Cigna Drug and Biologic Coverage Policy
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- Henry Phelps
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1 Cigna Drug and Biologic Coverage Policy Subject Drugs / Biologics Not Covered Unless Approved Under Medical Necessity Review Employer Group Plans: Value Prescription Drug List and Advantage Prescription Drug List Table of Contents Coverage Policy... 1 General Background...44 References...45 Effective Date... 7/1/2018 Next Review Date... 1/1/2019 Coverage Policy Number Related Coverage Resources INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Coverage Policy Employer group plans may adopt a Prescription Drug List that does not cover certain drugs or biologics unless those products are approved based on a medical necessity review. Cigna approves coverage for these drugs or biologics as medically necessary when sufficient information demonstrates that the clinical criteria set forth below are met. Unless otherwise stated, all Covered Alternative Drugs are required prior to the approval of the non-covered drug or biologic. Note: Receipt of sample product does not satisfy any criteria requirements for coverage Cigna Value Prescription Drug List or Advantage Prescription Drug List Therapeutic ADD/ADHD and Stimulants Cotempla XR ODT (methylphenidate extended-release orally disintegrating tablets 8.6 mg, 17.3 mg and 25.9 mg) Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in a pediatric individual 6 to 17 years of age Documented contraindication per FDA label, intolerance, inability to use, or not a candidate (e.g., stabilized condition where therapeutic interchange is inappropriate) for FIVE of the following: o o o o Methylphenidate ER tablet (generic for Ritalin SR) or Metadate ER tablet (methylphenidate ER) Methylphenidate ER tablet (generic for Concerta) Methylphenidate ER capsules (generic for Ritalin LA) Dexmethylphenidate XR (generic for Focalin XR) Page 1 of 45
2 Analgesics: Antimigraine preparations Desoxyn (methamphetamine 5 mg Dexedrine (dextroamphetamine 5 mg, 10 mg, 15 mg sustained release capsules) Mydayis (mixed salts of a singleentity amphetamine product 12.5 mg, 25 mg, 37.5 mg, 50 extended-release capsules) Vyvanse (lisdexamfetamine dimesylate) D.H.E 45 (dihydroergotamine mesylate 1 mg/ml Injection) o Aptensio XR (methylphenidate ER capsules) o Quillichew ER (methylphenidate ER chewable o Quillivant XR (methylphenidate ER suspension) o Daytrana (methylphenidate transdermal patch) Desoxyn candidate for (e.g., stabilized condition where therapeutic interchange is inappropriate) ALL of the following: o dextroamphetamine/amphetamine (generic for Adderall) o dextroamphetamine (Procentra solution or generic for Zenzedi) Dexedrine candidate for (e.g., stabilized condition where therapeutic interchange is inappropriate) ONE of the following: o dextroamphetamine/amphetamine ER (generic for Adderall XR) Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in an individual 13 years of age and older Failure or inadequate response, contraindication per FDA label, intolerance, inability to use, or not a candidate (e.g., stabilized condition where therapeutic interchange is inappropriate) for ALL of the following: o Dextroamphetamine/amphetamine ER capsule (generic for Adderall XR) o Adzenys XR-ODT (amphetamine ER orally disintegrating tablet) o Dyanavel XR (amphetamine ER suspension) One of the following: Diagnosis of ADHD and documented failure / inadequate response, contraindication per FDA label, intolerance, inability to use, or not a candidate for (e.g., stabilized condition where therapeutic interchange is inappropriate) ONE of the following: o dextroamphetamine/amphetamine ER (generic for Adderall XR) Diagnosis of Binge-Eating Disorder in an adult and at least one binge eating day a month for 3 month D.H.E 45 Documented intolerance, not a candidate for, or inability to use sumatriptan injection Page 2 of 45
3 Imitrex (sumatriptan 6 mg/ 0.5 ml refill) Imitrex (sumatriptan 25 mg, 50mg, and 100 mg Imitrex (sumatriptan 5 mg/spray and 20 mg/spray nasal spray) Migranal (dihydroergotamine mesylate nasal solution) Treximet (naproxen sodium / sumatriptan succinate 60 mg 10 mg tablets and 500 mg 85 mg Documented intolerance, not a candidate for, or inability to use ALL of the following: o oral sumatriptan tablets o sumatriptan nasal spray o sumatriptan succinate solution for injection Imitrex tablets Documented failure/inadequate response, contraindication per FDA label, intolerance, or not a candidate for ONE of the following: oral rizatriptan tablets, oral almotriptan tablets, oral eletriptan tablets, oral frovatriptan tablets, sumatriptan succinate solution for injection, oral zolmitriptan tablets Imitrex nasal spray Documented intolerance, inability to use, or not a candidate for Onzetra Xsail (sumatriptan nasal powder) Documented failure/inadequate response, contraindication per FDA label, intolerance, or not a candidate for ONE of the following: oral rizatriptan tablets, oral almotriptan tablets, oral eletriptan tablets, oral frovatriptan tablets, oral sumatriptan tablets, sumatriptan succinate solution for injection Migranal Documented failure/inadequate response, contraindication per FDA label, intolerance, or not a candidate for sumatriptan nasal spray Documented failure/inadequate response, contraindication per FDA label, intolerance, or not a candidate for ONE of the following: oral rizatriptan tablets, oral almotriptan tablets, eletriptan oral tablets, oral frovatriptan tablets, oral sumatriptan tablets, sumatriptan succinate solution for injection Documented intolerance to generic Treximet Documented inability to use naproxen and sumatriptan concurrently. Note: Naproxen is available generically as a prescription product in the following strengths and dosage forms: 250 mg, 375 mg, and 500 mg tablets and 125 mg / 5 ml oral suspension. Sumatriptan is available generically in the following strengths: 25 mg, 50 mg, and 100 mg tablets. Page 3 of 45
4 Analgesics: Narcotics Sumavel DosePro (sumatriptan succinate 4 mg or 6 mg / 0.5 ml jet injector) Zembrace SymTouch (sumatriptan succinate 3 mg / 0.5 ml auto-injector) Zomig (zolmitriptan 2.5 mg and 5 mg Zomig (2.5 mg/spray and 5 mg/spray nasal spray) Zomig-ZMT (zolmitriptan 2.5 mg and 5 mg orally disintegrating Belbuca (buprenorphine buccal film) Documented intolerance, not a candidate for, or inability to use ALL of the following: o oral sumatriptan tablets o o sumatriptan nasal spray sumatriptan succinate 4 mg or 6 mg / 0.5 ml solution for injection Zomig tablets Documented failure/inadequate response, contraindication per FDA label, intolerance, or not a candidate for ONE of the following: oral rizatriptan tablets, oral almotriptan tablets, oral eletriptan tablets, oral frovatriptan tablets, oral sumatriptan tablets, sumatriptan succinate solution for injection One of the following: Treatment of migraine headaches and ALL of the following: o Documented intolerance to 1 generic formulation of Zomig tablets o Documented failure/inadequate response, candidate for sumatriptan nasal spray o Documented failure/inadequate response, candidate for ONE of the following: oral rizatriptan tablets, oral almotriptan tablets, oral eletriptan tablets, oral frovatriptan tablets, oral sumatriptan tablets, sumatriptan succinate solution for injection Treatment of cluster headaches o Documented intolerance, not a candidate for, or inability to use sumatriptan injection Zomig-ZMT Documented failure/inadequate response, contraindication per FDA label, intolerance, or not a candidate for ONE of the following: rizatriptan orally disintegrating tablets,oral rizatriptan tablets, oral almotriptan tablets, oral eletriptan tablets, oral frovatriptan tablets, oral sumatriptan tablets, sumatriptan succinate solution for injection Documented intolerance, not a candidate for, or inability to use buprenorphine transdermal patch (Butrans ) Page 4 of 45
5 Analgesics: Nonsteroidal Antiinflammatory Drugs Conzip (tramadol 100 mg, 200 mg, and 300 mg extended release capsules) levorphanol (levorphanol 2 mg OxyContin (oxycodone hydrochloride 10 mg,15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg extended-release Roxicodone (oxycodone hydrochloride 5 mg, 15 mg, 30 mg immediate release Cambia (diclofenac 50 mg powder packet) Naprelan (naproxen 375 mg, 500 mg, and 750 mg extended release naproxen CR (naproxen 375 mg and 500 mg controlled release naproxen ER (naproxen 375 mg and 500 mg Conzip Documented intolerance or inability to use BOTH of the following: tramadol 50 mg tablets (Ultram ) AND tramadol 100 mg, 200 mg, or 300 mg extended release tablets (Ryzolt ) Follow Opioid Therapy Coverage Policy #1704 for additional criteria Opioid Therapy Coverage Policy Adult individual 18 years of age or older Used for the acute treatment of migraine attacks Documented intolerance or inability to use diclofenac tablets or diclofenac delayed release tablets Documented contraindication per FDA label, intolerance, inability to use, or not a candidate for FOUR generic nonsteroidal anti-inflammatory drugs (excluding diclofenac) contraindication per FDA label, intolerance, inability to use, or not a candidate for generic triptans Documented intolerance to naproxen 250 mg, 375 mg, or 500 mg immediate release tablets Documented contraindication per FDA label, intolerance, or not a candidate for four generic nonsteroidal antiinflammatory drugs (excluding naproxen) Page 5 of 45
6 Analgesics: Non-salicylate and Barbiturate combinations Analgesics: Non-salicylate and Narcotic combinations extended release Sprix (ketorolac nasal solution; mg / spray) Tivorbex (indomethacin 20 mg and 40 mg capsules) Vivlodex (meloxicam 5 mg and 10 mg capsules) Zipsor (diclofenac 25 mg capsule) Zorvolex (diclofenac 18 mg and 35 mg capsule) Bupap (acetaminophen / butalbital 300 mg 50 mg Vanatol LQ (butalbital 50 mg, acetaminophen 325 mg, caffeine 40 mg/ 15 ml syrup) Vanatol S (butalbital 50 mg, acetaminophen 325 mg, caffeine 40 mg/ 15 ml syrup) Capital with codeine (acetaminophen / codeine phosphate 120 mg - 12 mg / 5 ml suspension) Documented contraindication per FDA label, intolerance, or inability to use ketorolac 10 mg tablets contraindication per FDA label, inability to use, or not a candidate for diclofenac 1 % topical gel (Voltaren gel) Documented contraindication per FDA label, inability to use, or not a candidate for THREE generic nonsteroidal anti-inflammatory drugs (excluding ketorolac) The approval will be limited to a five day supply. Documented intolerance to indomethacin 25 mg or 50 mg capsules Documented contraindication per FDA label, inability to use, or not a candidate for FOUR generic nonsteroidal anti-inflammatory drugs (excluding indomethacin) Documented intolerance to meloxicam 7.5 mg or 15 mg tablets Documented contraindication per FDA label, inability to use, or not a candidate for FOUR generic nonsteroidal anti-inflammatory drugs (excluding meloxicam) Documented intolerance to diclofenac 50 mg tablets or diclofenac 25 mg delayed release tablets Documented contraindication per FDA label, inability to use, or not a candidate for FOUR generic nonsteroidal anti-inflammatory drugs (excluding diclofenac) Documented intolerance or not a candidate for acetaminophen / butalbital 325 mg 50 mg tablets Documented contraindication per FDA label, intolerance, or inability to use acetaminophen / butalbital / caffeine 325 mg 50 mg 40capsules AND tablets Documented contraindication per FDA label, intolerance, or inability to use acetaminophen / butalbital / caffeine 325 mg 50 mg 40 mg capsules AND tablets Documented intolerance, inability to use, or not a candidate for acetaminophen / codeine tablets Documented intolerance to acetaminophen / codeine phosphate 120 mg - 12 mg / 5 ml solution Page 6 of 45
