Kaiser Permanente Georgia 1

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

I S S U E 4 V O L U M E 12 A U G U S T 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 . . . . . . . . . . . . 3 uQRM Updates . . . . . . . . . . . . . . . . . 3 uFloorstock changes. . . . . . . . . . . . . 3

The following medications will be added to the Commercial Formulary effective August 29,2018:• Fluvoxamine is a selective serotonin (5-HT) reuptake inhibitor (SSRI) indicated for

the treatment of obsessive compulsive disorder (OCD) in patients 8 years of age and older. Fluvoxamine IR 25mg, 50mg, and 100mg, will be added for a more comprehen-sive list of first-line treatment options for OCD. The ER formulation will not be added to the formulary due to insufficient efficacy data, a higher incidence of adverse ef-fects, and higher acquisition cost compared to the IR formulation.

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 September 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.

• Isentress HD 600 mg (raltegravir) is an HIV integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV infection in adult patients and pediatric patients weighing at least 40 kg. Twice-daily Isentress 400 mg tablets are currently on the Commercial Formulary. Other HIV-1 INSTI medications include dolutegravir (Tivicay; component in Triumeq and Juluca), elvitegravir (component in Stribild and Genvoya), and bictegravir (component in Biktarvy). Recently, the FDA released a safety alert regarding the potential risk of neural tube birth defects when dolutegravir is used by women at the time of becoming pregnant or early in the first trimester. Isentress HD 600 mg tablets are dosed once daily and provide an alternative to dolutegravir-containing regimens for women of childbearing age.

The following medication will be added to the Commercial Formulary effective November 1, 2018:

Alvesco (ciclesonide) is an inhaled corticosteroid (ICS) indicated for maintenance therapy of asthma for patients age 12 years and older. There have been multiple studies conducted in pediatric patients < 12 years of age demonstrating similar efficacy to other ICS in this population. Ciclesonide is included in the Global Initiative for Asthma (GINA) guidelines and the National Asthma Education and Prevention Program (NAEPP) Asthma Care Quick Reference. Ciclesonide should not be used for the relief of acute bronchospasms. This will replace the current KP preferred ICS, QVAR, due to discontinuation from market by the manufacturer once our supply is exhausted.

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 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:

• Aimovig (erenumab-aooe) is a first-in-class calcitonin gene-related peptide (CGRP) indicated for the preventative treatment of migraine in adults who are refractory to other treatment options:

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

Formulary Additions, Con’t• Actemra (tocilizumab) is an IL-6 inhibitor, disease-modifying antirheumatic drug (bioDMARD)

indicated for rheumatoid arthritis (RA). Actemra will provide an additional and potentially more cost-effective DMARD option for rheumatoid arthritis and may be considered after an inadequate response to our preferred TNF-inhibitor bioDMARDs (Humira, Enbrel).

• Cefdinir 300 mg (capsules) is a 3rd generation cephalosporin indicated for the treatment of mild to moderate infections caused by susceptible strains of bacteria. Infections may include community acquired pneumonia, acute exacerbations of chronic bronchitis, acute maxillary sinusitis, pharyngitis/tonsillitis, acute bacterial otitis media, and uncomplicated skin and skin structure infections. Cefdinir 125 mg/5 mL and 250 mg/5 mL suspensions are currently on the Commercial Formulary. However, they are recommended for use in pediatric patients. The capsule formulation will provide a 3rd generation cephalosporin option for adult and adolescent patients.

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)Effective August 29, 2018:

Departmental Floorstock AdditionsMedication Department

Tropicamide 0.5% 15 mlContact Solution

Radiology (Retinal imaging)

Calcium gluconate vials 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:• Avatrombopag (Doptelet)- FDA approved for the treatment of thrombocytopenia in adult

patients with chronic liver disease who are scheduled to undergo a procedure. [Specialty Tier 5]

• Binimetinib (Mektovi)-FDA approved for treatment in combination with encorafenib, forthe treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation. [Specialty Tier 5]

• Encorafenib (Brafto)-FDA approved for treatment in combination with binimetinib, forthe treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation. [Specialty Tier 5]

Changes to QRM CriteriaPCSK-9 inhibitors: Repatha (evolocumab) will now be the KP preferred product. For Praluent (alirocumab) coverage, the patient must have a documented contraindication, intolerance to or failure of Repatha. Please see full QRM guidelines here: http://kpnet.kp.org:81/ga/healthcare/docs/drug/restrictedMedications.pdf

Kaiser Permanente Georgia 4

Class Review

October 2018:

Medication Class ReviewsLaxatives

Antidiarrheals

AntacidsUlcer drugs

Medical DevicesAntidotes

Cardiotonics

EstrogensContraceptives, Oral

ProgestinsOxytocics

Vaginal ProductsChemicals

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

Medication Name Tier Implementation Dateadalimumab 80 mg/0.8 mL pen injector kit; 80MG/0.8ML & 40 MG/0.4ML kit (Humira)

