ISSUE 1 VOLUME 12 FEBRUARY At A Glance. Ingrezza (valbenazine)- A treatment for adult patients with tardive dyskinesia.

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1 ISSUE 1 VOLUME 12 FEBRUARY 2018 u New QRM Medications uformulary Deletions uqhp Updates ustanding order unational Medicare Part D Formulary uclinical Update umedtac news Formulary Update At A Glance A PUBLICATION OF THE GEORGIA PHARMACY AND THERAPEUTICS (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 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. New QRM (Prior Authorization) Medications Certain medications require Quality Resource Management (QRM) review to confirm medical coverage criteria are satisfied prior to granting 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). Tremfya (guselkumab)- A treatment for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Austedo (deutetrabenazine)- A treatment for adult patients with tardive dyskinesia and chorea associated with Huntington s Disease. Ingrezza (valbenazine)- A treatment for adult patients with tardive dyskinesia. Emflaza (deflazacort)- A treatment for Duchenne muscular dystrophy (DMD). Kaiser Permanente Georgia 1

2 Formulary Deletions Xulane mcg(ethinyl estradiol and norelgestromin)- transdermal estrogen/progestin contraceptive will be removed from the KPGA Commercial Formulary effective 3/28/18. Xulane requires step therapy for QHP Members. Upcoming Formulary Items Interregional Practice Recommendations The 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. 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 15th, 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) New Interregional Practice Recommendations have been approved for the following ETS Program Medications: Kymriah (tisagenleucel)- CD-19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL). Yescarta (axicabtagen ciloleucel)- CD-19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy. 2 Kaiser Permanente Georgia Medications not added to the Formulary Odactra (house dust mite allergen extract)- Sublingual immunotherapy for the treatment of house dust mite-induced allergic rhinitis in adults. Idhifa (enasidenib)- Treatment of adult pateints with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation as detected by an FDA-approved test. Gocovri (amantadine extended-release)-treatment of dyskinesia in patients with Parkinson s Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. QHP Formulary Updates for 2018 Concerta (Methylphenidate ER)- Treatment of attention-deficit/hyperactivity disorder (ADHD) Concerta will move from preferred Brand to Brand Tier 3 to align with the HMO formulary. Concerta 18 mg, 27mg, 36 mg, 54 mg tablets are currently on the Brand Adjudicated as Generic List.

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, RPh Director of Pharmacy Karen Bolden, RN, BSN Clinical Services Alyssa Dayton, MD Obstetrics and Gynecology Carole Gardner, MD Geriatric Medicine Jay Polokoff, MD Pediatrics Craig Kaplan, MD Adult Primary Care George Kawamura, MD Adult Primary Care Amy Levine, MD Pediatrics Felecia Martin, PharmD Pharmacy/Geriatrics Shayne Mixon, PharmD Pharmacy Operations Rachel Robins, MD Hospitalist Jennifer Rodriguez, MD Behavioral Health Designated Alternates: Jacqueline Anglade, MD Obstetrics and Gynecology Lesia Jackson, RN Clinical Services New Standing Order Initiating Statins in Persons with Diabetes and Prediabetes with 10-year ASCVD risk > 7.5% Inclusions: Type 1 or Type 2 Diabetes diagnosis per problem list in KP Health Connect OR Prediabetes with 10-year ASCVD risk score >7.5% AND Prescribed diabetes medication in the past 12 months Exclusions: Age > 75 or <40 years LDL <70 Dialysis LFTs >3 ULN currently and/or history of while on statins Hospice/Palliative care History of rhabdomyolysis (CK elevations of at least 10x the ULN) If eligible, pharmacist will do the following: Initiate moderate to high-intensity statin* Modify dose if higher risk for adverse events. (Examples include, history of myalgia, older age, female, Asian race, drug interaction, patient resistance, statin re-trial, muscle disorder, renal function, etc.) Discontinue alternative lipid lowering therapy when clinically indicated and replace with statin therapy Renew expired statin prescriptions, reorder statin prescription to fill at KP pharmacy if patient agreeable Screen for drug-drug interactions *Statin includes atorvastatin mg, simvastatin mg, pravastatin 40 mg, lovastatin 40 mg, rosuvastatin 5-40 mg daily or intermittent dosing as clinically indicated. Pharmacist will reorder statin prescription for KP pharmacy fill from outside pharmacy prescription. Continue prescribed statin unless it is clinically indicated to modify dose (i.e. drug interaction, adjust statin dose to moderate or high-intensity, etc.) Departmental Floorstock Additions Medication Kenalog 40 (Triamcinolone) injectable suspension Nystatin powder Depo-Provera (medroxyprogesterone) Depot injectable suspension Cantharidin Plus (Cantharidin-podophyllum, Salicylic acid) Restylane Silk, Lift Phenylephrine nasal spray 0.25 % Amiodarone 150 mg Vial to Bag Department Urogynecology ENT Pediatrics, Adult Primary Care Dermatology Cosmetic Dermatology ACC/CDU Pyxis Procedure Suite for TEE procedures Kaiser Permanente Georgia 3