7 Anaphylaxis Therapy Agents Anti-diuretic and vasopressor hormone agents Anti-infective agents: topical antibiotics Anti-infective agents: antifungals Adrenaclick (epinephrine 0.15 mg and 0.3 mg autoinjector) Auvi-Q (epinephrine 0.15 mg and 0.3 mg autoinjector) Auvi-Q (epinephrine 0.1mg/0.1ml) EpiPen (epinephrine 0.3 mg auto-injector) EpiPen Jr (epinephrine 0.15 mg auto-injector) DDAVP (desmopressin acetate 0.01% nasal solution) DDAVP (0.1 mg, 0.2 mg Plexion (sulfacetamide sodium / sulfur 9.8 % 4.8 % cleanser, cleansing cloth, cream, and lotion) Diflucan (fluconazole 50 mg, 100 mg, 150 mg, 200 mg tablets, 10 mg/ml, 40 mg/ml suspension) Ertaczo (sertaconazole 2 % cream) Extina (ketoconazole 2 % foam) Documented intolerance, inability to use, or inability to obtain generic epinephrine auto-injector. Where covered, a maximum of four auto-injectors will be allowed per 30 days. Individual weighs 16.5 to 33 pounds (7.5 to 15 kg) Documented inability to obtain generic epinephrine autoinjector. Where covered, a maximum of four auto-injectors will be allowed per 30 days. DDAVP nasal solution Documented inability to use desmopressin tablets DDAVP Documented failure / inadequate response or intolerance to FIVE of the following: o sulfacetamide sodium / sulfur 10 % - 5 % emollient cream, topical lotion, and topical cleanser o sulfacetamide sodium / sulfur 10 % - 4 % cleansing pads o sulfacetamide sodium / sulfur 9 % % topical wash Diflucan Individual is 12 years of age and older Documented diagnosis of interdigital tinea pedis Documented inadequate response, contraindication per FDA label, or intolerance to naftifine cream, clotrimazole cream, and econazole cream Extina 2 % foam Individual is 12 years of age and older Documented diagnosis of seborrheic dermatitis Page 7 of 45
8 Jublia (efinaconazole 10 % solution) Kerydin (tavaborole 5 % solution) Loprox (ciclopirox 0.77 % cream) Loprox (ciclopirox 1 % shampoo) Luzu (luliconazole 1 % cream) Oxistat (oxiconazole 1% lotion) Oxistat (oxiconazole 1 % cream) Onmel (itraconazole 200 mg Penlac (ciclopirox 8 % nail lacquer solution) candidate for sulfacetamide sodium shampoo and ciclopirox shampoo Individual is an adult (18 years of age and older) Documented diagnosis of onychomycosis of the toenail(s) Documented inadequate response, contraindication per FDA label, intolerance, or not a candidate for itraconazole capsules, terbinafine tablets, and ciclopirox nail lacquer solution Loprox 0.77 % cream candidate for FOUR of the following: naftifine cream, clotrimazole cream, econazole cream, oxiconazole cream, or ketoconazole cream Loprox 1 % shampoo Individual is an adult (18 years of age and older) Documented diagnosis of seborrheic dermatitis candidate for sulfacetamide sodium shampoo and ketoconazole foam Documented diagnosis of tinea pedia, tinea cruris, or tinea corporis Documented inadequate response, contraindication per FDA label, or intolerance to naftifine cream, clotrimazole cream, and econazole cream Documented failure / inadequate response to oxiconazole 1 % cream candidate for ketoconazole cream Oxistat 1 % cream candidate for ketoconazole cream Documented intolerance or inability to use itraconazole 100 mg capsules candidate for terbinafine tablets Penlac 8 % nail lacquer solution Page 8 of 45
9 Anti-infective agents: antiprotozoals Anti-infective agents: inhaled aminoglycosides Anti-infective agents: antivirals Sporanox (itraconazole 100mg capsules, 10 mg/ml solution) Vusion (miconazole / zinc oxide 0.25 % - 15 % ointment) Mepron (atovaquone 750 mg/ 5 ml oral suspension) Bethkis (tobramycin 300 mg / 4 ml nebulization solution) Tobi (tobramycin 300 mg / 5 ml nebulization solultion) Sitavig (acyclovir 50 mg buccal tablet) Zovirax (acyclovir 5% cream) Zovirax (acyclovir 5% ointment) Documented diagnosis of onychomycosis of the fingernail(s) or toenail(s) Documented contraindication per FDA label, intolerance, inadequate response, or not a candidate for itraconazole capsules and terbinafine tablets Sporanox Pediatric individual 4 weeks of age or older Documented diagnosis of diaper dermatitis Presence of candida infection The approval will be limited to a seven day supply. One of the following: Prevention or treatment of Pneumocystis jiroveci pneumonia (PCP) in adults or individuals 13 years of age and older o Documented intolerance to 1 generic formulation of Mepron AND o Documented intolerance to trimethoprim/sulfamethoxazole (TMP-SMX) Prevention or treatment of Toxoplasma gondii encephalitis (TE) in adults or adolescents o Documented intolerance to 1 generic formulation of Mepron AND o Documented intolerance to 1 of the following: trimethoprim/sulfamethoxasole (TMP-SMX), pyrimethamine or sulfadiazine Documented intolerance to tobramycin 300 mg / 5 ml nebulization solution Documented intolerance or inability to use Tobi Podhaler Documented intolerance to Kitabis Pak (tobramycin 300 mg / 5 ml nebulization solution) Tobi nebulization solution Documented intolerance or inability to use Tobi Podhaler Documented intolerance to Kitabis Pak (tobramycin 300 mg / 5 ml nebulization solution) Documented diagnosis of recurrent herpes labialis Documented inability to use acyclovir capsules and tablets Zovirax ointment Page 9 of 45
10 Anti-infective agents: Macrolides Anti-infective agents: Penicillins Anti-infective agents: Tetracycline Antibiotics Zovirax (acyclovir 200 mg capsules, 400 mg and 800 mg tablets, 200 mg/5 ml suspension) Valcyte (valganciclovir 450 mg tablets, 50 mg/ml solution) E.E.S. 200 (erythromycin ethylsuccinate 200 mg/5 ml suspension) EryPed 400 (erythromycin 400 mg/5 ml suspension) Augmentin (125 mg amoxicillin /31.25mg clavulanate/5ml suspension, 250 mg amoxicillin / 62.5mg clavulanate/5ml suspension, 875 mg amoxicillin/125 mg clavulanate Augmentin ES- 600 (600 mg amoxicillin /42.9 mg clavulanate / 5 ml suspension) Augmentin XR (1,000 mg amoxicillin /62.5 mg clavulanate Acticlate (doxycycline hyclate 75 mg and 150 mg Documented inability to use acyclovir capsules and tablets Documented contraindication per FDA label, intolerance, inability to use, or not a candidate for valacyclovir tablets and famciclovir tablets Zovirax Valcyte E.E.S. 200 Documented inability to use or not a candidate for erythromycin ethylsuccinate 400 mg tablets Augmentin Documented failure / inadequate response or intolerance to doxycycline hyclate 75 mg, 100 mg or 150 mg tablets intolerance, or not a candidate for ALL of the following: o doxycycline hyclate extended release 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o doxycycline hyclate 50 mg or 100 mg capsules o doxycycline monohydrate 75 mg or 150 mg capsules Page 10 of 45
