CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy ProgramsPolicy 2025 P 2287-8

Zoryve® (roflumilast) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Defines prior authorization and medical necessity criteria for Zoryve topical products (0.3% cream, foam, 0.15% cream, 0.05% cream) for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis for UnitedHealthcare Commercial Plans effective 2026-02-01. Specifies initial and reauthorization requirements, combination therapy exclusions, trial/failure requirements, and authorization durations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyZoryve® (roflumilast) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2287-8

Change TypeMultiple formulation and criteria additions/revisions

Effective DateFeb 1, 2026

Next Review Date

Key ActionPrior authorization is required and approvals are granted when the listed initial or reauthorization criteria are met; automated approval may occur based on previous claims/medication history and diagnosis codes.

SourceLink

POLICY UPDATE CHANGES

Effective 2/1/2026 program includes Zoryve formulations with updated criteria and 12-month authorizations.

11/2023 updated to not allow use in combination with Targeted Immunomodulators and simplified reauthorization criteria.

2/2024 added criteria for Zoryve foam for seborrheic dermatitis.

12/2024 added Zoryve 0.15% cream for atopic dermatitis and updated plaque psoriasis criteria to specify 0.3% cream; updated all authorizations to 12 months.

2/2025 updated step therapy requirements for atopic dermatitis to one agent and removed Eucrisa as required step agent.

7/2025 added Zoryve foam to plaque psoriasis criteria.

11/2025 added Zoryve 0.05% cream to atopic dermatitis criteria.

3Covered Indications

Formulations Covered

12 moAuthorization Duration

>=4wRequired Trial Duration

Coverage Summary

Scope: This policy defines prior authorization and medical necessity criteria for Zoryve (roflumilast) topical products — 0.3% cream, foam, 0.15% cream, and 0.05% cream — for the covered indications of plaque psoriasis, seborrheic dermatitis, and mild-to-moderate atopic dermatitis per formulation labeling. Effective date: 2026-02-01. Authorization duration: 12 months. Coverage stance: covered_with_criteria.

Key thresholds and statistics

Topical trial duration for initial therapyMinimum 4 weeks trial and failure, contraindication, or intolerance

Authorization duration12 months

Formulations Covered4

Initial Therapy Criteria

Initial Authorization - Zoryve 0.3% cream or Zoryve foam for plaque psoriasis

Approved when ALL of the following are met:

ALL of the following

Diagnosis of plaque psoriasis
ALL of the following
- ONE of
  - Corticosteroids (e.g., betamethasone, clobetasol, desonide)
  - Vitamin D analogs (e.g., calcitriol, calcipotriene)
  - Tazarotene
  - Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)

Initial Authorization - Zoryve foam for seborrheic dermatitis

Approved when ALL of the following are met:

ALL of the following

Diagnosis of seborrheic dermatitis
ALL of the following
- AT LEAST ONE of
  - Topical corticosteroids (e.g., betamethasone, hydrocortisone)
  - Topical, shampoo, or systemic antifungals (e.g., ketoconazole, ciclopirox, itraconazole)
  - Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)

Initial Authorization - Zoryve 0.15% cream or Zoryve 0.05% cream for mild to moderate atopic dermatitis

Approved when ALL of the following are met:

ALL of the following

Diagnosis of mild to moderate atopic dermatitis
ALL of the following
- ONE of
  - Topical corticosteroid requirement varies by severity
    For mild atopic dermatitis: a topical corticosteroid (any potency) (e.g., DesOwen (desonide), hydrocortisone)
    For moderate atopic dermatitis: a topical corticosteroid of at least a medium- to high-potency (e.g., Elocon (mometasone furoate), Synalar (fluocinolone acetonide), Lidex (fluocinonide))

Reauthorization / Continuation Therapy Criteria

Reauthorization - Zoryve 0.3% cream or Zoryve foam for plaque psoriasis

Approved when BOTH of the following are met:

