ZORYVE (roflumilast cream)

ZORYVE (roflumilast cream)

Self-Administration – topical

Diagnosis considered for coverage:

• Indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older

Coverage Criteria:

For diagnosis of plaque psoriasis:

• Dose does not exceed applying once daily to affected areas, AND
• Patient is 12 years of age or older, AND
• Diagnosis of plaque psoriasis (supported by chart note documentation), AND
• Prescribed by or in consultation with a dermatologist, AND
• One of the following (A or B):
  • A. Minimum duration of a 4-week trial and failure, contraindication, or intolerance to TWO of the following topical therapies:
    • Corticosteroids (i.e., betamethasone, clobetasol) 
    • Vitamin D analogs (i.e., calcitriol, calcipotriene) 
    • Tazarotene 
    • Calcineurin inhibitors (i.e., tacrolimus, pimecrolimus) 
    • Anthralin 
    • Coal tar, OR
  • B. Minimum duration of a 4-week trial and failure, contraindication, or intolerance to ONE of the following topical combination therapies:
    • Vitamin D analog/corticosteroid (i.e., Enstilar, Taclonex, Wynzora) 
    • Duobrii (halobetasol/tazarotene)

Reauthorization Criteria:

For diagnosis of plaque psoriasis:

• Documentation of positive clinical response to therapy evidenced by ONE of the following:
  • Reduction in the body surface area (BSA) involvement from baseline
  • Improvement in symptoms (i.e., pruritus, inflammation) from baseline

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 

• Contraindications include moderate to severe liver impairment (Child-Pugh B or C).
• Drug interactions:
  • Drugs that Inhibit Cytochrome P450 (CYP) Enzymes-The coadministration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit
  • Oral Contraceptives Containing Gestodene and Ethinyl Estradiol- The coadministration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects. The risk of such concurrent use should be weighed carefully against benefit.

Policy Updates:

• 2/21/2023 – New policy approved by P&T.

References:

1.    Zoryve Prescribing Information. Arcutis Biotherapeutics Inc. Westlake Village, CA. July 2022. 
2.    Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70.