Prudoxin — Blue Cross Blue Shield of New Mexico

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 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
• 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
• If the request is for one of the following brand agents with an available generic (Prudoxin cream, Zonalon cream, doxepin hydrochloride cream 5%), then ONE of the following: A. The patient is currently being treated with the requested agent and is stable [chart notes required] OR B. Tried and had an inadequate response to the generic [chart notes required] OR C. The generic was discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required] OR D. The patient has an intolerance or hypersensitivity to the generic not expected to occur with the brand agent [chart notes required] OR E. The patient has an FDA labeled contraindication to the generic not expected to occur with the brand agent [chart notes required] OR F. The generic is expected to be ineffective or cause adherence barriers, worsen a comorbid condition, or cause harm [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 prescription drug in the same pharmacologic class or mechanism of action as the generic and discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required] OR I. There is support for the use of the requested brand agent over the generic
• 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

3 months (BCBSNM pruritus indications) or 12 months (other requests)