Step Therapy Form

This policy provides a list of drugs that require step therapy.
____ *For Eucrisa requests, this policy applies only to Fidelis Health Plan members, for all other Eucrisa requests refer to CP.PMN.110 FDA Approved Indication(s) Various. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that the drugs identified within this policy are medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Electronic Step Therapy:

1. Drugs listed in the table below may be approved for the 12 months for members who have had a previous trial of or who have contraindications to required step-through agents, when the request does not exceed the maximum indicated dose and stated quantity limit. Drug Name Edarbi® (azilsartan medoxomil) amlodipine/ olmesartan (Azor®) amlodipine/ olmesartan/HCTZ (Tribenzor®) venlafaxine SR (Effexor ER®) Equetro® (carbamazepine SR) Required Step-Through Agents
   Two of the following: candesartan, irbesartan, or losartan
   Losartan or irbesartan Maximum Dose
   (Quantity Limit) 80 mg daily (1 tablet/day) Age Limit N/A 10/40 mg daily N/A Losartan or irbesartan 10/40/25 mg daily N/A Venlafaxine IR Carbamazepine IR 225 mg daily (1 tablet/day) 1,600 mg daily (two 100 mg tablets/day, N/A N/A Page 1 of 9

   CLINICAL POLICY Step Therapy
   Maximum Dose
   (Quantity Limit) eight 200 mg tablets/day, or four 300 mg tablets/day) 3 mg daily for adults, 2 mg daily for geriatric (1 tablet/day) 70 mg daily (1 tablet/day) 25 mg daily (0.3 tablet/day for 6.25 mg, 0.4 tablet/day for 12.5 mg) 80 mg daily (0.2 tablet/day) Age Limit ≥ 18 years N/A ≥ 12 years
   ≥ 18 years
   7.5 mg daily (0.4 tablet/day) ≥ 18 years
   5 mg per dose, up to 10 mg daily (0.3 tablet/day or 0.2 mL/day) 1,600 mg daily (2 tablets/day) 24 mg daily (1 tablet/day for 2 mg, 4 mg, 6 mg; 2 tablets/day for 8 mg, 12 mg) 1 application to affected area daily ≥ 12 years
   N/A N/A ≥ 12 years
   2 applications daily ≥ 12 years
   Drug Name Required Step-Through Agents
   eszopiclone (Lunesta®) Zaleplon and zolpidem tartrate Vyvanse® (lisdexamfetamine dimesylate) almotriptan malate (Axert®) Generic Adderall XR® Two of the following:
   naratriptan, rizatriptan, or sumatriptan eletriptan (Relpax®) Two of the following:
   frovatriptan succinate (Frova®) zolmitriptan (Zomig®, Zomig ZMT®) Aptiom® (eslicarbazepine) ropinirole ER (Requip® XL) adapalene gel 0.3%, adapalene lotion 0.1% (Differin®) Azelex® (azelaic acid cream) naratriptan, rizatriptan, or sumatriptan Two of the following:
   naratriptan, rizatriptan, or sumatriptan Two of the following:
   naratriptan, rizatriptan, or sumatriptan Carbamazepine or oxcarbazepine Requip® IR Two of the following
   topical products: benzoyl peroxide, clindamycin, erythromycin, or tretinoinPrior authorization may be required for tretinoin Two of the following
   topical products: benzoyl peroxide, clindamycin, erythromycin, or tretinoinPrior authorization may be required for tretinoin Page 2 of 9

