Formulary. Update. Kaiser Permanente Georgia 1

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1 u Formulary Additions ISSUE 3 VOLUME 7 JUNE 2013 u Formulary Deletions u Quantity Limits u New Criteria Restricted Medications u Floorstock Additions u National Medicare Part D Formulary u National MPD Formulary, Negative Changes u Clinical Update u Medications Reviewed at P&T, But Not Added to the Formulary u Appendix A: 2014 MPD Tier Status Changes Formulary Update Formulary Additions Ciprofloxacin (generic Ciloxan) 0.3% ophthalmic solution is currently available on the National Medicare Part D (MPD) Formulary as Tier 2, generic, and was added to the Commercial Formulary effective June 20, Ciprofloxacin is a second-generation fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. Ciprofloxacin 0.3% ophthalmic solution is indicated for the treatment of superficial ocular infections (corneal ulcers, conjunctivitis) due to susceptible strains. Ciprofloxacin ophthalmic solution has relatively few side effects and is comparable in safety to other ophthalmic fluoroquinolones. Ciprofloxacin has better gram negative activity (especially against Pseudomonas aeruginosa) than other existing quinolones. Rizatriptan benzoate (generic Maxalt) 5 mg and 10 mg tablets are currently available on the National MPD Formulary as Tier 2, generic, and were added to the Commercial Formulary effective June 20, Rizatriptan is a second-generation triptan indicated for the acute treatment of migraines with or without aura in adults and in pediatric patients 6 to 17 years of age. In comparative studies, rizatriptan and sumatriptan have demonstrated overall comparable efficacy in the treatment of acute migraine attacks. Rizatriptan oral disintegrating tablets (generic Maxalt MLT) remain non-formulary. 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 Deletions Fluticasone (Flovent) 44 mcg HFA will be removed from the Commercial Formulary effective July 17, According to the Guidelines for the Diagnosis and Management of Asthma, inhaled corticosteroids (ICS) are the most consistently effective long-term control medication at all steps of care for persistent asthma. No one ICS agent is preferred over another. Although not FDA approved for children <4 years of age, the guidelines recommend appropriately dosed ICSs for children of all ages. Flovent 44 mcg is no longer the only ICS approved for the use in children 4 years of age. The FDA now also approves our formulary agents for use use in children 4 years of age: QVAR 40 mcg, 80 mcg, Asmanex 110 mcg, 220 mcg, and budesonide suspension 0.25 mg/2 ml, 0.5 mg/2 ml. Kaiser Permanente Georgia 1

2 Formulary Deletions, Continued Budesonide (Pulmicort Respules) 1 mg/2 ml will be removed from the Commercial Formulary effective July 17, Budesonide nebulization suspension 0.25 mg/2 ml and 0.5 mg/ml are available generically and are on the Commercial Formulary. Budesonide (Pulmicort Respules) 1 mg/2 ml is not available as a generic and is almost 5 times the cost of generic budesonide nebulization suspension. If the budesonide 1 mg/2 ml is needed, consider using two of the budesonide 0.5 mg/2 ml vials. Quantity Limits In order to encourage appropriate drug utilization and contain medication cost, quantitylimits are implemented on certain medications. The quantity limit identifies the maximum quantity of medication that can be dispensed over a specific period of time at the applicable benefit co-pay for the patient. The table below shows the additions, changes and deletion of medications with quantity limits: Action Medication Name Quantity Limit Changed Rivaroxaban (Xarelto) 15 mg 42 tablets/180 days Added Armodafinil (Nuvigil) 50 mg 60 tablets/30 days Added Tolvaptan (Samsca) 15 mg 30 tablets/365 days Added Tolvaptan (Samsca) 30 mg 60 tablets/365 days Removed Dextroamphetamine CR (Dexedrine) 15 mg 30 capsules/30 days New Criteria Restricted (QRM) Medications Criteria restricted medications require review and authorization by Quality Resource Management (QRM) prior to coverage. The prior authorization process and criteria apply to the commercial Formulary, not the Medicare Part D Formulary. Providers must call QRM to request review 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 medications will be added to the list of Criteria Restricted Medications (QRM) effective July 1, Alogliptin (Nesina) 6.25 mg, 12.5 mg, 25 mg tablets Alogliptin and metformin (Kazano) 12.5 mg/500 mg, 12.5 mg/1000 mg tablets Alogliptin and pioglitazone (Oseni) 12.5 mg/15 mg, 12.5 mg/30 mg, 12.5 mg/45 mg, 25 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg tablets Teriflunomide (Aubagio) 7 mg, 14 mg, film-coated tablets Canagliflozin (Invokana) 100 mg, 300 mg tablets Dimethyl fumarate (Tecfidera) 120 mg, 240 mg delayed release capsules Mipomersen sodium (Kynamro) 200 mg/ml injection solution Teduglutide (Gattex) 5 mg vial Lomitapide (Juxtapid) 5 mg, 10 mg, 20 mg capsules Medical Office Floorstock Additions The medications below will be added to the electronic floorstock ordering forms on the intranet: Department Name Urgent Care Behavioral Health Ophthalmology Medication Added Dextrose 50% in water IV disp syringe Depo Provera (Medroxyprogesterone) 150 mg/ml Glucose gel 15 Olanzapine 5 mg and 10 mg ODT tablets Schirmer tear test strips Upcoming Formulary Decisions 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 24, 2013 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) Formulary Reviews (August 2013): Medication Class Reviews Vitamins MVI Minerals & Electrolytes Hematopoietic Agents Anticoagulants Hemostatic Agents Otic Agents Mouth/Throat/Dental Antiseptics & Disinfectants Diagnostic Products Skeletal Muscle Relaxants Endocrine and Metabolic Agents - Misc. Non-narcotic Analgesics Opiod Analgesics Anti-inflammatory Analgesics 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: Daniel Lee, MD, FACS Physician Program Director of Pharmacy P&T Committee Members: Seeme Ahmad, MD* Behavioral Health Debbi Baker, PharmD, BCPS Clinical Pharmacy Gary Beals, RPh Director of Pharmacy Karen Bolden, RN, BSN Clinical Services Deborah Burzotta, PharmD Pharmacy Operations Alyssa Dayton, MD Obstetrics and Gynecology Carole Gardner, MD Elder Care Patrice Gaspard, MD Pediatrics Marcus Griffith, MD* Behavioral Health Donald Hanchett, MD Ambulatory Medicine David Jones, MD Pediatrics Felecia Martin, PharmD Pharmacy/Geriatrics LaJune Oliver, MD Ambulatory Medicine Rachel Robins, MD Hospitalist Designated Alternates: Jacqueline Anglade, MD Obstetrics and Gynecology Lesia Jackson, RN Clinical Services *Attend alternating meetings 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 tier placements are listed below with the corresponding effective date. Please see Appendix A for the 2014 MPD tier changes. Medication Name Tier Effective Date Mipomersen sodium (Kynamro) inj 200 mg/ml 5 4/1/2013 Pasireotide diaspartate (Signifor) inj 0.3 mg, 0.6 mg, 0.9 mg 5 4/1/2013 Unoprostone isopropyl (Rescula) ophthalmic sol 0.15% 4 4/1/2013 Dimethyl fumarate (Tecfidera) DR capsules 120 mg and 240 mg, kit 5 4/15/2013 Canagliflozin (Invokana) tablet 100 mg, 300 mg 4 5/7/2013 Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine National MPD Negative Changes After review of Part D prescription claims submitted to CMS, it was determined that the below listed drugs do not meet the criteria for coverage under Part D. This has been confirmed by CMS and validated by the FDA website. A Part D covered drug is available only by prescription, approved by the Food and Drug Administration (FDA) (or is a drug described under section 1927(k)(2)(A)(ii) or (iii) of the Act), used and sold in the United States, and used for a medically accepted indication (as defined in section 1927(k)(6) of the Act). CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA. Prescriptions for these drugs listed below will no longer receive Part D coverage effective June 1, Aluvea 39% cream Clomiphene citrate 50 mg tab Denta 5000 plus cream Dentagel 1.1% gel Fluoridex defense 1.1% gel Neutral sodium fluoride Prevident 1.1% gel & 5000 dry mouth Prevident 5000 booster paste and booster plus Prevident 5000 plus cream Prevident dental rinse SF 1.1% gel SF 5000 plus cream Stannous fluoride 0.63% rinse Prior authorization will be required for the drug listed below. This Prior Authorization drug is specific for coverage by Medicare Part D for Pulmonary Arterial Hypertension or EXCLUDED from Coverage for use in Erectile Dysfunction. For Prescribers: Please ensure when ordering sildenafil to select the pre-populated instructions for the specified indication or populate the instuctions with the indication. The pharmacist will check the indication to detemine Medicare coverage. Prescriptions for the below listed drug will require prior authorization for coverage effective July 2, Sildenafil Citrate 20 mg tablets Kaiser Permanente Georgia 3

