Zoryve® foam or cream, 0.3%

Drug - Zoryve® foam or cream, 0.3% (roflumilast) [Arcutis Biotherapeutics, Inc.]

August 2026

Therapeutic area - Antipsoriatics, Topical

Initial approval criteria

Plaque psoriasis

Patient must meet an age-appropriate medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; AND
Patient must have a diagnosis of plaque psoriasis; AND
Patient’s estimated baseline psoriasis involvement (as % BSA [body surface area]) is provided at time of request; AND
Patient’s treatment locations (e.g., arms and elbows, legs and knees, or intertriginous areas) is provided at time of request; AND
Patient does not have moderate to severe liver impairment (Child-Pugh B or C); AND
Patient is not receiving any of the following concomitant therapy:
- Biologic DMARD (e.g., Humira [adalimumab]); OR
- Janus kinase (JAK) inhibitor (e.g., Xeljanz [tofacitinib]); OR
- Phospodiesterase 4 (PDE4) inhibitor (e.g., Otezla [apremilast]); AND
Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of two of the following topical agents:
- Coal tar
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
- Tazarotene
- Vitamin D analogs (e.g., calcitriol, calcipotriene)
- Corticosteroids (medium potency or higher); OR
Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of fixed dose combination calcipotriene and betamethasone dipropionate (e.g., Estilar); AND
Zoryve is prescribed by or in consultation with a dermatologist; AND
Initial approval is for 6 months

Seborrheic dermatitis

Patient must meet the age limit indicated in the FDA-approved label of the requested agent; AND
Patient must have a diagnosis of seborrheic dermatitis; AND
Patient’s estimated baseline psoriasis involvement (as % BSA [body surface area]) is provided at time of request; AND
Patient’s treatment locations (e.g., scalp, face. or body) is provided at time of request; AND
Patient does not have moderate to severe liver impairment (Child-Pugh B or C); AND
Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of two of the following topical agents:
- Topical or systemic antifungal; AND
- Topical corticosteroid; AND
Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of topical calcineurin inhibitors or topical crisaborole;
Initial approval is for 6 months

Patient continues to meet initial approval criteria; AND
Documentation of clinical response to therapy as supported by one of the following:
- Reduction in the body surface area (BSA) involvement from baseline; OR
- Improvement in symptoms (e.g., itching, redness) from baseline; AND
Absence of unacceptable adverse reactions (e.g., application site urticaria); AND
Renewal approval is for 12 months

One 60-gram tube or one 60-gram can per 34 days
If more than one 60-gram tube or 60-gram can is needed for a 34-day supply, prior authorization request must include the number of tubes and the corresponding days supplied.

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