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POLICY It is the policy of Florida Health Care Plan, Inc. (FHCP) to manage certain high risk or high cost medications through a Prior Authorization program or a Step Therapy. PURPOSE Prior Authorization and Stepped Care are tools in a process to assist in the proper implementation of medication use. This policy does not supersede FHCP Medicare Part D coverage criteria and Medicare Part D PA policy which is listed elsewhere. Medicare Part B PA and Step are not listed in this policy. Process for Prior Authorization Request
• Prior Authorization for a Medication may be requested by the member, or prescribing physician or a member’s authorized representative verbally or in writing by contacting the FHCP Central Referrals Department.
FHCP Central Referral Department will gather clinical information to be evaluated. A clinical pharmacist with Doctor of Pharmacy degree will perform the final determination. Appeals are reviewed by a Utilization Management Physician for final determination.
• For standard requests, FHCP notifies the requesting physician, member or members’ representative of its determination as expeditiously as the enrollee’s health condition requires, but no later than 14 days for commercial members after receipt of the request or 72 hours for Medicare members after receipt of the request.
• Medications which are provided and administered by a health care professional incident to a visit are generally part B (unless self-administered greater than fifty percent of the time). If a medication is provided by a pharmacy and administered by a physician it may be Part D. Further clarification can be found at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/determine.pdf
• For expedited requests, FHCP notifies the requesting physician, member or member’s
authorized representative’ representative of its determination as expeditiously as the enrollee’s health condition requires, but no later than 24 hours after receipt of the request and supporting clinical documentation. Should FHCP require additional information or documentation an additional 48 hours will be allowed to obtain the
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information and evaluate for a determination. Under no circumstances will an expedited request exceed 72 hours.
• Approved prior authorizations must be renewed by the member, or prescribing physician or a member’s authorized representative verbally or in writing through the FHCP Central Referrals Department prior to expiration date for continued coverage.
• FHCP Central Referrals Department notifies the requesting Physician, Member or
Member’s representative of a favorable or an adverse Prior Authorization determination in writing. All adverse determination notices will include the appropriate instructions on how to file an Appeal.
• All non-formulary medications are not covered. A prior authorization is required for any exceptions.
• When a Request is for a Prior Authorization Medication is denied FHCP will; 1. Specify reason for the denial in easily understandable language. 2. Refer to the guideline, protocol, benefit provision or other criterion upon which the
decision is based. 3. Notify the member and requesting physician they may request a copy of any
criterion used to make the decision. 4. Provide member and requesting physician with a description of appeal rights,
including the right to submit written comments, documentation or other information relevant to the appeal and the timeframes for deciding appeals.
• Provide member with a description of the expedited appeal process for urgent pre-
service or urgent concurrent denials. Once a prior authorization request has been approved, coverage will be authorized for up to 12 months for most medications. However, certain generic medications may be covered indefinitely at discretion of the clinical reviewer. An enrollee is not required to re-request an approval to continue using the prescription drug, as long as all of the following conditions are met:
o The member’s prescribing physician continues to prescribe the drug. o The drug continues to be considered safe and effective for treating the
member’s disease or medical condition. o The member continues to remain eligible under the plan.
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SUMMARY OF CHANGES FROM PREVIOUS VERSION
Updates Linzess, WBC stimulating Factors Ferriprox, Humira, Repatha, Avastin/Zirabev, Simponi, Xyrem, Zelboraf ADD: Ruxience Delete: Embeda PROCEDURE BY MEDICATION (See Attachment 1)
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Table of Contents
Abilify Maintena (Aripiprazole injection) J0401 ............................................................................. 1
Abraxane (paclitaxel protein bound)-J9264 ................................................................................... 2
Actemra (tocilizumab)-J3262 ......................................................................................................... 3
Actimmune (interferon gamma-1b) ............................................................................................... 4
Adcetris (brentuximab vedotin)-J9042 ........................................................................................... 5
Adcirca-GENERIC ONLY (tadalafil) ................................................................................................. 6
Adempas (riociguat) ....................................................................................................................... 7
Afinitor (Everolimus) ...................................................................................................................... 8
Akynzeo (netupitant-palonosetron) tablet .................................................................................... 9
Alecensa (alectinib) ...................................................................................................................... 10
Alimta (pemetrexed) J9305 .......................................................................................................... 11
Amitiza (lubiprostone) .................................................................................................................. 12
Ampyra GENERIC ONLY (dalfampridine) ...................................................................................... 13
Anadrol (Oxymetholone) .............................................................................................................. 14
Aptiom (eslicarbazepine) .............................................................................................................. 15
Retacrit ......................................................................................................................................... 16
Arcalyst (rilonacept) ..................................................................................................................... 17
Arzerra (ofatumumab) J9303 ....................................................................................................... 18
Augmentation therapy for Alpha-1 Antitrypsin Deficiency (Aralast/Prolastin) J0256 .................. 19
Zirabev (Bevacizumab-bvzr) Q5118 ............................................................................................. 20
Avonex (Interferon Beta-1a) ......................................................................................................... 21
Axert (almotriptan) ....................................................................................................................... 22
Azilect (rasagiline mesylate) GENERIC ONLY ............................................................................... 23
Banzel (rufinamide) ...................................................................................................................... 24
Baqsimi (glucagon) nasal powder ................................................................................................. 25
Bavencio (Avelumab) J9023 ......................................................................................................... 26
Berinert [C1 Esterase Inhibitor (Human)] J0597 ........................................................................... 27
Betaseron (Interferon Beta-1b) .................................................................................................... 28
Blenoxane (Bleomycin) J9040 ...................................................................................................... 29
Blincyto (Blinatumomab) J9039 ................................................................................................... 30
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Boniva Infusion (Ibandronate) J1740 ........................................................................................... 31
Bosulif (bosutinib) ........................................................................................................................ 32
Botox/Xeomin (botulinum toxin) J0585 J0588 ............................................................................. 33
