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roflumilast cream 0.15% — Blue Cross Blue Shield of Montana

seborrheic dermatitis

Initial criteria

  • 1. ONE of the following:
  • A. The patient has a diagnosis of mild to moderate atopic dermatitis (AD) AND ALL of the following:
  • 1. ONE of the following: (a) The 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 a 4-week duration of therapy OR (b) The patient has an intolerance or hypersensitivity to at least a low-potency topical corticosteroid used in the treatment of AD OR (c) The patient has an FDA labeled contraindication to ALL topical corticosteroids used in the treatment of AD AND
  • 2. ONE of the following: (a) The patient has tried and had an inadequate response to a topical calcineurin inhibitor used in the treatment of AD after at least a 6-week duration of therapy OR (b) The patient has an intolerance or hypersensitivity to a topical calcineurin inhibitor used in the treatment of AD OR (c) The patient has an FDA labeled contraindication to ALL topical calcineurin inhibitors used in the treatment of AD AND
  • 3. BOTH of the following: (a) The patient is currently treated with topical emollients and practicing good skin care AND (b) The patient will continue the use of topical emollients and good skin care practices in combination with the requested agent OR
  • B. The patient has a diagnosis of plaque psoriasis AND BOTH of the following: (1) The patient's affected body surface area (BSA) is ≤ 20% AND (2) ONE of the following: (a) The patient has tried and had an inadequate response to a topical corticosteroid used in the treatment of plaque psoriasis after at least a 2-week duration of therapy OR a topical calcineurin inhibitor OR (b) The patient has an intolerance or hypersensitivity to therapy with a topical corticosteroid used in the treatment of plaque psoriasis OR a topical calcineurin inhibitor OR (c) The patient has an FDA labeled contraindication to ALL topical corticosteroids used in the treatment of plaque psoriasis AND ALL topical calcineurin inhibitors OR
  • C. The patient has a diagnosis of seborrheic dermatitis AND ONE of the following: (1) BOTH of the following: (A) ONE of the following: (1) The prescriber has stated or documented the patient has stage four advanced metastatic cancer and the requested agent is being used to treat the cancer or related condition AND (B) The use is consistent with best practices, supported by evidence-based literature, and FDA approved OR (2) BOTH of the following: (1) ONE of the following: (A) The patient has tried and had an inadequate response to ONE topical antifungal OR ONE topical corticosteroid used in the treatment of seborrheic dermatitis OR (B) The patient has an intolerance or hypersensitivity to ONE topical antifungal OR ONE topical corticosteroid OR (C) The patient has an FDA labeled contraindication to ALL topical antifungals AND topical corticosteroids AND (2) ONE of the following: (A) The patient has seborrheic dermatitis of the scalp OR (B) The patient has tried and had an inadequate response to ONE topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) OR (C) The patient has an intolerance or hypersensitivity to ONE topical calcineurin inhibitor OR (D) The patient has an FDA labeled contraindication to ALL topical calcineurin inhibitors OR
  • D. The 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) The patient’s age is within FDA labeling for the requested indication OR (B) There is support for the requested agent use for the patient’s age AND (2) The requested dosage form and strength is FDA labeled for the requested indication AND
  • 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist) or has consulted with one AND
  • 4. The patient does NOT have any FDA labeled contraindications to the requested agent
  • For members residing in Ohio and plans Fully Insured or HIM Shop (SG): The patient does not have contraindications AND one of the following: (i) has another FDA labeled indication for the agent and route of administration OR (ii) has another indication supported in compendia OR (iii) prescriber has submitted two peer-reviewed journal articles supporting safety and efficacy.

Reauthorization criteria

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

Approval duration

12 months; for AD or seborrheic dermatitis: BCBSIL 12 months, all other plans 3 months; plaque psoriasis 12 months; all other FDA labeled indications 12 months