ISSUE 3 VOLUME 10 JUNE

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1 u Formulary Additions unew Criteria Restricted Medications u Quantity Limits u Floorstock Lists u Medications Reviewed at P&T, But Not Added to the Formulary u National Medicare Part D Formulary u Rx Notifier u Non-Formulary Cost Considerations u Clinical Update ISSUE 3 VOLUME 10 JUNE 2016 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. Formulary Additions Pioglitazone (generic Actos) 15 mg, 30 mg, and 45 mg tablets were added to the Commercial Formulary effective May 24, Pioglitazone (generic Actos) is a thiazolidinedione indicated for the treatment of type 2 diabetes mellitus, as monotherapy or combination therapy in adjunct to diet and exercise, to improve glycemic control. In June 2011, the FDA informed the public that use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. A recent study published July 21, 2015 in JAMA looked at long-term data from nearly 200,000 diabetes patients to revisit the debate of whether pioglitazone significantly increases the risk of bladder cancer. Based on this published cohort and nested case-control analyses conducted in KP Northern California, among persons with diabetes, pioglitazone use was not associated with a statistically significant increased risk of bladder cancer. The increased prostate and pancreatic cancer risks associated with ever use of pioglitazone merit further investigation to assess whether they are causal or are due to chance, residual confounding, or reverse causality. According to the KP National treatment algorithm for diabetes, pioglitazone is a third line treatment agent following metformin, sulfonylureas, and/or insulin. Kaiser Permanente Georgia 1

2 Formulary Additions, Continued Duloxetine (generic Cymbalta) 20 mg, 30 mg, 60 mg capsules will be added to the Commercial Formulary effective June 29, Duloxetine is a dual reuptake inhibitor of serotonin and norepinephrine, similar to venlafaxine. Duloxetine has several FDA approved indications including: major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain, and fibromyalgia. Duloxetine shares the same boxed warning of other antidepressants including increased risk of suicidal thoughts and behavior. The effectiveness of antidepressant medications is generally comparable between and within classes of medications, including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), bupropion, tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). Duloxetine is a cost-effective treatment option for several indications. In support of KPGA DUAT initiative to reduce Lyrica use, if your patient is currently taking dual therapy with duloxetine and lyrica, consider discontinuation of lyrica in favor of monotherapy with duloxetine. Duloxetine is a recommended antidepressant option in the elderly. Consider duloxetine in the elderly instead of alternate antidepressants, such as TCA (and SSRIs in patients with falls). Also, duloxetine may be preferred over gabapentin for treatment of neuropathic pain in older adults with a history of falls or fractures. Duloxetine should be avoided if Cr Cl <30 due to risk of GI adverse effects. Gabapentin dose should be reduced for Cr Cl <60 due to risk of CNS adverse effects. Carbamazepine extended-release (generic Tegretol XR) 100 mg tablet will be added to the Commercial Formulary effective June 29, Carbamazepine is used for the treatment of partial seizures with complex symptomatology (psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), mixed seizure patterns, trigeminal neuralgia, and glossopharyngeal neuralgia. Carbamazepine 100 mg extended-release tablets recently became available as a generic. Carbamazepine 200 mg and 400 mg extended-release tablets are currently on the Commercial Formulary. 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. Providers must call QRM to request authorization consideration at 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 added to the list of Criteria Restricted Medications (QRM): Alemtuzumab (Lemtrada) 12 mg/1.2 ml intravenous solution Upcoming Formulary Items 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 July 18, 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) Quantity Limits In order to encourage appropriate drug utilization and contain medication cost, quantity limits are implemented on certain medications. The quantity limit defines the maximum quantity of a medication that can be dispensed over a specific period of time at the applicable benefit co-pay for the patient. The quantity limit for the medication below will be added to the list effective July 1, mechlorethamine (Valchlor) 0.016% gel Quantity Limit 60 gm/dispense 2 Kaiser Permanente Georgia

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 Elder Care Patrice Gaspard, MD Marcus Griffith, MD* Behavioral Health David Jones, MD Craig Kaplan, MD Ambulatory Medicine Felecia Martin, PharmD Pharmacy/Geriatrics Shayne Mixon, PharmD Pharmacy Operations Rachel Robins, MD Hospitalist Jennifer Rodriguez, MD* Behavioral Health Ivorique Turner, MD Ambulatory Medicine Designated Alternates: Jacqueline Anglade, MD Obstetrics and Gynecology Lesia Jackson, RN Clinical Services *Attend alternating meetings Medical Office Floorstock Additions Approved medications will be added to the electronic floorstock ordering forms on the intranet. GW Urgent Care Pyxis OB-GYN Procedure room Pyxis Cardiology Department Name Interventional Radiology Kinrix 0.5 mg SDV Vancomycin 1 gm kit; GelFoam 50 Makena SDV Ondansetron 8 mg/2 ml vials Lumason Propofol 10 mg/ml Medications Reviewed, but Not Added to the Formulary Isavuconazonium (Cresemba) 186 mg capsules and 372 mg IV solution were not added to the Commercial Formulary, decision pending for National MPD formulary Eluxadoline (Viberzi) 75 mg, 100 mg tablets were not added to the Commercial Formulary, decision pending for National MPD formulary Alemtuzumab (Lemtrada) 12 mg/1.2 ml IV Solution, decision pending for National MPD formulary 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. National MPD Formulary 2016 tier changes are listed below with the corresponding effective date. Pradaxa caps 110 mg 3 4/5/2016 Narcan liqd 4 mg/0.1ml 3 4/5/2016 Brilinta tabs 60 mg 3 4/5/2016 Extavia kit 0.3 mg 3 4/5/2016 Targretin caps 75 mg 3 4/5/2016 National MPD Formulary 2017 tier changes are listed below with the corresponding effective date. 1 = Value Generic 3 = Brand 5 = Specialty 2 = Generic 4 = Non-Preferred Brand 6 = Injectable Part D Vaccine Evzio Soaj 0.4 mg/0.4ml 4 1/1/2017 Alocril Soln 2 % 4 1/1/2017 Asmanex 30 Metered Doses AEPB 110 mcg/inh 4 1/1/2017 Asmanex 120 Metered Doses AEPB 220 mcg/inh 4 1/1/2017 Asmanex 60 Metered Doses AEPB 220 mcg/inh 4 1/1/2017 Kaiser Permanente Georgia 3

