ISSUE 2 VOLUME 8 APRIL 2014 u Formulary Additions..... 1 u Formulary Deletions......2 u New standing Order...... 2 u Floorstock Additions.... 3 u Quanitity Limits........ 3 u New Approved Compound.. 3 u National Medicare Part D Formulary.............. 3 u Clinical Update......... 4 u Medications Reviewed at P&T, But Not Added to the Formulary.............. 4 u Appendix A: Department Floorstock List Additions... 5 u Appendix B: MPD Tier Status Changes............... 6 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 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. Formulary Additions Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (Stribild) tablets were added to the Qualified Health Plans Formulary effective April 17, 2014. Stribild is indicated as a complete regimen for treatment of HIV-1 infection in adults who are antiretroviral treatmentnaïve. The Health and Human Services panel on antiretroviral guidelines recently recommended Stribild as one of the preferred regimens for treatment-naïve HIV-infected adults. Stribild should be considered when patients are not good candidates for lower-cost preferrred formulary alternatives including Atripla and Complera. Kaiser Permanente Georgia 1
Formulary Additions, Continued Epinephrine auto-injector (generic Adrenaclick) 0.15 mg and 0.3 mg were added to the Commercial and Qualified Health Plans Formulary effective May 8, 2014. Epinephrine auto-injector is a single-dose sympathomimetic catecholamine indicated in the emergency treatment of severe allergic reactions (Type 1) including anaphylaxis. It is intended for immediate administration in patients with a history of anaphylactic reactions. Generic epinephrine auto-injector is expected to be equally as safe and effective as EpiPen. Features of the epinephrine auto-injector device which differs from the EpiPen include labeled end caps, red injector tip that indicates where the needle is and which end to inject as well as instructions affixed to the unit to aid in administration. Patients should be instructed to recap the needle after injecting the epinephrine auto-injector. Since there are differences between devices, including administration instructions, patient education is essential to help ensure proper administration and treatment. Formulary Deletions Epipen and EpiPen Jr. 0.15 mg, 0.3 mg will be removed from the Commercial Formulary effective June 19, 2014. The low cost-effective alternative, epinephrine auto-injector (generic Adrenaclick) will be the preferred formulary alternative. Fluticasone 50 mcg and flunisolide 25 mcg intranasal spray will be removed from the Commercial Formulary and all intranasal steroids (INS) will be excluded from the Commercial Drug Benefit effective July 3, 2014. In October 2013, triamcinolone (Nasacort) became the first intranasal steroid to gain approval by the FDA for over-the-counter (OTC) status. Nasacort is now available OTC in the same prescription strength (55mcg) and is indicated for ages 2 and older for treatment of nasal allergy symptoms. INS are considered the most effective medication class for controlling allergic rhinitis symptoms. The overall clinical response does not appear to vary significantly between INS products irrespective of the differences in topical potency, lipid solubility, and binding affinity. When given at recommended doses, INS are not generally associated with clinically significant systemic side effects. Local side effects such as nasal irritation and bleeding have been reported. Medications that are available without a prescription that are in the same