UnitedHealthcare Zoryve prior auth policy update

Coverage Criteria for Zoryve

Initial Therapy — Plaque Psoriasis

Covered when ALL of the following are met:

Diagnosis of plaque psoriasis

Applies to Zoryve 0.3% cream and Zoryve foam.

Prior topical therapy: Minimum duration of a 4-week trial and failure, contraindication, or intolerance to at least one of the following topical therapies: topical corticosteroids (e.g., betamethasone, clobetasol, desonide), tazarotene, vitamin D analogs (calcitriol, calcipotriene), calcineurin inhibitors (tacrolimus, pimecrolimus), anthralin, or coal tar.4 weeks

Combination therapy exclusion: Patient is not receiving the requested product in combination with a targeted immunomodulator or JAK inhibitor (examples listed in policy, e.g., etanercept, certolizumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tildrakizumab, tofacitinib, baricitinib, upadacitinib, apremilast).

Initial Therapy — Seborrheic Dermatitis

Covered when ALL of the following are met:

Diagnosis of seborrheic dermatitis

Applies to Zoryve foam.

Prior therapy: Minimum duration of a 4-week trial and failure, contraindication, or intolerance to at least one of the following: topical corticosteroids (e.g., betamethasone, hydrocortisone), topical calcineurin inhibitors (tacrolimus, pimecrolimus), or topical/shampoo/systemic antifungals (e.g., ketoconazole, ciclopirox, itraconazole).4 weeks

Combination therapy exclusion: Patient is not receiving Zoryve foam in combination with a biologic immunomodulator (e.g., dupilumab, tralokinumab) or a Janus kinase inhibitor (e.g., upadacitinib, tofacitinib, topical ruxolitinib, abrocitinib).

Authorization will be issued for 12 months if criteria met.

Initial Therapy — Atopic Dermatitis

Covered when ALL of the following are met:

Diagnosis of mild to moderate atopic dermatitis

Applies to Zoryve 0.15% cream.

Prior therapy: History of failure, contraindication, or intolerance to one of the following topical therapies: for moderate disease a medium- to high-potency topical corticosteroid (e.g., mometasone, fluocinonide); for mild disease any potency topical corticosteroid (e.g., desonide, hydrocortisone); or one topical calcineurin inhibitor (pimecrolimus or tacrolimus).

Combination therapy exclusion: Patient is not receiving Zoryve 0.15% cream in combination with a targeted immunomodulator or JAK inhibitor (examples listed in policy, e.g., tralokinumab, abrocitinib, dupilumab, upadacitinib).

Authorization will be issued for 12 months if criteria met.

Reauthorization / Continuation Therapy

Covered when ALL of the following are met:

Clinical response: Documentation of positive clinical response to therapy

Required for reauthorization of any Zoryve formulation.

Combination therapy exclusion: Patient is not receiving the Zoryve product in combination with targeted immunomodulators or JAK inhibitors as listed in the policy.

Authorization period: 12 months.

Use of Zoryve products in combination with targeted immunomodulators or Janus kinase (JAK) inhibitors is excluded. Requests may be denied if the patient is receiving the requested Zoryve product together with listed biologic immunomodulators (examples include dupilumab, tralokinumab, etanercept, certolizumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tildrakizumab) or JAK inhibitors (examples include tofacitinib, baricitinib, upadacitinib) or other agents specified in the policy. Authorization for Zoryve will not be issued when concomitant use with these targeted immunomodulators or JAK inhibitors is documented.

Initial authorization requires documentation of prior trial and failure, contraindication, or intolerance to at least one specified topical therapy relevant to the indication. Where specified, a minimum 4-week trial is required (for example, for plaque psoriasis and seborrheic dermatitis). Acceptable prior therapies include topical corticosteroids, topical calcineurin inhibitors, vitamin D analogs, tazarotene, anthralin, coal tar, or appropriate topical/shampoo/systemic antifungals for seborrheic dermatitis; for atopic dermatitis, prior use of an appropriately potent topical corticosteroid (medium–high potency for moderate disease; any potency for mild disease) or one topical calcineurin inhibitor is required.

Initial Authorization Requirements (by formulation)

Initial therapy — Initial authorization requirements differ by formulation and indication

Initial authorization requirements differ by formulation and indication. Covered when ALL applicable formulation-specific criteria are met:

Plaque psoriasis (0.3% cream or foam): Diagnosis of plaque psoriasis AND minimum 4-week trial and failure/contraindication/intolerance to at least one specified topical therapy (topical corticosteroid, tazarotene, vitamin D analog, calcineurin inhibitor, anthralin, coal tar) AND not used in combination with targeted immunomodulators or JAK inhibitors.4 weeks

Applies to Zoryve 0.3% cream and Zoryve foam.

Seborrheic dermatitis (foam): Diagnosis of seborrheic dermatitis AND minimum 4-week trial and failure/contraindication/intolerance to at least one specified therapy (topical corticosteroid, topical calcineurin inhibitor, or antifungal) AND not used in combination with specified biologics or JAK inhibitors.4 weeks

Applies to Zoryve foam.

