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Kaiser Permanente Georgia 1

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ISSUE 6 VOLUME 9 DECEMBER 2015

FormularyUpdateu medications reviewed at P&t, But not added to the Formulary . . . . . . . . . . . . . . 4

u national medicare Part d Formulary . . . . . . . . . . . . . . 3

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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u Formulary deletions . . . . . .2

Formulary Additions

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At A Glance

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u non-Formulary cost considerations . . . . . . . . . . 5

u Floorstock additions . . . . . .3

Lenvatinib (Lenvima) 4mg, 10 mg capsules will be added to the Commercial Formulary effective January 1, 2016. Lenvatinib is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). Lenvatinib should be used as the first line agent for the treatment of locally recurrent or metastatic, progressive DTC not amenable to RAI therapy based on the response rate and significant improvement in progression-free survival (PFS). Lenvatinib yielded improved PFS and overall response rate (ORR) compared to placebo in the treatment of RAI-refractory DTC in patients with or without prior VEGF-targeted therapy. The ORR with lenvatinib is greater than that seen with sorafenib (Nexavar) which is the current formulary option. Tolerability of the recommended starting dose of lenvatinib must be strongly considered. The starting dose of lenvatinib is poorly tolerated with over two-thirds of patients requiring dose reductions related to adverse side effects. As a result, the FDA is interested in exploring the efficacy of lower doses (20 mg and 14 mg), but the safety and tolerability of these doses need to be established in a required post-marketing study first.

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uPcoming Formulary items

Filgrastim (Zarxio) 300 mcg/0.5 mL, 480 mcg/0.8 mL will be added to the Commercial Formulary effective December 21, 2015. Filgrastim (Zarxio) is the first biosimilar approved by the FDA, based on the reference product filgrastim (Neupogen) and approved for all of the same indications: cancer with myelosuppressive chemotherapy (decrease febrile neutropenia), AML, with induction or consolidation chemotherapy (reduce time to neutrophil recovery), cancer, undergoing bone marrow transplantation (reduce neutropenia duration), patients undergoing autologous peripheral blood progenitor cell collection & therapy (mobilization of hematopoietic progenitor cells) and patients with severe chronic neutropenia. Zarxio was compared with Neupogen in five animal studies assessing pharmacodynamics, toxicity, toxicokinetics, and local tolerance. Nonclinical results confirmed that the pharmacologic and toxicologic profiles of Zarxio and Neupogen are similar. The warnings and precautions and contraindications are the same as Neupogen. Beginning January 1, 2016, Zarxio will be the preferred filgrastim for Kaiser Permanente.

An important aspect of the formulary process is the involvement of all practitioners. So that each of you has an opportunity to participate in the process, upcoming P&T agenda items are listed below. Please contact your P&T Committee representative or your clinical service chief by January 26, 2016 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 Additions, ContinuedPalbociclib (Ibrance) 75 mg, 100 mg, and 125 mg capsules will be added to the Commercial Formulary effective January 1, 2016. Palbociclib is an inhibitor of cyclin-dependent

kinase (CDK) 4 and 6 indicated for the treatment of postmenopausal women with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy, in combination with letrozole, for metastatic disease. Per the National Comprehensive Cancer Network (NCCN) guidelines, palbociclib plus letrozole may be considered for first-line endocrine therapy in postmenopausal patients with ER-positive, HER2-negative, recurrent or metastatic breast cancer. In the pivotal trial, palbociclib plus letrozole significantly increased PFS when compared to letrozole monotherapy (20.2 months versus 10.2 months, respectively. Palbociclib has warnings for neutropenia, infections, and pulmonary embolisms. There is an increased incidence of AEs (i.e., neutropenia, alopecia) when palbociclib is added to letrozole therapy, which requires more frequent clinical and laboratory assessment.

Desoximetasone (generic Topicort) 0.25% cream will be added to the Commercial Formulary effective January 1, 2016. Desoximetasone 0.25% cream is a high-potency topical corticosteroid used for the treatment of various acute and chronic skin inflammatory conditions. Topical corticosteroids within a potency class are interchangeable for most conditions. Adverse reactions are infrequently reported with desoximetasone. Reactions reported are: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Desoximetasone 0.25% cream is a high-potency alternative that is available as a generic at a lower cost than other high-potency formulary options (approximately 3 times less costly than fluocinonide-E 0.05% cream).

