ISSUE 3 VOLUME 9 JUNE

Transcription

1 ISSUE 3 VOLUME 9 JUNE 2015 u Formulary Additions u Formulary Deletions u New standing Order u Floorstock Additions unew Criteria Restricted Medications u National Medicare Part D Formulary u Medications Reviewed at P&T, But Not Added to the Formulary u Non-Formulary Cost Considerations u Clinical Update u Appendix A: MPD Initial Tier Placements u Appendix B: MPD Tier Changes Formulary At A Glance Update 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 Testosterone 1% pump was added to the Commercial Formulary effective June 12, Testosterone gel (generic Vogelxo; alternative to AndroGel) is used for the treatment of hypogonadism (low testosterone) associated with genetic conditions or damage to the pituitary gland or hypothalamus (e.g. from chemotherapy, radiation, tumors, trauma or toxic substances). Testosterone 1% gel has been shown to provide less fluctuation in testosterone levels than the injection, and reduces the risk of application site reactions associated with the patch. Terbinafine 250 mg tablet will be added to the Commercial Formulary effective July 1, Terbinafine is used for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Oral terbinafine is the drug treatment of choice for onychomycosis because of its greater efficacy and safety profile compared to itraconazole and fluconazole, and its relative low cost. At treatment doses, terbinafine is fungicidal for dermatophytes, while itraconazole and fluconazole are fungistatic, leading to higher relative cure rates for terbinafine than the other two medications. Kaiser Permanente Georgia 1

2 Formulary Addition, Continued Podofilox (generic Condylox) 0.5% topical solution will be added to the Commercial Formulary effective July 1, Podofilox 0.5% solution is indicated for topical treatment of external genital warts. There are no head to head studies comparing the podofilox solution to the gel. However, the efficacy of the gel appears similar to that reported for the solution. The most common adverse events reported following topical podofilox gel or solution application are primarily local reactions at the treated skin site. While the gel can be applied with the applicator tip or finger, the solution must be applied with a cotton-tipped applicator that is supplied with the drug and should be disposed of after each application. Formulary Deletions Podofilox (Condylox) 0.5% gel will be removed from the Commercial Formulary effective July 1, Condylox 0.5% gel is indicated for topical treatment of external genital and perianal warts. Currently, there is a total market shortage of the gel with no estimated release date. Podofilox 0.5% solution is a viable formulary alternate available at a generic copay. Bumetanide 0.5 mg and 1 mg tablets were removed from the Commercial Formulary effective June 12, Bumetanide is a loop diuretic approved for the treatment of edema associated with heart failure, or hepatic or renal disease. Furosemide is used first line conventionally, but some patients may have an increased response to bumetanide or torsemide, due to increased oral bioavailability with these medications compared to furosemide. There is little to no evidence comparing bumetanide and torsemide therapy to determine superiority of one diuretic over the other. Both furosemide and toresmide are cost-effective alternatives on the Commercial Formulary. Androderm 2 mg and 4 mg patches will be removed from the Commercial Formulary effective July 1, Androderm is an androgen indicated for replacement therapy in males for conditions including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Androderm has higher fluctuation in testosterone levels and an increased risk of application site reactions compared to the testosterone gel. A possible increase in cardiovascular risk has been identified in patients who use testosterone. Testosterone cypionate injection and testosterone 1% gel pump are cost-effective alternatives available on the Commercial Formulary. New Standing Order 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. Canagliflozin (Invokana) and dapagliflozin (Farxiga) will be changed to equivalent doses of empagliflozin (Jardiance) via standing order. These three products belong to the sodium-glucose cotransporter 2 (SGLT2) inhibitors class of antidiabetic medications. Copaxone 20 mg/ml injection will be changed to glatiramer acetate 20 mg/ml injection via standing order. The FDA recently approved Glatopa, a generic or biosimilar version of Copaxone 20 mg/ml. 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 24, 2015 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 2015): 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 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 Elder Care 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 Patrice Gaspard, MD Pediatrics Marcus Griffith, MD* Behavioral Health David Jones, MD Pediatrics 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 The medications below will be added to the electronic floorstock ordering forms on the intranet: Department Name Neurology Wound Care Surgery Medication Added Botox 100 units/ml Hibiclens liquid 4 oz 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 medications will be added to the list of Criteria Restricted Medications (QRM). Jardiance (empagliflozin) Glyxambi (empagliflozin and linagliptan) Trulicity (dulaglutide) Tanzeum (albiglutide) Ruconest (C1 inhibitor (recombinant)) Hetlioz (tasimelteon) Cerdelga (eliglustat) Zavesca (miglustat) Vpriv (velaglucerase alfa) Cerezyme (imiglucerase) Elelyso (taliglucerase alfa) The following medications will be added to the list of Criteria Restricted Medications (QRM) effective January 1, Avonex (interferon beta-1a) Copaxone (glatiramer acetate) Plegridy (peginterferon beta-1a) 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. APPENDIX A CONTAINS A DETAILED LIST OF NATIONAL MPD FORMULARY INITIAL TIER PLACEMENTS AND APPENDIX B CONTAINS LIST OF MPD 2016 TIER CHANGES. Medications Reviewed, but Not Added to the Formulary Memantine hydrochloride extended-release and donepezil (Namzaric) 28 mg/10mg capsule was not added to the Commercial Formulary, decision pending for National MPD formulary Insulin human (Afrezza) 4 unit and 8 unit inhalation powders were not added to the Commercial Formulary, decision pending for National MPD Formulary Eliglustat (Cerdelga) 84 mg capsule was not added to the Commercial Formulary, decision pending for National MPD formulary Netupitant and palonosetron (Akynzeo) mg capsule was not added to the Commercial Formulary, decision pending for National MPD formulary Albiglutide (Tanzeum) 30 mg and 50 mg pen-injectors, decision pending for National MPD formulary Dulaglutide (Trulicity) 0.75 mg/0.5 ml and 1.5 mg/0.5 ml solution pen-injectors, decision pending for National MPD formulary Empagliflozin (Jardiance) 10 mg and 25 mg tablets, decision pending for National MPD formulary Ombitasvir, paritaprevir, ritonavir, dasabuvir (Viekira Pak) mg pack, decision pending for National MPD formulary Carbidopa/levodopa (Duopa) 4.36 mg/20mg per 1 ml enteral suspension, decision pending for National MPD formulary Kaiser Permanente Georgia 3

