ISSUE 1 VOLUME 11 FEBRUARY 2017 u Formulary Additions . . . .1 uNew Criteria Restricted Medications ...... 2 u New Standing orders . . . .3 u Medications Reviewed at P&T, But Not Added to the Formulary ...... 3 u National Medicare Part D Formulary ...... 4 u Floorstock additions . . . 4

u Clinical Update . . . . . 5 FormularyUpdate At A Glance

Formulary Additions

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. A PUBLICATION OF THE GEORGIA PHARMACY AND THERAPEUTICS (P&T) COMMITTEE. The is most commonly delivered to transgender women via a transdermal patch, Formulary Update contains information regarding oral or sublingual tablet, or injection of a conjugated ester (estradiol valerate or formulary additions, deletions, exclusions, brief estradiol cypionate). The injection formulations provide an additional option for descriptions of products, and current drug related news. It also lists items to be discussed at upcoming transgender patients. 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. Kaiser Permanente Georgia 1 Formulary Additions, Continued Upcoming (Brilinta®) added to the Commercial Formulary effective March 15, Formulary Items 2017 is a 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 for maintenance therapy (Class IIa, Level B).

Clopidogrel remains the preferred, safe, and cost-effective formulary P2Y12 inhibitor, An important aspect of the however, Brilinta® is an alternative option for high-risk patients or those who may be non- formulary process is the responders to clopidogrel. Brilinta® carries a Black Box warning to avoid maintenance doses involvement of all practitioners. of greater than 100 mg in combination as it reduces the effectiveness of Brilinta®. Please contact your P&T Committee representative or your (Stromectol®) generic added to the Commercial Formulary effective clinical service chief by March 31, March 15, 2017 is an oral anti-helminthic agent indicated in onchocerciasis and intestinal 2017 if you wish to comment on any strongyloidiasis with off-label uses for the treatment of scabies and lice. While over-the- of the medications, class reviews, or other agenda items under counter (OTC) products remain 1st line for scabies and lice, Stromectol® is the most cost- consideration. To make formulary effective prescription option and is recommended as an alternative therapy by the Centers for addition requests, you must submit Disease Control and Prevention (CDC). a Formulary Additions/Deletions Form and Conflict of Interest Form to Drug Information Services or call Formulary Removals (404) 949-5331. 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 Medications

Criteria 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 Agonist • Indication: Improve glycemic control in adult patients with T2DM

2 Kaiser Permanente Georgia Questions and Changes to Criteria Restricted Medications Concerns? Ledipasvir/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

• (Zurampic®), an antigout medication that increases by

inhibiting uric acid and organic anion transporters was not added to the Commercial If you have any questions or Formulary. This mediation is a third line agent for the treatment of hyperuriciemia, concerns, please contact any of and is to be used in combination with a oxidase inhibitor such as the following P&T Committee or febuxostat for patients with unable to achieve target serum uric members and designated acid levels. Decison pending for National MPD formulary. alternates: P&T Chair: Carole Gardner, MD New Standing Order for 90-day Supply of P&T Committee Members: Statins, Renin-Angiotensin System Debbi Baker, PharmD, BCPS Agonists, and oral Diabetes Medications Clinical Pharmacy Eligible Medications for Conversion Gary Beals, RPh Director of Pharmacy , lovastatin, pravastatin, rosuvastatin, simvastatin Karen Bolden, RN, BSN benazepril, captopril, enalapril, lisinopril/lisinopril-HCTZ, /losartan-HCTZ, Clinical Services ramipril Alyssa Dayton, MD Glimepiride, glipizide, metformin IR/ER Obstetrics and Gynecology Carole Gardner, MD Elder Care Days’ Supply Remaining Equivalent Days Supply + Refills Patrice Gaspard, MD 0 to 90 90 + 0 Pediatrics 91 to 180 90 + 1 David Jones, MD Pediatrics 181 to 270 90 + 2 Craig Kaplan, MD 271 to 360 90 + 3 Ambulatory Medicine Felecia Martin, PharmD Pharmacy/Geriatrics Shayne Mixon, PharmD REVISED Standing Order for Combivent Pharmacy Operations Rachel Robins, MD Respimat to Stiolto Respimat Hospitalist Jennifer Rodriguez, MD Combivent Respimat Equivalent to Stiolto Respimat Behavioral Health 4 to 6 puffs daily 2 puffs once daily Designated Alternates: Jacqueline Anglade, MD

Obstetrics and Gynecology

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

Kaiser Permanente Georgia 3 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- Class Review scriptions to eligible Commercial and QHP members effective March 15, 2017. Most, but not all, Commercial and QHP members have a 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.

National Medicare Part D Formulary April 2017: Medication Class Reviews Kaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T Antiemetics Committee reviews drugs and decides on tier status. The National Medicare Part D Digestive Aids Pharmacy and Therapeutics Committee is charged with reconciling regional differences in MPD Formulary recommendations through consensus building in order to maintain Gastrointestinal Agents- one National MPD Formulary for Kaiser Permanente. Misc MPD Formulary 2017 initial tier placements and tier changes are listed Dietary Products below: Pharmaceutical Adjuvants Hematological Agentsl Implementation Medication Name Tier Date Gout Agents Corticosteroids rucaparib (Rubraca) 200 mg, 300 mg tablets 5 12/22/2016 Androgen/Anabolics linaclotide (Linzess) 72 mcg capsules (new strength) 3 Pending Antidiabetics maraviroc (Selzentry 25 mg and 75 mg tablets (new strength) 3 Pending Thyroid 2017 MPD Tier Changes Antineoplastics Ophthalmic Agents Medication Name Initial Tier Tier Change Insulin R U -500 Kwik- 4 3 pen Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine

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- Ophthalmology MOB/Procedure Suite ephrine 2.5% Moxifloxacin in BSS 0.1mg/mL Ophthalmology/Procedure Suite

Kaiser Permanente Georgia 4 Non-Formulary Cost Considerations Class Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls • Zurampic® is a 3rd line option used in combination with inhibitors (XOI). • Zurampic® (lesinurad) • Cost-effective formulary alternatives • Allopurinol have stronger data and recommenda- Agents for gout • Uloric® (febuxostat) • • Colcrys® () 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.

• LABAs are recommended as 1st line for maintenance therapy of COPD • LABA monotherapy is contraindi- cated for asthma treatment due to • Arcapta Neohaler® (inda- increased risk of severe exacerba- caterol) tion, hospitalization and asthma- • Perforomist Nebulizing Solu- related death. However, LABAs are Long-acting beta2 tion® (formoterol) • Striverdi Respimat® (oldat- recommended in conjunction with agonists (LABA) • Brovana Nebulizing Solu- erol) tion® (arformoterol) inhaled glucocorticoids for patients • Serevent Diskus® (salme- with moderate to severe asthma terol) symptoms. • The cost of Servent Disksus is now 2.5 times the cost of Striverdi Respimat without an improvement in efficacy.

Clinical Updates

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. FDA Drug Safety Communication: Updated FDA review concludes that use of The researchers selected the integrase inhibitor (dolutegravir) and the non- reverse transcriptasetype 2 diabetes inhibitor medicine (rilpivirine) pioglitazone may because the drugs were safe, effective, and had high barriers that prevented HIV from becoming resistantbe linked to anthe increased agents. risk As of patients bladder cancer. may often struggle with the number of drugs taken for the treatment of HIV, the results of this studyhttp://www.fda.gov/Drugs/DrugSafety/ may open new doors. However, current Infectious Disease Society of America (IDSA) guidelines take precedence for establishing the standarducm519616.htm of care in the treatment of HIV.

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

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