Prudoxin — Blue Cross Blue Shield of Alabama

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