4 Medicare Part D 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. Class Review Intial Tier Placements-Recently launched and approved medications Medication Name Tier Implementation Date emicizumab-kxwh 150 mg/ml, 105 mg/0.7 ml, 60 mg/0.4 ml, 30 mg/ml injection (Hemlibra) tretnoin 0.06% microsphere gel (Retin-A) letermovir 240 mg, 480 mg tablets; 240 mg/12 ml, 480 mg/24 ml injection (Prevymis) bosutinib 400 mg tablets (Bosulif)** arsenic trioxide 12 mg/6 ml (Trisenox)** buprenorphine 100 mg/0.5 ml, 300 mg/1.5 ml ER subcutaneous injection (Sublocade) nivolumab 240 mg/24 ml (Opdivo)** trasluzumab-dkst 420 mg injection (Ogivri)** vestronidase alfa-vjbk 10 mg/5 ml injection (Mepsevii) netarsudil dimesylate 0.02% ophthalmic (Rhopressa) Launch Pending ertugliflozin and metformin mg, mg, mg, mg tablets (Segluromet) Launch Pending ertugliflozin and sitagliptin mg, mg tablets (Stelujan) Launch Pending ertugliflozin 5 mg, 15 mg tablets (Steglatro) Launch Pending macimorelin 0.5 mg solution (Macrilen) Launch Pending brigatinib 90 mg, 180 mg tablets and initiation pak (Alunbrig)** 11/22/ /24/ /4/ /6/ /11/ /22/2017 1/2/2018 1/31/2018 April 2018: Medication Class Reviews Antiemetics Digestive Aids Gastrointestinal Agents-misc Dietary Products ;dh Gout Agentspnotics Corticosteroids Antineoplastics Androgent/Anabolics Pharmaceutical Adjuvants Antidiabetics Thyroid Ophthalmics angiotensin II 25 mg/ml injection (Giapreza) Launch Pending **Protected Class Kaiser Permanente Georgia 4

5 Formulary Cost Considerations Class formulary Medications Formulary Alternatives Clinical/Cost Pearls Interleukin Antagonists for moderate to severe plaque psoriasis Stelara*(Usekinumab) Taltz*(Ixekizumab) Tremfya*(Guselkumab) Siliq* (Brodalumab) *QRM (Prior Authorization Required) Documented inadequate response (of at least a 3 month trial), intolerance or contraindication to BOTH of the following: 1. ONE or more tumor necrosis factor (TNF-α) inhibitors: Humira (Adalimumab) Enbrel (Etanercept) Inflectra (Infliximab-dyyb) 2. Cosentyx (Secukinumab)- Formulary Biologics are a treatment option for patients diagnosed with moderate to severe plaque psoriasis with inadequate response to topical, oral and phototherapy. KP systemic psoriasis therapy order of preference for patients failing topical options: 1. Narrowband ultraviolet B (NBUVB) phototherapy with or without topical drugs 2. Systemic non-biologic agents (cyclosporine, acitretin, and methotrexate) for select patients 3. Otezla (Apremilast) 4. Etanercept or adalimumab: preferred first-line biologics 5. Inflectra (Infliximab) 6. Cosentyx (Secukinumab) 7. Stelara (Ustekinumab) Siliq (Brodalumab) carries a Boxed Warning for suicidal ideation and behavior, including completed suicides. Siliq is only available through a restricted program called the Brodalumab REMS program. Given these safety concerns, it should be considered last line for plaque psoriasis. FDA Drug Safety Communication: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, the U.S. Food and Drug Administration (FDA) is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. We continue to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed. Loperamide is FDA-approved to help control symptoms of diarrhea, including Travelers Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics. Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death. Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. Some individuals are taking high doses of loperamide to treat symptoms of opioid withdrawal. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. For some cases of abnormal heart rhythms in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Also counsel patients to take loperamide only as prescribed or according to the OTC Drug Facts label and advise patients that drug interactions with commonly used medicines may increase the risk of serious cardiac events. Patients, consumers, and health care professionals are urged to report side effects involving loperamide or other medicines to the FDA Med- Watch program. Clinical Updates Kaiser Permanente Georgia 5