Budesonide EC capsules 3mg (generic entocort) ......................................................................... 34
Bydureon/BCISE/Byetta (Exenatide) Step Therapy Drug – Not Prior Authorization .................... 35
Bystolic (nebivolol) ....................................................................................................................... 36
Caprelsa (vandetanib) .................................................................................................................. 37
Carbaglu (carglumic acid) ............................................................................................................. 38
Cayston (aztreonam for inhalation) ............................................................................................. 39
Cerezyme (imiglucerase) .............................................................................................................. 40
Cesamet (nabilone) ...................................................................................................................... 41
Cialis (tadalafil) ............................................................................................................................. 42
Cinryze (c-1 esterase inhibitor) .................................................................................................... 43
Cloderm (Clocortolone) ................................................................................................................ 44
Cometriq (cabozantinib) ............................................................................................................... 45
Cotellic (cobimetinib) ................................................................................................................... 46
Cresemba (Isavuconazole) ............................................................................................................ 47
Cubicin GENERIC only (Daptomycin) J0878 .................................................................................. 48
Cuprimine(Penicillamine) ............................................................................................................. 49
Cyramza (ramucirumab) J9308 ..................................................................................................... 50
Daliresp (roflumilast) .................................................................................................................... 51
Daraprim (pyrimethamine) .......................................................................................................... 52
Darzalex (daratumumab) j9145 .................................................................................................... 53
Denavir(peniciclovir) .................................................................................................................... 54
Diabetic Test strips (other than Ascensia Products) ..................................................................... 55
Dibenzyline (phenoxybenzamine) ................................................................................................ 56
Diclofenac Topical 3% (Generic Solaraze) .................................................................................... 57
Dificid (fidaxomicin) ...................................................................................................................... 58
Doxepin topical (generic Zonalon) ............................................................................................... 59
Doxil/Lipodox (Doxorubicin liposomal) Q2050 ............................................................................. 60
Dronabinol (generic marinol) ....................................................................................................... 61
Elaprase (idursulfase) J1743 ......................................................................................................... 62
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Elitek (rasburicase)J2783 .............................................................................................................. 63
Emend (Aprepitant) capsules ....................................................................................................... 64
Empliciti (elotuzumab) J9176 ....................................................................................................... 65
Emsam (selegiline patch) .............................................................................................................. 66
Enbrel (etanercept) ...................................................................................................................... 67
Entyvio (vedolizumab) J3380 ........................................................................................................ 68
Generic flolan (epoprostinil) ........................................................................................................ 69
Erbitux (cetuximab) J9055 ............................................................................................................ 70
Ergomar (ergotamine tablets) ...................................................................................................... 71
Erivedge (vismodegib capsules) ................................................................................................... 72
Ertaczo (Sertaconazole) ................................................................................................................ 73
Eucrisa (crisaborole)- STEP THERAPY DRUG- NOT PRIOR AUTHORIZATION ................................. 74
Exelderm (sulconazole nitrate) ..................................................................................................... 75
Exjade generic (Deferasirox) ........................................................................................................ 76
Fanapt (Iloperidone) ..................................................................................................................... 77 Farxiga(dapagliflozin/Xigduo (dapagliflozin/Metformin) Step Therapy ....................................... 78
Farydak (panobinostat) ................................................................................................................ 79
Fentanyl patch (generic Duragesic) .............................................................................................. 80
Feraheme (ferumoxytol) injection Q0138/Q0139 ........................................................................ 81
Ferriprox (deferiprone) ................................................................................................................ 82
Fetzima (levomilnacipran) ............................................................................................................ 83
Finacea (Azelaic Acid) ................................................................................................................... 84
Firazyr (icatibant) ......................................................................................................................... 85
Firmagon (degarelix) .................................................................................................................... 86
Fosrenol-Generic (lanthanum carbonate) .................................................................................... 87
Frova (frovatriptan) ...................................................................................................................... 88
Fusilev (levoleucovorin) J0641 ..................................................................................................... 89
Fycompa (perampanel) ................................................................................................................ 90
Gammagard (IVIG) J1569 .............................................................................................................. 91
Gazyva (obinutuzumab) J9301 ..................................................................................................... 92
Geodon injection (ziprasidone) J3486 .......................................................................................... 93
Gilenya (Fingolimod) .................................................................................................................... 94
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Gilotrif (Afatinib) .......................................................................................................................... 95
Halaven (eribulin mesylate) J9179 ............................................................................................... 96
Halog cream (Halcinonide) ........................................................................................................... 97
Hepatitis C Direct Acting Antivirals Mavyret Zepatier .................................................................. 98
Humira (adalimumab) .................................................................................................................. 99