Formulary DeletionsFilgrastim (Neupogen) 300 mcg/0.5 mL , 480 mcg/0.8 mL will be removed from the Commercial Formulary effective January 20, 2016. Zarxio will be the preferred filgrastim for Kaiser Permanente.

Sodium Sulfacetamide 10% (generic Bleph-10) ophthalmic solution will be removed from the Commercial Formulary effective January 20, 2016. Sodium sulfacetamide ophthalmic solution is an ophthalmic antibiotic indicated for the treatment of conjunctivitis and other superficial eye infections due to susceptible

organisms. It is also indicated for the treatment of trachoma in combination with systemic sulfonamide therapy. Other ophthalmic antibiotics indicated for the treatment of conjunctivitis and other superficial eye infections currently available on the KPGA Commercial formulary include: trimethoprim/polymyxin B (preferred alternative), gentamicin 0.3% ophthalmic solution, and ciprofloxacin 0.3% ophthalmic solution. The cost of sodium sulfacetamide has increased over the past few years to an average cost per prescription of over $35.


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

Patrice Gaspard, MDPediatrics

Marcus Griffith, MD*Behavioral Health

David Jones, MDPediatrics

Craig Kaplan, MDAmbulatory Medicine

Felecia Martin, PharmDPharmacy/Geriatrics

Shayne Mixon, PharmDPharmacy Operations

Rachel Robins, MDHospitalist

Jennifer Rodriguez, MD*Behavioral Health

Ivorique Turner, MDAmbulatory Medicine

Designated Alternates:Jacqueline Anglade, MD

Obstetrics and Gynecology

Lesia Jackson, RNClinical Services

*Attend alternating meetings

Approved standing orders are written instructions issued by medical practitioners, in accordance with the regulations, authorizing pharmacy personnel at pharmacies owned or operated by Kaiser Foundation Health Plan to supply and administer specified medications under circumstances specified in the order.

• Filgrastim (Neupogen) will be changed to filgrastim (Zarxio) via standing order.

• Whole tablets will be changed to equivalent dose half-tablets for approved medica-tions via standing order.

New Standing Order

New Criteria Restricted MedicationsCriteria restricted medications require review by Quality Resource Management (QRM) prior to coverage. The prior authorization process and criteria apply to all formularies except the Medicare Part D Formulary. Providers must call QRM to request authorization consideration at 404-364-7320. A complete listing of prior authorization medications and their corresponding criteria is available on the intranet under Healthcare Delivery/Guides & References/Formularies/Criteria Restricted (QRM) Medications. The following medication will be removed from the list of Criteria Restricted Medica-tions (QRM) effective January 1, 2016.

• Plerixafor (Mozobil) 24 mg/1.2 mL injection solution

Medical Office Floorstock AdditionsApproved medications will be added to the electronic floorstock ordering forms on the intranet.

Medication Name Tier

Geriatrics

Triple antibiotic oint 0.9gm UD

Epinephrine 0.3 mg kit (Epipen)

Zostavax SDV

Adacel Tdap Vaccine PF 0.5mL

Prevnar 13 prefilled syringe 0.5mL

OtolaryngologyFungoid 2% tincture 1oz

Nystatin-triamcinolone cream 15 gm

ACC Pyxis Acetaminophen 650 mg suppositories

Internal MedicineZarxio 300 mcg/0.5 mL, 480 mcg/0.8 mL

Oncology

Urgent Care

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. National MPD Formulary tier changes are listed below with the corresponding effective date:

Medication Name Tier Effective Date

Spiriva Respimat Aers 2.5 mcg/Act Tier 3 1/1/2016

Humulin N Kwikpen Supn 100 unit/mL Tier 3 1/1/2016

Humulin 70/30 Kwikpen Supn 100 Unit/mL Tier 3 1/1/2016

Oxytrol Patch 3.9 mg/24hr Tier 3 1/1/2016

Cetuximab (Erbitux) 200 mg/100 mL Tier 3 12/1/2015Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine


Formulary Reviews (February 2016):

class review

Medication class Reviews

Antianxiety agents-misc

Antidepressants

Antipsychotics/antimanic agents

Migraine products

Anticonvulsants

Hematological agents - misc

Hypnotics

Stimulants/ADHD

Psychotherapeutics - misc

Antiparkinsons

Neuromuscular blockers

Antimyasthenics

Urinary antiinfectives

Urinary antispasmodics

Genitourinary - misc

Antiasthmatics

Drug Benefit Update: 2016 Medicare Part D Changes

• Total Drug Cost (TDC) threshold amount increases to $3,310 (from $2,960 in 2015) • True Out-of-Pocket (TrOOP) limit amount increases to $4,850 (from $4,700 in 2015)• Group members will continue to have a two-tier generic/brand drug benefit with different coverages and cost sharing.

