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    Zoryve® cream

    Drug - Zoryve® cream (roflumilast) [Arcutis Biotherapeutics, Inc.]

    March 2025

    Therapeutic Area - Antipsoriatics, Topical

    Initial approval criteria

    • Patient must be at least 12 years of age; 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

    Renewal criteria

    • 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., pruritus, inflammation) from baseline; AND
    • Absence of unacceptable adverse reactions (e.g., application site urticaria); AND
    • Renewal approval is for 12 months

    Quantity limits

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

    Questions

    Provider Call Center (844) 575-7887

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