Prudoxin — Blue Cross Blue Shield of Texas

Initial criteria

• 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 ≥ 4 weeks AND a topical calcineurin inhibitor used for ≥ 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
• If the patient has an FDA labeled indication, ONE of the following:
• A. The patient’s age is within FDA labeling for the requested indication OR
• B. There is support for using the requested agent for the patient’s age for the requested indication AND
• If the request is for one of the following brand agents with an available generic (Prudoxin cream; Zonalon cream doxepin hydrochloride cream 5%), ONE of the following:
• A. The patient is currently being treated with the requested agent and stable on the requested agent [chart notes required] OR
• B. The patient has tried and had an inadequate response to the generic [chart notes required] OR
• C. The generic was discontinued due to lack of efficacy or adverse event [chart notes required] OR
• D. The patient has an intolerance or hypersensitivity to the generic not expected with the brand [chart notes required] OR
• E. The patient has an FDA labeled contraindication to the generic not expected with the brand [chart notes required] OR
• F. The generic is expected to be ineffective or cause harm/adherence issues [chart notes required] OR
• G. The generic is not in the best interest of the patient based on medical necessity [chart notes required] OR
• H. The patient has tried another drug in the same pharmacologic class/mechanism and it was discontinued for lack of efficacy/adverse event [chart notes required] OR
• I. There is support for the use of the requested brand agent over the generic AND
• The patient will NOT use the requested agent in combination with another topical doxepin agent for the same indication AND
• The patient has NOT already received more than 8 days of therapy with a topical doxepin agent for the current course AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

1–12 months (plan-specific: BCBSIL/BCBSMT 12 months; BCBSNM pruritus 3 months, others 12 months; all other plans pruritus 1 month, others 12 months)