CurrentCentenePolicy CP PMN.46

Roflumilast (Daliresp; Zoryve)

Defines Centene medical necessity criteria, prior authorization requirements, and continuation criteria for oral roflumilast (Daliresp) for COPD and topical roflumilast (Zoryve) for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyRoflumilast (Daliresp; Zoryve)

Policy CodePolicy CP PMN.46

Change TypeMaterial revisions (new Zoryve indications, generic substitution, IL HIM step bypass)

Effective DateNov 1, 2011

Next Review Date

Key ActionProvider must submit supporting documentation (office chart notes, lab results or other clinical information) that member meets all approval criteria prior to authorization.

POLICY UPDATE CHANGES

Added newly FDA‑approved indications and dosage forms for Zoryve (cream 0.15% for atopic dermatitis, foam for seborrheic dermatitis, foam and cream for plaque psoriasis) and updated pediatric age requirements.

Specified that only Zoryve 0.3% cream should be used for plaque psoriasis per updated FDA labeling.

Added step therapy bypass for IL HIM (Illinois) per IL HB 5395 effective 1/1/2026.

Redirected brand Daliresp requests to generic roflumilast for continued and initial therapy requests.

Policy criteria revised to include generic roflumilast; removed econazole, luliconazole, oxiconazole, and sulconazole from Appendix B for seborrheic dermatitis.

4Covered Indications (per policy)

12 monthsApproval duration (typical)

FEV1 <50%Key COPD severity threshold

Coverage Summary

This policy defines Centene medical necessity criteria, prior authorization requirements, and continuation criteria for oral roflumilast (Daliresp) for COPD and topical roflumilast (Zoryve) for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis across Commercial, HIM, and Medicaid lines of business. Coverage stance: covered_with_criteria. Effective date: 11.01.11; Last review / P&T approval: 08.25 (last_review 2025-08-25; P&T Approval 08.24 for 07.25.24 changes).

Key thresholds & quick facts

COPD FEV1 thresholdFEV1 <50% predicted (current within past 30 days)

Blood eosinophil thresholdBlood eosinophil <100 cells/µL (current within past 30 days)

Plaque psoriasis BSA limitBSA <20% (or <25% if scalp is involved)

Approval duration12 months

Covered indications4

Policy ownerCentene corporate policy

Notes on dosing/formsDaliresp oral dosing limit 500 mcg/day; Zoryve formulations include 0.15% cream, 0.3% cream, and 0.3% foam (60 g) per prescribing info

Initial Therapy Criteria - Daliresp (roflumilast tablet)

Initial Approval Criteria - Daliresp (roflumilast tablet)

Provider must submit documentation supporting that member has met all approval criteria. Covered when ALL of the following are met:

ALL of the following

Request is for roflumilast tablet (Daliresp).
Diagnosis of chronic obstructive pulmonary disease (COPD).
Age ≥ 18 years.
Current (within the past 30 days) forced expiratory volume in one second (FEV1) < 50% predicted.FEV1 within past 30 days

Initial Therapy Criteria - Plaque Psoriasis (Zoryve 0.3% cream or foam)

Initial Approval Criteria - Plaque Psoriasis (Zoryve 0.3% cream or foam)

Covered when ALL of the following are met:

ALL of the following

Request is for roflumilast 0.3% cream or foam (Zoryve).
Diagnosis of plaque psoriasis.
Body surface area involvement < 20% (or <25% if scalp is involved).<20% (<25% if scalp)
Plaque psoriasis BSA threshold
Prescriber requirement

Initial Therapy Criteria - Seborrheic Dermatitis (Zoryve foam)

Initial Approval Criteria - Seborrheic Dermatitis (Zoryve foam)

Covered when ALL of the following are met:

ALL of the following

Request is for roflumilast foam (Zoryve).
Diagnosis of seborrheic dermatitis.
Body surface area involvement < 20%.<20%
Plaque/seborrheic BSA threshold
Prescribed by or in consultation with a dermatologist.
Prescriber specialty requirement

Initial Therapy Criteria - Atopic Dermatitis (Zoryve 0.15% cream)

Initial Approval Criteria - Atopic Dermatitis (Zoryve 0.15% cream)

Covered when ALL of the following are met:

ALL of the following

Request is for roflumilast 0.15% cream (Zoryve).
Diagnosis of atopic dermatitis.
Age ≥ 6 years.>=6 years
Failure of two generic medium to very high potency topical corticosteroids of different molecular identities, each tried for 2 weeks, unless involved areas include face, neck, or intertriginous areas.