Specialty Tier 5 7/30/2018

butalbital/acetaminophen 50 mg/300 mg capsules Specialty Tier 5 7/27/2018

elagolix sodium 150 mg, 200 mg tablets(Orilissa) Specialty Tier 5 7/26/2018

ivosidenib 250 mg tablets (Tibsovo) Specialty Tier 5 7/26/2018

pimavanserin tartrate 34 mg capsules, 10 mgtablets (Nu-plazid)

Specialty Tier 5 7/20/2018

plazomicin sulfate 500 mg/10 mL injection(Zemdri) Specialty Tier 5 7/19/2018

pegfligrastim-jmdb 6 mg/0.6 mL injection(Fulphila) Specialty Tier 5 7/11/2018

aripiprazole lauroxil 675 mg/2.4 mL injection (Aristada) Specialty Tier 5 7/5/2018

encorafenib 50 mg, 75 mg capsules (Braftovi)** Specialty Tier 5 6/29/2018

encorafenib 50 mg, 75 mg capsules (Braftovi)** Specialty Tier 5 6/29/2018

tofacitinib citrate 10 mg tablets (Xeljanz) Specialty Tier 5 6/21/2018

flofexidine 0.18 mg tablets (Lucemyra) Specialty Tier 5 6/20/2018

daptomycin 350 mg injection Specialty Tier 5 6/18/2018

netarsudil dimesylate 0.02% ophthalmicsolution (Rho-pressa)

Non-Preferred

Tier 46/3/2018

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

secnidazole 2 gm oral granule (Solosec)Non-

Preferred Tier 4

Pending

macimorelin 0.5 mg solution (Macrilen)Non-

Preferred Tier 4

Pending

angiotensin II 25 mg/mL injection (Giapreza)Non-

Preferred Tier 4

Pending

**Protected Class

Kaiser Permanente Georgia 5

Drugs Removed from the FormularyEffective 1-1-19

Combivent (ipratropium/albuterol) Respimat and Atrovent (ipratropium) HFA: The updated Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines position long acting bronchodilators (muscarinic antagonists [LAMAs] and beta2 agonists [LABAs]) and their combinations as the mainstay of therapy for the treatment of COPD. Due to the increased availability of long acting bronchodilators in the market, the recommended role in therapy for short acting bronchodilators such as ipratropium has been significantly limited. Furthermore, the combination products such as ipratropium/albuterol have been removed as alternatives for COPD treatment. Inhaled SABAs (e.g. Ventolin HFA) remain the mainstay of management of acute asthma exacerbations. See table below for preferred formulary alternatives.GOLD guidelines: https://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf

Table: Non-Formulary Cost Considerations

Non-Formulary Agents Preferred Formulary Alternatives Clinical/Cost PearlsCombivent Respimat (ipratropium/albuterol) • Stiolto (Tiotropium/Olodaterol) Respimat 2.5/2.5

mcg per actuation • Ventolin HFA (Albuterol) as needed for rescue.

The cost of Combivent is ~ 1.4 times the cost of Stiolto Respimat, and over 12 times the cost of Ventolin HFA.

Atrovent (Ipratropium) HFA • Spiriva (Tiotropium) Respimat 2.5 mcg/actuation • Ventolin HFA (Albuterol) as needed for rescue

The cost of Atrovent HFA is ~3 times that of Spiriva and 15 times the cost of Ventolin HFA.

IN THE NEWS....

The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition, bronchiolitis obliterans syndrome, in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.1 Additional data is still under review by the FDA and will be communicated when review is complete. https://www.fda.gov/Drugs/DrugSafety/ucm614085.htm. 1. Bergeron A, Chevret S, Granata A, et al. Effect of azithromycin on airflow decline-free survival after allogeneic hematopoietic stem cell transplant: the ALLOZITHRO randomized clinical trial. JAMA. 2017; 318(6): 557-566.

The U.S. Food and Drug Administration recently approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. The active ingredient in Epidiolex is cannabidiol (CBD), one of the two main chemical compounds found in marijuana. Epidiolex contains less than 0.1% of tetrahydrocannabinol (THC).

It is the first FDA approval of a drug for the treatment of patients with Dravet syndrome. Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures. Lennox-Gastaut syndrome begins in childhood and is characterized by multiple types of seizures. Both syndromes have a profound impact on these patients’ quality of life.

The FDA granted priority review for this application. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications. Product availability is expected Fall 2018 pending rescheduling from its current Schedule I. Epidiolex (cannabidiol) is currently under review by the KP Emerging Therapeutics Strategy Program. Experts from each region will be developing interregional practice recommendations for this medication. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm