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Pharmacy and Therapeutics Committee Therapeutic Class Review : Cystic Fibrosis January 2017 San Francisco Health Plan (SFHP) Quarterly Formulary and Prior Authorization Criteria Update January 2017 The following changes to SFHP formulary and prior authorization criteria were reviewed and approved by the SFHP Pharmacy and Therapeutics (P&T) Committee on 01/18/2017. Effective date for all changes is 02/15/2017. SFHP formulary can be accessed at http://www.sfhp.org/providers/formulary/ and prior authorization criteria at http://www.sfhp.org/providers/formulary/prior-authorization-requests/. Contents Drug Class Reviews ..................................................................................................................................... 2 Hematology: Erythropoietin Stimulating Agents........................................................................................2 Hematology: Iron Replacement .................................................................................................................2 Hematology: Thrombopoietin Receptor Agonists .....................................................................................2 Hematology: White Blood Cell Stimulators ...............................................................................................2 Infectious Disease: Antibiotics, Oral..........................................................................................................2 Infectious Disease: Antiparasitics..............................................................................................................3 Nutrition/Electrolytes: Enteral Nutrition Products ......................................................................................3 Nutrition/Electrolytes: Electrolytes/Vitamins/Minerals ...............................................................................3 Nutrition/Electrolytes: Phosphate Binders .................................................................................................4 Nutrition/Electrolytes: Potassium Depleters ..............................................................................................4 OBGYN: Hormone Replacement Therapy ................................................................................................4 Pain: Muscle relaxants ..............................................................................................................................4 Pain: NSAIDs and COX-2 inhibitors ..........................................................................................................4 Pulmonary: Asthma/COPD medications ...................................................................................................5 Pulmonary: Cystic Fibrosis ........................................................................................................................5 Endocrine/Diabetes: Basaglar® (insulin glargine) ....................................................................................5 Miscellaneous Formulary Changes.............................................................................................................. 6 Miscellaneous Prior Authorization Criteria Updates .................................................................................... 6 Interim Formulary Changes (10/06/16 – 12/31/16)...................................................................................... 7 Miscellaneous Changes.................................................................................................................................7 New Drugs to Market ...................................................................................................................................8 Pharmacy and Therapeutics Committee Therapeutic Class Review : Cystic Fibrosis January 2017 Drug Class Reviews Hematology: Erythropoietin Stimulating Agents Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, and Healthy San Francisco • No changes Prior Authorization Criteria Update: • Revised criteria for cancer/chemo-therapy-induced anemia to incorporate excluded patient