ModifiedCentenePolicy CP.PMN.46

Clinical Policy: Roflumilast (Daliresp, Zoryve)

Criteria and prior authorization guidance for coverage of roflumilast oral tablets (Daliresp) and topical formulations (Zoryve) for COPD, plaque psoriasis, seborrheic dermatitis, and atopic dermatitis under Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Roflumilast (Daliresp, Zoryve)

Policy CodePolicy CP.PMN.46

Change TypeMaterial updates: new topical indications, generic inclusion, IL HIM step therapy bypass

Effective DateNov 1, 2011

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing member meets the indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Added newly FDA-approved indication of plaque psoriasis for Zoryve foam.

For COPD, added step therapy bypass for generic roflumilast tablet for IL HIM per IL HB 5395.

Revised policy/criteria section to also include generic roflumilast.

Added Zoryve 0.05% cream with pediatric extension down to 2 years of age for atopic dermatitis.

4Diagnoses/indications

12 monthsStd approval duration

<50%COPD FEV1 threshold

500 mcg/dayMax Daliresp dose

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Recommended titration

HB 5395State law (IL)

Coverage Criteria and Medical Necessity

Initial Therapy

Covered when ALL of the following are met

COPD Coverage Criteria: 1) Request is for roflumilast tablet (Daliresp); 2) Diagnosis of COPD; 3) Age ≥ 18 years; 4) Current (within the past 30 days) FEV1 < 50% predicted; 5) Member meets one of: (a) failure of triple inhaled therapy (LABA + LAMA + ICS) at up to maximally indicated doses OR (b) both: (i) failure of dual inhaled therapy (LABA + LAMA) at up to maximally indicated doses AND (ii) current (within the past 30 days) blood eosinophil count < 100 cells/uL; 6) Daliresp is prescribed concurrently with a long-acting bronchodilator (LABA or LAMA); 7) For brand Daliresp requests, member must use generic rofllumilast unless contraindicated or clinically significant adverse effects are experienced; 8) Dose does not exceed both: (a) 500 mcg per day and (b) 1 tablet per day. Approval duration: 12 months.

Continuation Therapy

Covered for continuation when ALL of the following are met

COPD Continuation: 1) Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria OR (b) member receives benefit from referenced states for applicable product/regulation; 2) Request is for roflumilast tablet (Daliresp); 3) Member is responding positively to therapy; 4) For brand Daliresp requests, member must use generic roflumilast unless contraindicated or clinically significant adverse effects are experienced; 5) If request is for a dose increase, new dose does not exceed both: (a) 500 mcg per day and (b) 1 tablet per day. Approval duration: 12 months.

Plaque Psoriasis Initial

Covered when ALL of the following are met

Plaque Psoriasis Initial: 1) Request is for roflumilast 0.3% cream or foam (Zoryve); 2) Diagnosis of plaque psoriasis; 3) Body surface area involvement ≤ 20% (≤ 25% if scalp involved); 4) Prescribed by or in consultation with a dermatologist or rheumatologist; 5) Age: cream ≥ 6 years, foam ≥ 12 years; 6) Failure of both, used concurrently unless contraindicated or clinically significant adverse effects: (a) medium to ultra-high potency topical corticosteroid (see Appendix B) AND (b) calcipotriene, calcitriol, or tazarotene; for face/intertriginous areas, failure of a topical calcineurin inhibitor instead; 7) Request does not exceed 1 tube (cream) or can (foam) per month. Approval duration: 12 months.

Plaque Psoriasis Continuation

Covered for continuation when ALL of the following are met

Plaque Psoriasis Continuation: 1) Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria OR (b) member receives benefit from referenced states for applicable product/regulation; 2) Request is for roflumilast 0.3% cream or foam (Zoryve); 3) Member is responding positively to therapy; 4) If request is for a dose increase, new dose does not exceed 1 tube (cream) or can (foam) per month. Approval duration: 12 months.

Seborrheic Dermatitis Initial

Covered when ALL of the following are met

Seborrheic Dermatitis Initial: 1) Request is for roflumilast foam (Zoryve); 2) Diagnosis of seborrheic dermatitis; 3) Body surface area involvement ≤ 20%; 4) Prescribed by or in consultation with a dermatologist; 5) Age ≥ 9 years; 6) Failure of both: (a) topical antifungal (see Appendix B) AND (b) topical corticosteroid (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced; 7) Request does not exceed 1 can per month. Approval duration: 12 months.