therapeutic class and clinically equivalent to drugs that are available with a prescription are generally excluded from the drug benefit therefore fluticasone and flunisolide will be removed from the Commercial Formulary. Commercial members who wish to purchase a prescription for an INS will pay the full member price for the medication, $22.10 for the fluticasone (120 sprays) and $48.45 for flunisolide (200 sprays) at Kaiser Pharmacies. Formulary exceptions do not apply to benefit exclusions. Medicare and QHP formularies will remain unchanged. Trexall (methotrexate) 5 mg, 7.5 mg, 10 mg, 15 mg tablets will be removed from the Commercial formulary effective April 17, 2014. Methotrexate has several indications including oncology and rheumatology related uses. Methotrexate 2.5 mg is available on the Commercial Formulary and is significanly less costly than the brand Trexall. New Standing Orders Approved standing orders are written instructions issued by medical practitioners, in accordance with the regulations, authorizing pharmacy personnel at pharmacies owned or operated by Kaiser Foundation Health Plan to supply and administer specified medications under circumstances specified in the order. Calcium acetate 667 mg capsules will be changed to calcium acetate 667 mg tablets via standing order. Calcium acetate is indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption. The tablets and capsules are therapeutically equivalent. The tablets are more cost effective and the preferred dosage form at KPGA. EpiPen Jr. 0.15 mg will be changed to epinephrine auto-injector (generic Adrenaclick) 0.15 mg via standing order effective June 19, 2014. These products are therapeutically equivalent. The epinephrine auto-injector (generic Adrenaclick) is now the preferred product at KPGA. 2 Kaiser Permanente Georgia 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 May 30, 2014 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 Reviews (June 2014): Medication Class Reviews Dermatological Penicillins Cephalosporins Macrolids Tetracyclines Fluoroquinolones Aminoglycosides Sulfonamides Antimycobacterial Antifungals Antivirals Antimalarials Amebicides Antihelmintics Anti-infectives -- Misc
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 Medical Office Floorstock Additions P&T Committee annually reviews all of the department floorstock lists. Approved medications will be added to the electronic floorstock ordering forms on the intranet. APPENDIX A CONTAINS A DETAILED LIST OF ADDITIONS TO DEPARTMENT FLOOR- STOCK LISTS. 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 table below shows medications added to the quantity limit list effective April 17, 2014. Medication Name Sofosbuvir (Sovaldi) 400 mg tablet Simeprevir (Olysio) 150 mg capsules 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 initial tier placements are listed below with the corresponding effective date. PLEASE SEE APPENDIX B FOR THE 2015 MPD TIER CHANGES. Medication Name Tier Effective Date sofosbuvir (Sovaldi) tablets 400 mg 5 1/1/2014 perampanel (Fycompa) 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tab 4 2/4/2014 loxapine (Adasuve) powder inhalation 10 mg 4 Pending bazedoxifene and conjugated estrogens (Duavee) 0.625 mg/20 mg tablet eslicarbazepine acetate (Aptiom) 400 mg, 800 mg, 1200 mg tablets Quantity Limit 14 day supply/copay 14 day supply/copay New KPGA Approved Compounds Only medications on the list of Approved Compounds may be prepared at Kaiser Permanente pharmacies. The approved list of compounds and recipes are posted on the intranet under Healthcare Delivery/Pharmaceutical Services/Compounds. The medication listed below was added to the List of Approved Compounds: Vancomycin 25 mg/ml eye drops 4 Pending 4 Pending luliconazole (Luzu) 1% cream 4 Pending umeclidinium and vilanterol (Anoro Ellipta) inhalation powder 4 Pending Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine Lesia Jackson, RN Clinical Services *Attend alternating meetings Kaiser Permanente Georgia 3
