Zoryve roflumilast foam — Blue Cross Blue Shield of Oklahoma

Initial criteria

• 1. ONE of the following: (A) Diagnosis of mild to moderate atopic dermatitis (AD) AND ALL of the following criteria, OR (B) Diagnosis of plaque psoriasis AND BOTH specified criteria, OR (C) Diagnosis of seborrheic dermatitis AND ONE of the specified criteria, OR (D) Another FDA labeled indication and route of administration.
• For atopic dermatitis: (1) ONE of the following: (A) Tried and had an inadequate response to at least a low-potency topical corticosteroid after ≥4-week therapy OR (B) Intolerance or hypersensitivity to low-potency topical corticosteroid OR (C) FDA labeled contraindication to ALL topical corticosteroids used in AD; AND (2) ONE of the following: (A) Tried and inadequate response to topical calcineurin inhibitor after ≥6-week therapy OR (B) Intolerance or hypersensitivity to topical calcineurin inhibitor OR (C) FDA labeled contraindication to ALL topical calcineurin inhibitors used in AD; AND (3) BOTH of the following: (A) Currently treated with topical emollients and practicing good skin care AND (B) Will continue emollients and good skin care with requested agent.
• For plaque psoriasis: BOTH of the following: (1) Affected BSA ≤20%; AND (2) ONE of the following: (A) Tried and inadequate response to a topical corticosteroid after ≥2-week therapy OR a topical calcineurin inhibitor OR (B) Intolerance or hypersensitivity to topical corticosteroid or topical calcineurin inhibitor OR (C) FDA labeled contraindication to ALL topical corticosteroids AND ALL topical calcineurin inhibitors used in plaque psoriasis.
• For seborrheic dermatitis: ONE of the following: (1) BOTH of the following: (A) Prescriber states or documents stage IV advanced, metastatic cancer and the drug is used to treat the cancer or an associated condition AND (B) Use is consistent with best practices, supported by literature, and FDA approved for that use; OR (2) BOTH of the following: (1) ONE of the following: (A) Tried and inadequate response to ONE topical antifungal OR ONE topical corticosteroid used in seborrheic dermatitis OR (B) Intolerance or hypersensitivity to ONE topical antifungal OR ONE topical corticosteroid OR (C) FDA labeled contraindication to ALL topical antifungals AND corticosteroids; AND (2) ONE of the following: (A) Seborrheic dermatitis of the scalp OR (B) Tried and inadequate response to ONE topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) OR (C) Intolerance/hypersensitivity to ONE topical calcineurin inhibitor OR (D) FDA labeled contraindication to ALL topical calcineurin inhibitors used in seborrheic dermatitis.
• For any FDA labeled indication: BOTH of the following: (A) ONE of: (1) Patient’s age within FDA labeling for requested indication OR (2) Supported for use at patient’s age for the indication; AND (B) Requested dosage form and strength of Zoryve is FDA labeled for the indication.
• Prescriber is a specialist in the area (e.g., dermatologist) or has consulted with a specialist.
• Patient has no FDA labeled contraindications to the requested agent.
• Alternate approval if member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH: (a) No FDA labeled contraindications; AND (b) ONE of: (i) Another FDA labeled indication for agent and route, OR (ii) Another indication supported in compendia for agent and route, OR (iii) Prescriber submitted TWO peer-reviewed journal articles supporting proposed use.

Reauthorization criteria

• 1. Patient previously approved for the requested agent through plan’s PA process.
• 2. Patient has had clinical benefit with requested agent.
• 3. Prescriber is a specialist in the area of diagnosis or has consulted with specialist.
• 4. Patient has no FDA labeled contraindications to the requested agent.

Approval duration

12 months