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tapinarof cream 1 %Blue Cross Blue Shield of Oklahoma

other FDA labeled indications

Initial criteria

  • The patient has a diagnosis of plaque psoriasis AND BOTH of the following: 1. The patient's affected body surface area (BSA) ≤ 20% AND 2. ONE of the following: A. The patient has tried and had an inadequate response to a topical corticosteroid or topical calcineurin inhibitor used in the treatment of plaque psoriasis after at least a 2-week duration of therapy OR B. The patient has an intolerance or hypersensitivity to therapy with topical corticosteroids or topical calcineurin inhibitors used in the treatment of plaque psoriasis OR C. The patient has an FDA labeled contraindication to ALL topical corticosteroids and ALL topical calcineurin inhibitors used in the treatment of plaque psoriasis
  • OR The patient has a diagnosis of atopic dermatitis (AD) AND BOTH 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 or topical calcineurin inhibitor or topical emollients used in treatment of AD after at least a 4-week duration of therapy OR B. The patient has an intolerance or hypersensitivity to therapy with low-potency topical corticosteroid or topical calcineurin inhibitor used in treatment of AD OR C. The patient has an FDA labeled contraindication to ALL low-potency topical corticosteroid or topical calcineurin inhibitor used in treatment of AD AND 2. 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 The patient has another FDA labeled indication for the requested agent and route of administration
  • If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. There is support for using the requested agent for the patient’s age for the requested indication
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist) or has consulted with such a specialist
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • Additional approval for members in Ohio who are Fully Insured or HIM Shop (SG) AND BOTH of the following: A. The patient does NOT have any FDA labeled contraindications to the requested agent AND B. ONE of the following: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication that is supported in compendia for the requested agent and route of administration OR 3. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals supporting the proposed use(s) as generally safe and effective
  • Non-oncology compendia allowed: DrugDex level 1, 2A or 2B, AHFS-DI (supportive narrative text)
  • Oncology compendia allowed: NCCN 1 or 2A, AHFS-DI (supportive narrative text), DrugDex level 1, 2A, or 2B, Clinical Pharmacology (supportive narrative text), LexiDrugs evidence level A, or peer-reviewed medical literature

Reauthorization criteria

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

Approval duration

12 months (3 months for AD in certain plans)