CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zoryve (roflumilast) topical formulations — Coverage Criteria

Covers prior authorization, coverage criteria, and quantity limits for Zoryve cream 0.15% and 0.3% and Zoryve foam 0.3% for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis for plan members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoryve (roflumilast) topical formulations — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of BSA, prior topical/systemic therapy trials, and specialist involvement to request up to a 12‑month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-covered indications listed

12 monthsAuth duration

60 g/30 daysQuantity limit

>=6 / >=9Pediatric thresholds

Coverage and Medical Necessity Criteria

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Plaque Psoriasis initial criteria

Age: Member is 6 years of age or older, diagnosed with plaque psoriasis>=6 years
BSA affected is between 2-20%. Documentation of BSA affected is provided.2-20% BSA
Prescriber: Zoryve is prescribed by, or in consultation with, a specialist in dermatology or rheumatology.
Topical steroid trial: Member experienced an inadequate treatment response to at least a 2-4 consecutive week trial within the last 12 months of a high or ultra-high potency topical corticosteroid (e.g., augmented betamethasone, clobetasol). Contraindications, adverse effects and/or intolerance must be documented.2-4 weeks within last 12 months
examples: augmented betamethasone, clobetasol
Additional therapies: Member experienced an inadequate treatment response or intolerance from two of the following therapies in combination with a topical corticosteroid within the last 12 months. Contraindications, adverse effects and/or intolerance must be documented.two therapies within last 12 months
therapies: topical calcineurin inhibitors, topical vitamin D analogs, topical retinoid, phototherapy, oral systemic non-biologic drugs
Concomitant therapy exclusion: Zoryve will not be used concomitantly with Vtama (tapinarof) cream, any biologic DMARD (e.g., adalimumab, infliximab) or any targeted synthetic DMARD (e.g., apremilast).

Continuation of Therapy

Authorization of 12 months may be granted when ALL of the following are met

Continuation criteria: Member achieves or maintains a positive clinical response as evidenced by improvement in signs and symptoms of the condition (e.g., itching, redness, flaking, scaling, swelling, lichenification, burning, cracking, pain, clear or almost clear skin) OR reduction in body surface area (BSA) affected from baseline.documented improvement or BSA reduction

Concomitant therapy exclusions apply (see indication-specific lists).

All uses of Zoryve outside the FDA‑approved indications listed in this policy are considered experimental/investigational and not medically necessary. In addition, Zoryve is not to be used concomitantly with Vtama (tapinarof) cream, Eucrisa (crisaborole) ointment, Opzelura (ruxolitinib) cream, any therapeutic biologic (for example, adalimumab or infliximab), or any targeted synthetic DMARD (for example, apremilast or JAK inhibitors).

For indication‑specific therapy requirements, prior inadequate response or documented intolerance to the listed topical corticosteroid and adjunct therapies must be provided; concomitant use with the agents listed above is excluded for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis.

Continuation authorizations also require that members demonstrate maintained clinical benefit; even for continuing therapy, the same concomitant‑therapy exclusions apply.

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the requested medication. Initial and continuation authorizations may be granted for up to 12 months when all applicable clinical criteria are met. Requests for indications not listed in this policy or requests lacking required documentation may be denied.

Authorization duration: up to 12 months for initial and continuation requests when criteria met
Requests for non-covered indications or missing documentation may be denied

Denial Risk

Documentation and Indication Requirements

Requests missing required documentation or for indications not supported by the policy are at risk for denial. Ensure documentation clearly supports the indication, age criteria, affected body surface area (BSA) when applicable, prior therapy trials, and specialist involvement when required.

Denial risk if documentation of BSA, prior therapy trials, or specialist consultation is absent
Non-covered indications (not listed under Indications) may result in denial

Documentation Required

Required Documentation

Provide complete clinical documentation with initial and continuation requests. Maintain and submit chart notes or medical record evidence as specified below to support medical necessity.

Initial requests: chart notes or medical record documentation of affected area(s) and percentage of BSA affected (if applicable)
Initial requests: chart notes, medical record documentation, or claims history supporting previous medications tried and response to therapy; if a therapy is not advisable, document clinical reason to avoid it
Continuation requests: chart notes or medical record documentation showing decreased BSA affected and/or improvement in signs and symptoms

Step Therapy

Step Therapy Requirements

Step therapy requirements must be met prior to approval. Document prior trials, durations, and reasons for failure or intolerance for each required agent or therapy.

Plaque Psoriasis (PsO): inadequate response to ≥2–4 week trial of a high or ultra-high potency topical corticosteroid within the last 12 months; plus inadequate response or intolerance to two of: topical calcineurin inhibitors, topical vitamin D analogs, topical retinoid, phototherapy, or oral systemic non-biologic drugs within the last 12 months
Atopic Dermatitis (AD): inadequate response or intolerance to at least one moderate- to very high-potency topical corticosteroid for ≥2 consecutive weeks; plus inadequate response or intolerance to two of the following formulary topical drugs (tacrolimus 6 weeks, pimecrolimus 6 weeks, Eucrisa 4 weeks) within the last 12 months
Seborrheic Dermatitis: for ages 9–15, inadequate response or intolerance to two of topical ketoconazole, topical corticosteroids, or topical calcineurin inhibitors within the last 12 months; for ages ≥16, inadequate response to a 4-week trial of topical ketoconazole plus inadequate response or intolerance to two of ciclopirox shampoo/cream, topical corticosteroids, or topical calcineurin inhibitors within the last 12 months
Concomitant use exclusions: Zoryve will not be used concomitantly with Vtama (tapinoraf) cream, Eucrisa (crisaborole) ointment, Opzelura (ruxolitinib) cream, any therapeutic biologic (e.g., adalimumab, infliximab), or targeted synthetic DMARDs (e.g., apremilast, JAK inhibitors); documented contraindications or intolerances must be provided where applicable

Indications and Age Definitions

Plaque psoriasis indication — Zoryve cream 0.3%

IndicationTopical treatment of plaque psoriasis, including intertriginous areas

Formulation/StrengthZoryve cream 0.3%

Age threshold>= 6 years of age

Coverage noteCovered when criteria in Plaque Psoriasis — Initial Therapy are met (see coverage criteria).

Atopic dermatitis indication — Zoryve cream 0.15%

IndicationTopical treatment of mild to moderate atopic dermatitis

Formulation/StrengthZoryve cream 0.15%

Age threshold>= 6 years of age

Coverage noteCovered when criteria in Atopic Dermatitis — Initial Therapy are met (see coverage criteria).

Seborrheic dermatitis indication — Zoryve foam 0.3%

IndicationTreatment of seborrheic dermatitis

Formulation/StrengthZoryve foam 0.3%

Age threshold>= 9 years of age

Coverage noteCovered when criteria in Seborrheic Dermatitis — Initial Therapy are met (see coverage criteria).

Background and Product Information

Zoryve is a topical formulation of the PDE4 inhibitor roflumilast available as creams and a foam. The approved preparations and labeled uses are: Zoryve cream 0.3% for topical treatment of plaque psoriasis (including intertriginous areas) in patients aged 6 years and older; Zoryve cream 0.15% for topical treatment of mild to moderate atopic dermatitis in patients aged 6 years and older; and Zoryve foam 0.3% for treatment of seborrheic dermatitis in patients aged 9 years and older.

This policy limits coverage to those FDA‑approved indications and requires clinical documentation of age, affected body surface area (BSA) where specified, and prior treatment trials or documented contraindications/intolerance before authorization will be granted. Continuation of therapy requires evidence of clinical improvement or reduction in BSA from baseline.