11 Adoxa (doxycycline monohydrate 50 mg and 100 mg tablets, 150 mg capsules, and Pak) Doryx (doxycycline hyclate 50 mg, 120 mg, 150 mg, and 200 mg delayed release Minocin (minocycline 50 mg, 75 mg, and 100 mg capsules) Monodox (doxycycline monohydrate 50 mg, 75 mg, and 100 mg capsules) Oracea (for rosacea only) (doxycycline monohydrate 40 mg biphasic release capsules) Targadox (doxycycline hyclate 50 mg Adoxa, where available Documented intolerance to doxycycline monohydrate 50 mg, 75 mg, 100 mg, or 150 mg capsules intolerance, or not a candidate for the following: o doxycycline hyclate extended release 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets Doryx, where available intolerance, or not a candidate for ALL of the following: o minocycline 45 mg, 90 mg, or 135 mg extended release tablets o doxycycline hyclate 50 mg or 100 mg capsules o doxycycline monohydrate 50 mg, 75 mg, 100 mg, or 150 mg capsules Minocin, where available intolerance, or not a candidate for ALL of the following: o minocycline 50 mg, 75 mg, or 100 mg tablets o minocycline 45 mg, 90 mg, or 135 mg extended release tablets Monodox intolerance, or not a candidate for ALL of the following: o o o doxycycline monohydrate 50 mg, 75 mg, or 100 mg tablets doxycycline hyclate 50 mg, 75 mg, or 100 mg delayed release tablets minocycline 50 mg, 75 mg, or 100 mg capsules Oracea intolerance, or not a candidate for ALL of the following: o doxycycline monohydrate 50 mg tablets o doxycycline hyclate 50 mg delayed release tablets o minocycline 45 mg extended release tablets Documented failure / inadequate response or intolerance to doxycycline hyclate 50 mg capsules intolerance, or not a candidate for ALL of the following: o doxycycline hyclate extended release 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o doxycycline hyclate 50 mg or 100 mg capsules o doxycycline monohydrate 75 mg or 150 mg capsules Page 11 of 45
12 Anti-infective agents: Vancomycin and Derivaties Anti-inflammatory combination products Antimycobacterial agents Solodyn (minocycline 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg extended release Ximino ER (minocycline 45 mg, 90 mg, 135 mg extended release capsules) Vibramycin (doxycycline hyclate 100 mg capsules) Vancocin (Vancomycin 125 mg, 250 mg capsules Duexis (famotidine / ibuprofen 26.6 mg 800 mg Vimovo (esomeprazole / naproxen 20 mg 375 mg or 500 mg Mycobutin (rifabutin) Antineoplastics Nilandron (nilutamide 150 mg Anti-Parkinson Agents Gocovri (amantadine) extended release capsules Lodosyn (carbidopa 25 mg Requip XL (ropinerole 2 mg, 4 Documented intolerance or inability to use multiple tablets of minocycline 45 mg, 90 mg, or 135 mg extended release tablets intolerance, or not a candidate for ALL of the following: o doxycycline hyclate extended release 50 mg, 75 mg, 100 mg, or 150 mg tablets o minocycline 50 mg, 75 mg, or 100 mg tablets o minocycline 50 mg, 75 mg, or 100 mg capsules Vibramycin intolerance, or not a candidate for ALL of the following: o doxycycline hyclate 100 mg tablets o doxycycline hyclate 100 mg delayed release tablets o doxycycline monohydrate 100 mg capsules Vancocin Documented inability to use famotidine 20 mg or 40 mg tablets and ibuprofen 800 mg tablets concurrently Documented inability to use esomeprazole 20 mg capsules and naproxen 375 mg or 500 mg tablets concurrently Mycobutin (rifabutin) Follow Oncology Medications Coverage Policy #1403 for additional criteria Oncology Medications Coverage Policy ALL of the following: For the treatment of dyskinesia in patients with Parkinson's disease (PD) Receiving levodopa-based treatment Documented failure/inadequate response or intolerance to amantadine immediate-release capsules, tablets, or oral solution Lodosyn Individual is currently on a carbidopa/levodopa regimen Page 12 of 45
13 mg, 6 mg, 8 mg, 12 mg extended release Requip XL candidate for (e.g., stabilized condition where therapeutic interchange is inappropriate) the following: pramipexole extended release tablets Zelapar (seligiline 1.25 mg orally disintegrating Antitussive Agents Tussicaps (chlorpheniramine / hydrocodone 4 mg 5 mg and 8 mg 10 mg extended release capsules) Asthma and Respiratory: Inhalers, Albuterol Proventil (albuterol sulfate 108 mcg / act aerosol solution) candidate for (e.g., stabilized condition where therapeutic interchange is inappropriate) ONE of the following:rasagiline or seligiline tablets Documented inability to use chlorpheniramine / hydrocodone 8 mg 10 mg / 5 ml extended release suspension Documented intolerance or inability to use ProAir (albuterol sulfate 108 mcg / act aerosol solution) Asthma and Respiratory: Inhalers, Glucocorticoids Ventolin (albuterol sulfate 108 mcg / act aerosol solution) Xopenex (levalbuterol tartrate 45 mcg / act aerosol) Aerospan (flunisolide) Alvesco (ciclesonide) Armonair Respiclick (fluticasone propionate) Arnuity Ellipta (fluticasone) Asmanex / HFA (mometasone) Pulmicort Flexhaler (budesonide) contraindication per FDA label, intolerance, inability to use, or not a candidate for Qvar /Qvar Redihaler (beclomethasone) Page 13 of 45
14 Asthma and Respiratory: Inhalers, Long Acting Anticholinergics Flovent Diskus / HFA (fluticasone) Seebri Neohaler (glycopyrrolate) Tudorza Pressair (aclidinium) One of the following: For asthma o Documented failure / inadequate response, contraindication per FDA label, intolerance, inability to use, or not a candidate for Qvar /Qvar Redihaler (beclomethasone) For eosinophilic esophagitis o Documented failure / inadequate response, contraindication per FDA label, intolerance, inability to use, or not a candidate for budesonide 1 mg/2 ml inhalation suspension Documented intolerance, failure / inadequate response, contraindication per FDA label, inability to use, or not a candidate for Incruse Ellipta (umeclidinium) Asthma and Respiratory: Inhalers, Long Acting Beta Agonists Respiratory, Asthma/COPD: Asthma combinations Asthma and Respiratory: Inhaled Beta- Spiriva /Spiriva Respimat (tiotropium) Arcapta Neohaler (indacaterol) Serevent Diskus (COPD only) (salmeterol) Dulera (mometasone / formoterol) AirDuo RespiClick (fluticasone / salmeterol) Bevespi Aerosphere Spiriva Handihaler and Spiriva Respimat 2.5 mcg/actuation: For COPD - Documented intolerance, failure / inadequate response, contraindication per FDA label, inability