EUCRISA, Crisaborole Form

Crisaborole (Eucrisa™) is a phosphodiesterase 4 inhibitor. ____ *For Health Insurance Marketplace (HIM), for Fidelis Health plan members, refer to the HIM Step Therapy policy, HIM.PA.109. FDA Approved Indication(s) Eucrisa is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. 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 Eucrisa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Atopic Dermatitis (must meet all):

1. Diagnosis of atopic dermatitis;
2. Age ≥ 3 months;
3. Failure of a 2-week trial of two generic medium-to-very high potency topical corticosteroids of different molecular identities, unless contraindicated (e.g., areas involving the face, neck or intertriginous areas) or clinically significant adverse effects are experienced;
   4. For age ≥ 2 years: Failure of a 2-week trial of topical tacrolimus, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization may be required for topical tacrolimus

4. Dose does not exceed 60 grams (1 tube) per 30 days. Approval duration:
   Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): Page 1 of 7

   CLINICAL POLICY
   Crisaborole a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Atopic Dermatitis (must meet all):
   3. Member meets one of the following (a or b): 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);
5. Member is responding positively to therapy;

6. If request is for a dose increase, new dose does not exceed 60 grams (1 tube) per 30 days.
   Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      Page 2 of 7

   CLINICAL POLICY
   Crisaborole III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Drug Name Dosing Regimen Dose Limit/ Maximum Dose Varies Varies Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Very High Potency Topical Corticosteroids augmented betamethasone 0.05% (Diprolene AF) ointment, gel, lotion clobetasol propionate 0.05% (Temovate ) cream, ointment, gel, solution diflorasone diacetate 0.05% (Maxiflor, Psorcon E) cream, ointment halobetasol propionate 0.05% (Ultravate) cream, ointment High Potency Topical Corticosteroids amcinonide 0.1% ointment, lotion augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion betamethasone valerate 0.1%, 0.12% (Luxiq®) ointment, foam clobetasol propionate 0.025% (Impoyz ) cream diflorasone 0.05% (Florone, Florone E, Maxiflor,Psorcon E) cream fluocinonide acetonide 0.05% (Lidex, Lidex E) cream, ointment, gel, solution fluticasone propionate 0.005% cream, ointment Page 3 of 7

   CLINICAL POLICY
   Crisaborole Drug Name Dosing Regimen Dose Limit/ Maximum Dose halcinonide 0.1% cream, ointment, solution (Halog®) halobetasol propionate 0.01% lotion (Bryhali®) mometasone furoate 0.1% ointment Medium Potency Topical Corticosteroids clocortolone pivalate 0.1% cream desoximetasone 0.05%, 0.025% (Topicort) cream, ointment, gel fluocinolone acetonide 0.025% (Synalar) cream, ointment flurandrenolide 0.05% lotion, ointment (Cordran®) hydrocortisone valerate 0.2% cream mometasone 0.1% (Elocon) cream, ointment, lotion triamcinolone acetonide 0.025%, 0.1% (Aristocort, Kenalog) cream, ointment Topical Calcineurin Inhibitors Tacrolimus (Protopic®) 0.03% or 0.1% ointment Apply topically to the affected area(s) BID Apply a thin layer to affected area twice daily. Age 2-15 years, use 0.03% ointment only. Varies Varies Therapeutic alternatives 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. Appendix C: Contraindications/Boxed warnings • Contraindication(s): hypersensitivity to crisaborole or any component of the formulation • Boxed warning(s): none reported Dosing Regimen Apply to the affected areas twice daily N/A Maximum Dose V. Dosage and Administration Indication Mild-to-moderate atopic dermatitis VI. Product Availability Ointment (2%): 60 g, 100 g VII.