Kaiser Permanente Georgia 1

u Formulary additions . . . . . .1

ISSUE 1 VOLUME 11 FEBRUARY 2017

FormularyUpdate

u medications reviewed at P&t, But not added to the Formulary . . . . . . . . . . . . . . 3

u 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

unew criteria restricted medications . . . . . . . . . . . . . . 2

u Floorstock additions . . . . . 4

Estradiol valerate and cypionate intramuscular Injections added to the Commercial formulary effective March 15, 2017 are estrogen replacement therapies used in transgender care as feminizing hormone therapy. Estradiol is most commonly delivered to transgender women via a transdermal patch, oral or sublingual tablet, or injection of a conjugated ester (estradiol valerate or estradiol cypionate). The injection formulations provide an additional option for transgender patients.

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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 March 31, 2017 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, Continued Ticagrelor (Brilinta®) added to the Commercial Formulary effective March 15,

2017 is a P2Y12 inhibitor indicated for the reduction of the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI, and to reduce the rate of stent thrombosis in patients who have been stented for the treatment of ACS (ST-segment elevation myocardial infarction (STEMI) or non-ST segment elevation myocardial infarction (NSTEMI). The cardiovascular guidelines have been updated since initial formulary review and include Brilinta® as a P2Y12 inhibitor option for patients with ACS (STEMI or NSTEMI) treated with dual anti-platelet therapy (DAPT) after stenting for at least 12 months (Class I, Level B). Additionally, in patients with ACS (STEMI or NSTEMI) treated with DAPT after stenting and in patients with NSTEMI treated with medical therapy alone (without revascularization), it is reasonable to use ticagrelor over clopidogrel for maintenance therapy (Class IIa, Level B).

Clopidogrel remains the preferred, safe, and cost-effective formulary P2Y12 inhibitor, however, Brilinta® is an alternative option for high-risk patients or those who may be non-responders to clopidogrel. Brilinta® carries a Black Box warning to avoid maintenance doses of aspirin greater than 100 mg in combination as it reduces the effectiveness of Brilinta®.

Ivermectin (Stromectol®) generic added to the Commercial Formulary effective March 15, 2017 is an oral anti-helminthic agent indicated in onchocerciasis and intestinal strongyloidiasis with off-label uses for the treatment of scabies and lice. While over-the-counter (OTC) products remain 1st line for scabies and lice, Stromectol® is the most cost-effective prescription option and is recommended as an alternative therapy by the Centers for Disease Control and Prevention (CDC).

Formulary Removals The following medications will be removed from the commercial Formulary effective March 15, 2017:

• Serevent Diskus® (salmeterol) inhalation - The preferred formulary long-acting beta2 agonist (LABA) indicated for the treatment of asthma and chronic obstructive pulmonary disorder (COPD) is Striverdi Respimat® (olodaterol) inhalation. The cost of Serevent Diskus® has increased in the last year and is about 2.5 times the cost of Striverdi Respimat®.

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. 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 medications will be added to the list of Criteria

The following medications will be criteria restricted and subject to QRM review:• Empagliflozin/metformin (Synjardy®)

• Class: Antidiabetic• Mechanism of Action: SGLT2 inhibitor and Biguanide• Indication: Improve glycemic control in adult patients with T2D

• Lixisenatide (Adlyxin®)• Class: Antidiabetic• Mechanism of Action: GLP-1 Receptor Agonist• Indication: Improve glycemic control in adult patients with T2DM

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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

Patrice Gaspard, MDPediatrics

David Jones, MDPediatrics

Craig Kaplan, MDAmbulatory Medicine

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

Changes to Criteria Restricted MedicationsLedipasvir/Sofosbuvir (Harvoni®) • Alignment with National Guidelines• Based on available data, less than 12 weeks of treatment is not recommended for

treatment-naiive African-American patients infected with Hepatitis C Genotype 1 without cirrhosis, and a viral load < 6 million IU/ml.

Medications Reviewed, but Not Added to the Formulary

• Lesinurad (Zurampic®), an antigout medication that increases uric acid excretion by inhibiting uric acid and organic anion transporters was not added to the Commercial Formulary. This mediation is a third line agent for the treatment of hyperuriciemia, and is to be used in combination with a xanthine oxidase inhibitor such as allopurinol or febuxostat for patients with gout unable to achieve target serum uric acid levels. Decison pending for National MPD formulary.