Clinical Updates Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning about Pediatric Use for Pulmonary Arterial Hypertension. The FDA is now clarifying a previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). In August 2012, the FDA revised the Revatio (sildenafil) drug label, adding a warning stating that use of Revatio, particularly chronic use, is not recommended in children. The drug label was updated based on the results of increasing mortality seen in pediatric PAH patients using Revatio in long term clinical trials in pediatric patients with PAH. FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring. The purpose of the August 2012 recommendation was to raise awareness of clinical trial results showing a higher risk of mortality in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose. This recommendation was not intended to suggest that Revatio should never be used in children; however, some health care professionals have interpreted this information as a contraindication, and have refused to prescribe or administer the drug. The evidence behind FDAs initial recommendation has not changed; this communication is clarifying the strength of the warning communicated in the Revatio drug label. Additional Clinical Alerts Drug Safety Labeling Changes http://www.fda.gov/safety/medwatch/ SafetyInformation/ucm388717.htm Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk. Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high. The FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. FDAs request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The manufacturer is expected to submit the trial data to FDA by early March 2014, after which FDA will conduct a thorough analysis and report findings publicly. At this time, FDA considers information from the NEJM study to be preliminary. Analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk. Recommedation: Patients should not stop taking saxagliptin and should speak with their health care professionals about any questions or concerns. Health care professionals should continue to follow the prescribing recommendations in the drug labels. Medications Reviewed, but Not Added to the Formulary Sofosbuvir (Sovaldi) 400 mg tablet, decision pending for National MPD formulary Simeprevir (Olysio) 150 mg capsule, decision pending for National MPD formulary Brimonidine (Mirvaso) 0.33% topical gel, decision pending for National MPD formulary Hydrocodone bitatrate (Zohydro ER) 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg capsules, decision pending for National MPD formulary Levomilnacipran (Fetzima) 20 mg, 40 mg, 80 mg, 120 mg capsules, decision pending for National MPD formulary Vortioxetine (Brintellix) 5 mg, 10 mg, 20 mg capsules, decision pending for National MPD formulary Lubiprostone (Amitiza) 8 mcg, 24 mcg capsules, decision pending for National MPD formulary Rimexolone (Vexol) 1% ophthalmic suspension, decision pending for National MPD formulary Dolutegravir (Tivicay) 50 mg tablet, decision pending for National MPD formulary 4 Kaiser Permanente Georgia
