CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zoryve (roflumilast) topical formulations — coverage criteria

Coverage criteria for Zoryve topical cream (0.05%, 0.15%, 0.3%) and 0.3% foam for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis for Medicaid members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoryve (roflumilast) topical formulations — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age, diagnosis, affected BSA, specialist involvement, and prior inadequate response or intolerance to required therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial and continuation authorization duration

60 g/30 daysquantity limit per formulation

ages 2+ to 12+age indications across formulations

restrictedconcomitant use restrictions

Coverage Criteria

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Zoryve Cream 0.3% — Plaque Psoriasis (Initial)

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

Zoryve 0.3% cream initial criteria: 1. Documentation that the member is 6 years of age or older with a diagnosis of plaque psoriasis; 2. Documentation that body surface area (BSA) affected is between 2% and 20%; 3. Zoryve is prescribed by, or in consultation with, a specialist in dermatology, allergy/immunology, or rheumatology; 4. Documentation of inadequate treatment response or intolerance 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; 5. Documentation that contraindications, adverse effects and/or intolerance are provided for prior therapies as applicable; 6. Zoryve will not be used concomitantly with Vtama (tapinoraf) cream, any biologic DMARD (e.g., adalimumab, infliximab) or any targeted synthetic DMARD (e.g., apremilast).

Contraindications, adverse effects and/or intolerance must be documented for prior therapies.

Zoryve Foam 0.3% — Plaque Psoriasis (Initial)

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

Zoryve foam initial criteria: 1. Documentation that the member is 12 years of age or older with a diagnosis of plaque psoriasis; 2. Documentation that BSA affected is ≤25% overall with ≥10% affecting the scalp and ≤20% affecting non-scalp areas; 3. Zoryve is prescribed by, or in consultation with, a specialist in dermatology or rheumatology; 4. Documentation of inadequate treatment response or intolerance 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; 5. Documentation of inadequate response or intolerance to one additional therapy in combination with a topical corticosteroid within the last 12 months (options include topical calcineurin inhibitors, topical vitamin D analogs, topical retinoid, phototherapy, or oral systemic non-biologic drugs such as methotrexate or cyclosporine); 6. Zoryve will not be used concomitantly with Vtama (tapinoraf) cream, any biologic DMARD (e.g., adalimumab, infliximab) or any targeted synthetic DMARD (e.g., apremilast).

Contraindications, adverse effects and/or intolerance must be documented.

Zoryve Cream 0.15% and 0.05% — Atopic Dermatitis (Initial)

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

Atopic dermatitis initial criteria: 1. Documentation that the member is 2 years of age or older (age eligibility varies by formulation); 2. Zoryve is prescribed by, or in consultation with, a specialist in dermatology or allergy/immunology; 3. Documentation that the member has mild to moderate atopic dermatitis with BSA affected of 3% to 20%; 4. Documentation of inadequate response or intolerance to at least one medium to super-high potency topical corticosteroid for at least 2 consecutive weeks. Contraindications, adverse effects and/or intolerance must be documented; 5. Documentation of inadequate response or intolerance to one of the following formulary topical drugs: tacrolimus ointment for 6 consecutive weeks, pimecrolimus cream for 6 consecutive weeks, or Eucrisa (crisaborole) ointment for 4 consecutive weeks. Contraindications, adverse effects and/or intolerance must be documented; 6. Zoryve will not be used concomitantly with Eucrisa (crisaborole) ointment, Opzelura (ruxolitinib) cream, Vtama (tapinoraf) cream, Anzupgo (delgocitinib) cream, any therapeutic biologics, or JAK inhibitors.

Contraindications, adverse effects and/or intolerance must be documented.

Zoryve Foam 0.3% — Seborrheic Dermatitis (Initial)

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

Seborrheic dermatitis initial criteria: 1. Documentation that the member is 9 years of age or older with a diagnosis of seborrheic dermatitis; 2. Zoryve is prescribed by, or in consultation with, a specialist in dermatology; 3. Member meets one of the following: a. For members 9-15 years of age: documentation of inadequate response or intolerance to two of the following therapies within the last 12 months (topical ketoconazole, topical corticosteroids, topical calcineurin inhibitors). Contraindications, adverse effects and/or intolerance must be documented. b. For members 16 years of age and older: documentation of inadequate response or intolerance to a 4-week trial within the last 12 months of topical ketoconazole AND inadequate response or intolerance to two additional therapies within the last 12 months (ciclopirox, topical corticosteroids, topical calcineurin inhibitors). Contraindications, adverse effects and/or intolerance must be documented; 4. Zoryve will not be used concomitantly with Vtama (tapinoraf) cream, any biologic DMARD (e.g., adalimumab, infliximab) or any targeted synthetic DMARD (e.g., apremilast).

Contraindications, adverse effects and/or intolerance must be documented.

Continuation of Therapy — Zoryve

Authorization of 12 months may be granted for members currently using Zoryve when ALL of the following are met

Continuation criteria: 1. Documentation that the member achieves or maintains a positive clinical response as evidenced by improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, swelling, lichenification, burning, cracking, pain, clear or almost clear skin) or a reduction in body surface area (BSA) affected from baseline; 2. Zoryve will not be used concomitantly with Vtama (tapinoraf) cream, Eucrisa (crisaborole) ointment, Opzelura (ruxolitinib) cream, Anzupgo (delgocitinib) cream, any therapeutic biologic (e.g., adalimumab, infliximab), or any targeted synthetic DMARD (e.g., apremilast, JAK inhibitors).