Humulin U-500 (insulin) ............................................................................................................. 100
Ibrance (palbociclib) ................................................................................................................... 101
Iclusig (ponatanib) ...................................................................................................................... 102
Idhifa (enasidenib) ...................................................................................................................... 103
Imbruvica (ibrutinib) ................................................................................................................... 104
Imfinzi (durvalumab) J9173 ........................................................................................................ 105
Imlygic (talimogene laherparepvec) ........................................................................................... 106
Increlex (mecasermin) ................................................................................................................ 107
Inlyta (axitinib) ........................................................................................................................... 108
Invega Sustenna (Paliperidone injection) J2426 ........................................................................ 109
Iressa (gefitinib) .......................................................................................................................... 110
Itraconazole (generic sporanox) ................................................................................................. 111
IVIG- Gammagard, Privigen, Octogam, Flebogam, Gammunex,Gammar, Gammaplex ............. 112
Ixempra (ixabepilone) J9207 ...................................................................................................... 113
Jakafi (ruxolitinib) ....................................................................................................................... 114
Januvia (Sitagliptin) .................................................................................................................... 115
Jevtana (cabazitaxel) J9043 ........................................................................................................ 116
Kadcyla (ado-trastuzumab) J9354 .............................................................................................. 117
Kalydeco (ivacaftor) .................................................................................................................... 118
Kevzara (sarilumab) .................................................................................................................... 119
Keytruda (pembrolizumab) J9271 .............................................................................................. 120
Kineret (anakinra) ....................................................................................................................... 121
Kuvan (sapropterin) .................................................................................................................... 122
Kynamro (mipomersen) ............................................................................................................. 123
Kyprolis (carfilzomib) J9047 ........................................................................................................ 124
Latuda (lurasidone) .................................................................................................................... 125
Lenvima (lenvatinib) ................................................................................................................... 126
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Letairis Generic (ambrisentan) ................................................................................................... 127
Levulan (aminolevulinic acid) .................................................................................................... 128 Lidocaine patches (generic Lidoderm) ....................................................................................... 129
Linzess (linaclotide) .................................................................................................................... 130
Livalo (pitavastatin) .................................................................................................................... 131
Lokelma (Sodium zirconium cyclosilicate) .................................................................................. 132
Lonsurf (trifluridine and tipiracil) ............................................................................................... 133
Lotronex (alosetron) ................................................................................................................... 134
Lynparza (olaparib) ..................................................................................................................... 135
Mekinist (trametinib) ................................................................................................................. 136
Menest (conjugated estrogens) ................................................................................................. 137
Movantik (Naloxegol) ................................................................................................................. 138
Mozobil (plerixafor) J2562 .......................................................................................................... 139
Multaq (dronedarone) ................................................................................................................ 140
Myrbetriq (mirabegron) ............................................................................................................. 141
Naftin (naftifine) ......................................................................................................................... 142
Naftin (naftifine) ......................................................................................................................... 143
Nebupent (pentamidine isothionate) nebulized ........................................................................ 144
Nerlynx (neratinib) ..................................................................................................................... 145
Neupro (rotigotine) .................................................................................................................... 146
Nexavar (sorafenib) .................................................................................................................... 147
Nicotrol (Nicotine replacement) ................................................................................................. 148
Ninlaro (ixazomib) ...................................................................................................................... 149
Nisoldipine (generic Sular) ......................................................................................................... 150
Noxafil (posaconazole) ............................................................................................................... 151
Nucala (mepolizumab) ............................................................................................................... 152
Nucynta ER (tapentadol) ............................................................................................................ 153
Nuedexta (Dextromethorphan/quinidine) ................................................................................. 154
Nulojix (belatacept) J0485 .......................................................................................................... 155
Ocrevus (ocrelizumab) J2350 ..................................................................................................... 156
Odomzo (sonidegib) ................................................................................................................... 157
Omnitrope (somatotropin) ......................................................................................................... 158
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Onfi (clobazam) -Generic ............................................................................................................ 159
Onglyza (Saxagliptin) Kombiglyze (Saxagliptin/Metformin)- Step Therapy ................................ 160
Opsumit (macitentan) ................................................................................................................ 161
Opdivo (nivolumab) J9299 .......................................................................................................... 162
Orencia (Abatacept) J0129 ......................................................................................................... 163
Orenitram (Macitentan) ............................................................................................................. 164
Orfandin (nitisinone) .................................................................................................................. 165
