policy purpose coverage criteria and medicare part d pa ...page 1 of 3 policy it is the policy of...

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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

Medications Requiring Prior Authorizations Effective Date: 04/01/20 FHCP: MCG004 Review/Revision: 64

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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)


Page 1 of 10

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


Page 5 of 10

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


Page 7 of 10

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


Page 8 of 10

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


Page 9 of 10

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


Page 1 of 273

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


Page 2 of 273

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


Page 3 of 273

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


Page 4 of 273

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.


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


Page 5 of 273

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






Page 6 of 273

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


Page 7 of 273

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.


• 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.



Page 8 of 273

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.



Page 9 of 273

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


• FDA approved indications • Must have failed generic ondansetron, generic granisetron (oral/IV), aprepitant, Aloxi,

and low-dose olanzapine (when supported by NCCN guidelines)



Page 10 of 273

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

Exchange Pharmacy X Medical Commercial Commercial Pharmacy X Medical Exchange Step Therapy Limited Distribution X Quantity Limit


Page 11 of 273

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



• Prescriber must be an oncologist



Page 12 of 273

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



Page 13 of 273

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


• 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.

Exchange Pharmacy X Medical Commercial Commercial Pharmacy Medical Exchange Step Therapy Limited Distribution X Quantity Limit


Page 14 of 273

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


• 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).



Page 15 of 273

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.



Page 16 of 273

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.


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.



Page 17 of 273

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.



Page 18 of 273

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:


• Failure of rituxumab • Prescriber must be an oncologist



Page 19 of 273

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.



• 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.



Page 20 of 273

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.



Page 21 of 273

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


• Failure of glatiramer for new starts



Page 22 of 273

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.



Page 23 of 273

Azilect (rasagiline mesylate) GENERIC ONLY

• Azilect is a monoamine oxidase inhibitor type B indicated for treatment of Parkinson’s disease



• FDA approved indications • Must have failed recent trial of combination selegiline and Levodopa/Carbidopa.



Page 24 of 273

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.



Page 25 of 273

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.



Page 26 of 273

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.






Page 27 of 273

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



• 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.

Medicare D Medicare B Med D policy Different Medical Commercial Exchange Pharmacy X Medical Exchange Commercial Pharmacy X Limited Distribution Step Therapy Quantity Limit


Page 28 of 273

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


• Failure of glatiramer for new starts



Page 29 of 273

Blenoxane (Bleomycin) J9040

• Blenoxane is an antineoplastic, and can be used as a sclerosing agent for malignant pleural effusions.



• FDA approved indications. • Must be prescribed by oncologist.



Page 30 of 273

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






Page 31 of 273

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


Page 32 of 273

Bosulif (bosutinib)

• Bosolif is indicated for treatment of Ph+ CML after failure of a first line tyrosine kinase inhibitor.



• 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.



Page 33 of 273

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:


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.



Page 34 of 273

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.


Criteria for coverage as follows: • Written by a gastroenterologist • Approved referrals will be for a maximum of 6 months.



Page 35 of 273

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.


Criteria for coverage as follows: • Step therapy after trial of metformin.



Page 36 of 273

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.


• FDA approved indications • Coverage will be based on failure or intolerance to Atenolol and Metoprolol



Page 37 of 273

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



• Prescriber must be a Hematologist/Oncologist.



Page 38 of 273

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.



Page 39 of 273

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



Page 40 of 273

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


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.



Page 41 of 273

Cesamet (nabilone)

• Cesamet is a cannabinoid indicated to prevent nausea and vomiting related to chemotherapy.


Criteria for coverage as follows: Failure of ondansetron AND palonosetron AND aprepitant



Page 42 of 273

Cialis (tadalafil)

• Cialis is used to treat erectile dysfunction and benign prostatic hypertrophy (BPH). Coverage is only for BPH.



• Coverage is for BPH only. • Failure of trial of finasteride or dutasteride in combination with tamsulosin.



Page 43 of 273

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


• FDA approved indications. • Patient must have two or more angioedema attacks per month. • Must have failed danazol.



Page 44 of 273

Cloderm (Clocortolone)

• Cloderm is a medium potency corticosteroid. • Medical history and studies are reviewed in Referrals and if approved will notify


• FDA approved indications. • Failure of 2 generically available topical steroids in past 6 months. • Approved by Referrals based on pharmacy history.



Page 45 of 273

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


• FDA approved indications. • Prescriber must be a Hematologist/Oncologist. • Combination use with other tyrosine kinase inhibitors is excluded.



Page 46 of 273

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:


• Must be prescribed by Oncologist. • Must be used in combination with Zelboraf.



Page 47 of 273

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


• 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.



Page 48 of 273

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.



• 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.



Page 49 of 273

Cuprimine(Penicillamine)

• Cuprimine is indicated for treatment of Rheumatoid arthritis, Wilsons Disease and cystinuria.



• 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.

Exchange Pharmacy X Medical Commercial Commercial Pharmacy Medical Exchange

Step Therapy Limited Distribution

Quantity Limit


Page 50 of 273

Cyramza (ramucirumab) J9308

• Cyramza is a VEGF-2 antagonist indicated for treatment of NSCLC, Gastric and GE junction adenocarcinoma, and metastatic colorectal cancer.


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.



Page 51 of 273

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


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.



Page 52 of 273

Daraprim (pyrimethamine)

• Daraprim is used to treat toxoplasmosis • Medical history and studies are reviewed in Referrals and if approved will notify


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.



Page 53 of 273

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






Page 54 of 273

Denavir(peniciclovir)

• Denavir is an antiviral used to treat oral HSV. • Medical history and studies are reviewed in Referrals and if approved will notify


Criteria for coverage as follows: • FDA approved indications. • failure of acyclovir



Page 55 of 273

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.



Page 56 of 273

Dibenzyline (phenoxybenzamine)

• Dibenzyline is used to treat pheochromocytoma. • Medical history and studies are reviewed in Referrals and if approved will notify


Criteria for coverage as follows: • Diagnosis of Pheochromocytoma.



Page 57 of 273

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


• Diagnosis of actinic keratosis. • Prescribed by a dermatologist.

Exchange Pharmacy X Medical Commercial Commercial Pharmacy X Medical Exchange Step Therapy Limited Distribution Quantity Limit X


Page 58 of 273

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

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