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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