doxepin hydrochloride cream 5% — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following: (A) diagnosis of moderate pruritus associated with atopic dermatitis AND ONE of the following: (1) tried and inadequate response to BOTH a topical corticosteroid (≥4 weeks) AND a topical calcineurin inhibitor (≥6 weeks) OR (2) intolerance or hypersensitivity to both a topical corticosteroid AND a topical calcineurin inhibitor OR (3) FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors
• (B) diagnosis of moderate pruritus associated with lichen simplex chronicus AND ONE of the following: (1) tried and 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) has another FDA labeled indication for the requested agent and route of administration
• (D) has another indication supported in compendia for the requested agent and route of administration
• If FDA labeled indication: ONE of the following: (A) age within FDA labeling OR (B) support for use at patient’s age
• If request is for brand with an available generic: ONE of the following: (A) currently treated and stable on brand OR (B) tried and inadequate response to generic OR (C) generic discontinued due to lack of efficacy, diminished effect, or adverse event OR (D) intolerance/hypersensitivity to generic not expected with brand OR (E) FDA labeled contraindication to generic not expected with brand OR (F) generic expected to be ineffective based on clinical characteristics/adherence barriers/comorbid condition/functional ability/adverse reaction OR (G) generic not in best interest of patient based on medical necessity OR (H) tried another drug in same pharmacologic class/mechanism discontinued for lack of efficacy/diminished effect/adverse event OR (I) support for use of brand agent over generic
• Will NOT use requested agent in combination with another topical doxepin for same indication
• Has NOT already received 8 days of topical doxepin therapy for current course
• Has NO FDA labeled contraindications to requested agent

Reauthorization criteria

• Same criteria as initial; continued medical necessity and no contraindications

Approval duration

BCBSMT: 12 months; BCBSNM: 3 months for pruritus associated with atopic dermatitis or lichen simplex chronicus, else 12 months; all other plans: 1 month for pruritus associated with atopic dermatitis or lichen simplex chronicus, else 12 months