Appendix A KPGA Medical Office Floorstock Additions Department Name Cardiology Chronic Kidney Disease Employee Health Endocrinology General Surgery Infectious Disease Internal Medicine OB GYN Ophthalmology Oncology Oncology Infusion Radiology Medication Added Ondansetron HCL/PF 4 mg/2ml SDV 2 ml Energix B Adult 20 mcg/1 ml, SDV Clonidine 0.1 mg UD tab (Catapress) Glucagon 1 mg vial (Glucagon Emergency Kit) Ceftriaxone 1 gm vial (Rocephin) Dipenhydramine 50 mg/ml prefilled syringe Zirgan 0.15% gel Famotidine 20 mg/50 ml premix bag (Pepcid) Lorazepam 2 mg/ml, 1 ml vial (Ativan) Labetalol HCL 5 mg/ml MDV 20 ml 5 Kaiser Permanente Georgia
Appendix B 2015 National MPD Tier Status Changes Product Description 2014 Tier Status 2015 Tier Status BUSPIRONE HCL TAB 5MG 1 2 BUSPIRONE HCL TAB 10MG 1 2 DOXEPIN HCL CAP 100MG 1 2 DOXEPIN HCL CAP 10MG 1 2 DOXEPIN HCL CAP 25MG 1 2 DOXEPIN HCL CAP 50MG 1 2 DOXEPIN HCL CAP 75MG 1 2 OXYTROL DIS 3.9MG/24 3 4 GLUCAGEN HYPOKIT INJ HYPOKIT 3 4 RAPAMUNE SOL 1MG/ML 5 4 RAPAMUNE TAB 1MG 5 4 RAPAMUNE TAB 2MG 5 4 ABILIFY DISCMELT TAB 10MG 3 4 ABILIFY DISCMELT TAB 15MG 3 4 ABILIFY INJ 9.75MG 3 4 ABILIFY SOL 1MG/ML 3 4 ABILIFY TAB 10MG 3 4 ABILIFY TAB 15MG 3 4 ABILIFY TAB 20MG 3 4 ABILIFY TAB 2MG 3 4 ABILIFY TAB 30MG 3 4 ABILIFY TAB 5MG 3 4 ACTOS TAB 15MG 3 4 AMITIZA CAP 24MCG 3 4 AMITIZA CAP 8MCG 3 4 BACTROBAN CRE 2% 3 4 BANZEL SUS 40MG/ML 3 4 BANZEL TAB 200MG 3 4 BANZEL TAB 400MG 3 4 CAMPRAL TAB 333MG 3 4 CARIMUNE NANOFILTERED INJ 12GM 3 4 CARIMUNE NANOFILTERED INJ 3GM 3 4 CARIMUNE NANOFILTERED INJ 6GM 3 4 CYKLOKAPRON INJ 100MG/ML 3 4 DACOGEN INJ 50MG 3 4 DOXIL INJ 2MG/ML 3 4 EPIVIR HBV TAB 100MG 3 4 GRIS-PEG TAB 125MG 3 4 GRIS-PEG TAB 250MG 3 4 METADATE CD CAP 10MG 3 4 METADATE CD CAP 20MG 3 4 METADATE CD CAP 30MG 3 4 6 Kaiser Permanente Georgia
7 Kaiser Permanente Georgia Appendix B 2015 National MPD Tier Status Changes Product Description 2014 Tier Status 2015 Tier Status METADATE CD CAP 40MG 3 4 METADATE CD CAP 50MG 3 4 METADATE CD CAP 60MG 3 4 MYFORTIC TAB 180MG 3 4 MYFORTIC TAB 360MG 3 4 PRANDIN TAB 0.5MG 3 4 PRANDIN TAB 1MG 3 4 PRANDIN TAB 2MG 3 4 PROTONIX INJ 40MG 3 4 RAPAMUNE TAB 0.5MG 3 4 RENAGEL TAB 400MG 3 4 RENAGEL TAB 800MG 3 4 RENVELA PAK 2.4GM 3 4 RENVELA TAB 800MG 3 4 RESTASIS EMU 0.05% 3 4 SINGULAIR CHW 4MG 3 4 SINGULAIR CHW 5MG 3 4 SINGULAIR GRA 4MG 3 4 SINGULAIR TAB 10MG 3 4 STALEVO 100 TAB 3 4 STALEVO 125 TAB 3 4 STALEVO 150 TAB 3 4 STALEVO 200 TAB 3 4 STALEVO 50 TAB 3 4 STALEVO 75 TAB 3 4 TAZORAC GEL 0.05% 3 4 TAZORAC GEL 0.1% 3 4 TRILEPTAL SUS 300MG/5M 3 4 TWINJECT INJ 0.15MG 3 4 TWINJECT INJ 0.3MG 3 4 URSO 250 TAB 250MG 3 4 URSO FORTE TAB 500MG 3 4 VENLAFAXINE HCL ER TAB 150MG ER 3 4 VENLAFAXINE HCL ER TAB 225MG ER 3 4 VENLAFAXINE HCL ER TAB 37.5 ER 3 4 VENLAFAXINE HCL ER TAB 75MG ER 3 4 VFEND IV INJ 200MG 3 4 VIRAMUNE SUS 50MG/5ML 3 4 VIRAMUNE TAB 200MG 3 4 ZINECARD INJ 250MG 3 4 ZOSYN INJ 2-0.25GM 3 4 ZOSYN INJ 3-0.375G 3 4
Appendix B 2015 National MPD Tier Status Changes Product Description 2014 Tier Status 2015 Tier Status ZOSYN INJ 4-0.5GM 3 4 ZOSYN SOL 2-0.25GM 3 4 ZOSYN SOL 3-0.375G 3 4 ZOSYN SOL 4-0.50GM 3 4 HUMATROPE COMBO PACK INJ 5MG 4 5 HUMATROPE INJ 12MG 4 5 HUMATROPE INJ 24MG 4 5 HUMATROPE INJ 6MG 4 5 NEXAVAR TAB 200MG 4 5 NORDITROPIN FLEXPRO INJ 15/1.5ML 3 5 NORDITROPIN FLEXPRO INJ 5/1.5ML 4 5 NORDITROPIN NORDIFLEX PEN INJ 30/3ML 4 5 NUTROPIN AQ NUSPIN 5 INJ NUSPIN 5 4 5 NUTROPIN AQ PEN INJ 10MG/2ML 3 5 NUTROPIN AQ PEN INJ 20MG/2ML 4 5 NUTROPIN INJ 10MG 4 5 TEV-TROPIN INJ 5MG 4 5 TOBI PODHALER CAP 28MG 4 5 Tier 1 = Value Generic Tier 2 = Generic Tier 3 = Brand Tier 4 = Non-Preferred Brand Tier 5 = Specialty Tier 6 = Injectable Part D Vaccine 8 Kaiser Permanente Georgia