Seborrheic Dermatitis Continuation

Covered for continuation when ALL of the following are met

Seborrheic Dermatitis Continuation: 1) Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria OR (b) member receives benefit from referenced states for applicable product/regulation; 2) Request is for roflumilast foam (Zoryve); 3) Member is responding positively to therapy; 4) If request is for a dose increase, new dose does not exceed 1 can per month. Approval duration: 12 months.

Atopic Dermatitis Initial

Covered when ALL of the following are met

Atopic Dermatitis Initial: 1) Request is for roflumilast 0.15% or 0.05% cream (Zoryve); 2) Diagnosis of atopic dermatitis; 3) Age: 0.15% cream ≥ 6 years; 0.05% cream 2 to < 6 years; 4) Failure of both, each tried for 2 weeks unless contraindicated or clinically significant adverse effects: (a) topical corticosteroids — age 2 to < 6 years: two generic medium potency topical corticosteroids of different molecular identities; age ≥ 6 years: two generic medium to very high potency topical corticosteroids of different molecular identities (unless face/neck/intertriginous areas involved) AND (b) topical tacrolimus; 5) Dose does not exceed 1 tube per month. Approval duration: 12 months.

Atopic Dermatitis Continuation

Covered for continuation when ALL of the following are met

Atopic Dermatitis Continuation: 1) Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria OR (b) member receives benefit from referenced states for applicable product/regulation; 2) Request is for roflumilast 0.15% or 0.05% cream (Zoryve); 3) Member is responding positively to therapy; 4) If request is for a dose increase, new dose does not exceed 1 tube per month. Approval duration: 12 months.

Other Indications

Other Indications: 1) If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to the appropriate no coverage or non-formulary policy for the relevant line of business; 2) If the requested use (diagnosis, age, dosing) is NOT specifically listed under section III and criterion 1 above 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 HIM, CP.PMN.53 for Medicaid).

Updated Coverage Criteria Highlights

Policy includes coverage for roflumilast products with updated criteria to include generics and new topical indications.

Dosing and product availability: Daliresp: initiate 250 mcg QD for 4 weeks then increase to 500 mcg QD; maximum 500 mcg/day. Zoryve: apply appropriate cream or foam once daily; strengths available 0.05%, 0.15%, 0.3% (cream) and 0.3% (foam).see dosing

Includes generics where applicable

Regulatory updates: Zoryve foam added with FDA-approved indication for plaque psoriasis; Zoryve 0.05% cream added with pediatric extension to age 2 for atopic dermatitis.N/A

Material change to indications

State-specific step therapy: Illinois (IL) HIM: step therapy bypass added for generic roflumilast per IL HB 5395.N/A

Non–FDA approved uses of roflumilast that are not specifically 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 policy: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

Roflumilast is contraindicated in patients with moderate to severe liver impairment (Child‑Pugh B or C). Use in these members is a basis for denial of coverage.

Appendix B was revised to remove several topical antifungal agents from the list of therapeutic alternatives for seborrheic dermatitis. Specifically, econazole, luliconazole, oxiconazole, and sulconazole were removed due to insufficient evidence to support their use for this indication.

Daliresp (oral roflumilast) is not a bronchodilator and is not indicated for relief of acute bronchospasm. Requests for Daliresp to treat acute bronchospasm are inconsistent with labeled limitations and are not appropriate uses.

Annual review notes across multiple review cycles indicate no significant changes for several updates; the policy history documents routine reviews and targeted updates. Where changes were made, the rationale and effective dates are recorded (for example, inclusion of generics and new topical indications). For routine annual reviews that made no substantive changes, the policy retains prior criteria and references.