Orilissa (elagolix) ........................................................................................................................ 166
Oxandrin (Oxandrolone) ............................................................................................................. 167
Oxymorphone ER (generic Opana ER) ........................................................................................ 168
Panretin (alitretinion) ................................................................................................................. 169
Perjeta (pertuzumab) J9306 ....................................................................................................... 170
Pomalyst (pomalidomide) .......................................................................................................... 171
Prolia (Denosumab) J0897 .......................................................................................................... 172
Promacta (eltrombopag) ............................................................................................................ 173
Pulmicort Respules (Budesonide) ............................................................................................... 174
Pulmozyme (Dornase Alfa) ......................................................................................................... 175
QTERN (Saxagliptin/Dapagliflozin)- Step Therapy ...................................................................... 176
Quinine ....................................................................................................................................... 177
QVAR (beclomethasone) inhaler ................................................................................................ 178
Radicava (edaravone) J1301 ....................................................................................................... 179
Rapaflo(silodosin) ....................................................................................................................... 180
Rebif (Interferon Beta-1a) .......................................................................................................... 181
Relistor (methylnaltrexone) ....................................................................................................... 182
Repatha (evolocumab) ............................................................................................................... 183
Generic Remodulin (treprostinil) ................................................................................................ 184
Renflexis (infliximab-abda) Q5104 ............................................................................................. 185
Revlimid (Lenalidomide) ............................................................................................................. 186
Riluzole (generic rilutek .............................................................................................................. 187
Risedronate STEP Therapy ......................................................................................................... 188
Risperdal Consta (Risperidone injection) J2794 ......................................................................... 189
Ruxienxe (rituximab) J9312 ........................................................................................................ 190
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Rozlytrek (entrectinib) ................................................................................................................ 191
Rydapt (midostaurin) ................................................................................................................. 192
Samsca (tolvaptan) ..................................................................................................................... 193
Sandostatin LAR (Octreotide) ..................................................................................................... 194
Saphris (asenapine) .................................................................................................................... 195
Sensipar (cinacalcet) -Generic .................................................................................................... 196
Sildenafil citrate 20mg (generic Revatio) ................................................................................... 197
Silenor 3 mg (doxepin) ............................................................................................................... 198
Simponi (golimumab) ................................................................................................................. 199
Somatuline (lanreotide) ............................................................................................................. 200
Sprycel (dasatinib) ...................................................................................................................... 201
Stelara (ustekinumab) J3357 ...................................................................................................... 202
Stivarga (Regorafenib) ................................................................................................................ 203
Sustol (granisetron) extended-release injection J1627 .............................................................. 204
Sutent (sunitinib) ........................................................................................................................ 205
Sylatron (peg-interferon alpha 2b) ............................................................................................. 206
Sylvant (siltuximab) J2860 .......................................................................................................... 207
Symlin (Pramlintide .................................................................................................................... 208
Synagis (palivizumab) ................................................................................................................. 209
Synarel (nafarelin) ...................................................................................................................... 210
Synera (lidocaine and tetracaine patch) ..................................................................................... 211
Tafinlar (dabrafenib) .................................................................................................................. 212
Tagrisso (osimertinib) ................................................................................................................. 213
Tarceva (erlotinib) ...................................................................................................................... 214
Generic Targretin (Bexarotene) .................................................................................................. 215
Tasigna (nilotinib) ....................................................................................................................... 216
Generic Tasmar (tolcapone) ....................................................................................................... 217
Tazorac (tazarotene) .................................................................................................................. 218
Tecentriq (atezolizumab) J9022 ................................................................................................. 219
Generic Tekturna (aliskiren) STEP THERAPY- DRUG NOT PRIOR AUTHORIZATION .................... 220
Tetrabenazine (generic xenazine) .............................................................................................. 221
Thalomid (Thalidomide) ............................................................................................................. 222
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Thyrogen (Thyrotropin alpha) .................................................................................................... 223
Tobi (Nebulized Tobramycin) ..................................................................................................... 224
Tracleer (bosentan) .................................................................................................................... 225
Tramadol ER ............................................................................................................................... 226
Trelegy Ellipta ............................................................................................................................. 227
Tretinoin (Generic Retin A) ......................................................................................................... 228
Tretinoin capsules (generic Vesanoid) ....................................................................................... 229
Trintellix (vortioxetine) ............................................................................................................... 230
Trisenox (arsenic trioxide ........................................................................................................... 231
