Calcipotriene/Betamethasone Dipropionate Foam (Enstilar) Form

Calcipotriene 0.005%/betamethasone dipropionate 0.064% foam (Enstilar®) is a combination topical product of a vitamin D analog and a corticosteroid. FDA Approved Indication(s) Enstilar is indicated for the topical treatment of plaque psoriasis (PsO) in patients - 12 years 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 Enstilar is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Plaque Psoriasis (must meet all):

1. Diagnosis of PsO;
   2. Age ≥ 12 years;
   3. Failure of a medium to ultra-high potency topical corticosteroid (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced;
   4. Failure of one of the following, unless clinically significant adverse effects are experienced or all are contraindicated: calcipotriene, calcitriol, tazarotene;
2. Dose does not exceed 60 g every 4 days (7 cans per month). Approval duration: 1 month B. Other diagnoses/indications (must meet 1 or 2):

3. 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: Page 1 of 6

   CLINICAL POLICY Calcipotriene/Betamethasone Dipropionate Foam CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

4. 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. Plaque Psoriasis (must meet all):
5. 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);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed 60 g every 4 days (7 cans per month). Approval duration: Up to 1 month of total treatment (a single continuous course of therapy up to 4 weeks is recommended)
      B. Other diagnoses/indications (must meet 1 or 2):
6. 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

7. 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.
   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. Page 2 of 6

   CLINICAL POLICY Calcipotriene/Betamethasone Dipropionate Foam IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration PsO: plaque psoriasis 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 calcipotriene (Dovonex®) cream, ointment, solution calcitriol (Vectical™) ointment tazarotene (Tazorac®) gel, cream Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Apply topically to the affected area(s) QHS Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Ultra-High Potency Topical Corticosteroids augmented betamethasone dipropionate 0.05% (Diprolene®, Alphatrex®) ointment, gel clobetasol propionate 0.05% (Temovate®, Temovate E®) cream, ointment, gel, solution diflorasone diacetate 0.05% (Apexicon®) ointment halobetasol propionate 0.05% (Ultravate®) cream, ointment High Potency Topical Corticosteroids augmented betamethasone dipropionate 0.05% (Diprolone®, Diprolene® AF) cream, lotion betamethasone dipropionate 0.05% ointment desoximetasone (Topicort®) 0.25%, 0.05% cream, ointment, gel diflorasone 0.05% (Apexicon E®) cream fluocinonide acetonide 0.05% cream, ointment, gel, solution triamcinolone acetonide 0.5% (Aristocort®, Kenalog®) cream, ointment Medium/Medium to High Potency Topical Corticosteroids betamethasone dipropionate 0.05% cream desoximetasone 0.05% (Topicort®) cream, ointment, gel fluocinolone acetonide 0.025% (Synalar®) cream, ointment fluticasone propionate 0.05% (Cutivate®) cream Apply topically to the affected area(s) BID Page 3 of 6 Dose Limit/ Maximum Dose 100 g/week 200 g/week Once daily application Should not be used for longer than 2 consecutive weeks Should not be used for longer than 2 consecutive weeks Should not be used for longer than 2 consecutive weeks

   CLINICAL POLICY Calcipotriene/Betamethasone Dipropionate Foam Drug Name Dosing Regimen Dose Limit/ Maximum Dose mometasone furoate 0.1% (Elocon®) cream, lotion, ointment triamcinolone acetonide 0.1%, 0.25%,0.5% (Aristocort®, Kenalog®) cream, ointment 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 None reported
   V. Dosage and Administration
   Drug Name calcipotriene 0.005%/ betamethasone dipropionate 0.064% (Enstilar) Dosing Regimen Apply topically to affected area(s) QD for up to 4 weeks. Avoid use on face, groin, axillae, skin treatment site with atrophy present, or with occlusive dressing unless directed by a healthcare provider. Maximum Dose 60 g/4 days
   VI. Product Availability
   Can containing 0.005% calcipotriene/0.064% betamethasone dipropionate foam: 60 g, 120 g (2 cans of 60 g) VII.