populations per National Comprehensive Cancer Network (NCCN) guidelines • Consolidated Aranesp® and Epogen®/Procrit® criteria • Added Mircera® to criteria • Updated quantity limits to reflect standard dosing Hematology: Iron Replacement Formulary Update: Medi-Cal, Healthy San Francisco, Medicare/Medi-Cal • Add the following OTC medications to formulary: o Slow Release iron 45 mg tablet o Ferrous sulfate 220 mg/5 ml elixir o Ferrous gluconate 325 mg tablet Prior Authorization Criteria Update: • No changes (apply blanket criteria for non-specialty non-formulary or PA required medications without drug specific criteria) Hematology: Thrombopoietin Receptor Agonists Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, and Healthy San Francisco • No changes Prior Authorization Criteria Update: • Updated criteria to include additional labeled indications for Promacta®: severe aplastic anemia and thrombocytopenia associated with HCV infection. • Updated criteria for diagnosis of chronic immune (idiopathic) thrombocytopenia (ITP) to include Rituxan® as prior treatment option. • Added Nplate® to criteria. Hematology: White Blood Cell Stimulators Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers • Added Zarxio™ to formulary with prior authorization • Removed Neupogen® from formulary Prior Authorization Criteria Updates: • Updated criteria to prefer Zarxio™ over Granix® and Neupogen® Infectious Disease: Antibiotics, Oral Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers and Healthy San Francisco • Added age maximum of 12 years to formulary oral solutions/suspensions and chewable tablets. • Added quantity limit to formulary cefdinir, erythromycin and minocycline to ensure appropriate prescribing. • Removed the following from formulary due to low utilization: demeclocycline, cefadroxil, cefditoren, ceftibuten, erythromycin base 250 mg tablet, PCE® (erythromycin base) • Added the following: amoxicillin 500 mg tablet, amoxicillin/clavulonate (Augmentin XR®) 1000-62.5 mg ER tablet, cefdinir • Updated fill limit for azithromycin and clarithromycin to 1 fill per 60 days to prevent continuous use Pharmacy and Therapeutics Committee Therapeutic Class Review : Cystic Fibrosis January 2017 • Removed fill limit from linezolid to allow use for multi drug resistant tuberculosis Prior Authorization Criteria Updates: • Updated oral fluoroquinolone criteria based on formulary change for ciprofloxacin and levofloxacin solution • Updated Xifaxan® criteria with the following: o Removed sulfamethoxazole-trimethoprim from criteria for traveler’s diarrhea and included levofloxacin as another formulary fluoroquinolone alternative o For IBS-D diagnosis, changed requirement for preferred therapy from loperamide to at least one other product • Added criteria for non-formulary fluoroquinolones to require trial with formulary products • No changes Sirturo® and CDI agents PA criteria Infectious Disease: Antiparasitics Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers and Healthy San Francisco ® • Changed Albenza (albendazole) quantity limits from #2 fills/year to #4 tablets/365. ® • Removed Yodoxin (idoquinol) 210, 650 mg tablet from formulary as medication is obsolete. ® • Added Alinia (nitazoxanide) 500mg tab, 100mg/5ml susp to formulary with quantity limit of #30/365 • Added tinidazole 250, 500mg tablet to formulary with quantity limit of #30/365. ® • Changed atovaquone/proguanil (Malarone ) quantity limits from #2 fills/year to #180 tabs/365. ® • Added Daraprim to formulary with prior authorization. Prior Authorization Criteria Updates: • Topical Antiparasitics Criteria ® o Updated criteria to reflect current formulary status of spinosad (Natroba ) as PA required. o Updated criteria to allow approval of spinosad after trial and failure of first-line, formulary options. o Updated criteria to include spinosad as an option for second-line therapy before using third-line, non-formulary options. o Removed Lindane shampoo from criteria as no longer recommended. ® • Created new criteria for Nebupent . ® • Created new criteria for Daraprim . Nutrition/Electrolytes: Enteral Nutrition Products Formulary