Coding, Dosing, and Clinical Thresholds

Codes referencedmixed

N/A	No specific CPT/HCPCS/ICD-10 codes listed in this document section

Product strengths / presentationsmixed

250 mcg	Daliresp tablet strength
500 mcg	Daliresp tablet strength
0.05%	Zoryve cream strength
0.15%	Zoryve cream strength
0.3%	Zoryve cream and foam strength

FEV1 threshold

FEV1 thresholdCurrent (within the past 30 days) FEV1 < 50% predicted

ApplicabilityRequired for COPD initial approval (member age ≥ 18 years)

Documentation timeframeFEV1 must be current within the past 30 days

Blood eosinophil threshold

Blood eosinophil thresholdCurrent (within the past 30 days) blood eosinophil count < 100 cells/uL

ContextRequired when COPD step criteria rely on failure of dual inhaled therapy (LABA+LAMA)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization required — provider must document that all listed indication-specific criteria are met. Provider must submit clinical documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Requests that do not follow updated step therapy or that do not acknowledge use of generic roflumilast may be redirected or denied.
For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395 (effective 1/1/2026).

Documentation Required

Prescribing Information — Include Dosing Regimen and Product Strength

Provider must document dosing regimen and product strength when submitting a request. For COPD (Daliresp): initial titration at 250 mcg PO once daily for 4 weeks then 500 mcg PO once daily maintenance; maximum 500 mcg/day; tablets available in 250 mcg and 500 mcg strengths. For topical Zoryve: state concentration (0.05%, 0.15%, or 0.3%), formulation (cream or foam), and prescribed frequency (apply once daily); maximum once daily application.

Background and Policy Scope

Roflumilast is a selective phosphodiesterase‑4 (PDE‑4) inhibitor available as oral tablets (Daliresp) and topical formulations (Zoryve). Oral Daliresp is indicated to reduce the risk of COPD exacerbations in patients with severe COPD with chronic bronchitis and is intended for use in combination with long‑acting bronchodilator therapy rather than as acute bronchodilator relief. Topical roflumilast formulations (cream and foam) have FDA‑approved dermatologic indications including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis at specified strengths and age ranges.

Definitions and Abbreviations

FEV1 — definition

DefinitionFEV1 = forced expiratory volume in one second

Use in policyFEV1 referenced as a COPD severity threshold for coverage criteria

Abbreviation sourceListed in Appendix A: Abbreviation/Acronym Key

ICS/LABA/LAMA — definitions

ICS/LABA/LAMAICS = inhaled corticosteroid; LABA = long-acting beta2-agonist; LAMA = long-acting antimuscarinic antagonist

Therapy contextCombination triple therapy (ICS+LABA+LAMA) referenced in COPD step requirements

Appendix location

Policy Summary

PayerCentene

PolicyClinical Policy: Roflumilast (Daliresp, Zoryve)

Policy CodePolicy CP.PMN.46

Change TypeMaterial updates: new topical indications, generic inclusion, IL HIM step therapy bypass

Effective DateNov 1, 2011

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing member meets the indication-specific criteria.

SourceLink

On This Page

State law override for step therapy

Eosinophil count must be documented within past 30 days

Plaque psoriasis BSA

Plaque psoriasis BSABody surface area involvement ≤ 20% (≤ 25% if scalp is involved)

Indication-specific age limitsCream ≥ 6 years; Foam ≥ 12 years

Prescriber requirementPrescribed by or in consultation with a dermatologist or rheumatologist

Daliresp dosing

Daliresp initiationStart 250 mcg once daily for 4 weeks, then increase to 500 mcg once daily

Maximum doseMaximum 500 mcg per day (no more than 1 tablet per day)

Titration rationaleInitiation at 250 mcg QD for 4 weeks may reduce discontinuation in some patients

Daliresp (roflumilast) tablets: available 250 mcg and 500 mcg — document initiation dose and maintenance dose.
Zoryve: list product strength (0.05%, 0.15%, 0.3%) and formulation (cream or foam) on the prescription and supporting documentation.

Note

Therapeutic Alternatives May Require PA

Therapeutic alternatives listed in Appendix B may require prior authorization; Appendix B provides preferred alternative inhaled COPD agents and topical alternatives referenced in criteria.

Appendix B lists preferred ICS/LABA and LABA/LAMA combinations and topical agents; these may not be on all formularies and may themselves require PA.