to use, or not a candidate for Incruse Ellipta (umeclidinium) Spiriva Respimat 1.25 mcg/actuation: For asthma - Documented failure/inadequate response, intolerance, contraindication per FDA label, inability to use, or not a candidate for ALL of the following: Qvar/Qvar Redihaler contraindication per FDA label, intolerance, inability to use, or not a candidate for Striverdi Respimat (olodaterol) contraindication per FDA label, intolerance, inability to use, or not a candidate for Advair (fluticasone / salmeterol), Breo Ellipta (fluticasone / vilanterol), generic fluticasone / salmeterol aerosol powder, AND Symbicort (budesonide / formoterol) Documented intolerance to generic fluticasone / salmeterol aerosol powder contraindication per FDA label, intolerance, inability to use, or not a candidate for Advair (fluticasone / salmeterol), Breo Ellipta (fluticasone / vilanterol), AND Symbicort (budesonide / formoterol) Page 14 of 45
15 Adrenergic and Anticholinergic Combinations Asthma and Respiratory: Nasal Sprays Asthma and Respiratory: Leukotriene modifiers Asthma and Respiratory: Xanthine derivatives (glycopyrrolate / formoterol) Stiolto Respimat (tiotropium / olodaterol) Utibron Neohaler (indacaterol / glycopyrrolate) Beconase AQ (beclomethasone) Dymista (azelastine / fluticasone) Nasonex (mometasone) Omnaris (ciclesonide) QNasl, Children s (beclomethasone) QNasl (beclomethasone) Rhinocort (budesonide) Veramyst (fluticasone) Xhance (fluticasone propionate) Zetonna (ciclesonide) Zyflo (zileuton 600 mg Zyflo CR (zileuton 600 mg extended release Elixophyllin (theophylline 80 mg/15 ml solution) Documented intolerance, failure / inadequate response, contraindication per FDA label, inability to use, or not a candidate for Anoro Ellipta (umeclidinium / vilanterol) contraindication per FDA label, intolerance, inability to use, or not a candidate for budesonide nasal suspension, flunisolide nasal solution, fluticasone nasal suspension, mometasone nasal suspension, and triamcinolone nasal aerosol Zyflo CR contraindication per FDA label, intolerance, inability to use or not a candidate for montelukast or zafirlukast Elixophyllin solution Inability to use theophylline extended release capsules or tablets Page 15 of 45
16 Biological DMARD Cardiovascular: Antithrombotic Agents Cardiovascular: Beta-blockers Cardiovascular: Diuretics Siliq (brodalumab injection) Simponi (golimumab) Simponi Aria (golimumab) Kineret (anakinra) Yosprala (aspirin delayed release / omeprazole 81 mg 40 mg tablets and mg Betapace (sotalol 80 mg, 120 mg, 160 mg Bystolic (nebivolol) Byvalson (nebivolol / valsartan) Edecrin (ethacrynic acid 25 mg ethacrynic acid (ethacrynic acid 25 mg Follow Immunomodulators Coverage Policy #1805 for additional criteria Immunomodulators Coverage Policy Follow Immunomodulators Coverage Policy #1805 for additional criteria Immunomodulators Coverage Policy Follow Immunomodulators Coverage Policy #1805 for additional criteria Immunomodulators Coverage Policy Individual is at risk of developing aspirin associated gastric ulcers defined as either of the following o 55 years of age or older o Documented history of gastric ulcers Individual requires aspirin for secondary prevention of cardiovascular and cerebrovascular events defined as one of the following: o Previous ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli o Previous myocardial infarction or unstable angina pectoris o Chronic stable angina pectoris o History of revascularization procedure (coronary artery bypass graft or percutaneous transluminal coronary angioplasty) when there is pre-existing condition for which aspirin is already indicated Documented intolerance to immediate release (including enteric coated) aspirin Betapace intolerance, or not a candidate for FIVE of the following: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol succinate, metoprolol tartrate, nadolol, pindolol, propranolol, timolol Documented inability to use valsartan and Bystolic (nebivolol) concurrently Note: Bystolic requires preauthorization on Value and Advantage Drug Lists candidate for ALL of the following: bumetanide, furosemide, and torsemide Page 16 of 45
17 Cardiovascular: Inotropic Agents Cardiovascular: Renin Inhibitors Lanoxin (digoxin 125 mcg and 250 mcg Lanoxin (digoxin 62.5 mcg and mcg Accupril (quinapril) Accuretic (quinapril / hydrochlorothiazide) Aceon (perindopril) Altace (ramipril) Atacand (candesartan) Atacand HCT (candesartan / hydrochlorothiazide) Lanoxin 125 mcg or 250 mcg tablets Documented inability to use or intolerance to one-half or one and one-half tablets of digoxin 125 mcg tablets Accupril intolerance, or not a candidate for FOUR of the following: benazepril, captopril, enalapril, fosinopril, lisinopril, ramipril, trandolapril Accuretic intolerance, or not a candidate for FOUR of the following: benazepril / hydrochlorothiazide, captopril / hydrochlorothiazide, enalapril / hydrochlorothiazide, fosinopril / hydrochlorothiazide, lisinopril / hydrochlorothiazide Documented inability to use quinapril and hydrochlorothiazide concurrently Aceon intolerance, or not a candidate for FOUR of the following: benazepril, captopril, enalapril, fosinopril, lisinopril, quinapril, ramipril, trandolapril Altace intolerance, or not a candidate for FOUR of the following: benazepril, captopril, enalapril, fosinopril, lisinopril, quinapril, trandolapril Atacand intolerance, or not a candidate for FOUR of the following: irbesartan, losartan, olmesartan, telmisartan, valsartan Atacand HCT intolerance, or not a candidate for FOUR of the following: irbesartan / hydrochlorothiazide, losartan / hydrochlorothiazide, olmesartan / hydrochlorothiazide, telmisartan / hydrochlorothiazide, valsartan / hydrochlorothiazide Documented inability to use candesartan and hydrochlorothiazide concurrently Page 17 of 45