4 National Medicare Part D Formulary, Cont. National MPD Formulary initial tier placements are listed below with the corresponding effective date. Class Review uridine triacetate 2 gm pkt oral granule (Xuriden) 5 3/1/2016 cariprazine 1.5 mg, 3 mg, 4.5 mg, 6 mg capsule; pack 1.5 & 3 mg (Vraylar) adalimumab 40 mg/0.8 ml pen; pediatric crohns start pack 40 mg/0.8 ml (Humira) 5 4/1/ /1/2016 incobotulinumtoxina 200 unit solution (Xeomin) 5 3/1/2016 levetiracetam 250 mg, 500 mg, 750 mg, 1000 mg tablet (Spritam) 5 4/1/2016 somatropin 10 mg/2 ml, 20 mg/2 ml solution (Nutropin AQ) 5 3/1/2016 docetaxel (non-alcohol) 20 mg/ml, 80 mg/4 ml, 160 mg/8 ml solution 5 3/1/2016 tofacitinib citrate 11 mg tablet (Xeljanz XR) 5 4/1/2016 uridine triacetate (emergency treatment) 10 gm pack (Vistogard) 5 3/1/2016 ixekizumab 80 mg/ml soln prefilled syring (Taltz) 5 3/30/2016 halobetasol propionate lotion 0.05% (Ultravate) 5 4/13/2016 miltefosine 50 mg capsule (Impavido) 4 Pending lesinurad 200 mg tablet (Zurampic) 4 Pending darucizumab 2.5 g/50 ml solution (Praxbind) talimogene laherparepvec unit/ml, unit/ ml suspension (Imlygic) Remove from 5 Remove from 5 Determined to be covered on Part B Determined to be covered on Part B reslizumab (Cingair) 5 Pending Rx Notifier: Get a Text Message when you Prescription is ready for Pickup! As a part of its commitment to delivering excellent service, Kaiser Permanente Pharmacy Services will be launching Rx Notifier on June 22, Rx Notifier is a web base application used to improve member communication by notifying members via mobile text message (SMS) when their prescription order is available for pick up from our KP pharmacies. Our Operations Pharmacists will promote and enroll patients individually to receive this service. Enrollment can be initiated at our pharmacies or over the phone. A text message is sent to the member s mobile device upon Product Verification completion. The service is completely confidential and no medical or prescription information is included in the message. August 2016: Medication Class Reviews Endocrine and metabolic agents - misc Analgesics - non-narcotic Analgesics - opioids Analgesics - antiinflammatory Vitamins Multi-Vitamins Minerals & electrolytes Hematopoietic agents Anticoagulants Hemostatics Otic Mouth/Throat/Dental Antiseptics & disinfectants Diagnostic products Skeletal muscle relaxants Kaiser Permanente Georgia 4

5 Non-Formulary Cost Considerations Class Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls Acne agents Differin (Adapalene) Tazorac (Tazarotene) Tretinoin (Retin-A) For the cost of every 1 patient treated with adapalene, approximately 3 patients can be treated with tretinoin (Retin-A). For the cost of 1 patient treated with Tazorac, approximately 5 patients can be treated with tretinoin (Retin-A). Antiplatelet Agents Effient (Prasugrel) Zontivity (Vorapaxar) Brilinta (Ticagrelor) Clopidogrel (generic Plavix) For the cost of 1 patient treated with Effient, approximately 109 patients can be treated with clopidogrel. For the cost of 1 patient treated with- Brilinta, approximately 86 patients can be treated with clopidogrel. Clinical Updates Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk. The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed. OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products. In 2009, a warning about the risk of serious bleeding was added to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products. However, a search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. All of these patients were hospitalized. Patients had underlying conditions such as the risk factors above that put them at greater risk for developing serious bleeding events. The FAERS database includes only reports submitted to FDA so there are likely additional cases about which we are unaware. FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. The FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally because use of metformin in these patients can increase the risk of developing a serious and potentially deadly condition called lactic acidosis. The FDA has concluded from the review of studies published in the medical literature that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function and are requiring changes to the metformin labeling to reflect this new information. Health care professionals should follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function. Additional Clinical Alerts Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ ucm htm Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ ucm htm Kaiser Permanente Georgia 5