CurrentmhnPolicy CP.PMN.208

Halobetasol Propionate/Tazarotene (Duobrii) for plaque psoriasis

Defines medical necessity and prior authorization criteria for Duobrii (halobetasol propionate 0.01% / tazarotene 0.045% lotion) for treatment of plaque psoriasis in adults for health plans affiliated with Centene Corporation.

Policy Summary

Payermhn

PolicyHalobetasol Propionate/Tazarotene (Duobrii) for plaque psoriasis

Policy CodePolicy CP.PMN.208

Change TypeStep therapy exception addedappendix updates

Effective Date09.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, BSA ≤20%, age ≥18, prior use/failure of required generics (unless IL HIM bypass), and dose ≤100 g/month.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Updated Appendix B to add halobetasol propionate 0.01% lotion as an alternative and updated tazarotene dosing regimen.

100 gmaximum dispensed tube size / monthly limit

≤20%maximum body surface area involvement for approval

≥18minimum age for coverage

12 moapproval duration

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Coverage Criteria

Initial Approval — Plaque Psoriasis

Covered when ALL of the following are met:

Initial approval criteria: 1. Diagnosis of plaque psoriasis 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 cause clinically significant adverse effects (For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395); 5. Failure of generic tazarotene unless contraindicated or causes clinically significant adverse effects (For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395); 6. Dose does not exceed 100 g per month (one tube per month).

Approval duration: 12 months

Continuation (Renewal) — Plaque Psoriasis

Covered when ALL of the following are met:

Continuation criteria: 1. Member currently receiving medication via Centene benefit or has previously met initial approval criteria, or is in continuity of care under applicable state/product requirements; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose does not exceed 100 g per month (one tube per month).

Approval duration: 12 months

Other diagnoses/Indications

If request is for a use not listed in initial criteria or policy:

Other indications handling: 1. If the drug had a recent label change (within the last 6 months) not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/no-coverage or CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary as applicable); 2. If the requested use (diagnosis, age, dosing regimen) is not listed under section III and item 1 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, CP.PMN.53 for Medicaid).

Refer to specified related policies

Non-FDA approved uses that are not specifically addressed in this policy are excluded from coverage unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable 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.

Requests for off‑label uses that are not supported by adequate documentation per the referenced off‑label use policies will not be authorized.

Product Limits & Coding

Maximum monthly quantity

Maximum monthly quantity100 g per month (one 100 g tube)

Maximum tube size100 g tube

Maximum weekly dose (documented dosing)50 g per week (dosing guidance)

Body surface area threshold

Body surface area threshold≤ 20% BSA involvement

Criterion contextRequired for initial approval of plaque psoriasis

Approval noteApplies in conjunction with other initial criteria (age ≥18, prescriber specialty, step therapy)

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Duobrii. Providers must document that the member meets all initial or continuation criteria and that dosing does not exceed 100 g per month (one tube per month). Approval duration is 12 months for both initial and continued therapy.

Initial approval requires meeting all plaque psoriasis criteria (BSA ≤ 20%, age ≥ 18, prescribed by/consult with dermatologist or rheumatologist, prior failures per step therapy requirements unless contraindicated, dose ≤ 100 g/month).
Continuation requires prior approval or current receipt under Centene benefit or continuity of care, positive response to therapy, and dose ≤ 100 g/month.

Denial Risk

Non‑FDA Indication Denial Risk

For requests for indications that are not FDA‑approved and are not specifically addressed in this policy, the request will be denied unless sufficient documentation is provided demonstrating efficacy and safety per the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Definitions

Duobrii

Product compositionLotion combining halobetasol propionate 0.01% (corticosteroid) and tazarotene 0.045% (retinoid)

IndicationTopical treatment of plaque psoriasis in adults

Formulation/packagingLotion 0.01%/0.045% available in 100 g tubes

Contraindication

ContraindicationPregnancy

Boxed warningsNone reported

Clinical implicationDo not use in pregnant patients; assess pregnancy status prior to prescribing

Background

Duobrii is a fixed‑combination topical lotion that contains halobetasol propionate 0.01% (a high‑potency corticosteroid) and tazarotene 0.045% (a topical retinoid). It is indicated for the topical treatment of plaque psoriasis in adults. The product is supplied as a lotion in a 100 g tube.