18 Avapro (irbesartan) Azor (amlodipine / olmesartan) Benicar (olmesartan) Benicar HCT (olmesartan / hydrocholothiazide) Cozaar (losartan) Diovan (valsartan) Diovan HCT (valsartan / hydrochlorothiazide) Avapro intolerance, or not a candidate for FOUR of the following: candesartan, losartan, olmesartan, telmisartan, valsartan Azor candidate for ALL of the following: amlodipine / benazepril, amlodipine / telmisartan, amlodipine / valsartan Documented inability to use olmesartan and amlodipine concurrently Benicar intolerance, or not a candidate for FOUR of the following: candesartan, irbesartan, losartan, telmisartan, valsartan Benicar HCT intolerance, or not a candidate for FOUR of the following: candesartan / hydrochlorothiazide, irbesartan / hydrochlorothiazide, losartan / hydrochlorothiazide, telmisartan / hydrochlorothiazide, valsartan / hydrochlorothiazide Documented inability to use olmesartan and hydrochlorothiazide concurrently Cozaar intolerance, or not a candidate for FOUR of the following: candesartan, irbesartan, olmesartan, telmisartan, valsartan Diovan intolerance, or not a candidate for FOUR of the following: candesartan, irbesartan, losartan, olmesartan, telmisartan Diovan HCT intolerance, or not a candidate for FOUR of the following: candesartan / hydrochlorothiazide, irbesartan / hydrochlorothiazide, losartan / hydrochlorothiazide, olmesartan / hydrochlorothiazide, telmisartan / hydrochlorothiazide Documented inability to use valsartan and hydrochlorothiazide concurrently Page 18 of 45
19 Edarbi (azilsartan) Edarbyclor (azilsartan / chlorthalidone) Exforge (amlodipine / valsartan) Exforge HCT (amlodipine / hydrochlorothiazide / valsartan) Hyzaar (losartan / hydrochlorothiazide) candidate for FIVE of the following: candesartan, irbesartan, losartan, olmesartan, telmisartan, valsartan candidate for FIVE of the following: candesartan / hydrochlorothiazide, irbesartan / hydrochlorothiazide, losartan / hydrochlorothiazide, olmesartan / hydrochlorothiazide, telmisartan / hydrochlorothiazide, valsartan / hydrochlorothiazide Exforge candidate for ALL of the following: amlodipine / benazepril, amlodipine / olmesartan, amlodipine / telmisartan Documented inability to use valsartan and amlodipine concurrently Exforge HCT contraindication per FDA label, intolerance, inability to use, or not a candidate for FOUR of the following: o generic Azor (amlodipine / olmesartan) and hydrochlorothiazide concurrently o generic Benicar HCT (olmesartan / hydrochlorothiazide) and amlodipine concurrently o generic Tribenzor (amlodipine / hydrochlorothiazide / valsartan) o generic Diovan HCT (valsartan / hydrochlorothiazide) and amlopidine concurrently o generic Exforge (amlodipine / valsartan) and hydrochlorothiazide concurrently o generic Avalide (irbesartan / hydrochlorothiazide) and amlodipine concurrently o generic Atacand HCT (candesartan / hydrochlorothiazide) and amlodipine concurrently o generic Accuretic (quinapril / hydrochlorothiazide) and amlodipine concurrently Hyzaar intolerance, or not a candidate for FOUR of the following: candesartan / hydrochlorothiazide, irbesartan / hydrochlorothiazide, olmesartan / hydrochlorothiazide, telmisartan / hydrochlorothiazide, valsartan / hydrochlorothiazide Documented inability to use losartan and hydrochlorothiazide concurrently Page 19 of 45
20 Lotensin (benazepril) Lotensin HCT (benazepril / hydrochlorothiazide) Lotrel (amlodipine / benazepril) Mavik (trandolapril) Micardis (telmisartan) Micardis HCT (telmisartan / hydrochlorothiazide) Prinvil (lisinopril) Lotensin intolerance, or not a candidate for FOUR of the following: captopril, enalapril, fosinopril, lisinopril, quinapril, ramipril, trandolapril Lotensin HCT intolerance, or not a candidate for FOUR of the following: captopril / hydrochlorothiazide, enalapril / hydrochlorothiazide, fosinopril / hydrochlorothiazide, lisinopril / hydrochlorothiazide, quinapril / hydrochlorothiazide Documented inability to use benazepril and hydrochlorothiazide concurrently Lotrel candidate for ALL of the following: amlodipine / olmesartan, amlodipine / telmisartan, amlodipine / valsartan Documented inability to use benazepril and amlodipine concurrently Mavik intolerance, or not a candidate for FOUR of the following: benazepril, captopril, enalapril, fosinopril, lisinopril, quinapril, ramipril Micardis intolerance, or not a candidate for FOUR of the following: candesartan, irbesartan, losartan, olmesartan, valsartan Micardis HCT intolerance, or not a candidate for FOUR of the following: candesartan / hydrochlorothiazide, irbesartan / hydrochlorothiazide, losartan / hydrochlorothiazide, olmesartan / hydrochlorothiazide, valsartan / hydrochlorothiazide Documented inability to use telmisartan and hydrochlorothiazide concurrently Prinvil intolerance, or not a candidate for FOUR of the following: benazepril, captopril, enalapril, fosinopril, quinapril, ramipril, trandolapril Page 20 of 45
21 Tekturna (aliskiren) Tekturna HCT (aliskiren / hydrochlorothiazide) Tarka (trandolapril / verapamil) Tribenzor (amlodipine / hydrochlorothiazide / olmesartan) Twynsta (amlodipine / telmisartan) intolerance, or not a candidate for FIVE of the following: benazepril, captopril, enalapril, fosinopril, lisinopril, quinapril, ramipril, trandolapril, candesartan, irbesartan, losartan, olmesartan, telmisartan, valsartan intolerance, or not a candidate for FIVE of the following: benazepril / hydrochlorothiazide, captopril / hydrochlorothiazide, enalapril / hydrochlorothiazide, fosinopril / hydrochlorothiazide, lisinopril / hydrochlorothiazide, quinapril / hydrochlorothiazide, candesartan / hydrochlorothiazide, irbesartan / hydrochlorothiazide, losartan / hydrochlorothiazide, olmesartan / hydrochlorothiazide, telmisartan / hydrochlorothiazide, valsartan / hydrochlorothiazide Tarka candidate for amlodipine / benazepril Documented inability to use trandolapril and verapamil concurrently Tribenzor contraindication per FDA label, intolerance, inability to use, or not a candidate for FOUR of the following: o generic Azor (amlodipine / olmesartan) and hydrochlorothiazide concurrently o generic Benicar HCT (olmesartan / hydrochlorothiazide) and amlodipine concurrently o generic Diovan HCT (valsartan / hydrochlorothiazide) and amlopidine concurrently o generic Exforge (amlodipine / valsartan) and hydrochlorothiazide concurrently o generic Exforge HCT (amlodipine / hydrochlorothiazide / valsartan) o generic Avalide (irbesartan / hydrochlorothiazide) and amlodipine concurrently o generic Atacand HCT (candesartan / hydrochlorothiazide) and amlodipine concurrently o generic Accuretic (quinapril / hydrochlorothiazide) and amlodipine concurrently Twynsta candidate for ALL of the following: amlodipine / benazepril, amlodipine / olmesartan, amlodipine / valsartan Documented inability to use telmisartan and amlodipine concurrently Page 21 of 45