Step Therapy

Step Therapy Requirements

Step therapy requirements summarized in the criteria must be followed unless IL HIM bypass applies. For COPD: failure of triple inhaled therapy (LABA + LAMA + ICS) or failure of dual inhaled therapy (LABA + LAMA) plus blood eosinophils <100 cells/µL is required prior to approval of Daliresp, except for IL HIM requests per IL HB 5395. For dermatology indications (plaque psoriasis, seborrheic dermatitis, atopic dermatitis): topical corticosteroids and other specified topical agents must be tried and failed as listed, unless contraindicated or clinically significant adverse effects occur.

For plaque psoriasis, prior failure of a medium to ultra-high potency topical corticosteroid plus calcipotriene, calcitriol, or tazarotene is required unless exceptions apply.
For atopic dermatitis, specified topical corticosteroids and tacrolimus must be tried for the listed durations unless contraindicated.

Prior Authorization

Requests Not Following Updated Step Therapy/Generics

Requests that do not follow updated step therapy pathways or do not acknowledge availability/use of generic roflumilast may be redirected or denied. For COPD brand Daliresp requests, the member must have used generic roflumilast unless contraindicated or experienced clinically significant adverse effects. Illinois HIM requests have a statutory bypass per IL HB 5395 — document if bypass is being claimed.

If requesting brand when a generic is available, include documentation of contraindication to generic or evidence of adverse reaction to generic roflumilast.
If claiming IL HIM bypass, include documentation that the request is for an Illinois HIM member and reference IL HB 5395.

Documentation Required

Required Documentation

Required documentation — provider must submit clinical documentation (office notes, labs, or other supporting information) demonstrating that each of the indication-specific criteria are met, including diagnostic testing (e.g., FEV1 for COPD), recent labs (e.g., blood eosinophil count), prior therapy trials, and prescriber specialty consult notes when required.

For COPD: include current (within 30 days) FEV1 and blood eosinophil count when applicable, and documentation of inhaled therapy trials and concurrent long-acting bronchodilator use.
For dermatology indications: include body surface area involvement, prior topical therapy trials and durations, and dermatologist or rheumatologist consultation notes as required.

Denial Risk

Contraindicated Condition — Denial Risk

Contraindication risk — requests for members with moderate to severe liver impairment (Child-Pugh B or C) should be denied per policy; include relevant liver function documentation if requesting approval despite liver disease.

Contraindication: moderate to severe liver impairment (Child-Pugh B or C).

Defined in Appendix A: Abbreviation/Acronym Key

COPD — definition

COPDCOPD = chronic obstructive pulmonary disease

Policy rolePrimary respiratory indication for oral roflumilast (Daliresp) coverage criteria

Appendix locationDefined in Appendix A: Abbreviation/Acronym Key

FEV1 — definition (duplicate)

FEV1 (duplicate)FEV1 = forced expiratory volume in one second

ReferenceAppears in Appendix A abbreviation list and COPD criteria

Clinical relevanceUsed to determine severity threshold for COPD coverage (FEV1 < 50%)

ICS — definition

ICSICS = inhaled corticosteroid

Role in therapyComponent of triple inhaled therapy referenced in COPD step requirements

Appendix locationDefined in Appendix A: Abbreviation/Acronym Key

LABA — definition

LABALABA = long-acting beta2-agonist

Role in therapyComponent of dual or triple inhaled therapy (LABA+LAMA or ICS+LABA+LAMA) in COPD criteria

Appendix locationDefined in Appendix A: Abbreviation/Acronym Key

LAMA — definition

LAMALAMA = long-acting antimuscarinic antagonist

Role in therapyComponent of dual or triple inhaled therapy (LABA+LAMA or ICS+LABA+LAMA) in COPD criteria

Appendix locationDefined in Appendix A: Abbreviation/Acronym Key

Daliresp — product definition

Daliresp formulationsOral roflumilast (Daliresp) tablets available in 250 mcg and 500 mcg strengths; indicated for COPD

IndicationDaliresp indicated to reduce risk of COPD exacerbations in severe COPD with chronic bronchitis (per policy context)

Product availabilityTable lists Daliresp tablets: 250 mcg, 500 mcg

Zoryve — product definition

Zoryve presentationsTopical roflumilast (Zoryve) available as cream strengths 0.05%, 0.15%, 0.3% and foam 0.3%

IndicationsTopical formulations indicated for dermatologic conditions including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis

PackagingCream and foam available in 60 g tube/can per product availability table