WHA

Zoryve (roflumilast) – PA, ST, NF

Indications for Prior Authorization

Zoryve (roflumilast) 0.3% cream
  • For diagnosis of Plaque Psoriasis (PsO)
    Indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.

Zoryve (roflumilast) 0.15% cream
  • For diagnosis of Atopic Dermatitis (AD)
    Indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

Zoryve (roflumilast) foam
  • For diagnosis of Seborrheic Dermatitis
    Indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

Criteria

Zoryve 0.3% cream

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

  • 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 [3]:
    • Corticosteroids (e.g., betamethasone, clobetasol)
    • Vitamin D analogs (e.g., calcitriol, calcipotriene)
    • Tazarotene
    • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
    • Combination topical therapy (e.g., vitamin D analog/corticosteroid)
    AND
  • Prescribed by or in consultation with a dermatologist
Zoryve 0.3% cream

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

  • Patient demonstrates positive clinical response to therapy as evidenced by one of the following [1, 3]:
    • Reduction in the body surface area (BSA) involvement from baseline
    • Improvement in symptoms (e.g., pruritus, inflammation) from baseline
Zoryve 0.15% cream

Step Therapy

Length of Approval: 12 Month(s)
For diagnosis of Atopic Dermatitis (AD)

  • Diagnosis of mild to moderate atopic dermatitis
    • AND
  • Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to ONE of the following [4]:
    • Medium or higher potency topical corticosteroid
    • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
Zoryve foam

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Seborrheic Dermatitis

  • 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 [2, 5, 6]:
    • Corticosteroids (e.g., betamethasone, clobetasol)
    • Antifungals (e.g., ciclopirox, ketoconazole)
    • Calcineurin inhibitors (e.g., tacrolimus)
    AND
  • Prescribed by or in consultation with a dermatologist
Zoryve foam

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Seborrheic Dermatitis

  • Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for one of the following [2, 7]:
    • Scaling
    • Erythema
    • Pruritus
    • Body surface area (BSA) involvement
Zoryve foam

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Seborrheic Dermatitis

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of seborrheic dermatitis
    • AND
  • Patient is 9 years of age or older
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 4-week trial and failure, contraindication, or intolerance to TWO of the following generic topical therapies [2, 5, 6]:
    • Corticosteroids (e.g., betamethasone, clobetasol)
    • Antifungals (e.g., ciclopirox, ketoconazole)
    • Calcineurin inhibitors (e.g., tacrolimus)
    AND
  • Prescribed by or in consultation with a dermatologist

  • Guideline ID
    GL-164816

  • Formulary
    premium

  • Effective date
    Mar 1, 2025

  • P&T approval date
    Oct 19, 2022

P & T Revisions

2025-02-09, 2025-01-26, 2024-09-17, 2024-08-07, 2024-07-11, 2024-07-02, 2024-06-05, 2024-02-04, 2024-01-07, 2023-11-30, 2023-09-28, 2023-01-09, 2022-09-21, 2022-10-04, 2022-09-21

  1. Zoryve Cream Prescribing Information. Arcutis Biotherapeutics Inc. Westlake Village, CA. July 2024.
  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. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.
  5. Clark GW, Pope SM, Jaboori KA. Diagnosis and treatment of seborrheic dermatitis. Am Fam Physician. 2015; 91(3):185-90.
  6. 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.
  7. 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.
  • 2025-02-09: Removed NF criteria from plaque psoriasis and atopic dermatitis criteria; reduced the atopic dermatitis step from a trial of 3 agents to 1; updated the verbiage for the topical calcineurin inhibitors in the AD step
  • 2025-01-26: Addition of NF criteria for Zoryve 0.3% cream and 0.1% cream; removal of anthralin and coal tar as step options for psoriasis; annual review - no additional criteria changes
  • 2024-09-17: Addition of NF criteria for Zoryve 0.3% cream and 0.1% cream; removal of anthralin and coal tar as step options for psoriasis; annual review - no additional criteria changes
  • 2024-08-07: Addition of 0.15% cream and step criteria for atopic dermatitis
  • 2024-07-11: Addition of non-formulary criteria for Zoryve foam; updated guideline name to include PA, NF
  • 2024-07-02: Updated attached GPI.
  • 2024-06-05: Addition of non-formulary criteria for Zoryve foam
  • 2024-02-04: Addition of the foam formulation and criteria for seborrheic dermatitis
  • 2024-01-07: Updated indication and criteria to include patients 6 years of age or older. Program update to standard reauthorization language.
  • 2023-11-30: Updated indication and criteria to include patients 6 years of age or older
  • 2023-09-28: Annual review - no criteria changes
  • 2023-01-09: Commercial formulary strategy to update step to a single generic topical agent.
  • 2022-09-21: New program.
  • 2022-10-04: New program.
  • 2022-09-21: New program.