   CLINICAL POLICY Step Therapy
   Drug Name adapalene/benzoyl peroxide (Epiduo®) clindaymycin phosphate/tretinoin gel (Veltin®, Ziana®) sulfacetamide sodium with sulfur wash (Sumadan Wash®) clobetasol propionate foam (Olux®), clobetasol proprionate gel Required Step-Through Agents
   Two of the following
   topical products: benzoyl peroxide, clindamycin, erythromycin, or tretinoinPrior authorization may be required for tretinoin Two of the following
   topical products: benzoyl peroxide, clindamycin, erythromycin, or tretinoinPrior authorization may be required for tretinoin Two of the following
   topical products: benzoyl peroxide, clindamycin, erythromycin, or tretinoinPrior authorization may be required for tretinoin betamethasone cream/ solution/ointment calcipotriene/ betamethasone diproprionate (Taclonex®) Calcipotriene and betamethasone diproprionate as a separate agents cefixime for suspension (Suprax®) fenoprofen calcium (Nalfon ®) mefenamic acid Nevanac® (nepafenac ophthalmic suspension)
   Cefdinir or cefpodoxime Ibuprofen Ibuprofen Diclofenac ophthalmic or ketorolac ophthalmic Page 3 of 9 Maximum Dose
   (Quantity Limit) 1 application daily
   Age Limit ≥ 12 years
   1 application to affected area daily
   ≥ 12 years
   2 applications daily ≥ 12 years
   50 mL/week scalp or topical solutions and shampoo; 59 mL/week spray solution; 50 g/week other topicals (foam 3 g/day, gel 2 g/day) 100 g per week topically, or 60 g foam every 4 days topically; treatment of more than 30% body surface area not recommended 400 mg daily; 8 mg/kg/day if a child weighing ≤ 45 kg 3,200 mg daily (4 tablets/day) 1,250 mg daily (5 capsules/day) 0.1%: 3 drops daily each affected eye N/A N/A N/A N/A N/A N/A

   Maximum Dose
   (Quantity Limit) Adults and pediatric patients weighing ≥ 35 kg: 200/300 mg PO QD Pediatric patients weighing between 17 to < 35 kg: 17 kg to < 22 kg: 100/150 mg PO QD 22 kg to < 28 kg: 133/200 mg PO QD 28 kg to < 35 kg: 167/250 mg PO QD Varies Age Limit N/A N/A 800 mg /day (2 capsules) N/A CLINICAL POLICY Step Therapy
   Drug Name lamivudine/tenofovir disoproxil fumarate (Cimduo™, Temixys™) Required Step-Through Agents
   If treatment naïve: any formulary HIV antiretroviral agent If treatment experienced: any HIV antiretroviral agent Ubrelvy™ (ubrogepant)Ubrelvy should not be prescribed concurrently with other CGRP inhibitors (e.g., Aimovig™, Ajovy™, Emgality™, Nurtec® ODT, Qulipta™, Vyepti™) celecoxib (Celebrex®) Two 5HT1B/1D-agonist migraine medications (e.g., sumatriptan, rizatriptan, zolmitriptan) One of the following (a, b, c, or d), unless member is

   65 years old, has prior gastrointestinal bleed, or active peptic ulcer disease (not gastroesophageal reflux disease [GERD]): a) Meloxicam; b) Generic NSAID; c) Current use of a corticosteroid; d) Current use of an anticoagulant or antiplatelet (e.g., aspirin, warfarin, low molecular weight heparin, direct thrombin inhibitors, factor Xa inhibitors, clopidogrel). Page 4 of 9

   Maximum Dose
   (Quantity Limit) 60 grams/ 30 days Age Limit N/A CLINICAL POLICY Step Therapy
   Drug Name Eucrisa™ (crisaborole)† †applies only to Fidelis Health Plan members, for all other Eucrisa requests refer to CP.PMN.110 Required Step-Through Agents
   One of the following (a or b):
   a) Generic topical corticosteroid (e.g. betamethasone, clobetasol, halobetasol, fluocinolone); b) For age ≥ 2 years: topical calcineurin inhibitor (e.g. tacrolimus, pimecrolimus). Drugs are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Approval duration: 12 months II. Continued Therapy A. Step Therapy (must meet all):

2. Member meets one of the following (a, b, or c): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); c. Documentation supports that member is currently receiving Cimduo or Temixys for HIV infection and has received this medication for at least 30 days;

