Adbry — Blue Cross Blue Shield of New Mexico

Initial criteria

• The patient is under age 18 years AND does NOT have any FDA labeled contraindications to the requested agent AND has an indication supported in TWO articles from major peer-reviewed professional medical journals AND there is support for the age in TWO articles corresponding to the patient’s age bracket OR
• ALL of the following: The member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND the patient does NOT have any FDA labeled contraindications to the requested agent AND ONE of: (a) patient has another FDA labeled indication, OR (b) patient has another compendia-supported indication, OR (c) prescriber has submitted TWO peer-reviewed journal articles supporting safety and effectiveness (acceptable designs: randomized, double-blind, placebo-controlled trials)
• Non-oncology compendia allowed: DrugDex level 1, 2A or 2B, AHFS-DI (narrative supportive); Oncology compendia allowed: NCCN 1 or 2A, AHFS-DI, DrugDex level 1, 2A, or 2B, Clinical Pharmacology, LexiDrugs level A, or peer-reviewed medical literature

Reauthorization criteria

• Patient previously approved through plan’s Prior Authorization process AND
• Diagnosis of moderate-to-severe atopic dermatitis AND BOTH of: (1) reduction or stabilization from baseline in affected body surface area, flares, pruritus, erythema, edema, xerosis, erosions/excoriations, oozing/crusting, lichenification, or a decrease in EASI or IGA score; AND (2) continued use of standard maintenance therapies (e.g., topical emollients, good skin care practices) OR
• Diagnosis other than moderate-to-severe atopic dermatitis AND clinical benefit demonstrated with requested agent AND
• If requested agent is Adbry for atopic dermatitis, then ONE of: (a) patient <18 years, OR (b) initiating therapy, OR (c) treated <16 consecutive weeks, OR (d) treated ≥16 weeks AND patient <100 kg and achieved or not achieved clear skin with dosing adjustment, OR (e) weight ≥100 kg
• Prescriber is a specialist (e.g., dermatologist, allergist, immunologist) or has consulted one AND
• The patient will NOT use the requested agent in combination with another immunomodulatory agent (TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR if combined, prescribing info does not limit combination and supporting data are provided AND
• No FDA labeled contraindications to the requested agent

Approval duration

12 months