Update: Medi-Cal and Medicare/Medi-Cal • Removed all PA required products without utilization from formulary except PKU products (e.g. Boost Breeze, etc) • Added highly utilized non-formulary products to formulary with prior authorization (e.g. Ensure Plus Liquid, etc) Prior Authorization Criteria Updates: • Enteral Nutrition Products criteria: o Add requirement of dietary adjustment in addition to medical diagnosis and nutritional risk; cancer diagnoses do not require dietary adjustment o Add criteria for renal and hepatic products • Specialty Infant Enteral Products: no changes Nutrition/Electrolytes: Electrolytes/Vitamins/Minerals Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco, Medicare/Medi-Cal • Added generic utilized products to formulary without restrictions (e.g. calcium gluconate, potassium chloride etc) • Removed high cost products with formulary alternatives from formulary with grandfathering where appropriate • Removed non-utilized products from formulary (e.g. calcitriol solution, etc) Pharmacy and Therapeutics Committee Therapeutic Class Review : Cystic Fibrosis January 2017 Nutrition/Electrolytes: Phosphate Binders Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers and Healthy San Francisco • Added Renvela® powder packets to formulary for consistency with Renvela® tablets • Added Velphoro® and Auryxia® to formulary with prior authorization requirement for calcium acetate Prior Authorization Criteria Updates: • Added Velphoro® to PA criteria • Updated criteria for Velphoro® and Auryxia® to reflect formulary status changes Nutrition/Electrolytes: Potassium Depleters Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco • Added Veltassa® to formulary without restrictions • Added SPS oral powder (Kayexalate®, Kionex®) to formulary without restrictions OBGYN: Hormone Replacement Therapy Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco • Removed the following from formulary due to lack of utilization: o Femring® (estradiol acetate) vaginal ring o Estropipate (Ogen®) tablet o Norethindrone acetate-ethyl estradiol (Femhrt®) tablet o Estradiol/norethindrone acetate (Activella®) tablet o Menest® (estrogens, esterified) tablet • Added Estrogel® (estradiol) 1.25 g transdermal gel with pump to formulary with quantity limit #50g/30 days Oncology Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco • Added all non-formulary oral tablet and capsule formulations to formulary with prior authorization Prior Authorization Criteria Updates: • Updated oral and IV oncolytics criteria with requirement for NCCN category 2b or greater evidence rating, genetic testing results and labs where indicated per package insert • Retired all drug specific antineoplastics criteria Pain: Muscle relaxants Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco • Removed carisoprodol 350 mg tablets from formulary with grandfathering • Added quantity limit of #120/30 days to methocarbamol Prior Authorization Criteria Updates: • Retired criteria for Skeletal Muscle Relaxants; will apply blanket criteria for non-specialty non-formulary or PA required medications without drug specific criteria Pain: NSAIDs and COX-2 inhibitors Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco • Added to formulary without restrictions: o Diclofenac sodium 100 mg extended-release tablets o Celecoxib (Celebrex®) • Added ketorolac to formulary with a quantity limit of 5 tablets per year • Added age limit, maximum of 12 years, to utilized liquid formulations (grandfathered existing users) o Indomethacin (Indocin®) 25 mg/5 mL oral suspension o Naproxen (Naprosyn®) 125 mg/5 mL oral suspension Pharmacy and Therapeutics Committee Therapeutic Class Review : Cystic Fibrosis January 2017 • Removed all medications requiring prior authorization from formulary if there was no utilization during the measurement period Prior Authorization Criteria Updates: • Retired criteria for celecoxib and ketorolac Pulmonary: Asthma/COPD medications Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco • Removed step therapy requirement from Proair HFA® • Removed quantity limit from montelukast tablets and chewable