Kaiser Permanente Georgia 1

u Formulary additions . . . . . .1ISSUE 2 VOLUME 11 APRIL 2017

FormularyUpdate

u medications reviewed at P&t, But not added to the Formulary . . . . . . . . . . . . . 3u national medicare Part d Formulary . . . . . . . . . . . . . . 4

A PUBL ICAT ION OF THE GEORGIA PHARMACY AND THERAPEUT ICS (P&T) COMMITTEE . 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

u criteria restricted medication revisons . . . . . . . 2

u Floorstock additions . . . . . 4

Armodafinil added to the Commercial formulary effective April 26, 2017 is indicated for the improvement of wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder. It is also used off-label for several disorders, including ADHD, chronic MS-related fatigue, and bipolar disorder. Armodafinil is the R-enantiomer of modafinil and both medications are pharmacologically similar. Adding armodafinil to the KPGA Commercial formulary provides a lower-cost alternative to stimulants with a lower abuse potential.

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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 May 30 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.

Formulary Removals The following medications will be removed from the Commercial Formulary

effective June 30, 2017:

• Complera- antiretroviral combination used for the treatment of human immunodeficiency virus (HIV). Although Complera is efficacious for HIV treatment, it is associated with kidney and bone toxicities due to the tenofovir disoproxil formulation (TDF). Odefsey is an alternative to Complera that contains tenofovir alafenamide (TAF) which has a reduced risk of kidney injury and bone loss. The cost of Complera is now 1.2 times the cost of Odefsey, and there is an ongoing interregional initiative to reduce Complera market share at KP.

Changes to Criteria Restricted MedicationsMultiple Sclerosis Medications:

• Glatopa 20 mg/ml will be covered for new KP Members who are already established on glatiromer acetate 20 mg or 40 mg if there is no clinical reason to change therapy.

• Daclizumab (Zinbryta): A baseline negative pregnancy test AND either a prescription for birth control OR documentation of the patient declining contraception and being counseled of the potential risk of pregancy has been added to criteria for female members of child bearing age.

Omalizumab (Xolair):

• Aligned with interregional guidelines and updated to reflect change in labeling which now includes 6-11 year olds.

Lumacaftor/ivacaftor (Orkambi):

• Aligned with interregional guidelines and updated to reflect changes to labeling which now includes 6-11 year olds.

Denosmab (Xgeva):

• Updated to reflect current National Comprehensive Cancer Network Guidelines. Denosumab recommended as first line for bone metastases associated with prostate cancer.

Class Non-formulary Medications

Formulary Alternatives

Clinical/Cost Pearls

LAMA

• Tiotropium (Spiriva Handi-haler)18 mcg/cap

• Aclidinium (Tudorza Pressair) 400 mcg/inh

• Umeclidinium (Incruse El-lipta) 62.5 mcg/inh

• Glycopyrrolate (Seebri Neo-haler) 15.6 mcg/cap

• Tiotropium (Spiriva Respimat) 2..5 mcg/inh

• Inhaled bronchodilators in COPD are central to symptom management.

• The cost of Non-formulary LAMA inhal-ers are more than 1.7 times the cost of the preferred KPGA LAMA, Spiriva Respimat

LABA/LAMAs

• Glycopyrrolate/indacaterol (Utibron Neohaler) 15.6 mcg/27.5 mcg/cap

• Umeclidinium/vilanterol (Anoro Ellipta) 62.5 mcg/25 mcg

• Glycopyrrolate/formoterol • (Bevespi Aerosphere) 9

mcg/4.8 mcg

• Totropium/olodaterol (Stiolto Respimat) 2.5 mcg/2.5 mcg

• Combination treatment with a LABA/LAMA increases FEV1 and reduces symptoms compared to monotherapy.

• The cost of Non-formulary LABA/LAMA inhalers are more than 1.3 times the cost of the preferred KPGA LABA/LAMA inhaler, Stiolto Respimat.

Non-Formulary Cost Considerations

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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, MDElder Care

David Jones, 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

Medications Reviewed, but Not Added to the Formulary

• Pimavanserin (Nuplazid)-treatment of hallucinations or delusions associated with Parkinson’s Disease Psychosis

• Cariprazine (Vraylar)-atypical antipsychotic indicated for the treatment of schizophrenia and the acute treatment of mania or mixed episodes associated with bipolar disorder.

• Glycopyrrolate inhalation powder (Seebri Neohaler)-Long-term maintenance treament of COPD.

• Glycopyrrolate and indacaterol Inhalation powder (Utibron Neohaler)- Long-term maintenance treatment of COPD.

Standing Order for Infliximab (Remicade) to Infliximab-dyyb (Inflectra) Intravenous

infusion Inflectra is a biosimilar approved by the FDA, based on the reference product infliximab (Remicade). Inflectra has no clinically meaningful difference in terms of safety and effectiveness from infliximab (Remicade).

Nifedipine* Equivalent to Amlodipine

30 mg 2.5 mg once daily

60 mg 5 mg once daily

90 mg 10 mg once daily

*Total daily dose

REMICADE Equivalent to INFLECTRA

Infliximab (Remicade®)100 mg

Infliximab-dyyb (Inflectra®)100 mg

Standing Order for Nifedipine ER to Amlodipine

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class review

June 2017:

Medication class Reviews

Dermatological

Penicillins

Cephalosporins

Macrolides

Aminoglycosides

Fluoroquinolones

Sulfonamides

Antimycobacterial

Antifungals

Antimalarials

Amebicides

Antihelmintics

Anti-infectives-Misc.