4 Clinical Updates High Risk Medication Alert: Nonbenzodiazepine Hypnotics in the Elderly. If a patient age 65 or older receives zolpidem (Ambien), eszopiclone (Lunesta), and/or zaleplon (Sonata) for >90 days per calendar year, HEDIS and CMS quality metrics are negatively affected. All patients seeking treatment for insomnia should be educated on good sleep hygiene practices (see.piinsomnia in KPHC) as well as undergo assessment and treatment for underlying conditions such as anxiety, depression or pain. If medical treatment is required, melatonin 3 mg (OTC) or trazodone 25 mg (titrated to mg nightly as needed) are considered safer options for elderly patients. Melatonin and trazodone should be administered 1 hour before bedtime. Please use KPHC Smart Rx Insomnia Greater than 64 Years to order safer medication options for the elderly. If a non-benzodiazepine sedative hypnotic is required after adequate trials of first line therapies, consider using the lowest possible dose for the shortest possible duration (<10 days). In July, TSPMG prescribers will receive actionable patient lists to reduce use of these medications in the elderly. MedSafety Alert: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR. The FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs. FDA is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR) either 6.25 mg or 12.5 mg should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities. The recommended initial dose of immediate-release zolpidem products (Ambien and Edluar) is 5 mg for women and either 5 mg or 10 mg for men. The recommended initial dose of zolpidem extended-release (Ambien CR) is 6.25 mg for women and either 6.25 or 12.5 mg for men. If the lower doses (5 mg for immediate-release, 6.25 mg for extended-release) are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release. However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness. Additional Clinical Alerts Important information on the use against prolonged use of magnesium sulfate to stop pre-term labor due to bone changes in exposed babies ucm htm Potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine) ucm htm MedSafety Alert: Valproate Anti-Seizure Products Contraindicated for Pregnant Women for Prevention of Migraine Headaches. The FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate s pregnancy category for migraine use will be changed from D to X. Valproate products are approved for the treatment of certain types of epilepsy, the treatment of manic episodes associated with bipolar disorder, and the prevention of migraine headaches. They are also used off-label (for uses not approved by FDA) for other conditions, particularly other psychiatric conditions. Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder. Valproate products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable. Medications Reviewed, but Not Added to the Formulary Bosutinib (Bosulif) 100 mg and 500 mg tablets, decision pending for the National MPD Formulary Pasireotide (Signifor) 0.3 mg/ml, 0.6 mg/ml, 0.9 mg/ml injection solution, decision pending for the National MPD Formulary Epinephrine (Auvi-Q) 0.15 mg, 0.3 mg Auto-Injector, not added to the Commercial Formulary; decision pending for the National MPD Formulary Malathion (generic Ovide) 0.5% lotion, not added to the Commercial Formulary Citalopram (generic Celexa) 10 mg/5 ml oral solution, not added to the Commercial Formulary 4 Kaiser Permanente Georgia

5 Appendix A 2014 National MPD Tier Status Changes Product Description 2013 Tier 2014 Tier Rationale ATORVASTATIN CALCIUM TABS 80MG 2 1 Inexpensive generic, great potent option for patients that can help reduce their risk, improve KP quality metrics, and help reduce downstream costs in hospitalization and procedures related to vascular events and morbidity. PHENOBARBITAL SODIUM INJ 130MG/ML N/A 2 Barbs covered for all conditions in 2014 PHENOBARBITAL SOL 20MG/5ML N/A 2 Barbs covered for all conditions in 2014 MEPHOBARBITAL TAB 32MG N/A 2 Barbs covered for all conditions in 2014 MEPHOBARBITAL TAB 50MG N/A 2 Barbs covered for all conditions in 2014 