6 MEDTAC NEWS Written by Jim Toth, MD Medication Treatment and Appropriateness Committee (MEDTAC) West Representative And welcome to another episode of MEDTAC News! In today s newsletter, let s talk about another facet of HRME (High Risk Medications in the Elderly) related to prescribing skeletal muscle relaxers in our members age 65 or greater. First, let s talk about a typical clinical scenario: John B is a 74 year old luge enthusiast. He s coming down turn 8 and loses it. He hits the wall at 75 miles an hour, the luge goes left and he goes right, and he tumbles and bounces and slides ingloriously down the remainder of the icy track. He staggers to his feet and is helped to a stretcher, where he s brought to your urgent care / office for evaluation. You welcome him warmly (he s a new member) and perform an exam. You notice a few bruises starting to develop but otherwise, he s neurologically intact. He says, Doc, I feel like I ve been in a car wreck. Everything hurts. I ve got whiplash and I can barely turn my head to the right or left. My back is starting to spasm, I can feel it tightening up even as we speak. I ve got a figure skating pairs short program tomorrow at 9 (John s a talented athlete). I ll never get my step sequences or spin combos to sync up if I can t even turn my head. Doc, I need a muscle relaxer. My old doctor used to write Flexeril for me and boy does it work great! Please doc? Can I get some Flexeril? What do you do? It s a tough situation. He s in pain. He s right, he can barely turn his head. He s leaning forward with his hand on his low back, barely able to stand up straight. The gold s on the line, and you feel empathy for your aging athlete new member who s in obvious pain. Here s what I would do. First, I d empathize. John, you took a pretty big hit coming out of turn 8. You ve got bruises developing all over your body and your muscles look stiff and sore. I imagine you must be in some pretty bad pain right now. And to make matters worse, it sounds like you re afraid you won t be able to perform to your usual standards in your next event. Then I d explain the physiology. John, when a person goes through an injury like what you ve had, certain things happen in the body. Muscles and tendons and ligaments get stretched or torn. The inflammation that results can cause your muscles to stiffen up and even go into spasm. This inflammation causes pain and also loss of your normal range of motion. Next I d explain why I disagree with John s request for muscle relaxers: John, it sounds like your previous doctor prescribed muscle relaxers for you when you were injured like this in the past. I need to tell you though, I don t think that s the best idea for how to treat you now. First, your pain and spasms are due to inflammation. Muscle relaxers aren t anti-inflammatories. They work by stopping nerve impulses in your brain and spinal cord. Blocking those nerve impulses can cause your muscles to relax, sure, but they can also cause EVERYTHING to relax. The effect on your central nervous system is similar to if you ve taken Valium, a strong sedative and sleeping pill. Not only will you be sleepy and sedated, your balance and coordination will be tremendously affected. You could experience dizziness, blurred vision, confusion and muscle weakness! That camel spin you ve been working on is going to be pretty tough if you can t even keep your eyes open. You see John, just like there are normal processes that happen in your body after an injury, there are normal processes that happen to your metabolism as you get older. Now that you re 74, your body doesn t metabolize or eliminate medications at the same rate as when you were 20 or even 40. Now that you re older, medications last longer in your system, and the effects can be additive over time. Now if you were to take Flexeril, your risk of falling and having an even worse injury would be greatly increased. Your pain and muscle spasms are bad today, but a hip fracture after a fall would be even worse. Finally, I d prescribe an appropriate therapy. John, I want to keep you safe as you recover from your injuries. Let s address the inflammatory response with appropriate anti-inflammatory therapies. I need you to get some rest to allow your body to heal. Apply ice to areas that are bruised and swollen. You can try a heating pad applied to muscles that are stiff and sore and not moving correctly. Tylenol is good for pain. We can try ibuprofen or naproxen for a limited time, but prolonged use can affect your kidneys or stomach. A few days should be fine. Finally, stretching those stiff and sore muscles should help. You can do that on your own, or I can process a referral to Physical Therapy. The physical therapist can help get you moving again pretty quickly, by focusing on flexibility and getting those muscle working again. Let s skip the sedatives and go right to the treatment that will do you the most good. John was worried at first that he wasn t going to get his muscle relaxers. But he appreciated being heard and having his pain and his fears acknowledged. He left with a better understanding of why his muscles were in spasm after his injury and also how best to treat the inflammatory process causing the muscle spasm. He decided to ice his injuries, rest, and attend a few visits to Physiotherapy. He decided to skip his figure skating event to allow his injuries to heal, but went on to take a silver in snowboarding freestyle. His 180 followed by a double hand grab was killer! On the podium, he thanked his Kaiser doctor for the right treatment at the right time! Kaiser Permanente Georgia 6