tablets • Removed albuterol ER tablets from formulary due to lack of utilization • Added Advair Diskus to formulary with quantity limit of #60 per 30 days Prior Authorization Criteria Updates: • New criteria proposed for Daliresp® based on GOLD guideline placement. • Retired criteria for zafirkast and Zyflo®. • Updated PA criteria for albuterol products to reflect new formulary status for Proair HFA® and Advair Diskus®. Pulmonary: Cystic Fibrosis Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco • Added Orkambi® (lumacaftor/ivacaft or) to formulary with PA • Added acetylcysteine 200 mg/ml vial to formulary without restrictions Prior Authorization Criteria Updates: TM • Placed tobramycin PAK (KITABIS PAK) on same level as tobramycin (TOBI®) • Added non-cystic fibrosis bronchiectasis diagnosis to tobramycin criteria Endocrine/Diabetes: Basaglar® (insulin glargine) Formulary Update: Medi-Cal, Healthy Kids, Healthy Workers and Healthy San Francisco • Made Basaglar® the preferred insulin glargine product and removed Lantus® vials and Lantus Solostar® from formulary. Prior Authorization Criteria Updates: • Updated criteria to prefer Basaglar® over Lantus® and other long acting insulin. Formulary and Prior Authorization Criteria Updates January 2017 Miscellaneous Formulary Changes Drug Formulary Status Recommend Desmopressin 0.1, 0.2mg tab F-QL #3/day F-QL F Amitiza® (lubiprostone) 8, 24 mcg cap Linzess® (linactolide) 145, 290 mcg cap Movantik® (naloxegol) 12.5, 25 mg tab NF NF F-PA *Applies to Medi-Cal, Healthy Kids, Healthy Workers, Healthy San Francisco formularies; excluded for Medi-Cal/Medicare formulary Products listed as F-PA are NF for Healthy San Francisco. F = Formulary, no restrictions; F-QL = Formulary, quantity limit applies; F-PA = Formulary, PA required; NF = Non-formulary Miscellaneous Prior Authorization Criteria Updates Drug Proton Pump Inhibitors Agents for Constipation Revision Summary • Added rabeprazole as one of the alternatives for Dexilant® and esomeprazole • Removed requirement for trial of caps for Prevacid SoluTab & Protonix Granules • Added Movantik® and Relistor® • Revised diagnosis information in “Diagnosis Considered for Coverage” and “Coverage Criteria” sections 6 Formulary and Prior Authorization Criteria Updates January 2017 Interim Formulary Changes (10/06/16 – 12/31/16) Miscellaneous Changes Drug name Molindone 5, 10, 25 mg tablet Dolutegravir 10, 25 mg tablet Atazanavir sulfate 50 mg powder Lamivudine 25 mg/5 ml solution Emtricitabine/tenofovir 200mg-25mg Trihexyphenidyl 2 mg/5 ml elixir Terbutaline sulfate mg/ml vial Diphenhydramine 50 mg/ml vial Granisetron mg/ml vial Ondansetron PF 4 mg/2 ml vial Calcitonin,salmon 200/ml vial Dexamethasone 4 mg/ml vial Leuprolide acetate 5 mg kit Leuprolide acetate 30 mg syringe kit Ixabepilone 15, 45 mg vial Irinotecan 40 mg/2ml, 100 mg/5ml, 300mg/15ml vial Topotecan 4 mg vial Ofatumumab 100 mg/5ml vial, 1000 mg/50 vial Eribulin mesylate 1 mg/2 ml vial Ipilimumab 50 mg/10ml, 200mg/40ml vial Ziv-aflibercept 100 mg/4ml, 200 mg/8ml vial Elotuzumab 300, 400 mg vial Atezolizumab 1200 mg/20 vial Amikacin sulfate 1000mg/4ml vial Cidofovir 75 mg/ml vial Ganciclovir sodium 500 mg vial Carboplatin 10 mg/ml vial Carmustine 100 mg vial Cisplatin mg/ml vial Cyclophosphamide 500 mg, 1g, 2g vial Bendamustine 25, 100 mg vial Ifosfamide/mesna 1g-1g kit Ifosfamide 1g, 3g vial Oxaliplatin 50 mg/10ml vial, 100mg/20ml vial Temozolomide 100 mg vial Thiotepa 15 mg vial Busulfan 60 mg/10ml vial Carboplatin 150 mg vial Fluorouracil 1 g/20 ml vial Gemcitabine 200 mg, 1g vial Nelarabine 250mg/50ml vial Pemetrexed disodium 100, 500 mg vial Pentostatin 10 mg vial Cladribine 10 mg/10ml vial Decitabine 50 mg vial Floxuridine 500 mg vial Fludarabine phosphate 50 mg vial Fluorouracil 500mg/10ml, 5 g/50ml vial Vinblastine sulfate 1 mg/ml vial Formulary Change* NF X (carve-out) X (MB) NF 7 Formulary and Prior Authorization Criteria Updates January 2017 Drug name Vincristine sulfate 1 mg/ml vial Vinorelbine tartrate 10 mg/ml, 50 mg/5 ml vial Bleomycin sulfate 15 unit vial Doxorubicin Peg-liposomal 2 mg/ml vial Epirubicin 50 mg/25ml vial , 