MEPHOBARBITAL TAB 100MG N/A 2 Barbs covered for all conditions in 2014 BUTALBITAL/ASA/CAFFEINE CAP N/A 2 Barbs covered for all conditions in 2014 BUTALBITAL/ASPIRIN/CAFFEI NE TAB N/A 2 Barbs covered for all conditions in 2014 MARGESIC CAP N/A 2 Barbs covered for all conditions in 2014 CAPACET CAP N/A 2 Barbs covered for all conditions in 2014 ANOLOR 300 CAP N/A 2 Barbs covered for all conditions in 2014 ESGIC CAP N/A 2 Barbs covered for all conditions in 2014 BUTALBITAL/ACETAMINOPHEN/ CAFFEINE CAP N/A 2 Barbs covered for all conditions in 2014 ALAGESIC CAP N/A 2 Barbs covered for all conditions in 2014 BUTALBITAL/ACETAMINOPHEN/ CAFFEINE TAB N/A 2 Barbs covered for all conditions in 2014 REPAN TAB N/A 2 Barbs covered for all conditions in 2014 FIORICET TAB N/A 2 Barbs covered for all conditions in 2014 BUTALBITAL/ACETAMINOPHEN/ CAFFEINE TAB N/A 2 Barbs covered for all conditions in 2014 ESGIC TAB N/A 2 Barbs covered for all conditions in 2014 PHRENILIN FORTE CAP FORTE N/A 2 Barbs covered for all conditions in 2014 PHRENILIN TAB MG N/A 2 Barbs covered for all conditions in 2014 BUTALBITAL/ACETAMINOPHEN TAB MG N/A 2 Barbs covered for all conditions in 2014 MARTEN-TAB TAB MG N/A 2 Barbs covered for all conditions in 2014 PROMACET TAB MG N/A 2 Barbs covered for all conditions in 2014 BUPAP TAB MG N/A 2 Barbs covered for all conditions in 2014 CEPHADYN TAB MG N/A 2 Barbs covered for all conditions in 2014 TENCON TAB MG N/A 2 Barbs covered for all conditions in 2014 ESGIC-PLUS TAB N/A 2 Barbs covered for all conditions in 2014 ESGIC-PLUS CAP N/A 2 Barbs covered for all conditions in 2014 ZEBUTAL CAP N/A 2 Barbs covered for all conditions in 2014 ALAGESIC LQ SOL N/A 2 Barbs covered for all conditions in 2014 DOLGIC PLUS TAB N/A 2 Barbs covered for all conditions in 2014 ORBIVAN CAP N/A 2 Barbs covered for all conditions in 2014 ORBIVAN CF TAB MG N/A 2 Barbs covered for all conditions in 2014 RE-PB HYOS ELX N/A 2 Barbs covered for all conditions in 2014 QUADRAPAX ELX N/A 2 Barbs covered for all conditions in 2014 SE-DONNA PB HYOS ELX PB HYOS N/A 2 Barbs covered for all conditions in 2014 PB-HYOS ELX N/A 2 Barbs covered for all conditions in 2014 Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine Kaiser Permanente Georgia 5

6 Appendix A 2014 National MPD Tier Status Changes, Continued Product Description 2013 Tier 2014 Tier Rationale BELLADONNA ALKALOIDS/PHEN OBARBITAL TAB 16.2MG N/A 2 Barbs covered for all conditions in 2014 PHENAZOPYRIDINE PLUS TAB PLUS N/A 2 Barbs covered for all conditions in 2014 PYRELLE H.B. TAB N/A 2 Barbs covered for all conditions in 2014 PHENAZOFORTE PLUS TAB PLUS N/A 2 Barbs covered for all conditions in 2014 SERVIRA TAB 48MG N/A 2 Barbs covered for all conditions in 2014 SECONAL CAP 100MG N/A 2 Barbs covered for all conditions in 2014 DOLGIC PLUS TAB N/A 2 Barbs covered for all conditions in 2014 LUMINAL INJ 130MG/ML N/A 4 Barbs covered for all conditions in 2014 LUMINAL INJ 60MG/ML N/A 4 Barbs covered for all conditions in 2014 PHENOBARBITAL SODIUM INJ 65MG/ML N/A 4 Barbs covered for all conditions in 2014 MEBARAL TAB 100MG N/A 4 Barbs covered for all conditions in 2014 MEBARAL TAB 32MG N/A 4 Barbs covered for all conditions in 2014 MEBARAL TAB 50MG N/A 4 Barbs covered for all conditions in 2014 FIORINAL CAP N/A 4 Barbs covered for all conditions in 2014 SEDAPAP TAB MG N/A 4 Barbs covered for all conditions in 2014 DOLGIC PLUS TAB N/A 4 Barbs covered for all conditions in 2014 SECONAL CAP 100MG N/A 4 Barbs covered for all conditions in 2014 DONNATAL EXTENTABS TAB EXTENTAB N/A 4 Barbs covered for all conditions in 2014 SYLATRON KIT 888MCG 3 4 Initial tier placement KADCYLA INJ 100MG -- 5 Initial tier placement KADCYLA INJ 160MG -- 5 Initial tier placement KYNAMRO INJ 200MG/ML -- 5 Initial tier placement POMALYST CAP 1MG -- 5 Initial tier placement POMALYST CAP 2MG -- 5 Initial tier placement POMALYST CAP 3MG -- 5 Initial tier placement POMALYST CAP 4MG -- 5 Initial tier placement RAVICTI LIQ 1.1GM/ML -- 5 Initial tier placement SIGNIFOR INJ 0.3MG/ML -- 5 Initial tier placement SIGNIFOR INJ 0.6MG/ML -- 5 Initial tier placement SIGNIFOR INJ 0.9MG/ML -- 5 Initial tier placement VORAXAZE INJ 1000UNIT -- 5 Initial tier placement ZEMAIRA INJ 1000MG -- 5 Initial tier placement Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine 6 Kaiser Permanente Georgia