Tykerb (lapatinib) ....................................................................................................................... 232
Tymlos (abaloparatide) .............................................................................................................. 233
Tysabri (natalizumab) J2323 ....................................................................................................... 234
Tyzeka (Telbivudine) ................................................................................................................... 235
Vectibix (Panitumumab) J9303 ................................................................................................... 236
Velcade (bortezomib) J9044 ....................................................................................................... 237
Velphoro (sucroferric oxyhydroxide) .......................................................................................... 238
Venclexta (venetoclax) ............................................................................................................... 239
Ventavis (iloprost) nebulized ...................................................................................................... 240
Vesicare (solifenacin) ................................................................................................................. 241
Victoza (liraglutide) .................................................................................................................... 242
Vimpat (lacosamide) ................................................................................................................... 243
Visudyne (Verteporfin) ............................................................................................................... 244
Voriconazole (generic Vfend) ..................................................................................................... 245
Votrient (Pazopanib) .................................................................................................................. 246
Welchol (colesevelam) ............................................................................................................... 247
White blood cell colony stimulating factors Granix/Leukine/Zarzio/Nivastym (filgrastim-aafi), , Zarxio-Filgrastim-sndz, , Fulphila, Udenyca, , Leukine- sargramostim) ...................................... 248
Xalkori (crizotinib) ...................................................................................................................... 251
Xartemis (Oxycodone and Acetaminophen) ER Tablets ............................................................. 253
Xeljanz (tofacitinib) .................................................................................................................... 254
Xgeva (denosumab) J0897 .......................................................................................................... 255
Xolair (omalizumab) J2357 ......................................................................................................... 256
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Xtandi (enzalutamide) ................................................................................................................ 257
Xyrem (Sodium Oxybate) ........................................................................................................... 258
Yervoy (ipilimumab) J9228 ......................................................................................................... 259
Zaltrap (ziv-aflibercept) J9400 .................................................................................................... 260
Zavesca (miglustat) ..................................................................................................................... 261
Zejula (niraparib) ........................................................................................................................ 262
Zelboraf (vemurafenib) .............................................................................................................. 263
Zolinza (Vorinostat) .................................................................................................................... 264
Zortress (everolimus) capsules ................................................................................................... 265
Zydelig (idelalisib) Tablets .......................................................................................................... 266
Zyflo (zileuton) ............................................................................................................................ 267
Zykadia (ceritinib) capsules ........................................................................................................ 268
Zyprexa Relprevv (Olanzapine injection) .................................................................................... 269
Zytiga (Abiraterone) [GENERIC] .................................................................................................. 270
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Abilify Maintena (Aripiprazole injection) J0401
• Aripiprazole is a psychotropic medication. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications • Failure of oral aripiprazole • Approved when written/ordered by a Psychiatrist or Neurologist through referrals for
new starts.
Exchange Pharmacy X Medical Commercial X Commercial Pharmacy X Medical Exchange X Step Therapy Limited Distribution Quantity Limit
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Abraxane (paclitaxel protein bound)-J9264
• Abraxane is an anti-neoplastic agent indicated to treat metastatic breast cancer, advanced non-small cell lung cancer, and metastatic pancreatic adenocarcinoma.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when used in alignment with NCCN recommendations of class 2A or greater.
Exchange Pharmacy Medical Commercial X Commercial Pharmacy Medical Exchange X Step Therapy Limited Distribution Quantity Limit
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Actemra (tocilizumab)-J3262
• Actemra is indicated to treat rheumatoid arthritis. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy. Criteria for coverage as follows:
• FDA approved indications must be prescribed by a rheumatologist. • Must fail Simponi, Kevzara, Enbrel, Renflexis, and Xeljanz.
Exchange Pharmacy X Medical Commercial Commercial Pharmacy Medical Exchange X Step Therapy Limited Distribution Quantity Limit
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Actimmune (interferon gamma-1b)
• Actimmune is indicated to prevent infection in Chronic Granulomatous disease, and also delay the time to progression with severe malignant osteopetrosis.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows: • FDA approved indications • Coverage will be based on medical history/status, antibiotic failure for chronic
granulomatous disease. • Limited to specialist trained in management of prescribed condition.
Exchange Pharmacy X Medical Commercial Commercial Pharmacy X Medical Exchange Step Therapy Limited Distribution Quantity Limit
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Adcetris (brentuximab vedotin)-J9042
• ADCETRIS is an antibody-drug conjugate FDA indicated to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when used in alignment with NCCN recommendations of class 2A or greater.
Exchange Pharmacy Medical Commercial X Commercial Pharmacy Medical Exchange X Step Therapy Limited Distribution Quantity Limit
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Adcirca-GENERIC ONLY (tadalafil)
• Adcirca is indicated for treatment of pulmonary arterial hypertension (WHO group 1). • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician.
Criteria for coverage as follows: • FDA approved indications • Pulmonary hypertension must be diagnosed by right heart catheterization. • Evaluation, EKG, catheterization results and an objective test of exercise ability (6
minute walk) must be submitted with referral. • This medication is contraindicated in patients using organic nitrates either regularly or
intermittently.
Exchange Pharmacy X Medical Commercial Commercial Pharmacy Medical Exchange Step Therapy Limited Distribution Quantity Limit
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Adempas (riociguat)
• Adempas is indicated to treat Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTPH).
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy.
Criteria for coverage as follows:
• FDA approved indications • Failure of tadalafil and ambrisentan • Prescriber must be a cardiologist or pulmonologist • Diagnosis of PAH supported by right heart catheterization. • Failure of sildenafil and bosentan.
Exchange Pharmacy X Medical Commercial Commercial Pharmacy Medical Exchange Step Therapy Limited Distribution Quantity Limit
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Afinitor (Everolimus)
• Afinitor is an oral tyrosine kinase inhibitor indicated to treat several malignancies. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• Prescribing restricted to oncology.
