roflumilast foam 0.3% — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following: (A) Diagnosis of mild to moderate atopic dermatitis (AD) AND ALL of the following: (1) ONE of the following: (A) Patient has tried and had an inadequate response to at least a low-potency topical corticosteroid used in the treatment of AD after at least 4-week duration of therapy OR (B) Patient has an intolerance or hypersensitivity to at least a low-potency topical corticosteroid used in treatment of AD OR (C) Patient has an FDA labeled contraindication to ALL topical corticosteroids used in treatment of AD; AND (2) ONE of the following: (A) Patient has tried and had an inadequate response to a topical calcineurin inhibitor used in treatment of AD after at least a 6-week duration of therapy OR (B) Intolerance or hypersensitivity to topical calcineurin inhibitor OR (C) FDA labeled contraindication to ALL topical calcineurin inhibitors used in treatment of AD; AND (3) BOTH of the following: (A) Patient is currently treated with topical emollients and practicing good skin care AND (B) Patient will continue topical emollients and good skin care in combination with requested agent
• OR (B) Diagnosis of plaque psoriasis AND BOTH of the following: (1) Patient's affected body surface area ≤ 20% AND (2) ONE of the following: (A) Tried and had inadequate response to topical corticosteroid used in treatment of plaque psoriasis after at least 2-week duration of therapy or a topical calcineurin inhibitor OR (B) Intolerance or hypersensitivity to therapy with topical corticosteroid or topical calcineurin inhibitor OR (C) FDA labeled contraindication to ALL topical corticosteroids AND ALL topical calcineurin inhibitors used in treatment of plaque psoriasis
• OR (C) Diagnosis of seborrheic dermatitis AND ONE of the following: (1) BOTH of the following: (A) ONE of the following: (1) Prescriber states patient has stage four advanced, metastatic cancer and requested agent is being used to treat the cancer OR (2) Documentation that patient has stage four advanced, metastatic cancer and requested agent is used to treat associated condition; AND (B) Use of requested agent is consistent with best practices for treatment of stage four advanced, metastatic cancer or associated condition; OR (2) BOTH of the following: (1) ONE of the following: (A) Patient has tried and had inadequate response to ONE topical antifungal OR ONE topical corticosteroid used in treatment of seborrheic dermatitis OR (B) Intolerance or hypersensitivity to ONE topical antifungal OR ONE topical corticosteroid used in treatment of seborrheic dermatitis OR (C) FDA labeled contraindication to ALL topical antifungals AND topical corticosteroids used in treatment of seborrheic dermatitis; AND (2) ONE of the following: (A) Patient has seborrheic dermatitis of the scalp OR (B) Patient has tried and had inadequate response to ONE topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) OR (C) Intolerance or hypersensitivity to ONE topical calcineurin inhibitor OR (D) FDA labeled contraindication to ALL topical calcineurin inhibitors used in treatment of seborrheic dermatitis
• OR (D) Patient has another FDA labeled indication for the requested agent and route of administration AND BOTH of the following: (1) ONE of the following: (A) Patient’s age is within FDA labeling for requested indication OR (B) Support exists for using requested agent for patient’s age; AND (2) Requested dosage form and strength of Zoryve is FDA labeled for requested indication
• AND Prescriber is a specialist in area of patient’s diagnosis (e.g., dermatologist) or has consulted with a specialist
• AND Patient does NOT have any FDA labeled contraindications to requested agent
• Additional approval pathway: Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND (a) Patient does NOT have FDA labeled contraindications AND (b) ONE of the following: (i) Patient has another FDA labeled indication and route; OR (ii) Indication supported in compendia; OR (iii) Prescriber submitted TWO peer-reviewed journal articles supporting use

Reauthorization criteria

• Patient has been previously approved for requested agent through plan’s Prior Authorization process
• Patient has had clinical benefit with requested agent
• Prescriber is a specialist in area of patient’s diagnosis (e.g., dermatologist) or has consulted with a specialist
• Patient does NOT have any FDA labeled contraindications to requested agent

Approval duration

12 months