22 Cardiovascular: Vasodilators Vaseretic (enalapril / hydrochlorothiazide) Vasotec (enalapril) Zestoretic (lisinopril / hydrochlorothiazide) Zestril (lisinopril) Cardizem (diltiazem 30 mg, 60 mg, and 120 mg Cardizem CD (diltiazem 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg extended release capsules) GoNitro (nitroglycerin sublingual powder) Vaseretic intolerance, or not a candidate for FOUR of the following: benazepril / hydrochlorothiazide, captopril / hydrochlorothiazide, fosinopril / hydrochlorothiazide, lisinopril / hydrochlorothiazide, quinapril / hydrochlorothiazide Documented inability to use enalapril and hydrochlorothiazide concurrently Vasotec intolerance, or not a candidate for FOUR of the following: benazepril, captopril, fosinopril, lisinopril, quinapril, ramipril, trandolapril Zestoretic intolerance, or not a candidate for FOUR of the following: benazepril / hydrochlorothiazide, captopril / hydrochlorothiazide, enalapril / hydrochlorothiazide, fosinopril / hydrochlorothiazide, quinapril / hydrochlorothiazide Documented inability to use lisinopril and hydrochlorothiazide concurrently Zestril intolerance, or not a candidate for FOUR of the following: benazepril, captopril, enalapril, fosinopril, quinapril, ramipril, trandolapril Cardizem candidate for ALL of the following o Verapamil 40 mg, 80 mg, and 120 mg tablets o Diltiazem CD extended release capsules o Diltiazem extended release tablets Cardizem CD candidate for ALL of the following o Verapamil extended release tablets o Verapamil extended release capsules o Diltiazem extended release tablets Documented intolerance or inability to use nitroglycerin sublingual tablets and nitroglycerin sublingual spray Page 22 of 45
23 Cholesterol Lowering Isordil (isosorbide dinitrate 40 mg tablet) Isordil Titradose (isosorbide dinitrate 5 mg tablet) Vytorin (ezetimibe / simvastatin 10 mg 10 mg, 20 mg, 40 mg, 80 mg Altoprev (lovastatin 20 mg, 40 mg, 60 mg extended release Antara (fenofibrate 30 mg and 90 mg capsules) Crestor (rosuvastatin) Fenoglide (fenofibrate 40 mg and 120 mg FloLipid (simvastatin) Lescol XL (fluvastatin) Lipitor (atorvastatin) Livalo (pitavastatin) Pravachol Documented inability to use two tablets of isosorbide dinitrate 20 mg tablets Isordil Titradose 5 mg tablets Vytorin Documented intolerance or not a candidate for rosuvastatin, atorvastatin, pravastatin, and lovastatin in combination with ezetimibe Documented failure / inadequate response or intolerance to lovastatin 20 mg and 40 mg Documented intolerance or not a candidate for pravastatin, simvastatin, atorvastatin, and fluvastatin Documented intolerance to fenofibrate 43 mg, 67 mg, or 130 mg capsules Documented failure / inadequate response, intolerance, or not a candidate for fenofibric acid (Trilipix ), fenofibrate (Tricor / Lofibra ), and gemfibrozil (Lopid ) Crestor Documented failure / inadequate response or intolerance to atorvastatin, simvastatin, and pravastatin Documented intolerance to fenofibrate 48 mg or 120 mg tablets intolerance, or not a candidate for fenofibric acid (Trilipix ), fenofibrate (Tricor / Lofibra ), and gemfibrozil (Lopid ) Documented inability to use simvastatin tablet Documented failure/inadequate response, contraindication per FDA label, intolerance, inability to use, or not a candidate for ALL of the following: atorvastatin, lovastatin, rosuvastatin and pravastatin Lescol XL Documented intolerance or not a candidate for atorvastatin, simvastatin, pravastatin, and lovastatin Lipitor Documented intolerance to rosuvastatin, simvastatin, and pravastatin Documented intolerance or not a candidate for atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin Page 23 of 45
24 (pravastatin) Pravachol Documented intolerance or not a candidate for atorvastatin, simvastatin, lovastatin, and fluvastatin Zocor (simvastatin) Zypitamag (Pitavastatin magnesium) Zocor Documented intolerance or not a candidate for rosuvastatin, atorvastatin, pravastatin, and lovastatin Documented intolerance or not a candidate for FIVE of the following: atorvastatin, fluvastatin/fluvastatin ER, lovastatin, pravastatin, rosuvastatin, simvastatin Dermatologic: Actinic Keratosis, Topical Dermatologic: Steroidal Antiinflammatory, Topical Solaraze, Diclofenac 3% topical gel Clobex (clobetasol 0.05 % lotion, liquid spray, shampoo) Cutivate (fluticasone 0.05% cream, lotion) Locoid (hydrocortisone butyrate 0.1 % cream, lipocream, lotion, ointment, solution) Kenalog (triamcinolone acetonide mg / gm aerosol solution) Trianex (augmented triamcinolone acetonide 0.05 % ointment) Documented failure or inadequate response, contraindication per FDA label, intolerance or not a candidate for ALL of the following topical therapies: o 5-fluorouracil cream (fluorouracil 0.5%, Fluoroplex 1%, Tolak 4%, Efudex 5%) o 5-fluorouracil solution (2% or 5%) o Imiquimod 5% cream o Picato (ingenol) 0.015% or 0.05% gel Documented failure / inadequate response or intolerance to FIVE dosage forms of clobetasol 0.05 %: lotion, liquid spray, shampoo, solution, ointment, cream, gel, or foam Cutivate contraindication per FDA label, or intolerance to betamethasone, clocortolone, desoximetasone, fluocinonide, flurandrenolide, hydrocortisone, mometasone, prednicarbate, triamcinolone Documented failure / inadequate response or intolerance to hydrocortisone butyrate 0.1 % solution, ointment, cream, and lipid cream Kenalog Documented failure / inadequate response or intolerance to ALL of the following: Triamcinolone acetonide cream, lotion and ointment Documented failure / inadequate response or intolerance to ALL of the following: Triamcinolone acetonide cream, lotion and ointment Page 24 of 45
