ZORYVE (roflumilast)

ZORYVE (roflumilast)

Self-Administration – topical

Diagnosis considered for coverage:

• Psoriasis: Indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older
• Seborrheic dermatitis: Indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older

Coverage Criteria:

Request for Zoryve cream:

• Diagnosis of plaque psoriasis; AND
• Patient is 6 years of age or older; AND
• Minimum duration of a 4-week trial and failure, contraindication, or intolerance to ONE of the following generic topical therapies:
  • Corticosteroids (e.g., betamethasone, clobetasol) 
  • Vitamin D analogs (e.g., calcitriol, calcipotriene) 
  • Tazarotene 
  • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
  • Anthralin 
  • Coal tar 
  • Combination topical therapy (e.g., vitamin D analog/corticosteroid); AND
• Prescribed by or in consultation with a dermatologist

Request for Zoryve foam:

• Diagnosis of seborrheic dermatitis; AND
• Patient is 9 years of age or older; AND
• Minimum duration of a 4-week trial and failure, contraindication, or intolerance to TWO of the following generic topical therapies:
  • Corticosteroids (e.g., betamethasone, clobetasol) 
  • Antifungals (e.g., ciclopirox, ketoconazole) 
  • Calcineurin inhibitors (e.g., tacrolimus); AND
• Prescribed by or in consultation with a dermatologist

Reauthorization Criteria:

Request for Zoryve cream:

• Diagnosis of plaque psoriasis; AND
• Patient demonstrates positive clinical response to therapy as 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

Request for Zoryve foam:

• Diagnosis of seborrheic dermatitis; AND
• Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for one of the following: 
  • Scaling 
  • Erythema 
  • Pruritus 
  • Body surface area (BSA) involvement 

Dosing:

Plaque Psoriasis:

• Apply Zoryve cream to affected areas once daily

Seborrheic Dermatitis:

• Apply a thin layer of Zoryve foam, 0.3%, once daily to affected areas on skin and/or scalp when they are not wet

Coverage Duration: 

For diagnosis of plaque psoriasis and seborrheic dermatitis:

• 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:

• Effective 2/21/2023 – New policy approved by P&T. (P&T, 2/21/2023)
• Effective 6/1/2024 – New formulation for Zoryve foam. Updated criteria for Zoryve cream. (P&T, 5/21/2024)

References:

1. Zoryve Cream Prescribing Information. Arcutis Biotherapeutics Inc. Westlake Village, CA. October 2023. 
2. Zoryve Foam Prescribing Information. Arcutis Biotherapeutics Inc. Westlake Village, CA. December 2023. 
3. 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. 
4. Clark GW, Pope SM, Jaboori KA. Diagnosis and treatment of seborrheic dermatitis. Am Fam Physician. 2015; 91(3):185-90. 
5. Sasseville, D. Seborrheic dermatitis in adolescents and adults. Available at: https://www.uptodate.com/contents/seborrheic-dermatitis-in-adolescents-and-adults?source=history_widget#H27253022. Accessed January 25, 2004. 
6. Zirwas, MJ, Draelos ZD, DuBois J, et al. Efficacy of roflumilast foam, 0.3%, in patients with seborrheic dermatitis: a double-blind, vehicle-controlled phase 2a randomized clinical trial. JAMA Dermatol. 2023; 159(6):613-620.