Other diagnoses / Indications

Other diagnoses/indications

Must meet one of the following pathways:

ANY of the following

For drugs on formulary/PDL, follow the no coverage criteria policy for the relevant line of business: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP PMN.255 (Medicaid).
For drugs NOT on formulary/PDL, follow non-formulary policy for line of business: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP PMN.16 (Medicaid).
If requested use is not specifically listed in section III and criterion 1 does not apply, refer to off-label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP PMN.53 (Medicaid).

Provider Actions & Requirements

Prior Authorization

Documentation required for approval

Provider must submit supporting documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria prior to authorization.

Prior Authorization

Generic substitution requirement for Daliresp

For brand Daliresp requests, the member must use generic roflumilast unless it is contraindicated or clinically significant adverse effects are experienced.

Applicable Codes & Product Forms

Topical product forms (descriptive)mixed

Zoryve cream 0.15%	60 g tube; indicated for atopic dermatitis (≥6 years)
Zoryve cream 0.3%	60 g tube; indicated for plaque psoriasis (≥6 years)
Zoryve foam 0.3%	60 g can; indicated for plaque psoriasis (≥12 years) and seborrheic dermatitis (≥9 years)

Oral product (descriptive)mixed

Daliresp 500 mcg tablet

Oral roflumilast; COPD indication; starting dose 250 mcg QD for 4 weeks then 500 mcg QD

Product availability / NDCs (listed indirectly)NDC

No codes listed

Clinical Evidence & Background

Roflumilast is a selective phosphodiesterase-4 inhibitor. Daliresp (oral roflumilast) is FDA-approved to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations; recommended dosing is 500 mcg PO once daily (with a starting dose of 250 mcg QD for 4 weeks). Zoryve (topical roflumilast) has multiple FDA-approved formulations and age indications: 0.15% cream for mild to moderate atopic dermatitis in patients ≥ 6 years; 0.3% cream for plaque psoriasis in patients ≥ 6 years; and 0.3% foam for plaque psoriasis (scalp and body) in patients ≥ 12 years and for seborrheic dermatitis in patients ≥ 9 years. Product availability includes 60 g tubes for creams and 60 g cans for foam. The policy references the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 report for COPD guidance. Recent material updates added newly FDA‑approved Zoryve dosage forms and indications (0.15% cream for atopic dermatitis, foam for seborrheic dermatitis, and foam plus cream for plaque psoriasis) and updated pediatric age requirements and labeling (e.g., specifying Zoryve 0.3% cream for plaque psoriasis).

References: Daliresp Prescribing Information (AstraZeneca, March 2020); Zoryve Prescribing Information (Arcutis Biotherapeutics, July 2024; Zoryve Foam Prescribing Information 2025); Global Initiative for Chronic Obstructive Lung Disease (GOLD): Global strategy for COPD, 2025 report.

Definitions

Term	Definition
FEV1
Forced expiratory volume in one second
ICS
Inhaled corticosteroid
LABA
Long-acting beta-agonist
LAMA
Long-acting antimuscarinic antagonist
Health Plan
A health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates.

Revision History

06.24.25added

Added step therapy bypass for IL HIM (Illinois) per IL HB 5395; applies to COPD and all step therapy requirement agents for IL HIM (added step therapy bypass for all step therapy requirements agents for IL HIM per IL HB 5395).

08.25.24clarified

Specified that only Zoryve 0.3% cream should be used for plaque psoriasis per updated FDA labeling (Date noted 07.25.24 / P&T Approval 08.24).

07.25.24revised

Added Zoryve 0.15% cream indication for atopic dermatitis and new dosage forms (foam for seborrheic dermatitis; foam and cream for plaque psoriasis) and updated pediatric age requirements (RT4: added criteria for Zoryve 0.15% cream and indication of atopic dermatitis; RT4: added criteria for Zoryve foam and indication of seborrheic dermatitis).

