CurrentAvMedPolicy N/A

Zoryve (roflumilast) topical products prior authorization

Defines prior authorization and step-edit requirements for AvMed coverage of topical Zoryve (roflumilast) products for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, and specifies documentation, age, trial, and quantity limits that prescribers must provide.

Policy Summary

PayerAvMed

PolicyZoryve (roflumilast) topical products prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and attach chart notes, pharmacy claims, and supporting documentation demonstrating required prior topical therapy trials and diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60gquantity limit per 30 days

12mauthorization length (atopic dermatitis)

6minitial auth (seborrheic/plaque)

12mreauthorization (seborrheic/plaque)

Coverage Criteria for Zoryve (roflumilast) Topical Products

Policy Summary

PayerAvMed

PolicyZoryve (roflumilast) topical products prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Atopic Dermatitis initial criteria: Diagnosis of atopic dermatitis; diagnosis present for ≥ 3 months; member meets formulation-specific age requirement (0.05% cream: 2–5 years; 0.15% cream: ≥ 6 years); provider requests an indicated Zoryve formulation (note: 0.3% cream and 0.3% foam are not indicated for atopic dermatitis); member has tried and failed BOTH: at least 14 days of a topical corticosteroid and at least 30 days of a topical calcineurin inhibitor (documentation and pharmacy paid claims required); prescriber selects appropriate Zoryve formulationas listed

All criteria must be met and documentation (chart notes and/or pharmacy paid claims) must be provided for approval.

Initial therapy — Seborrheic Dermatitis

Covered when ALL of the following are met for Seborrheic Dermatitis

Seborrheic Dermatitis initial criteria: Provider is requesting Zoryve 0.3% topical foam (other Zoryve formulations are not indicated for seborrheic dermatitis); member is ≥ 9 years of age; diagnosis of seborrheic dermatitis; member has history of failure, contraindication, or intolerance to BOTH: 30 days of one topical corticosteroid in the past 180 days AND 30 days of one topical antifungal in the past 180 days (chart notes documenting contraindication/intolerance must be attached; trials will be verified via pharmacy claims and/or chart notes)as listed

Initial authorization duration: 6 months; reauthorization requires documentation of improvement or stabilization.

Initial therapy — Plaque Psoriasis

Covered when ALL of the following are met for Plaque Psoriasis

Plaque Psoriasis initial criteria: Provider is requesting Zoryve 0.3% cream or 0.3% foam (0.05% and 0.15% creams are not indicated for plaque psoriasis); member meets formulation-specific age requirement (0.3% cream: ≥ 6 years; 0.3% foam: ≥ 12 years); diagnosis of plaque psoriasis; member has history of failure, contraindication, or intolerance to BOTH: 30 days (or 14 days for very high potency) of one topical corticosteroid in the past 180 days AND 30 days of one other topical agent for psoriasis in the past 180 days (e.g., calcipotriene, tacrolimus, tazarotene); chart notes documenting contraindication/intolerance must be attached; trials will be verifiedas listed

Initial authorization duration: 6 months; reauthorization requires documentation of improvement or stabilization.

Certain Zoryve formulations are limited to specific indications and age groups. 0.05% and 0.15% cream are not indicated for plaque psoriasis, while 0.3% cream and 0.3% foam are the formulations listed for plaque psoriasis and have formulation-specific age requirements (for example, 0.3% cream: ≥6 years; 0.3% foam: ≥12 years). Conversely, some strengths/vehicles are designated only for atopic dermatitis or seborrheic dermatitis in the request form, so prescribers must select the formulation that corresponds to the requested diagnosis and the member's age.

Initial Authorization Rules

Initial therapy

Initial authorization rules by indication

Initial authorization general: Initial authorization durations and product/age linkage: atopic dermatitis — length of authorization 12 months; seborrheic dermatitis — initial authorization 6 months (Zoryve 0.3% foam only; member ≥ 9 years); plaque psoriasis — initial authorization 6 months (Zoryve 0.3% cream or 0.3% foam with formulation-specific age limits). Member must meet formulation-specific age limits and required prior topical therapy trials as documented; trials will be verified via pharmacy paid claims and/or chart notes.as listed

All criteria listed for the selected indication must be met for approval.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization conditions

Reauthorization for seborrheic dermatitis and plaque psoriasis: For seborrheic dermatitis and plaque psoriasis: member has experienced disease improvement and/or stabilization as documented in chart notes; documentation must be submitted to support clinical response.documented improvement/stability

Reauthorization duration: 12 months when criteria met.

Reauthorization for atopic dermatitis: For atopic dermatitis: length of authorization listed as 12 months initially; continued therapy requires documentation per plan (chart notes and/or pharmacy claims) demonstrating ongoing appropriateness of therapy.

All criteria must be met and documentation provided for approval.

