UnitedHealthcare Zoryve Prior Auth & Coverage Update

Coverage Criteria

Initial Therapy - Plaque psoriasis

Covered when ALL of the following are met

Plaque psoriasis initial: (1) Diagnosis of plaque psoriasis

Prior topical trial: (2) Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies: corticosteroids (e.g., betamethasone, clobetasol, desonide), vitamin D analogs (e.g., calcitriol, calcipotriene), tazarotene, calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, coal tar4 weeks

No concomitant targeted immunomodulator: (3) Patient is not receiving the requested product in combination with a Targeted Immunomodulator (examples enumerated in policy) for treatment of the same indication

Examples enumerated in policy

Reauthorization - Plaque psoriasis

Covered when ALL of the following are met

Positive response: (1) Documentation of positive clinical response to therapy

No concomitant targeted immunomodulator: (2) Patient is not receiving the requested product in combination with a Targeted Immunomodulator for treatment of the same indication

Authorization issued for 12 months

Initial Therapy - Seborrheic dermatitis

Covered when ALL of the following are met

Diagnosis: (1) Diagnosis of seborrheic dermatitis

Prior therapy trial: (2) 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/shampoo/systemic antifungals (e.g., ketoconazole, ciclopirox, itraconazole), topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)4 weeks

No concomitant biologic or JAK: (3) Patient is not receiving Zoryve foam in combination with biologic immunomodulators (e.g., dupilumab, tralokinumab) or Janus kinase inhibitors (e.g., upadacitinib, tofacitinib, topical ruxolitinib, abrocitinib) for the same indication

Reauthorization - Seborrheic dermatitis

Covered when ALL of the following are met

Positive response: (1) Documentation of positive clinical response to therapy

No concomitant biologic or JAK: (2) Patient is not receiving Zoryve foam in combination with biologic immunomodulators or Janus kinase inhibitors for the same indication

Authorization issued for 12 months

Initial Therapy - Atopic dermatitis

Covered when ALL of the following are met

Diagnosis: (1) Diagnosis of mild to moderate atopic dermatitis

Prior therapy failure: (2) History of failure, contraindication, or intolerance to one of the following: for mild disease a topical corticosteroid (any potency); for moderate disease a topical corticosteroid of at least medium- to high-potency (e.g., mometasone, fluocinonide, fluocinolone); and one topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus)

Specific examples provided in policy

No concomitant targeted immunomodulator: (3) Patient is not receiving Zoryve 0.15% or 0.05% cream in combination with a targeted immunomodulator (examples listed) for treatment of the same indication

Reauthorization - Atopic dermatitis

Covered when ALL of the following are met

Positive response: (1) Documentation of positive clinical response to therapy

Authorization for 12 months

No concomitant targeted immunomodulator: (2) Patient is not receiving Zoryve 0.15% or 0.05% cream in combination with a targeted immunomodulator for treatment of the same indication

Concurrent use of specified targeted immunomodulators, biologic immunomodulators, or Janus kinase (JAK) inhibitors for the same indication will preclude approval of Zoryve. Examples listed in the policy for plaque psoriasis include agents such as 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), and Otezla (apremilast).

For seborrheic dermatitis, concurrent use of biologic immunomodulators (for example, Dupixent [dupilumab], Adbry [tralokinumab]) or JAK inhibitors (for example, Rinvoq [upadacitinib], Xeljanz [tofacitinib], Opzelura [topical ruxolitinib], Cibinqo [abrocitinib]) for the same indication excludes approval of Zoryve foam.

For atopic dermatitis, Zoryve 0.15% or 0.05% cream will not be approved when used in combination with targeted immunomodulators such as Adbry (tralokinumab-ldrm), Cibinqo (abrocitinib), Dupixent (dupilumab), or Rinvoq (upadacitinib) for the same indication.

Additional clinical rules permit UnitedHealthcare to approve initial or reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Use of automated approval and re-approval processes varies by program and therapeutic class.

Coding and Minimum Trials

Minimum trial duration

Minimum trial duration4 weeks

Applies toTopical comparator trials required for plaque psoriasis, seborrheic dermatitis, and as-specified atopic dermatitis criteria

Failure definitionFailure, contraindication, or intolerance to required topical therapies

Provider Actions and Requirements

Prior Authorization

Plaque psoriasis — Prior Authorization Required

Prior authorization required for Zoryve 0.3% cream or Zoryve foam when used for plaque psoriasis. Include diagnosis and that the member has had a minimum 4-week trial and failure, contraindication, or intolerance to specified topical comparators; verify patient is not receiving the requested product in combination with a targeted immunomodulator for the same indication.

