Duobrii (halobetasol propionate / tazarotene) topical lotion — coverage criteria
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Clinical policy governing medical necessity and prior authorization requirements for Duobrii (halobetasol propionate 0.01%/tazarotene 0.045%) topical lotion for treatment of plaque psoriasis in adults across Centene lines of business.
Step therapy bypass for Illinois HIM per IL HB 5395 added for certain requirements.
Coverage Criteria
Initial Therapy — Covered when ALL of the following are met for Initial Approval:
Covered when ALL of the following are met for Initial Approval:
Approval duration: 12 months
Continuation Therapy — Covered when ALL of the following are met for Continued Therapy:
Covered when ALL of the following are met for Continued Therapy:
Approval duration: 12 months
This policy applies only to the FDA‑approved indication(s) described elsewhere in the document. Non‑FDA approved indications that are not addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP PMN.53 (Medicaid).
Requests for treatment of non‑FDA approved indications that lack adequate supporting evidence per the off‑label use policies referenced in this policy will be considered not medically necessary and are not authorized. Providers should include documentation demonstrating efficacy and safety consistent with CP.CPA.09, HIM.PA.154, or CP PMN.53 when requesting coverage for off‑label use.
Coding and Product Availability
| NDC not listed | Lotion 0.019/0.045%: 100 g tubes |
Provider Actions and Requirements
Prior Authorization Required
Prior authorization is required for initial and continuation requests. Approvals (initial and continuation) are for 12 months when all criteria are met.
- Approval duration: 12 months
Step Therapy Requirements and IL HIM Bypass
Step therapy is required for initial approval unless contraindicated or adverse effects occur. For Illinois Health Insurance Marketplace (HIM) requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
- Initial therapy requires failure of generic halobetasol propionate and generic clobetasol propionate unless both are contraindicated or cause clinically significant adverse effects.
- Initial therapy requires failure of generic tazarotene unless contraindicated or causes clinically significant adverse effects.
- IL HIM bypass: Step therapy requirements do not apply for Illinois HIM requests effective 01/01/2026 (IL HB 5395).
Required Clinical Documentation; Documentation & Indication
Provider must submit supporting clinical documentation with the prior authorization request. Requests that lack sufficient documentation or that seek non‑FDA (off‑label) uses without adequate supporting evidence may be denied.
- Required documentation: office chart notes, relevant laboratory results, prior medication history showing trials and failures (including dates and reasons for discontinuation), and consultation notes if applicable.
- Documentation & Indication: If the request is for a non‑FDA approved indication, include sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP PMN.53 for Medicaid) or evidence of coverage documents.
- Requests lacking documentation that the member met all approval criteria or that do not justify off‑label use per the referenced policies may be denied.
Definitions
Background
Duobrii is a fixed‑combination topical lotion containing halobetasol propionate and tazarotene (halobetasol propionate 0.01% / tazarotene 0.045%). It is indicated by the FDA for the topical treatment of plaque psoriasis in adults. The recommended administration is to apply a thin layer once daily to affected areas until control is achieved; the commercial product is supplied as a 100 g tube. Policy dosing limits include a maximum of 50 g per week per the prescribing information and a policy limit of 100 g per month (one 100 g tube) for coverage determinations.
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