Evidence of clinical improvement from baseline must be provided.

Coding and Quantity Limits

inv-08: Body Surface Area (BSA)

Plaque psoriasis — Zoryve Cream 0.3%BSA affected between 2% and 20%

Plaque psoriasis — Zoryve Foam 0.3%BSA affected ≤25% overall with ≥10% scalp involvement and ≤20% non‑scalp involvement

Atopic dermatitis — Zoryve Cream 0.15% / 0.05%BSA affected between 3% and 20%

Seborrheic dermatitis — Zoryve Foam 0.3%Pediatric/adult cases referenced by age-specific treatment trials rather than a single BSA threshold (policy requires documented diagnosis and prior therapy trials)

inv-09: Quantity limit

Quantity limit (all formulations)60 grams per 30 days

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Include documentation of the member's age, diagnosis, numeric body surface area (BSA) affected, specialist involvement (dermatology, allergy/immunology, or rheumatology as applicable), and prior inadequate response or intolerance to required prior therapies.

Request must document age and specific diagnosis
Document affected BSA as a numeric value (e.g., 12% BSA)
Document prescriber specialty or consultation (dermatology, allergy/immunology, rheumatology)

Step Therapy

Step Therapy Requirements

Step therapy requirements apply and must be met prior to approval. Document trials (drug name), duration, and reason for failure or intolerance for each required prior therapy. Trials must be within the specified look‑back periods in the policy.

For Zoryve Cream (plaque psoriasis ages ≥6): inadequate response to a 2–4 week trial of a high/ultra‑high potency topical corticosteroid within the last 12 months, plus inadequate response/intolerance to two of the listed therapies in combination with a topical corticosteroid (topical calcineurin inhibitor, topical vitamin D analog, topical retinoid, phototherapy, or oral systemic non‑biologic).
For Zoryve Foam (plaque psoriasis ages ≥12): inadequate response to a 2–4 week trial of a high/ultra‑high potency topical corticosteroid within the last 12 months, plus inadequate response/intolerance to one of the listed therapies in combination with a topical corticosteroid (topical calcineurin inhibitor, topical vitamin D analog, topical retinoid, phototherapy, or oral systemic non‑biologic).
For Atopic Dermatitis (ages ≥2): inadequate response/intolerance to at least one medium to super‑high potency topical corticosteroid for ≥2 consecutive weeks, and inadequate response/intolerance to one of the three formulary topical agents (tacrolimus 6 weeks, pimecrolimus 6 weeks, or crisaborole 4 weeks).
For Seborrheic Dermatitis (ages 9–15): inadequate response/intolerance to two listed therapies within the last 12 months (topical ketoconazole, topical corticosteroids, topical calcineurin inhibitors). For ages ≥16: inadequate response/intolerance to a 4‑week trial of topical ketoconazole plus inadequate response/intolerance to two additional listed therapies within the last 12 months.

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation with the authorization request. Include specific prior treatment trials (drug, duration, and reason for failure or intolerance) to demonstrate step therapy and prior authorization requirements have been met.

Document each prior therapy tried, dates and duration of trial, and reason for discontinuation or inadequate response (e.g., adverse effect, intolerance, lack of efficacy)
Provide numeric BSA affected and description of clinical improvement for continuation requests (e.g., reduction in BSA, improvement in signs/symptoms)
Specify if any required prior therapies are contraindicated and provide supporting clinical rationale

Denial Risk

Denied for Unapproved Indications or Disallowed Concomitant Therapy

Requests for uses outside the FDA‑approved or compendial indications listed in the policy are considered experimental/investigational and will be denied. Concomitant use with disallowed therapies will result in denial.

Zoryve is not approved for indications beyond those specified (plaque psoriasis, atopic dermatitis, seborrheic dermatitis as described) — other uses are not medically necessary
Concomitant use is prohibited with listed agents (examples include Vtama/tapinoraf cream, Opzelura/ruxolitinib cream, Eucrisa/crisaborole ointment, Anzupgo/delgocitinib cream, any therapeutic biologic such as adalimumab or infliximab, or targeted synthetic DMARDs/JAK inhibitors such as apremilast).
Denial will be issued if the request shows concurrent use with any disallowed agent or for unapproved indications

Background

Zoryve (roflumilast) topical formulations are phosphodiesterase-4 (PDE4) inhibitors indicated for the treatment of seborrheic dermatitis in patients 9 years of age and older and for the treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older. These are the approved labeled indications addressed by this policy.

Definitions

inv-15: BSA affected

Plaque psoriasis — Zoryve Cream 0.3%2% to 20% BSA affected

Plaque psoriasis — Zoryve Foam 0.3%≤25% total BSA with ≥10% scalp and ≤20% non‑scalp involvement

Atopic dermatitis — Zoryve Cream (0.15% and 0.05%)3% to 20% BSA affected

Seborrheic dermatitis — Zoryve Foam 0.3%Policy does not specify a numeric BSA threshold; approval is based on age (≥9 years) and documented inadequate response to specified topical therapies

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZoryve (roflumilast) topical formulations — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age, diagnosis, affected BSA, specialist involvement, and prior inadequate response or intolerance to required therapies.

SourceLink

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