Applicable products: Zoryve 0.3% cream, Zoryve foam
Required diagnosis: plaque psoriasis
Required prior topical trial: minimum 4 weeks and failure, contraindication, or intolerance to one of: topical corticosteroids (e.g., betamethasone, clobetasol, desonide), vitamin D analogs (e.g., calcitriol, calcipotriene), tazarotene, topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, coal tar
Concurrent therapy restriction: patient must not be receiving the requested product in combination with a targeted immunomodulator for the same indication (examples: etanercept, certolizumab, golimumab, abatacept, adalimumab, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tildrakizumab, tofacitinib, baricitinib, upadacitinib, apremilast)

Prior Authorization

Seborrheic dermatitis — Prior Authorization Required

Initial Therapy

Initial therapy

Covered when ALL of the following are met

Plaque psoriasis initial: (1) Diagnosis of plaque psoriasis

Plaque psoriasis prior trial: (2) Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies: corticosteroids (e.g., betamethasone, clobetasol, desonide), vitamin D analogs (e.g., calcitriol, calcipotriene), tazarotene, calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, coal tar4 weeks

Seborrheic dermatitis initial: (3) Diagnosis of seborrheic dermatitis; minimum 4-week trial and failure/contraindication/intolerance to at least one of: topical corticosteroids, topical/shampoo/systemic antifungals, topical calcineurin inhibitors4 weeks

Reauthorization / Continuation Criteria

Reauthorization / Continuation

Reauthorization / Continuation — Covered when ALL of the following are met

Positive clinical response: (1) Documentation of positive clinical response to therapy

Authorization issued for 12 months

No concomitant excluded therapies: (2) Patient is not receiving the requested product in combination with listed targeted immunomodulators, biologic immunomodulators, or Janus kinase inhibitors for treatment of the same indication

Step Therapy Requirements

Comparator topical therapy	Required trial / rule
For plaque psoriasis: topical corticosteroids (e.g., betamethasone, clobetasol, desonide)	Minimum 4‑week trial with documented failure, contraindication, or intolerance required prior to approval of Zoryve 0.3% cream or foam
For plaque psoriasis: vitamin D analogs (e.g., calcitriol, calcipotriene)	Minimum 4‑week trial with documented failure, contraindication, or intolerance required prior to approval of Zoryve 0.3% cream or foam
For plaque psoriasis: tazarotene	Minimum 4‑week trial with documented failure, contraindication, or intolerance required prior to approval of Zoryve 0.3% cream or foam
For plaque psoriasis: calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)	Minimum 4‑week trial with documented failure, contraindication, or intolerance required prior to approval of Zoryve 0.3% cream or foam
For plaque psoriasis: anthralin	Minimum 4‑week trial with documented failure, contraindication, or intolerance required prior to approval of Zoryve 0.3% cream or foam
For plaque psoriasis: coal tar	Minimum 4‑week trial with documented failure, contraindication, or intolerance required prior to approval of Zoryve 0.3% cream or foam
For seborrheic dermatitis: topical corticosteroids (e.g., betamethasone, hydrocortisone)	Minimum 4‑week trial with documented failure, contraindication, or intolerance to at least one listed therapy required prior to approval of Zoryve foam
For seborrheic dermatitis: topical/shampoo/systemic antifungals (e.g., ketoconazole, ciclopirox, itraconazole)	Minimum 4‑week trial with documented failure, contraindication, or intolerance to at least one listed therapy required prior to approval of Zoryve foam
For seborrheic dermatitis: topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)	Minimum 4‑week trial with documented failure, contraindication, or intolerance to at least one listed therapy required prior to approval of Zoryve foam
For atopic dermatitis (mild): topical corticosteroid (any potency) (e.g., desonide, hydrocortisone)	History of failure, contraindication, or intolerance to an appropriate potency topical corticosteroid and one topical calcineurin inhibitor required prior to approval of Zoryve 0.15% or 0.05% cream
For atopic dermatitis (moderate): topical corticosteroid of at least medium‑ to high‑potency (e.g., mometasone, fluocinonide)	History of failure, contraindication, or intolerance to an appropriate potency topical corticosteroid and one topical calcineurin inhibitor required prior to approval of Zoryve 0.15% or 0.05% cream
For atopic dermatitis: topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus)	History of failure, contraindication, or intolerance to an appropriate potency topical corticosteroid and one topical calcineurin inhibitor required prior to approval of Zoryve 0.15% or 0.05% cream

Definitions

Targeted Immunomodulator — examples that preclude concurrent use

Definition - Targeted ImmunomodulatorDrugs such as biologic immunomodulators and JAK inhibitors that if used concurrently for the same indication preclude approval

Examples (policy-listed)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)

Additional examples for seborrheic dermatitis/atopic dermatitis contextDupixent (dupilumab); Adbry (tralokinumab); Cibinqo (abrocitinib); Opzelura (topical ruxolitinib)

Quantity Limits

Zoryve products — quantity / supply notes

Zoryve product supply limitsSupply limits may be in place

Authorization impactUnitedHealthcare may use previous claim/medication history and automated processes when applying limits

Unit/quantity specificsLimit details are variable and program-specific (see plan/program rules)

Background

Zoryve (roflumilast) topical formulations are phosphodiesterase 4 (PDE4) inhibitors available as creams and a foam. The policy covers Zoryve 0.3% cream and Zoryve foam for plaque psoriasis, Zoryve foam for seborrheic dermatitis, and Zoryve 0.15% cream (and the pediatric 0.05% cream) for mild to moderate atopic dermatitis. Indications and formulation availability differ by age and diagnosis, and coverage requires adherence to indication-specific step therapy and concomitant-therapy exclusions as outlined in the criteria.

Supply limits may be in place for Zoryve products, and program-specific automated approval rules can affect initial or reauthorization determinations based on prior claims or diagnosis coding.

OpenPayer

Zoryve (roflumilast) prior authorization and medical necessity

Coverage Criteria

Coding and Minimum Trials

Provider Actions and Requirements

Initial Therapy

Reauthorization / Continuation Criteria

Step Therapy Requirements

Definitions

Quantity Limits

Background