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Prudoxin — Blue Cross Blue Shield of Alabama

other FDA labeled indications

Initial criteria

  • ONE of the following:
  • • The patient has a diagnosis of moderate pruritus associated with atopic dermatitis AND ONE of the following:
  • - The patient has tried and had an inadequate response to BOTH a topical corticosteroid used for a minimum of 4 weeks AND a topical calcineurin inhibitor used for a minimum of 6 weeks OR
  • - The patient has an intolerance or hypersensitivity to a topical corticosteroid AND a topical calcineurin inhibitor OR
  • - The patient has an FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors
  • • OR the patient has a diagnosis of moderate pruritus associated with lichen simplex chronicus AND ONE of the following:
  • - The patient has tried and had an inadequate response to ONE topical corticosteroid OR
  • - The patient has an intolerance or hypersensitivity to ONE topical corticosteroid OR
  • - The patient has an FDA labeled contraindication to ALL topical corticosteroids
  • • OR the patient has another FDA labeled indication for the requested agent OR another indication supported in compendia for the requested agent and route of administration
  • AND age criteria:
  • - If the patient has an FDA labeled indication, then ONE of the following: The patient's age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient's age
  • AND brand versus generic criteria:
  • - If the request is for a brand agent when a generic is available (Prudoxin cream or Zonalon cream vs doxepin hydrochloride cream 5%), then ONE of the following:
  • ▪ The patient has an intolerance or hypersensitivity to the generic that is not expected to occur with the brand agent OR
  • ▪ The patient has an FDA labeled contraindication to the generic that is not expected to occur with the brand agent OR
  • ▪ There is support for the use of the requested brand agent over the generic
  • AND combination and course limitations:
  • - The patient will NOT be using the requested agent in combination with another topical doxepin agent for the requested indication
  • - The patient has NOT already received 8 days of therapy with a topical doxepin agent for the current course of therapy
  • - The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

1 month for pruritus associated with atopic dermatitis or lichen simplex chronicus; 12 months for all other requests