Halobetasol Propionate/Tazarotene (Duobrii) Form

Duobrii® lotion is a combination product containing halobetasol propionate 0.01% and tazarotene 0.045%. Halobetasol propionate is a corticosteroid and tazarotene is a retinoid.
FDA Approved Indication(s) Duobrii lotion is indicated for the topical treatment of plaque psoriasis (PsO) in adults.
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 Duobrii is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Plaque Psoriasis (must meet all):

1. Diagnosis of PsO with body surface area involvement ≤ 20%;
   2. Age ≥ 18 years;
   3. Prescribed by or in consultation with a dermatologist or rheumatologist;
   4. Failure of generic halobetasol propionate and generic clobetasol propionate, unless both are contraindicated or clinically significant adverse effects are experienced;
   5. Failure of generic tazarotene, unless contraindicated or clinically significant adverse effects are experienced;
2. Dose does not exceed 100 g per month (one tube per month). Approval duration: 12 months 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 5

   CLINICAL POLICY
   Halobetasol Propionate/Tazarotene 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 100 g per month (one tubes per month). Approval duration: 12 months 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 5

   CLINICAL POLICY
   Halobetasol Propionate/Tazarotene 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 50 g/week halobetasol propionate 0.05% cream/ointment (Ultravate®) clobetasol propionate 0.05% cream/foam/gel/ lotion/ointment/shampoo/ spray (Clobex®, Olux- E®, Olux®) Apply a thin layer to the affected skin QD to BID
   Treatment should be limited to two weeks. Apply a thin layer to the affected skin BID
   Treatment for mild to moderate plaque psoriasis should be limited to 2 weeks; moderate to severe treatment up to 4 weeks. Apply gel or cream, 0.05% with strength increased to 0.1% if tolerated and medically indicated, qPM to psoriatic lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film. 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. tazarotene (Tazorac®) cream and gel 2 mg/cm2/day 50 g/week Appendix C: Contraindications/Boxed Warnings • Contraindication(s): pregnancy • Boxed warning(s): none reported V. Dosage and Administration
   Indication Plaque psoriasis Dosing Regimen Apply a thin layer of lotion once daily to the affected areas until control is achieved.
   Maximum Dose 50 g/week VI. Product Availability
   Lotion 0.01%/0.045%: 100 g tubes VII.