4 Non-Formulary Cost Considerations Class Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls Macrolide antibiotics Antidiabetic medications Erythromycin Erythromycin ethylsuccinate (E.E.S.) QRM medications GLP-1 agonists: Exenatide (Byetta, Bydureon), liraglutide (Victoza), albiglutide (Tanzeum), dulaglutide (Trulicity) DPP-IV inhibitors: Linagliptin (Tradjenta), sitagliptin (Januvia), alogliptin (Nesina), saxagliptin (Onglyza) SGLT2 inhibitors: canagliflozin (Invokana), dapagliflozin (Farxiga), empagliflozin (Jardiance) Clinical Updates Azithromycin, clarithromycin Glipizide, metformin, glimepiride, Humulin N, Humulin 70/30 FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. For the cost of every 1 patient treated with E.E.S., 201 patients can be treated with azithromycin and 44 patients can be treated with clarithromycin For the cost of every 1 patient treated with erythromycin, 110 patients can be treated with azithromycin and 24 patients can be treated with clarithromycin For every 1 patient treated with Byetta/Bydureon, 12 patients can be treated with Humulin N and achieve greater average A1C reduction For every 1 patient treated with Tradjenta, 57 patients can be treated with metformin and achieve greater average A1C reduction For every 1 patient treated with Invokana, 115 patients can be treated with metformin and achieve greater average A1C reduction Additional Clinical Alerts Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels. SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin. The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients. A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, we have continued to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors. The FAERS cases were not typical for DKA because most of the patients had type 2 diabetes and their blood sugar levels, when reported, were only slightly increased compared to typical cases of DKA. Factors identified in some reports as having potentially triggered the ketoacidosis included major illness, reduced food and fluid intake, and reduced insulin dose. 4 Kaiser Permanente Georgia FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking ucm htm FDA warns consumers about the potential health risks of over-thecounter asthma products labeled as homeopathic ucm htm