200mg/0.1ml vial Mitomycin 5, 20, 40 mg vial Streptozocin 1 g vial Daunorubicin 5 mg/ml, 20 mg vial Arsenic trioxide 10 mg/10ml ampul Mitoxantrone2 mg/ml vial Paclitaxel 6 mg/ml vial Pegaspargase 750/ml vial Teniposide 50 mg/5 ml ampul Cabazitaxel 10mg/ml vial Dacarbazine 100, 200 mg vial Docetaxel 20mg/ml, 80 mg/4 ml vial Etoposide 20 mg/ml vial Etoposide phosphate 100 mg vial Aldesleukin 22mm unit vial Goserelin 6, 8 mg implant Leuprolide acetate 5, 25, 30, 45 mg syringe kit Cetuximab 100mg/50ml vial, 200mg/0.1ml vial Necitumumab 800mg/50ml vial Pertuzumab 420mg/14ml vial Trastuzumab 440 mg vial Bevacizumab 25 mg/ml vial Bortezomib 5 mg vial Quinidine gluconate 80 mg/ml vial Verapamil 5 mg/ml vial Formulary Change* *Applies to Medi-Cal formulary only; X = Excluded; MB = Medical Benefit New Drugs to Market Therapeutic class VITAMIN D PREPARATIONS PANCREATIC ENZYMES EMOLLIENTS LIPOTROPICS TOPICAL ANTI-INFLAMMA TORY, NSAIDS TOPICAL LOCAL ANESTHETICS TOPICAL ANTI-INFLAMMA TORY STEROIDAL ANALGESICS, NARCOTICS ALZHEIMER'S THX,NMDA RECEPTOR ANTAG-CHOLINES INHIB OPHTHALMIC ANTI-INFLAMMA TORY IMMUNOMODULA TOR-TYPE NSAID AND TOPICAL IRRITANT Drug Name Roxifol-D tab (Vitamin D3/Folic Acid) Pancreaze capsule,delayed release (Lipase/Protease/Amylase) Hylatopicplus® (Emollient Combination No.53) Vascepa® (Icosapent Ethyl) Formulary* NF NF Diclozor® (Diclofenac Sodium) kit NF Anastia® (Lidocaine Hcl) lotion Micort-HC® (Hydrocortisone Acetate) NF NF Hydromorphone® (hydromorphone hcl) ampule Namzaric® (Memantine Hcl/Donepezil Hcl) cap Restasis Multidose® (Cyclosporine) drops Nudiclo® (Diclofenac Sodium/Capsaicin) NF NF NF F NF NF 8 Formulary and Prior Authorization Criteria Updates January 2017 Therapeutic class COUNTER-IRRITA NT COMB. BETA-BLOCKERS AND THIAZIDE, THIA ZIDE -LIKE DIURETICS PANCREATIC ENZYMES HYPERPARATHYROID TX AGENTS VITAMIN D ANALOG-TYPE OPHTH. VEGF-A RECEPTOR ANTAG. RCMB MC ANTIBODY PANCREATIC ENZYMES HEPATITIS B TREATMENT AGENTS ANTIHYPERGLY,INS ULIN,LONG ACTGLP-1 RECEPT.AGONIST GLUCOCORTICOIDS GLUCOCORTICOIDS ANTIHYPERGLY,INCRE TIN MIMETIC(GLP-1 RECEP.AGONIST) ANTIHYPERGLY,INS ULIN,LONG ACTGLP-1 RECEPT.AGONIST NARCOTIC ANTAGONISTS GLUCOCORTICOIDS ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS ERYTHROPOIESIS-S TIMULA TING AGENTS TOPICAL ANTIFUNGALS INSULIN NARCOTIC WITHDRAWAL THERAPY AGENTS Drug Name kit Dutoprol® (metoprolol duccinate/HCTZ) 25 mg-12.5 mg ER tab Pancreaze® (Lipase/Protease/Amylase) cap Rayaldee® (Calcifediol) cap Formulary* Bevacizumab® (Bevacizumab) syringe NF Pertzye® (Lipase/Protease/Amylase) cap Vemlidy® (Tenofovir Alafenamide Fumarate) tab Xultophy® (Insulin Degludec/Liraglutide) NF X (carve-out) Readysharp Methylprednisolone® (Methylprednisolone Acetate) inj Readysharp Triamcinolone® (Triamcinolone Acetonide) inj Adlyxin® (Lixisenatide) pen inj NF Soliqua® (Insulin Glargine/Lixisenatide) pen EVZIO® (NALOXONE HCL) auto inj NF Readysharp Dexamethasone® (Dexamethasone Sod Phosphate) Rubraca ® (rucaparibcamsylate) tablet Mircera® (Methoxy Peg-Epoetin Beta) syringe Loprox® (Ciclopirox/Skin Cleanser No.40) kit Afrezza® (insulin inhalation) 4-8 unit Zubsolv® (buprenorphine/naloxone) 0.718 mg NF NF NF NF NF NF X (MCAL), NF (HK, HSF, HW) NF F-PA (MCAL) NF NF Keep NF X (MCAL) F-PA (HK, HW) The follow ing new products are not listed in above table: • Bulk chemicals (excluded from benefit) • Products that are not FDA approved including emollients (excluded from benefit) • Topical anti-inflammatory/analgesic combination kits (NF if separate ingredient products are available on formulary and/or available as OTC) • Local anesthetics ( NF if formulary agents are available) F = Formulary, no restrictions, F-QL = Formulary, quantity limit applies, F-AL = Formulary, age limit applies, F-ST = Formulary, step therapy applies, F-PA = Formulary, PA required, NF = Non-formulary, X = Excluded *Applies to Medi-Cal (MCAL), Healthy Kids (HK), Healthy Workers (HW) and Healthy San Francisco (HSF) formularies. All products are excluded on Medicare/Medi-Cal formulary. F-PA products on Medi-Cal, Healthy Kids and Healthy Workers formulary are NF for Healthy San Francisco. 9