Prudoxin — Blue Cross Blue Shield of Oklahoma

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. Tried and had an inadequate response to BOTH a topical corticosteroid used ≥ 4 weeks AND a topical calcineurin inhibitor used ≥ 6 weeks OR
• 2. Intolerance or hypersensitivity to a topical corticosteroid AND a topical calcineurin inhibitor OR
• 3. FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors
• B. The patient has a diagnosis of moderate pruritus associated with lichen simplex chronicus AND ONE of the following:
• 1. Tried and had an inadequate response to ONE topical corticosteroid OR
• 2. Intolerance or hypersensitivity to ONE topical corticosteroid OR
• 3. FDA labeled contraindication to ALL topical corticosteroids
• 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
• 2. If the patient has an FDA labeled indication, ONE of the following:
• A. Age within FDA labeling for requested indication OR
• B. Support for using the agent at patient’s age
• 3. If requesting brand agent with an available generic, ONE of the following:
• A. Patient currently treated with and stable on requested brand agent (chart notes required) OR
• B. Tried and had an inadequate response to generic (chart notes required) OR
• C. Generic discontinued due to inefficacy or adverse event (chart notes required) OR
• D. Intolerance or hypersensitivity to generic not expected with brand (chart notes required) OR
• E. FDA labeled contraindication to generic not expected with brand (chart notes required) OR
• F. Generic expected to be ineffective, cause adherence issues, worsen comorbid condition, reduce functional ability, or cause harm (chart notes required) OR
• G. Generic not in patient’s best interest based on medical necessity (chart notes required) OR
• H. Tried another drug in same pharmacologic class with inadequate response or adverse event (chart notes required) OR
• I. Support for use of requested brand agent over generic
• 4. Patient will NOT use requested agent in combination with another topical doxepin for same indication
• 5. Patient has NOT already received more than 8 days of topical doxepin therapy for current course
• 6. Patient does NOT have any FDA labeled contraindications to requested agent
• Compendia Allowed: AHFS or DrugDex 1, 2a, or 2b

Approval duration

BCBSIL & BCBSMT: 12 months; BCBSNM: 3 months for atopic dermatitis or lichen simplex chronicus, otherwise 12 months; All other plans: 1 month for atopic dermatitis or lichen simplex chronicus, otherwise 12 months