Policy Summary

PayerCentene

PolicyRoflumilast (Daliresp; Zoryve)

Policy CodePolicy CP PMN.46

Change TypeMaterial revisions (new Zoryve indications, generic substitution, IL HIM step bypass)

Effective DateNov 1, 2011

Next Review Date

Key ActionProvider must submit supporting documentation (office chart notes, lab results or other clinical information) that member meets all approval criteria prior to authorization.

On This Page

FEV1 must be within past 30 days

ONE of

a. Failure of inhaled therapies: Failure of triple inhaled therapy consisting of LABA + LAMA + ICS at up to maximally indicated doses; OR failure of dual inhaled therapy consisting of LABA + LAMA at up to maximally indicated doses.
b. Alternative (eosinophil) pathway: Both of the following: Current (within the past 30 days) blood eosinophil count < 100 cells/µL.eosinophil threshold 100 cells/µL; within past 30 days
Eosinophil threshold is 100 cells/µL

Daliresp is prescribed concurrently with a long-acting bronchodilator (i.e., LABA or LAMA).

For brand Daliresp requests, member must use generic roflumilast unless contraindicated or clinically significant adverse effects are experienced.

Generic substitution requirement for Daliresp

Dose limits: Dose does not exceed 500 mcg per day AND does not exceed 1 tablet per day.<=500 mcg/day; 1 tablet/day

Dose limits

Prescribed by or in consultation with a dermatologist or rheumatologist.

Prescriber requirement

Age requirement

Cream: Age ≥ 6 years.>=6 years
Foam: Age ≥ 12 years.>=12 years

Prior therapy requirement (ONE of)

a. Failure of topical corticosteroid + vitamin D analog/retinoid: Failure of medium to ultra-high potency topical corticosteroid (see Appendix B) AND failure of calcipotriene, calcitriol, or tazarotene (used concurrently), unless clinically significant adverse effects or contraindications exist.
b. Face or intertriginous areas: For face or intertriginous areas: Failure of a topical calcineurin inhibitor (e.g., tacrolimus or pimecrolimus), unless contraindicated or clinically significant adverse effects are experienced.

Request does not exceed 1 tube (cream) or 1 can (foam) per month.1 tube/can per month

Quantity limit

Failure of both topical antifungal (see Appendix B) AND topical corticosteroid (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated.

Prior therapy failures; Appendix B references

Age ≥ 9 years.>=9 years

Request does not exceed 1 can per month.1 can per month

Quantity limit

each tried 2 weeks; different molecular identities

Prior topical steroid trial requirement

Failure of topical tacrolimus (or topical calcineurin inhibitor), unless contraindicated or clinically significant adverse effects are experienced.

Request does not exceed 1 tube per month.1 tube per month

Quantity limit

Billing Rule

Dose and quantity limits

Oral dose limit: 500 mcg per day and no more than 1 tablet per day. Topical quantity limits: Zoryve limited to 1 tube (cream) or 1 can (foam) per month, depending on the indication.

Documentation Required

FEV1 and eosinophil lab timing

When required by the criteria, FEV1 and blood eosinophil count must be current within the past 30 days.

Prior Authorization

Prescriber specialty requirement

Certain topical indications require the medication to be prescribed by or in consultation with a specialist: plaque psoriasis requires a dermatologist or rheumatologist (prescribe or consult), and seborrheic dermatitis requires a dermatologist (prescribe or consult).

Documentation Required

Medical necessity determination

Providers must supply documentation to support medical necessity determinations; coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law.

Documentation Required

State Medicaid precedence

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy; providers should refer to the state Medicaid manual for applicable guidance.

3Q 2023 (Date = 04.18.23 / P&T 08.23)revised

Redirected brand Daliresp requests to generic roflumilast for continued and initial therapy requests (added redirection to generic roflumilast for brand Daliresp requests).

3Q 2024 (Date = 07.25.24 / P&T 08.24)revisedLatest

Revised policy criteria to include generic roflumilast (brand Daliresp requests must use generic unless contraindicated) and updated Zoryve pediatric age and product-form criteria; removed certain topical antifungal agents from Appendix B for seborrheic dermatitis per 3Q 2025 review notes (material changes reflect new FDA approvals and Appendix B removals).