ALL of the following

Documentation of positive clinical response to therapy
Patient is not receiving the requested product in combination with a Targeted Immunomodulator for treatment of the same indication
Examples: Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Stelara (ustekinumab), Skyrizi (risankizumab), Tremfya (guselkumab), Cosentyx (secukinumab), Taltz (ixekizumab), Siliq (brodalumab), Ilumya (tildrakizumab), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Otezla (apremilast))

Reauthorization - Zoryve foam for seborrheic dermatitis

Approved when BOTH of the following are met:

ALL of the following

Combination Therapy Exclusions & Related Limitations

Combination therapy exclusions: the policy does not allow concurrent use of Zoryve products with Targeted Immunomodulators (defined in the policy to include biologic therapies, oral/topical JAK inhibitors, and other targeted agents) for the same indication. For seborrheic dermatitis treated with Zoryve foam, the policy specifically excludes combination use with either a Biologic immunomodulator or a Janus kinase (JAK) inhibitor. See the policy definitions entry for the term Targeted Immunomodulator.

Supply limits and denial risk: supply limits may apply and UnitedHealthcare may use automated approval based on prior claims/medication history and diagnosis codes. Claims may be denied if the patient is receiving the requested Zoryve product in combination with the specified targeted agents/biologics/JAK inhibitors for the same indication.

Applicable Codes

Referenced diagnosis codes noted as possible automated approval logicICD-10

No codes listed

Examples of interacting/contraindicated concomitant therapies (not coverage codes)mixed

Enbrel (etanercept)	example biologic referenced in combination exclusion for plaque psoriasis
Cimzia (certolizumab)	example biologic referenced in combination exclusion for plaque psoriasis
Simponi (golimumab)	example biologic referenced in combination exclusion for plaque psoriasis
Orencia (abatacept)	example biologic referenced in combination exclusion for plaque psoriasis
adalimumab	example biologic referenced in combination exclusion for plaque psoriasis
Stelara (ustekinumab)	example biologic referenced in combination exclusion for plaque psoriasis
Skyrizi (risankizumab)	example biologic referenced in combination exclusion for plaque psoriasis
Tremfya (guselkumab)	example biologic referenced in combination exclusion for plaque psoriasis
Cosentyx (secukinumab)	example biologic referenced in combination exclusion for plaque psoriasis
Taltz (ixekizumab)	example biologic referenced in combination exclusion for plaque psoriasis

1–10 of 20

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Provider Actions and Operational Guidance

Prior Authorization

Prior authorization required

Prior authorization is required and approvals are granted when the listed initial or reauthorization criteria are met; automated approval may occur based on previous claims/medication history and diagnosis codes.

Documentation Required

Document trial/failure and clinical response

For initial requests document diagnosis and a ≥4-week trial with failure/contraindication/intolerance to specified topical therapies; for reauthorization document positive clinical response.

Clinical Evidence & References

Evidence and P&T history: P&T approval dates include 9/2022; 2/2023; 11/2023; 2/2024; 12/2024; 2/2025; 7/2025; 11/2025. References cited in the policy are the Zoryve package inserts (October 2025 and May 2025) and the AAD‑NPF guidelines (J Am Acad Dermatol 2021;84:432-70).

Background

Background: Zoryve is a topical phosphodiesterase-4 (PDE4) inhibitor. Indications vary by formulation and age: 0.3% cream for plaque psoriasis (patients ≥6 years), foam for seborrheic dermatitis (patients ≥9 years) and plaque psoriasis of scalp/body (patients ≥12 years), 0.15% cream for mild-to-moderate atopic dermatitis (patients ≥6 years), and 0.05% cream for mild-to-moderate atopic dermatitis in pediatric patients 2–5 years. This policy reflects formulation-specific indications and age groups per product labeling.

Revision History

9/2022P&T approval

Program initiated with P&T approval (new prior authorization program for Zoryve).

2/2023P&T revision

Revised trial and failure requirement from two topical therapies (or calcipotriene + betamethasone dipropionate) to a trial and failure of one topical therapy.