Step Therapy and Required Trials

Required trial / documentation	Verification method
Trial of at least 14 days of a topical corticosteroid (e.g., triamcinolone, mometasone, fluocinolone, fluocinonide, betamethasone)	Chart notes and/or pharmacy paid claims verifying therapy and dates
Trial of at least 30 days of a topical calcineurin inhibitor (e.g., tacrolimus ointment, pimecrolimus cream)	Chart notes and/or pharmacy paid claims verifying therapy and dates
For seborrheic dermatitis: trial of 30 days of one topical corticosteroid in the past 180 days and 30 days of one topical antifungal in the past 180 days (or documentation of contraindication/intolerance)	Chart notes and/or pharmacy paid claims; attach documentation of contraindication or intolerance if claimed
For plaque psoriasis: trial of 30 days (or 14 days for very high potency) of one topical corticosteroid in the past 180 days and 30 days of one other topical agent for psoriasis in the past 180 days (or documentation of contraindication/intolerance)	Chart notes and/or pharmacy paid claims; attach documentation of contraindication or intolerance if claimed
Documentation requirement — attach chart notes, lab results, diagnostics, and pharmacy paid claims to verify diagnosis, prior therapy trials, dates, and clinical response; documentation of contraindication/intolerance required when claimed	These documents will be used to verify trials and dates and may be required for approval; incomplete documentation may delay or result in denial

Diagnosis Codes and Age/Formulation Limits

Diagnosis codes (member-supplied)ICD-10

ICD-10

Diagnosis code to be supplied by prescriber (ICD code, if applicable).

Age limits by formulation — Zoryve topical products

0.05% creamApproved for atopic dermatitis in patients 2 to 5 years of age

0.15% creamApproved for atopic dermatitis in patients ≥ 6 years of age

0.3% creamApproved for plaque psoriasis in patients ≥ 6 years of age (not indicated for atopic dermatitis)

0.3% topical foamApproved for seborrheic dermatitis in patients ≥ 9 years and for plaque psoriasis in patients ≥ 12 years (not indicated for atopic dermatitis)

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization required — the prescriber must complete, sign (handwritten signature; preprinted stamps not valid), and submit the PA form with accurate contact information. Fax completed form to 1-305-671-0200. Incomplete, incorrect, or illegible requests (including missing phone/fax or provider signature) can delay processing or result in denial.

Prescriber signature required (no preprinted stamps).
Fax to 1-305-671-0200.
Include accurate phone and fax numbers to avoid delays.

Step Therapy

Step Therapy Requirements

Step therapy applies and members must have documented trials and failures of specified topical therapies for the requested indication before Zoryve will be authorized. Trials must be verified by chart notes and/or pharmacy paid claims and meet the duration requirements below.

Atopic dermatitis: failed BOTH — ≥14 days of a topical corticosteroid AND ≥30 days of a topical calcineurin inhibitor.
Seborrheic dermatitis (Zoryve 0.3% foam): failed BOTH — 30 days of one topical corticosteroid and 30 days of one topical antifungal within the past 180 days.
Plaque psoriasis (Zoryve 0.3% cream or foam): failed BOTH — 30 days (or 14 days for very high‑potency steroid) of one topical corticosteroid and 30 days of one other topical psoriasis agent (e.g., calcipotriene, tacrolimus, tazarotene) in the past 180 days.

Documentation Required

Required Supporting Documentation

Required supporting documentation must be attached to the PA request. To support each checked criterion, submit chart notes, relevant lab results/diagnostics, and pharmacy paid-claim history showing prior therapies and durations. Use chart documentation to show diagnosis duration, age eligibility, contraindications, or intolerance where applicable.

Attach chart notes documenting diagnosis and treatment response (e.g., improvement/stabilization for reauthorization).
Attach pharmacy paid claims or chart notes verifying prior therapy trials and durations.
For contraindication/intolerance claims, include chart notes documenting the reason.

Denial Risk

Incomplete Requests Risk Denial

Incomplete requests risk denial — missing required documentation, unsigned forms, illegible entries, or use of samples to initiate therapy will not satisfy step-edit/PA criteria and may result in denial.

Samples do not meet step-edit or preauthorization criteria.
Previous therapies will be verified via pharmacy paid claims or submitted chart notes.
Ensure all required fields and attachments are complete to avoid denial.

Background

Topical roflumilast (Zoryve) is available in multiple strengths and vehicles: 0.05% cream, 0.15% cream, 0.3% cream, and 0.3% topical foam. The different formulations are linked to specific labeled uses and age limits on the authorization form—providers must request the appropriate product for the diagnosis and confirm the member meets the formulation-specific age criteria. The request form also ties particular indications to particular vehicles (for example, the 0.3% foam is the formulation requested for seborrheic dermatitis and has a separate minimum age), and trials of prior topical therapies are required and will be verified through chart notes and pharmacy claims.

OpenPayer