency first approved Gardasil 9 for individuals ages 9 to 26. It covers nine types of HPV, including seven that can lead to cancer (16, 18, 31, 33, 45, 52, and 58).

https://www.medpagetoday.com/obgyn/cervicalcancer/75551

Decongestants should not be given to children under age 6, a recent study suggests. A study published in BMJ concluded that “decongestants should not be given to children younger than age 6 years and should be given with caution in those younger than age 12 years.” The authors found that “there is no evidence these products alleviate nasal symptoms in young children and there is evidence they cause adverse effects that include drowsiness and gastrointestinal upset.” Medscape mentioned that the FDA issued a public health advisory a decade ago instructing that OTC cough and cold products should not be given to children under 12.

https://www.bmj.com/content/bmj/363/bmj.k3786.full.pdf

Compounding ChangesEffective October 31, 2018

• Cefazolin eye drops 50 mg/ml ophthalmic solution- Natural Tears replaced with LiquiTears Eye drops• Thymol in 99% isopropyl alcohol- removed from the formulary in 2016 because of the unavailability of thymol crys-

tals. Added back to formulary with the availability of thymol crystals for the topical treatment of paronychia of the nail bed.