25 Dermatologic: Steroidal Antiinflammatory, Topical Ultravate (halobetasol propionate 0.05 % lotion) Ultravate X (halobetasol propionate / lactic acid 0.05 % - 10 % cream) Ultravate X (halobetasol propionate / lactic acid 0.05 % - 10 % ointment) Anusol-HC (hydrocortisone 2.5 % rectal cream) Anusol-HC (hydrocortisone acetate 25 mg rectal suppository) Cortifoam (hydrocortisone acetate 10 % foam) Proctocort (hydrocortisone 1 % cream) Proctocort (hydrocortisone 30 mg suppository) Verdeso (desonide 0.05 % foam) Halog (halcinonide 0.1% cream) Halog (halcinonide 0.1% ointment) Sernivo Documented failure / inadequate response or intolerance to FIVE of the following: o halobetasol propionate 0.05 % cream o halobetasol propionate 0.05 % ointment o clobetasol propionate 0.05 % cream o clobetasol propionate 0.05 % lotion o clobetasol propionate 0.05 % ointment o betamethasone dipropionate, augmented 0.05 % ointment o betamethasone dipropionate, augmented 0.05 % lotion intolerance, or not a candidate for ALL of the following o hydrocortisone 1 % or 2.5 % rectal cream o o hydrocortisone 100 mg / 60 ml rectal enema hydrocortisone acetate 25 mg or 30 mg rectal suppository contraindication per FDA label, or intolerance to fluocinolone body oil, fluticasone lotion, and topical hydrocortisone contraindication per FDA label, or intolerance, to triamcinolone cream, fluocinonide cream, betamethasone cream, halobetasol cream, and clobetasol cream contraindication per FDA label, or intolerance to triamcinolone ointment, fluocinonide ointment, betamethasone ointment, halobetasol ointment, and clobetasol ointment intolerance, or not a candidate for FIVE of the following: Page 25 of 45
26 Dermatologic: Anti-psoriatics Dermatologic: Acne Agents, Systemic Dermatologic: Acne Agents, Topical (betamethasone dipropionate 0.05 % emulsion) Vanos (fluocinonide 0.1 % cream) Dovonex (calcipotriene 0.005% cream) Sorilux (calcipotriene 0.005% foam) Vectical (calcitriol 3 mcg/gm ointment) Enstilar (calcipotriene 0.005% / betamethasone 0.064% foam) Taclonex (calcipotriene 0.005% / betamethasone 0.064% ointment and suspension) Absorica (isotretinoin 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg capsules) Differin (adapalene 0.1% cream, 0.3% gel) Differin (adapalene 0.1% lotion) o betamethasone dipropionate 0.05 % ointment o betamethasone dipropionate 0.05 % cream o betamethasone dipropionate 0.05 % lotion o augmented betamethasone dipropionate 0.05 % gel o betamethasone valerate 0.12 % foam Vanos 0.1 % cream Documented failure / inadequate response or intolerance to fluocinonide 0.05 % solution, ointment, cream, and gel candidate for ONE of the following: calcipotriene cream, ointment, solution candidate for tazarotene cream candidate for ONE of the following: calcipotriene cream, ointment, solution candidate for tazarotene cream Inability to use calcipotriene and betamethasone components separately Documented intolerance to Claravis (isotretinoin 10 mg, 20 mg, 30 mg, and 40 mg capsules), Myorisan (isotretinoin 10 mg, 20 mg, and 40 mg capsules), and Zenatane (isotretinoin 10 mg, 20 mg, 30 mg, and 40 mg capsules) Differin candidate for adapalene lotion Documented intolerance to adapalene lotion Page 26 of 45
27 Azelex (azaleic acid 20% cream) Epiduo (adapalene/ benzoyl peroxide 0.1%- 2.5% gel) Epiduo Forte (adapalene/ benzoyl peroxide 0.3%- 2.5% gel) Acanya (benzoyl peroxide / clindamycin 2.5 % - 1% topical gel) Benzaclin (benzoyl peroxide / clindamycin 5 % - 1% topical gel) Duac (benzoyl peroxide / clindamycin 5 % % topical gel) Onexton (benzoyl peroxide / clindamycin 3.75 % % topical gel) Clindagel (clindamycin 1 % gel) One of the following: For acne vulgaris o Documented failure / inadequate response, contraindication per FDA label, intolerance, or not a candidate for benzoyl peroxide / clindamycin 5 % % topical gel For rosacea o Documented failure / inadequate response, contraindication per FDA label, intolerance, or not a candidate for all of the following: Rosadan topical and metronidazole topical Epiduo Inability to use adapalene and benzoyl peroxide components separately Documented failure to 1 generic formulation of Epiduo Inability to use adapalene and benzoyl peroxide components separately Acanya candidate for ALL of the following: o benzoyl peroxide / clindamycin 5 % % topical gel o benzoyl peroxide / erythromycin 5 % - 3 % topical gel Benzaclin candidate for ALL of the following: o benzoyl peroxide / clindamycin 5 % % topical gel o benzoyl peroxide / erythromycin 5 % - 3 % topical gel Duac Documented intolerance to Neuac candidate for ALL of the following: o benzoyl peroxide / clindamycin 5 % - 1 % topical gel o benzoyl peroxide / erythromycin 5 % - 3 % topical gel Documented failure / inadequate response or intolerance to clindamycin 1 % solution, lotion, gel, foam, and swab candidate for Aczone Page 27 of 45
28 Veltin (clindamycin /tretinoin 1.2% % gel) Ziana (clindamycin / tretinoin 1.2 % %) Fabior (tazarotene 0.1% foam) Tazorac (tazarotene 0.05% cream) Tazorac (tazarotene 0.05% gel) Veltin Documented failure / inadequate response or inability to use topical clindamycin with topical tretinoin concurrently Ziana Documented failure / inadequate response or inability to use topical clindamycin with topical tretinoin concurrently intolerance, or not a candidate for tazarotene cream For plaque psoriasis: Documented intolerance OR not a candidate to 1 generic formulation of Tazorac AND documented failure / inadequate response, contraindication per FDA label, intolerance, or not a candidate for calcipotriene Tazorac (tazarotene 0.1% cream) Tazorac (tazarotene 0.1% gel) Atralin (tretinoin 0.05% gel) Avita (tretinoin 0.025% gel) Retin-A cream (tretinoin 0.1% 0.025%,0.05%) One of the following: For acne vulgaris o Documented intolerance to 1 generic formulation of Tazorac AND o Documented failure / inadequate response, candidate for adapelene and trentinoin For plaque psoriasis o Documented intolerance to 1 generic formulation of Tazorac AND o Documented failure / inadequate response, candidate for calcipotriene Atralin intolerance, or not a candidate for tretinoin cream candidate for topical adapalene and tazarotene Avita intolerance, or not a candidate for the following: tretinoin cream candidate for topical adapalene and tazarotene Retin-A cream intolerance, or not a candidate for the following: tretinoin gel Page 28 of 45
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