Individual Enhanced Plan Part D Cost SharingDrug Tier Initial Coverage

(to $3,310 TDC)Up to 30-day supply

Coverage Gap(up to $4,850 in TrOOP)Up to 30-day supply

Catastrophic Coverage

Tier 1Preferred Generics

KP: $5 copayMOI: $0 copay


$2 copay

Tier 2Generics



Tier 3Preferred Brands


45% brand discount 45% dispensing fee

$10 brand copay

Tier 4 Non-preferredBrands


Tier 5Specialty Drugs

33% coinsurance

Tier 6Part D InjectableVaccines

$0

Individual Basic Plan Part D Cost SharingDrug Tier Initial Coverage

(to $3,310 TDC)Up to 30-day supply

Coverage Gap(up to $4,850 in TrOOP)Up to 30-day supply

Catastrophic Coverage

Tier 1Preferred Generics



$5 copay

Tier 2Generics



Tier 3Preferred Brands


45% brand discount 45% dispensing fee

$15 brand copay

Tier 4 Non-preferredBrands


Tier 5Specialty Drugs

33% coinsurance

Tier 6Part D InjectableVaccines

$0

Abbreviations: MOI = Mail-order incentive - two copays for up to 90-day supply; TDC = Total Drug Costs;

TrOOP = Total Out-of-Pocket

This section contains a brief overview of some of the Medicare Part D drug benefit changes that will go into effect January 1, 2016.

Medications Reviewed, but Not Added to the Formulary• Peginterferon beta-1a (Plegridy) 125 mcg/0.5 mL, 63 mcg/0.5 mL & 95 mcg/0.5 mL ,

decision pending for National MPD formulary.• Alirocumab (Praluent) 75 mg, 150 mg pre-filled injection, decision pending for National

MPD formulary.• Pasireotide LAR (Signifor) 20 mg; 40 mg; 60 mg, decision pending for National MPD

formulary.• Fluticasone furoate and vilanterol (Breo Ellipta) 100mcg/25mcg, 200mcg/25mcg, was

not added to the Commercial Formulary, decision pending for National MPD formulary.

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Clinical UpdatesPlavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death. Clopidogrel is an an-tiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain

medical conditions.

A U.S. Food and Drug Administration (FDA) review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.

In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event.

FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.

FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis.

Health care professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment.

Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies

http://www.fda.gov/Safety/MedWatch/SafetyInformation/

SafetyAlertsforHumanMedicalProducts/ucm468720.htm

SGLT2 Inhibitors: Drug Safety Communication - Labels to Include

Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections

http://www.fda.gov/Safety/MedWatch/SafetyInformation/

SafetyAlertsforHumanMedicalProducts/ucm475553.htm

Non-Formulary Cost Considerations

Class Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls

Anticoagulants

• Pradaxa (Dabigatran)

• Xarelto (Rivaroxaban)

• Eliquis (Apixaban)

• Warfarin (generic Coumadin)

• For every 1 patient treated with Xarelto, approximately 48 patients can be treated with warfarin.

• For every 1 patient treated with Pradaxa, approximately 21 patients can be treated with warfarin.

Osmotic Laxatives

• Prepopik

• Suprep Bowel Prep

• Moviprep

• Osmoprep

• Polyethylene Glycol 3350/Potas-sium Chloride/Sodium Bicarbon-ate/Sodium Chloride/Sodium Sulfate Powder for Solution

• For the cost of 1 patient treated with Prepopik, 22 patients can be treated with polyethylene Glycol-electrolyte solution.

• For the cost of 1 patient treated with Moviprep, approximately 4 patients can be treated with polyethylene Glycol-electrolyte solution.

additional clinical alerts

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