Exchange Pharmacy X Medical Commercial Commercial Pharmacy X Medical Exchange Step Therapy Limited Distribution Quantity Limit
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Akynzeo (netupitant-palonosetron) tablet
• Akynzeo is indicated for chemotherapy induced nausea and vomiting • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• FDA approved indications • Must have failed generic ondansetron, generic granisetron (oral/IV), aprepitant, Aloxi,
and low-dose olanzapine (when supported by NCCN guidelines)
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Alecensa (alectinib)
• Alecensa is indicated to treat patients with ALK+ metastatic Non-Small cell lung cancer. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when there is an NCCN supported indication with a recommendation of class 2A or greater
• Prescriber must be an oncologist
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Alimta (pemetrexed) J9305
• Alimta is indicated to treat metastatic or locally advanced non-squamous NSCLC and Mesothelioma
• Medical history and studies are reviewed in Referrals and if approved will notify the physician
Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when there is an NCCN supported indication with a recommendation of class 2A or greater
• Prescriber must be an oncologist
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Amitiza (lubiprostone)
• Amitiza is indicated for chronic constipation and irritable bowel syndrome • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications • Prescriber must be a gastroenterologist • Must have failed lactulose and Miralax
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Ampyra GENERIC ONLY (dalfampridine)
• Ampyra is indicated to treat patients with multiple sclerosis who have walking disability. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• Diagnosis of multiple sclerosis AND patient is ambulatory (able to walk at least 25 feet) AND patient has walking impairment.
• Initial - 3 months. Renewal - 12 months Other Criteria: For renewal, walking speed has improved from baseline (based on 25 foot timed walk)
• Currently using a disease modifying agent.
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Anadrol (Oxymetholone)
• Anadrol is an anabolic steroid indicated to treat various types of anemia. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• FDA approved indications Medical history and information reviewed by referrals. Coverage will be response to previous treatments, and the consideration of other therapeutic options (ESAs, B12/folate, iron).
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Aptiom (eslicarbazepine)
• Aptiom is an anti-convulsant indicated for adjunctive treatment of partial seizures. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications • Must be written by neurology for adjunctive treatment of seizures. • Failure of Oxcarbazepine and carbamazepine.
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Retacrit
• ESAs are used to treat anemia related to Chronic Kidney Disease, Chemotherapy, Myelodysplastic Syndrome, Antiviral therapy. Prior authorization is required for pharmacy coverage of medication.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy.
Pharmacy coverage criteria as follows: • FDA approved indications • ESAs are not indicated for patients receiving myelosuppressive therapy when the
anticipated outcome is cure. • Patient must have adequate iron stores (ferritin ≥ 100 ng/ml, transferrin saturation
>20%). • Hemoglobin for initiation and maintenance must be compliant with current FDA
labeling.
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Arcalyst (rilonacept)
• Arcalyst is indicated to treat Cryopyrin Associated Periodic Syndromes (CAPS). • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy. Criteria for coverage as follows:
• Diagnosis of CAPS and Documentation of disability due to the condition, failure of anakinra, and nsaids.
• Prescribing limited to immunologist.
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Arzerra (ofatumumab) J9303
• Arzerra is indicated to treat chronic lymphocytic leukemia (CLL) • Medical history and studies are reviewed in Referrals and if approved will notify the
physician Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when there is an NCCN supported indication with a recommendation of class 2A or greater
• Failure of rituxumab • Prescriber must be an oncologist
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Augmentation therapy for Alpha-1 Antitrypsin Deficiency (Aralast/Prolastin) J0256
• This is an infusion therapy for patients with severe obstructive disease due to Alpha-1 Antitrypsin deficiency.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy.
Criteria for coverage as follows:
• FDA approved indications. • Patient must be a non-smoker. • Serum Concentration of Alpha-1 Antitrypsin must be less than 11micromoles/L. • Must have a high-risk AAT deficiency phenotype (PiZZ, PiZ (null) or Pi (null)(null) or other
phenotypes associated with serum AAT concentrations of less than 11 uM/L.) • Documented progressive COPD. • FEV1 between 35%-65% predicted. • Currently using Long acting bronchodilator and Oral or inhaled corticosteroids.
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Zirabev (Bevacizumab-bvzr) Q5118
• Zirabev an anti-VEGF monoclonal antibody used to treat metastatic, recurrent, or locally advanced cancers.
• Ophthalmic uses such as wet AMD and macular edema will be covered without clinical review for Zirabev or Avastin.
Criteria for coverage (for oncology indications) as follows: • FDA Approved Uses • Off-Label indications will be covered when used in alignment with NCCN
recommendations of class 2A or greater.
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Avonex (Interferon Beta-1a)
• Avonex is an interferon indicated to treat multiple sclerosis. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• Failure of glatiramer for new starts
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Axert (almotriptan)
• Axert is a 5-ht agonist indicated for treatment of migraine headaches. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications • This medication requires failure of rizatriptan and sumatriptan prior to coverage.
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Azilect (rasagiline mesylate) GENERIC ONLY
• Azilect is a monoamine oxidase inhibitor type B indicated for treatment of Parkinson’s disease
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy.
Criteria for coverage as follows:
• FDA approved indications • Must have failed recent trial of combination selegiline and Levodopa/Carbidopa.