• Renvela • Aripiprazole • Dulera Inhalation aerosol• Lialda • Gatifloxacin Ophthalmic Solution• Armodafinil

MPD Formulary 2017 Tier Changes:

Medication Name TierImplementation

Date

Deflazacort (Emflaza) 6, 18,30, 36 mg tablets, 22.75 mg/ml suspension

5 2/16/2017

Olaratumab 190 mg/19 ml solution (Lartuvo) IV infusion 5 2/23/2017

Telotristat (Xermelo) 250 mg tablets 5 3/3/2017

Ribociclib (Kisquali) 200 mg tablets 5 3/18/2017

Medical Office Floorstock Additions

Approved medications will be added to the electronic floorstock ordering forms on the intranet.

Medication Department

Flurox 0.25%/0.4% Ophthalmic Solution Ophthalmology

Medication Name Initial Tier Tier Change Effective Date

Naloxone (Evzio) auto-injector 0.4 mg/0.4 ml

4 5 5/2017

Epinephrine (AG Epipen) auto-injector 0.3 mg/0.3 ml

2 4 Pending CMS approval

Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine

National Medicare Part D FormularyKaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T Committee 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 Formulary for Kaiser Permanente.

MPD Formulary 2017 initial tier placements are listed below:

Step Therapy No Longer Required for the Following Medications:

ACA Formulary Only. Effective April 26, 2017

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Drug Utilization Evaluation

Drug Use Evaluation: Amiodarone Monitoring and Safety in Ambulatory Patients Danyae Lee, PharmD, PGY-1 Pharmacy Resident

Kaci Waters, PharmD, Acute Transitions, Clinical Pharmacy SpecialistCandace Nichols, PharmD, BCPS, Acute Transitions, Clinical Pharmacy Specialist

A Drug Use Evaluation (DUE) was performed to assess whether Kaiser Permanente Georgia’s amiodarone monitor-ing outcomes are in accordance with the Heart Rhythm Society’s (HRS) recommendations. Per the HRS, patients initi-ated on amiodarone should have baseline aminotransferase liver enzymes, thyroid function tests, pulmonary function tests, a chest x-ray, and an electrocardiogram (EKG). 1-2 If there are signs/symptoms of visual impairment or pulmo-nary toxicity, an ophthalmologic evaluation and CT scan should be performed respectively. To monitor for adverse effects, follow-up should include liver and thyroid function tests every 3-6 months for the first year, and every 6 months thereafter. 1-2 An EKG should be completed annually to monitor for improved arrhythmias. This retrospective review involved reviewing patients newly initiated on chronic amiodarone therapy from January 1, 2015 – December, 31, 2015.

Of the 101 patients included in the study, less than 25% received liver enzyme and thyroid follow-up labs at the rec-ommended monitoring interval. When assessing the continuity of amiodarone monitoring for a year of therapy, only 8% of patients received follow-up in accordance with the HRS guidelines. Eighty patients (79%) were documented as taking medications with the potential to interact by receiving concomitant digoxin, warfarin, or statin therapy. Lastly, 35 unique patients (35%) experienced at least one unplanned hospitalization post-amiodarone initiation, totaling unplanned hospitalizations at 66. The amiodarone monitoring results are based on the 12-month study period. There-fore, no conclusion about the use of amiodarone can be extrapolated to a period beyond a year. Although amiodarone is advantageous for cardiac clinical outcomes, it can be associated with drug interactions and adverse events related to toxicity. There is an opportunity in current clinical practice to better define amiodarone monitoring parameters to improve outcomes. KPGA Safety Net has recently relaunched Provider notifications when labs are overdue in amiodarone patients.

1. Goldschlager N, Epstein AE, Naccarelli GV, et al. A practical guide for clinicians who treat patients with amiodarone: 2007. Heart Rhythm. 2007;4(9):1250-592. Epstein AE, Olshansky B, Naccarelli GV, et al. Practical management guide for clinicians who treat patients with amiodarone. Ameri-can Journal of Medicine.2016;129(5)468-475

Current literature does not support greater safety or efficacy of one rapid-acting insulin analog over the other, thus Humalog® is the KPGA preferred non-formulary agent based on cost-effec-tiveness. NovoLog® is available for closed formulary members with a previous trial of Humalog®. This retrospective chart review was developed to determine if NovoLog® results in more effective A1c control for patients with a previous trial of Humalog® and to review utilization.

In this very small patient sample, Novolog® demonstrated a non-statistically significant mean A1c reduction of 0.8% (n=12). A clinically significant difference in A1c control has not been demon-strated in the literature. Regaring utilization, 70% of patients (n = 43) did not have a previous trial of Humalog® likely attributed to their open formulary Pharmacy Benefit. This reveals an opportu-nity to shift prescribing practice in this population. All closed formulary members did have a previ-ous trial for an appropriate duration.

Future directions include: (1) converting eligible patients to preferred agents resulting in lower cost-shares for patients; (2) re-tuning clinical decision support tools to re-emphasize Humalog® as the preferred non-formulary agent as it is almost 8 times less expensive than NovoLog®.

Drug Utilization Evaluation (DUE) of NovoLog® (insulin aspart) versus Humalog® (insulin lispro)

Michelle Aslami, PharmD, PGY1 Pharmacy Resident