CurrentHealth NetPolicy CP PMN.46

Clinical Policy: Roflumilast (Daliresp; Zoryve)

Defines medical necessity criteria, prior authorization and continuation requirements for roflumilast formulations (Daliresp oral tablets and Zoryve topical formulations) for Health Net lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerHealth Net

PolicyRoflumilast (Daliresp; Zoryve) coverage

Policy CodePolicy CP PMN.46

Change TypeNo material changes

Effective DateNov 1, 2011

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets specific initial or continuation criteria, including indication, dosing, and liver impairment assessment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration

<50%FEV1 threshold

500 mcg/dayDaliresp max dose

Child-Pugh B/Cliver contraindication

Age ≥6pediatric Zoryve

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Initial Therapy - COPD (Daliresp)

Covered when ALL of the following are met for Daliresp (oral tablet):

Daliresp initial: Request is for roflumilast tablet (Daliresp); diagnosis of COPD; age >= 18 years; current (within the past 30 days) FEV1 < 50% predicted; Daliresp prescribed concurrently with a long-acting bronchodilator (LABA or LAMA); dose does not exceed 500 mcg per day and 1 tablet per day; for brand Daliresp requests, member must use generic roflumilast unless contraindicated or clinically significant adverse effects are experienced; member meets one of the following (a or b): a) failure of triple inhaled therapy (LABA + LAMA + ICS) at up to maximally indicated doses OR failure of dual inhaled therapy (LABA + LAMA) at up to maximally indicated doses; b) both i and ii: i) failure of dual inhaled therapy as above; ii) current (within past 30 days) blood eosinophil count >= 100 cells/µLsee text

Approval duration: 12 months

Initial Therapy - Plaque Psoriasis (Zoryve)

Covered when ALL of the following are met for Zoryve 0.3% cream or foam (plaque psoriasis):

Plaque psoriasis initial: Request is for roflumilast 0.3% cream or foam (Zoryve); diagnosis of plaque psoriasis; body surface area involvement < 20% (<25% if scalp is involved); age: cream >= 6 years or foam >= 12 years; prescribed by or in consultation with a dermatologist or rheumatologist; member meets one of the following: a) failure of both medium to ultra-high potency topical corticosteroid AND calcipotriene/calcitriol/tazarotene used concurrently unless contraindicated or clinically significant adverse effects are experienced; b) for face or intertriginous areas: failure of a topical calcineurin inhibitor unless contraindicated or clinically significant adverse effects are experienced; request does not exceed 1 tube (cream) or can (foam) per monthBSA limits; age limits

Approval duration: 12 months

Initial Therapy - Seborrheic Dermatitis (Zoryve)

Covered when ALL of the following are met for Zoryve foam (seborrheic dermatitis):

Seborrheic dermatitis initial: Request is for roflumilast foam (Zoryve); diagnosis of seborrheic dermatitis; body surface area involvement < 20%; age >= 9 years; prescribed by or in consultation with a dermatologist; failure of both topical antifungal AND topical corticosteroid unless contraindicated or clinically significant adverse effects are experienced; request does not exceed 1 can per monthBSA <20%; age >=9

Approval duration: 12 months

Initial Therapy - Atopic Dermatitis (Zoryve)

Covered when ALL of the following are met for Zoryve 0.15% cream (atopic dermatitis):

Atopic dermatitis initial: Request is for roflumilast 0.15% cream (Zoryve); diagnosis of atopic dermatitis; age >= 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 the face, neck, or intertriginous areas where alternate agents apply; failure of topical tacrolimus or consideration of tacrolimus where applicable; dose does not exceed 1 tube per monthage and trial durations

Approval duration: 12 months

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Continuation - general: Member is currently receiving the medication via the benefit or has previously met initial approval criteria for the requested roflumilast product; member is responding positively to therapy; for brand requests, member must use generic roflumilast unless contraindicated or clinically significant adverse effects are experienced; if request is for a dose increase, the new dose does not exceed product-specific maximums (e.g., Daliresp 500 mcg/day and 1 tablet/day; Zoryve topical limits: 1 tube or can per month); state-specific addendums may applysee product limits

Approval duration: 12 months

Oral roflumilast (Daliresp)

Coverage and dosing information provided for roflumilast products

Daliresp (oral roflumilast) coverage: Indicated for COPD; dosing: initiation option 250 mcg PO once daily for 4 weeks then increase to 500 mcg PO once daily; maximum 500 mcg/daydose regimen per prescribing information

Monitor for tolerability and contraindications including moderate-to-severe hepatic impairment (Child-Pugh B or C).

Topical roflumilast (Zoryve)

Topical roflumilast (Zoryve) coverage and dosing

Zoryve topical indications: Indications include: plaque psoriasis — apply Zoryve 0.3% cream or foam once daily; seborrheic dermatitis — apply Zoryve foam once daily; atopic dermatitis — apply Zoryve 0.15% cream once dailyonce daily application

Topical dosing forms and strengths differ by indication.