11/2023P&T revision

Updated policy to prohibit use in combination with Targeted Immunomodulators and simplified reauthorization criteria to require only positive clinical response (and no combination use); background updated to include patients 6 years and older.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyZoryve® (roflumilast) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2287-8

Change TypeMultiple formulation and criteria additions/revisions

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Patient is not receiving the requested product in combination with a Targeted Immunomodulator for treatment of the same indication

Examples: Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Stelara (ustekinumab), Skyrizi (risankizumab), Tremfya (guselkumab), Cosentyx (secukinumab), Taltz (ixekolizumab), Siliq (brodalumab), Ilumya (tildrakizumab), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Otezla (apremilast)

Patient is not receiving Zoryve foam in combination with either a Biologic immunomodulator or a Janus kinase inhibitor for treatment of the same indication

Examples: Biologic immunomodulator (e.g., Dupixent (dupilumab), Adbry (tralokinumab-ldrm)); Janus kinase inhibitor (e.g., Rinvoq (upadacitinib), Xeljanz/XR (tofacitinib), Opzelura (topical ruxolitinib), Cibinqo (abrocitinib))

One topical calcineurin inhibitor (e.g., Elidel (pimecrolimus), Protopic (tacrolimus))

Patient is not receiving Zoryve 0.15% cream or Zoryve 0.05% cream in combination with a targeted immunomodulator for treatment of the same indication

Examples: Adbry (tralokinumab-ldrm), Cibinqo (abrocitinib), Dupixent (dupilumab), Rinvoq (upadacitinib)

Documentation of positive clinical response to therapy
Patient is not receiving Zoryve foam in combination with either a Biologic immunomodulator or a Janus kinase inhibitor for treatment of the same indication
Examples: Biologic immunomodulator (e.g., Dupixent (dupilumab), Adbry (tralokinumab-ldrm)); Janus kinase inhibitor (e.g., Rinvoq (upadacitinib), Xeljanz/XR (tofacitinib), Opzelura (topical ruxolitinib), Cibinqo (abrocitinib))

Reauthorization - Zoryve 0.15% cream or Zoryve 0.05% cream for atopic dermatitis

Approved when BOTH of the following are met:

ALL of the following

Documentation of positive clinical response to therapy
Patient is not receiving Zoryve 0.15% cream or Zoryve 0.05% cream in combination with a targeted immunomodulator for treatment of the same indication
Examples: Adbry (tralokinumab-ldrm), Cibinqo (abrocitinib), Dupixent (dupilumab), Rinvoq (upadacitinib)

Denial Risk

Combination therapy exclusion

Claims may be denied if patient is receiving the requested Zoryve product in combination with specified targeted immunomodulators, biologic immunomodulators, or Janus kinase inhibitors for treatment of the same indication.

Billing Rule

Supply limits and automated processes

Supply limits may apply; UnitedHealthcare may approve initial and reauthorization requests based solely on claim/medication history and diagnosis codes as part of automated processes.

Documentation Required

Prior authorization note for other topicals

Elidel and Protopic/tacrolimus ointment require prior authorization per policy footnote.

2/2024P&T addition

Added criteria for Zoryve foam for seborrheic dermatitis; background and references updated.

12/2024P&T addition/revision

Added Zoryve 0.15% cream for atopic dermatitis; specified plaque psoriasis product as 0.3% cream; updated all authorizations to 12 months and removed prescriber requirements.

2/2025P&T revision

Updated step therapy for atopic dermatitis to require one agent and removed Eucrisa as a required step agent; updated prior authorization footnote.

7/2025P&T addition

Added Zoryve foam to plaque psoriasis criteria; background and references updated.

11/2025P&T addition

Added Zoryve 0.05% cream to atopic dermatitis criteria; background and references updated.

2/1/2026Effective date (material change)Latest

Effective 2/1/2026 program includes Zoryve formulations with updated criteria and 12-month authorizations.