New Standing Order for 90-day Supply of Statins, Renin-Angiotensin System

Agonists, and oral Diabetes MedicationsEligible Medications for Conversion

atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin

benazepril, captopril, enalapril, lisinopril/lisinopril-HCTZ, losartan/losartan-HCTZ, ramipril

Glimepiride, glipizide, metformin IR/ER

REVISED Standing Order for Combivent Respimat to Stiolto Respimat

Combivent Respimat Equivalent to Stiolto Respimat

4 to 6 puffs daily

2 puffs once daily

*Exclusion: Patients with active orders for any other inhaled or nebulized therapies for respiratory disease • Revision: Add a prescription for one Ventolin canister, with zero refills, if applicable

for rescue

Days’ Supply Remaining Equivalent Days Supply + Refills

0 to 90 90 + 0

91 to 180 90 + 1

181 to 270 90 + 2

271 to 360 90 + 3

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class review

April 2017:

Medication class Reviews

Antiemetics

Digestive Aids

Gastrointestinal Agents-Misc

Dietary Products

Pharmaceutical Adjuvants

Hematological Agentsl

Gout Agents

Corticosteroids

Androgen/Anabolics

Antidiabetics

Thyroid

Antineoplastics

Ophthalmic Agents

National Medicare Part D Formulary

Kaiser 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 and tier changes are listed below:

Medication Name TierImplementation

Date

rucaparib (Rubraca) 200 mg, 300 mg tablets 5 12/22/2016

linaclotide (Linzess) 72 mcg capsules (new strength) 3 Pending

maraviroc (Selzentry 25 mg and 75 mg tablets (new strength) 3 Pending

Medical Office Floorstock Additions

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

Medication Department

Morphine 2 mg Syringe ACC/CDU

Dabigatran (Pradaxa) 75 mg UD tablets ACC/CDU

Abilify Maintena 300 mg, 400 mg Behavioral Health

Tropicamide 0.5% ophthalmic solution IM (Gwinnett, Southwood, Cascade)

Avastatin PF 2.5 mg/0.1 mL Ophthalmology MOB/Procedure Suites

Cyclopentolate 1%/Tropicamide 1%/Phenyl-ephrine 2.5%

Ophthalmology MOB/Procedure Suite

Moxifloxacin in BSS 0.1mg/mL Ophthalmology/Procedure Suite

Medication Name Initial Tier Tier Change

Insulin R U -500 Kwik-pen

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2017 MPD Tier Changes

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

NOTEWORTHY NEWS: QVAR®To improve affordability and adherence to first line preventative therapy for asthma, KPGA will be offering a mail order incentive for QVAR® HFA Inhaler pre-scriptions to eligible Commercial and QHP members effective March 15, 2017.

Most, but not all, Commercial and QHP members have a prescription drug benefit that qualifies them for a mail order incentive. Member with deductibles must meet their deductible before the mail order incentive applies.

*Medicare members are excluded because they have a different mail order incentive structure.

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Non-Formulary Cost ConsiderationsClass Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls

Agents for gout• Zurampic® (lesinurad)• Uloric® (febuxostat)• Colcrys® (colchicine)

• Allopurinol• Probenecid

• Zurampic® is a 3rd line option used in combination with xanthine oxidase inhibitors (XOI).

• Cost-effective formulary alternatives have stronger data and recommenda-tions based on the guidelines.

• The cost of non-formulary anti-gout agents are up to 46 times the cost of those that are formulary.

Long-acting beta2 agonists (LABA)

• Arcapta Neohaler® (inda-caterol)

• Perforomist Nebulizing Solu-tion® (formoterol)

• Brovana Nebulizing Solu-tion® (arformoterol)

• Serevent Diskus® (salme-terol)

• Striverdi Respimat® (oldat-erol)

• LABAs are recommended as 1st line for maintenance therapy of COPD

• LABA monotherapy is contraindi-cated for asthma treatment due to increased risk of severe exacerba-tion, hospitalization and asthma-related death. However, LABAs are recommended in conjunction with inhaled glucocorticoids for patients with moderate to severe asthma symptoms.

• The cost of Servent Disksus is now 2.5 times the cost of Striverdi Respimat without an improvement in efficacy.

FDA Drug Safety Communication:Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may

be linked to an increased risk of bladder cancer.

http://www.fda.gov/Drugs/DrugSafety/ucm519616.htm

FDA Dug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in

young children and pregnant women.http://www.fda.gov/Drugs/DrugSafety/

ucm532356.htm

Two-medication Antiretroviral Combo in Patients with Undetectable HIV Levels. Based on results from the SWORD-1 and SWORD-2 trials cited by MedPage Today, patients diagnosed with human immunodeficiency virus (HIV) infection who have success-fully suppressed serum virus to undetectable levels on multidrug antiretroviral therapy may be able to switch to a more convenient two-drug regimen without compromising efficacy.

Patients were switched to either a dolutegravir (Tivicay) plus rilpivirine (Edurant) two-drug combination or continued with their original three- or four-drug regimen. After 48-weeks, 95% of 513 patients who were switched maintained virus at undetectable levels com-pared with 96% of 511 patients who remained on their original treatment regimen.

The researchers selected the integrase inhibitor (dolutegravir) and the non-nucleoside reverse transcriptase inhibitor (rilpivirine) because the drugs were safe, effective, and had high barriers that prevented HIV from becoming resistant to the agents. As patients may often struggle with the number of drugs taken for the treatment of HIV, the results of this study may open new doors. However, current Infectious Disease Society of America (IDSA) guidelines take precedence for establishing the standard of care in the treatment of HIV.

http://www.medpagetoday.com/meetingcoverage/croi/63127

Clinical Updates