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Banzel (rufinamide)
• Banzel is indicated for treatment of Lennox Gastaut syndrome. Prior authorization only
applies to existing members who are new starts on the drug. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications • Approved when written/ordered by a Neurologist for seizures through referrals.
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Baqsimi (glucagon) nasal powder
• Baqsimi is indicated for severe hypoglycemia where patient is unable to eat, drink or
follow commands. • Baqsimi is intranasal but does not need to be inhaled, patient does not need to be
conscious for Baqsimi to be administered. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • Ordered by an endocrinologist. • Limit of 1 device per dispensing, two per year.
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Bavencio (Avelumab) J9023
• BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the
treatment of Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when used in alignment with NCCN recommendations of class 2A or greater.
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Berinert [C1 Esterase Inhibitor (Human)] J0597
• BERINERT is a plasma-derived C1 Esterase Inhibitor (Human) indicated for the treatment
of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications • Must be prescribed by an immunologist, allergist or hematologist • Must have C1INH deficiency demonstrated by labs (C1INH and C4 labs) • Must not be taking medications that can exacerbate the frequency and/or severity of
hereditary angioedema (HAE) attacks including estrogens and ACE inhibitors.
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Betaseron (Interferon Beta-1b)
• Betaseron is an interferon indicated to treat multiple sclerosis. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• Failure of glatiramer for new starts
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Blenoxane (Bleomycin) J9040
• Blenoxane is an antineoplastic, and can be used as a sclerosing agent for malignant pleural effusions.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications. • Must be prescribed by oncologist.
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Blincyto (Blinatumomab) J9039
• Blincyto is a Bispecific monoclonal antibody targeting CD-19, it is FDA indicated for
second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when used in alignment with NCCN recommendations of class 2A or greater.
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Boniva Infusion (Ibandronate) J1740
• Boniva IV is indicated for treatment of Osteoporosis. It is a parenteral bisphosphonate
given by IV infusion every 3 months. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications • Failure of zoledronic acid. • Not for use in patients with severe renal impairment (Crcl
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Bosulif (bosutinib)
• Bosolif is indicated for treatment of Ph+ CML after failure of a first line tyrosine kinase inhibitor.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy.
Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when there is an NCCN supported indication with a recommendation of class 2A or greater.
• Restricted to hematology/oncology. • Failure of imatinib.
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Botox/Xeomin (botulinum toxin) J0585 J0588
• Botulinum toxin is approved for medical and cosmetic purposes. FHCP covers this medication only for medically necessary purposes and is approved for:
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows: • Cervical dystonia, not responsive to physical therapy. • Blepharospasm that interferes significantly with vision. • Headache not responsive to preventive and acute therapy by Neurology for at least 16
weeks. • This information is sent to the Referrals Department.
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Budesonide EC capsules 3mg (generic entocort)
• Entocort is an oral steroid capsule that has low bioavailability. Entocort is indicated for mild to moderately active Crohn’s disease involving the ileum and/or the ascending colon and the maintenance of clinical remission in mild-to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows: • Written by a gastroenterologist • Approved referrals will be for a maximum of 6 months.
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Bydureon/BCISE/Byetta (Exenatide) Step Therapy Drug – Not Prior Authorization
• Byetta/Bydureon are injectable anti-diabetic agent used to treat Type 2 Diabetes. Bydureon/ Byetta are indicated for adjunctive use with a sulfonylurea and/or metformin.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy.
Criteria for coverage as follows: • Step therapy after trial of metformin.
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Bystolic (nebivolol)
• Bystolic is a beta-1 selective antagonist indicated for treatment of hypertension.
Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications • Coverage will be based on failure or intolerance to Atenolol and Metoprolol
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Caprelsa (vandetanib)
• Caprelsa medication indicated for treatment of metastatic medullary thyroid cancer • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when there is an NCCN supported indication with a recommendation of class 2A or greater.
• Prescriber must be a Hematologist/Oncologist.
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Carbaglu (carglumic acid)
• Carbaglu is indicated to treat NAGS deficiency. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications.
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Cayston (aztreonam for inhalation)
• Cayston is indicated for treatment of pulmonary pseudomonas in cystic fibrosis. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy.
Criteria for coverage as follows: • FDA approved indications. • Failure or intolerance to Tobramycin nebulized solution
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Cerezyme (imiglucerase)
• Cerezyme is indicated for the treatment of Gaucher’s disease. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician.
Criteria for coverage as follows: • Indicated for the treatment of a patient with Type 1 Gaucher’s disease with anemia,
thrombocytopenia, bone disease, hepatomegaly or splenomegaly.
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Cesamet (nabilone)
• Cesamet is a cannabinoid indicated to prevent nausea and vomiting related to chemotherapy.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows: Failure of ondansetron AND palonosetron AND aprepitant
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Cialis (tadalafil)
• Cialis is used to treat erectile dysfunction and benign prostatic hypertrophy (BPH). Coverage is only for BPH.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• Coverage is for BPH only. • Failure of trial of finasteride or dutasteride in combination with tamsulosin.