3. If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose and quantity limit as stated in the initial approval criteria for the relevant drug.
   Approval duration: 12 months III. Appendices/General Information Appendix A: Abbreviation/Acronym Key CR: controlled release DR: delayed release ER: extended release FDA: Food and Drug Administration IR: immediate release NSAID: non-steroidal anti-inflammatory drug SR: sustained release XL: extended release Appendix B: Therapeutic Alternatives
   Refer to required step-through drugs above in Section I.
   Page 5 of 9

   CLINICAL POLICY Step Therapy
   Appendix C: Contraindications/Boxed Warnings Refer to the package inserts for each of the drugs requiring step therapy. IV. Dosage and Administration
   Refer to the step therapy table in Section I. V. Product Availability
   Drug Name Edarbi (azilsartan medoxomil) venlafaxine SR (Effexor ER) eszopiclone (Lunesta) Rozerem (ramelteon) Vyvanse (lisdexamfetamine dimesylate) almotriptan malate (Axert) eletriptan (Relpax) frovatriptan succinate (Frova) zolmitriptan (Zomig, Zomig ZMT) Aptiom (eslicarbazepine) ropinirole SR (Requip XL) adapalene gel (Differin) Azelex (azelaic acid cream) adapalene/benzoyl peroxide (Epiduo) clindaymycin phosphate/tretinoin gel (Veltin, Ziana) sulfacetamide sodium with sulfur wash (Sumadan Wash) clobetasol propionate (Olux) calcipotriene/betamethasone diproprionate (Taclonex) Availability Tablets: 40, 80 mg Tablets: 37.5, 75, 150, 225 mg Tablets: 1, 2, 3 mg Tablets: 8 mg Capsules: 10, 20, 30, 40, 50, 60, 70 mg Tablets: 6.25, 12.5 mg
   Tablets: 20, 40 mg
   Tablets: 2.5 mg Tablets: 5 mg Nasal solution: 2.5, 5 mg/spray ODT (ZMT): 2.5, 5 mg
   Tablets: 200, 400, 600, 800 mg Tablets: 2, 4, 6, 8, 12 mg
   Topical cream, gel, lotion: 0.1% Topical gel: 03% Topical gel pump: 0.3% Topical cream: 20% Topical gel: 0.1%-2.5% Topical gel forte pump: 0.3%-2.5% Topical gel pump: 0.1%-2.5% Topical gel: 1.2%-0.025% Topical wash: 9%-4.5% Topical foam: 0.05%
   Topical gel: 0.05% Topical ointment: 0.005%-0.064% Topical suspension: 0.005%-0.064% Topical foam: 0.005%-0.064% Oral suspension: 100/5, 200/5, 500/5 mg/mL Tablets: 600 mg Capsules: 250 mg cefixime for suspension (Suprax) fenoprofen calcium (Profeno) mefanamic acid (Ponstel) Nevanac (nepafenac ophthalmic suspension) Nevanac opthalmic suspension: 0.1% Tablets: 5/20, 5/40, 10/20, 10/40 mg amlodipine/olmesartan (Azor) Tablets: 20/5/12.5, 40/10/12.5, 4/10/25, olmesartan/amlodipine/HCTZ (Tribenzor) 40/5/12.5, 40/5/25 mg Capsules: 100, 200, 300 mg Equetro (carbamazepine SR) Page 6 of 9

   CLINICAL POLICY Step Therapy
   Drug Name zolpidem tartrate ER (Ambien CR) lamivudine/tenofovir disoproxil fumarate (Cimduo, Temixys) Ubrelvy (ubrogepant) celecoxib (Celebrex) Eucrisa (crisaborole) *Available as branded product only Availability Tablets: 6.25, 12.5 mg Tablets: 300 mg lamivudine/ 300 mg tenofovir disoproxil fumarate Tablets (package size 10, 16, 30): 50 mg, 100 mg Capsules: 50 mg, 100 mg, 200 mg, and 400 mg Topical ointment: 2% VII.