Zonalon — Blue Cross Blue Shield of Kansas

Initial criteria

• 1. ONE of the following:
• A. The patient has a diagnosis of moderate pruritus associated with atopic dermatitis AND ONE of the following:
• 1. 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
• 2. The patient has an intolerance or hypersensitivity to a topical corticosteroid AND a topical calcineurin inhibitor OR
• 3. The patient has an FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors OR
• B. The patient has a diagnosis of moderate pruritus associated with lichen simplex chronicus AND ONE of the following:
• 1. The patient has tried and had an inadequate response to ONE topical corticosteroid OR
• 2. The patient has an intolerance or hypersensitivity to ONE topical corticosteroid OR
• 3. The patient has an FDA labeled contraindication to ALL topical corticosteroids OR
• C. The patient has another FDA labeled indication for the requested agent and route of administration OR
• D. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
• 2. 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 AND
• 3. If the request is for Prudoxin cream or Zonalon cream with available generic doxepin hydrochloride cream 5%, then ONE of the following:
• A. The patient has an intolerance or hypersensitivity to the generic that is not expected to occur with the brand agent OR
• B. The patient has an FDA labeled contraindication to the generic that is not expected to occur with the brand agent OR
• C. There is clinical support for the use of the requested brand agent over the generic AND
• 4. The patient will NOT be using the requested agent in combination with another topical doxepin agent for the requested indication AND
• 5. The patient has NOT already received 8 days of therapy with a topical doxepin agent for the current course of therapy AND
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

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