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Cinryze (c-1 esterase inhibitor)
• Cinryze used for the treatment of hereditary angioedema • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• FDA approved indications. • Patient must have two or more angioedema attacks per month. • Must have failed danazol.
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Cloderm (Clocortolone)
• Cloderm is a medium potency corticosteroid. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• FDA approved indications. • Failure of 2 generically available topical steroids in past 6 months. • Approved by Referrals based on pharmacy history.
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Cometriq (cabozantinib)
• Cometriq is indicated for treatment of metastatic medullary thyroid cancer • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• FDA approved indications. • Prescriber must be a Hematologist/Oncologist. • Combination use with other tyrosine kinase inhibitors is excluded.
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Cotellic (cobimetinib)
• Cotellic is indicated for treatment of BRAF+ metastatic or unresectable melanoma. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when there is an NCCN supported indication with a recommendation of class 2A or greater.
• Must be prescribed by Oncologist. • Must be used in combination with Zelboraf.
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Cresemba (Isavuconazole)
• Isavuconazole is an azole antifungal indicated for the treatment of invasive aspergillosis
and invasive mucormycosis • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• FDA approved indications. • Prescriber restricted to Infectious Disease or Pulmonology • For treatment of Invasive aspergillosis patient must have failed or have contraindication
to voriconazole. • For treatment of invasive mucormycosis patient must have failed or have
contraindication to amphotericin B.
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Cubicin GENERIC only (Daptomycin) J0878
• Cubicin is an IV antibiotic indicated for the treatment of resistant gram positive bacterial infections. FHCP will participate in a program to reduce the risk of further development of drug resistant strains of bacteria by encouraging appropriate use.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• Patient is identified as having an infection caused by VRE (Vancomycin Resistant Enterococcus) or VRSA (Vancomycin Resistant Staph Aureus) by culture and sensitivity; and linezolid is not a therapeutic option OR
• Patient has a skin or soft tissue infection caused by cMRSA and resistant/PT allergic to other generically availably oral agents or combinations which may be used to treat cMRSA (Sulfamethoxazole/TMP, Rifampin, Clindamycin, Doxycycline) and patient is allergic to vancomycin and Zyvox. OR
• Patient has MRSA (non-skin/soft tissue) and is allergic to Vancomycin and Oral Zyvox is not a therapeutic option.
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Cuprimine(Penicillamine)
• Cuprimine is indicated for treatment of Rheumatoid arthritis, Wilsons Disease and cystinuria.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications • Written by a Rheumatologist, or Neurologist, or Urologist or Hepatologist. • Coverage for Rheumatoid Arthritis requires failure of a TNF Agent, and A JAK inhibitor or
Abatacept.
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Cyramza (ramucirumab) J9308
• Cyramza is a VEGF-2 antagonist indicated for treatment of NSCLC, Gastric and GE junction adenocarcinoma, and metastatic colorectal cancer.
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows: • FDA approved indications, off label use will be covered when used in alignment with
NCCN recommendations of class 2A or greater. • Prescribed by a hematologists/oncologist.
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Daliresp (roflumilast)
• Daliresp is indicated to treat COPD, it is a selective phosphodiesterase type 4 inhibitor • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician.
Criteria for coverage as follows: • FDA approved indications. • Patient must have failed recent trial of combination of inhaled corticosteroids AND long
acting beta Agonist AND inhaled anti-cholinergic.
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Daraprim (pyrimethamine)
• Daraprim is used to treat toxoplasmosis • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician.
Criteria for coverage as follows: • Toxoplasmosis. • Patient must have failed recent trial of combination of inhaled corticosteroids AND long
acting beta Agonist AND inhaled anti-cholinergic.
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Darzalex (daratumumab) j9145
DARZALEX is a CD38-directed cytolytic antibody indicated:
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
• in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory
• Medical history and studies are reviewed in Referrals and if approved will notify pharmacy and the physician.
Criteria for coverage as follows:
• FDA approved indications, off label use will be covered when used in alignment with NCCN recommendations of class 2A or greater.
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Denavir(peniciclovir)
• Denavir is an antiviral used to treat oral HSV. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician.
Criteria for coverage as follows: • FDA approved indications. • failure of acyclovir
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Diabetic Test strips (other than Ascensia Products)
• Test strips other than Ascensia products are covered only when incompatible with an insulin pump, or if patient has a severe visual impairment.
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Dibenzyline (phenoxybenzamine)
• Dibenzyline is used to treat pheochromocytoma. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician.
Criteria for coverage as follows: • Diagnosis of Pheochromocytoma.
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Diclofenac Topical 3% (Generic Solaraze)
• This medication is a topical NSAID indicated for treatment of Actinic Keratosis. • Medical history and studies are reviewed in Referrals and if approved will notify
pharmacy and the physician. Criteria for coverage as follows:
• Diagnosis of actinic keratosis. • Prescribed by a dermatologist.
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Dificid (fidaxomicin)
• Dificid is an oral antibiotic indicated to treat clostridium difficile related diarrhea. • Medical history and studies are reviewed in Referrals and if approved will notify