Pharmacy Prior Authorization Criteria

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 0.3% cream

Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a diagnosis of plaque psoriasis
AND
• Patient is 6 years of age or older
AND
• Both of the following:
• 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 THREE 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
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to Vtama (tapinarof)
AND
• Prescribed by or in consultation with a dermatologist

Zoryve 0.15% cream

*Product may require step therapy

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 ALL of the following [4]:
• Medium or higher potency topical corticosteroid
• Pimecrolimus cream OR Tacrolimus ointment
• Eucrisa (crisaborole) ointment*

Zoryve 0.15% cream

*Product may require step therapy

Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a diagnosis of mild to moderate atopic dermatitis
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to ALL of the following [4]:
• Medium or higher potency topical corticosteroid
• Pimecrolimus cream OR Tacrolimus ointment
• Eucrisa (crisaborole) 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

P & T Revisions

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

References

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.

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Revision History

• 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.

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