Extracted dosing and contraindication guidance

Policy includes formulation-specific dosing and contraindication; updates note inclusion of generic roflumilast and pediatric age changes for topical indication.

Dosing and contraindication: For oral Daliresp, initiate at 250 mcg once daily for 4 weeks then increase to 500 mcg once daily; contraindicated in moderate to severe liver impairment (Child-Pugh B or C). For topical Zoryve, apply once daily per product strength and indication. Policy revisions include redirection to generic roflumilast for brand Daliresp requests and pediatric age updates for Zoryve per labeling changes.

Refer to full policy for complete medical necessity criteria and state-specific addendums.

Non-FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (for Commercial: CPCPA.09; Health Insurance Marketplace: HIM.PA.154; Medicaid: CP PMN.53) or other applicable evidence of coverage documents.

Use of roflumilast products in patients with moderate to severe liver impairment (Child‑Pugh B or C) is explicitly listed as a contraindication in the policy appendices and is not appropriate for these members.

Moderate to severe liver impairment (defined as Child‑Pugh B or C) is identified in the policy as a formal contraindication to roflumilast therapy and must be assessed prior to authorization.

Requests for roflumilast for indications that are not FDA‑approved and not covered by this policy will not be authorized unless the provider submits adequate clinical documentation supporting off‑label use per the referenced off‑label use policies; absent that documentation, such uses are not covered.

Per the policy appendices, use of roflumilast in individuals with moderate to severe hepatic impairment (Child‑Pugh B or C) is considered not medically necessary/contraindicated and may result in denial of the request.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required for requests for roflumilast (generic and brand Daliresp) and for topical roflumilast products (Zoryve). For brand Daliresp requests, the provider must demonstrate the member has tried and failed generic roflumilast or document a contraindication or clinically significant adverse reaction to the generic prior to approval. Step-therapy updates: step-therapy requirements apply per indication (COPD, plaque psoriasis, seborrheic dermatitis, atopic dermatitis) unless overridden by applicable state law (for Illinois HIM, certain step-therapy requirements or bypass provisions apply per IL HB 5395).

Prior authorization applies to generic roflumilast as well as brand Daliresp.
Step-therapy requirements detailed in the criteria (e.g., inhaled therapy trial(s) for COPD; topical steroid/calcineurin inhibitor trials for dermatologic indications) remain applicable unless state law provides a bypass (see IL HB 5395 for HIM line of business).
Provider must demonstrate the member meets the specific initial or continuation criteria for the requested indication.

Documentation Required

Required Documentation

Documentation requirement — Providers must submit supporting clinical documentation with the prior authorization request to establish that the member meets all approval criteria.

Acceptable documentation includes office chart notes, recent laboratory results (e.g., FEV1, blood eosinophil count), prior medication trial records, and consultation notes.
Failure to submit sufficient documentation may result in denial for lack of clinical information.

Documentation Required

Required Prescription Documentation

Required prescription documentation — The prior authorization request should include the prescribed indication and the complete dosing regimen for the requested product.

For Daliresp/roflumilast tablets: document COPD diagnosis, concomitant long-acting bronchodilator use, recent FEV1, and blood eosinophil count if applicable.
For Zoryve topical products: document diagnosis (plaque psoriasis, seborrheic dermatitis, or atopic dermatitis), body surface area involvement, prior topical/systemic therapy trials, age, and prescriber specialty or consultation when required.

Documentation Required

Required Dosing Documentation

Required dosing documentation — Providers must document the intended dosing regimen consistent with prescribing information and policy dose limits.

Daliresp (roflumilast tablet): starting dose may be 250 mcg once daily for 4 weeks then increased to 500 mcg once daily; maximum 500 mcg/day. Approvals require documentation that the requested dose does not exceed policy dose limits.
Zoryve topical: plaque psoriasis — apply 0.3% cream or foam once daily (use 0.3% cream for plaque psoriasis per labeling); seborrheic dermatitis — apply 0.3% foam once daily; atopic dermatitis — apply 0.15% cream once daily. Document quantity requested (policy limits: typically ≤1 tube/can per month unless specified otherwise).

Denial Risk

Contraindication — Hepatic Impairment

Contraindication — Hepatic impairment: roflumilast is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Use in these patients should be documented and will typically result in denial as not medically necessary or contraindicated.

Document liver function and Child-Pugh classification when relevant; absence of documentation of safe hepatic status may trigger denial.
If a member has moderate to severe hepatic impairment, note the contraindication and do not approve roflumilast therapy.

OpenPayer

Clinical Policy: Roflumilast (Daliresp; Zoryve)

Coverage Criteria and Dosing

Billing and Coding

Prior Authorization, Documentation, and Step Therapy

Background and Scope

Definitions and Abbreviations