Reauthorization / Continuation Criteria

Reauthorization — Reauthorization rules for all Zoryve formulations

Reauthorization for any Zoryve formulation is covered when ALL of the following are met:

Positive clinical response: Documentation of positive clinical response to therapy is provided.

Required for reauthorization of any Zoryve formulation.

No concomitant targeted immunomodulators/JAK inhibitors: Patient is not receiving the Zoryve product in combination with targeted immunomodulators or JAK inhibitors listed in the policy.

Authorization period: 12 months.

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required for Zoryve products (0.3% cream, foam, 0.15% cream). Approval is contingent on meeting indication‑specific requirements (diagnosis and required prior trials).

Affected products: Zoryve 0.3% cream, Zoryve foam, Zoryve 0.15% cream
Approval contingent on meeting diagnosis- and indication-specific criteria

Step Therapy

Initial Step Therapy — Trial and Failure Required

Initial approval requires documentation of a minimum 4‑week trial with failure, contraindication, or intolerance to specified topical therapies relevant to the indication prior to starting Zoryve.

Required minimum trial: 4 weeks
Examples of required trials (select per indication): topical corticosteroids (e.g., betamethasone, clobetasol, hydrocortisone, mometasone), topical retinoid (tazarotene), vitamin D analogs (calcitriol, calcipotriene), topical calcineurin inhibitors (tacrolimus, pimecrolimus), anthralin, coal tar, topical antifungals where applicable

Step Therapy Requirements

Step	Requirement	Notes
1	Prior trial and failure, contraindication, or intolerance to at least one topical corticosteroid, topical calcineurin inhibitor, vitamin D analog, tazarotene, anthralin, or coal tar.	Minimum duration of a 4-week trial where specified; applies to plaque psoriasis (0.3% cream or foam) and seborrheic dermatitis (foam).
	For seborrheic dermatitis: allowed prior therapies also include topical/shampoo/systemic antifungals (e.g., ketoconazole, ciclopirox, itraconazole).	See indication-specific lists for exact agents and formulations.
	For atopic dermatitis (0.15% cream): prior trial requirement is failure, contraindication, or intolerance to one appropriate topical therapy — for moderate disease a medium- to high-potency topical corticosteroid; for mild disease any potency topical corticosteroid; or one topical calcineurin inhibitor (pimecrolimus or tacrolimus).	Duration minimums are described in the policy; 4-week trial specified where noted for other indications.

Coding and Minimum Trial Duration

Minimum trial duration

Minimum trial duration4 weeks

Applies toInitial authorization step therapy for plaque psoriasis and seborrheic dermatitis (where specified)

Evidence requiredDocumentation of trial and failure, contraindication, or intolerance to at least one listed topical therapy

Formulation Indications and Age Ranges

Zoryve 0.3% cream

Drug and formulationZoryve (roflumilast) 0.3% cream

MechanismTopical phosphodiesterase-4 (PDE4) inhibitor

IndicationTopical treatment of plaque psoriasis, including intertriginous areas

Age rangePatients 6 years of age and older

Zoryve foam

Drug and formulationZoryve (roflumilast) foam

IndicationsSeborrheic dermatitis and plaque psoriasis of the scalp and body

Background and Indications

Zoryve (roflumilast) topical formulations are phosphodiesterase-4 (PDE4) inhibitors indicated for topical treatment of plaque psoriasis, seborrheic dermatitis, and mild-to-moderate atopic dermatitis in specified age groups. Different formulations have distinct labeled indications and age ranges: for example, Zoryve 0.3% cream is indicated for plaque psoriasis (including intertriginous areas) in patients 6 years of age and older; Zoryve foam is indicated for seborrheic dermatitis (≥9 years) and plaque psoriasis of the scalp and body (≥12 years); and Zoryve 0.15% cream is indicated for mild-to-moderate atopic dermatitis in patients 6 years of age and older.

Quantity Limits

Zoryve (all formulations) — Supply limits

Quantity limitsSupply limits may be in place

ApplicabilityApplies to all Zoryve formulations (0.3% cream, 0.15% cream, foam)

Authorization noteUnitedHealthcare may use claim/medication history and automated processes when approving which can affect supply and re-approval

Policy Revision History

2025-07revisedLatest

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

2025-02revised

Standardized authorization length to 12 months and simplified reauthorization to require documentation of positive clinical response and absence of combination with targeted immunomodulators; removed prescriber requirements.

2024-12added

OpenPayer

Zoryve (roflumilast) topical formulations — prior authorization and medical necessity

Coverage Criteria for Zoryve

Initial Authorization Requirements (by formulation)

Reauthorization / Continuation Criteria

Provider Actions, Documentation, and Denial Risks

Step Therapy Requirements

Coding and Minimum Trial Duration

Formulation Indications and Age Ranges

Background and Indications

Quantity Limits

Policy Revision History