5 Appendix A National MPD Formulary Initial Tier Placements Medication Name Tier Effective Date aripiprazole 300 mg, 400 mg injection (Abilify Maintena) Tier 4 3/3/3015 buprenorphine and naloxone tablet, sublingual (Zubsolv) Tier 4 3/3/3015 carbidopa-levodopa , 36.25/145, 48.75/195, 61.25/245 capsule extend-ed Tier 4 3/3/3015 release (Rytary) carbidopa-levodopa /mL suspension for pump (DUOPA) Tier 4 3/3/3015 edoxaban 15 mg, 30 mg, 60 mg tablet (Savaysa) Tier 4 3/3/3015 morphine and naltrexone mg, mg, 50-2 mg mg, Tier 4 3/3/3015 mg, mg capsule, ER (Embeda) palbociclib 125 mg, 100 mg and 75 mg capsule (Ibrance) Tier 5 3/3/3015 lenvatinib 10 mg, 14 mg, 20 mg, 24 mg capsule (Lenvima) Tier 5 3/3/3015 meningiococcal Group B vaccine [rdna, component, adsorbed]) injection Tier 6 3/3/3015 (Bex-sero) secukinumab150 mg/ml SQ and pen injection (Cosentyx) Tier 5 3/3/3015 atazanavir sulfate-cobicistat tablet (Evotaz) Tier 5 3/3/2015 darunavir 800 mg and cobicistat 150 mg tablet (Prezcobix) Tier 5 3/3/2015 ivacaftor 50 mg, 75 mg packet, 150 mg tablet (Kalydeco) Tier 5 4/1/2015 panobinostat 10 mg, 15 mg, 20 mg capsule (Farydak) Tier 5 4/1/2015 pasireotide 20 mg; 40 mg; 60 mg injection (Signifor LAR) Tier 5 3/3/2015 avibactam and ceftazidime 2 gm /0.5 gm injection (Avycaz) Tier 4 5/5/2015 isavuconazonium 186 mg capsule; 372 mg injectable (Cresemba) Tier 5 5/5/2015 naloxegol 12.5 mg, 25 mg tablets (Movantik) Tier 4 5/5/2015 cholic acid 50 mg, 250 mg capsule (Cholbam) Tier 5 5/5/2015 naloxegol 12.5 mg, 25 mg tablets (Movantik) Tier 4 5/5/2015 miltefosine 50 mg capsules (Impavido) Tier 4 Pending finafloxacin 0.30% suspension (Xtoro) Tier 4 Pending filgrastim-sndz 300 mcg/0.5ml and 480 mcg/0.8 ml injection (Zarxio) Tier 5 Pending dinutuximab 17.5 mg/5 ml (3.5 mg/ml) injection (Unituxin) Tier 5 Pending Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivat-ed Tier 6 Pending Poliovirus Vaccine IM injection (Quadracel) ivabradine 5mg tablets (Corlanor) Tier 4 Pending 5 Kaiser Permanente Georgia

6 6 Kaiser Permanente Georgia Appendix B National MPD 2016 Formulary Tier Changes Medication Name 2016 Tier Pravastatin 10mg, 20mg,40mg, 80mg 2 Enalapril 2.5mg, 5mg, 10mg, 20mg 2 Abilify 2.5mg, 5mg,10mg,15mg, 20mg, 30mg 4 Advair Diskus 100/50, 250/50, 500/50 4 Protopic ointment 0.03%, 0.1% 4 Renvela 2.4gm pak, 800mg 4 Savella 12.5mg, 25mg, 50mg, 100 mg 4 Restasis 0.05% emulsion 4 Androgel pump 1% 4 Androderm DIS 2mg/24hr, 4mg/24hr 4 Avelox 400mg 4 Ceftin 125mg/5mL suspension 4 Aggrenox 25mg-200mg 4 Capex shampoo 0.01% 4 Cellcept suspension 200mg/mL 4 Cipro suspension 250mg/5mL, 500mg/5mL 4 Comtan 200mg 4 Differin 0.1%, 0.3% gel, ointment 4 Dilaudid liquid 1mg/mL 4 Epipen Jr 4 Mycobutin 150mg cap 4 Vibramycin 25mg/5mL suspension 4 Zenpep 5000 unit 4 E.E.S granules suspension 200mg/5mL, 4 Eryped 200mg/5mL, 400mg/5mL suspension 4 Erythrocin lactobionate 500mg 4 Diltrate SR 40mg 4 Isordil Titradose 40 mg 4 Namenda 5mg, 10mg tab, 10mg/5mL solution 4 Methylin 2.5mg chew tab 4 Creon 12000, 24000,3000,36000, 6000 unit cap 4 Zenpep 10000, , unit cap 4 Protonix Pak 4 Retin-A micro gel 0.1%, 0.04% 4 Spiriva Handihaler 4 Serevent diskus 50 mcg 4 Qvar 40mcg, 80mcg 4 Colcrys 0.6mg 4 Vyvanse 20mg, 30mg, 40mg, 50mg, 60mg, 70mg 4 Vogelxo pump 1% 4