Adbry — Blue Cross Blue Shield of Texas

off-label use (Ohio fully insured or HIM Shop plans)

Initial criteria

Patient age < 18 years AND
No FDA labeled contraindications to the requested agent AND
Indication supported in TWO articles from major peer-reviewed professional medical journals as generally safe and effective (randomized, double blind, placebo controlled) AND
Support for the patient’s age bracket in TWO peer-reviewed articles demonstrating safety and efficacy (infancy, childhood, adolescence)
OR ALL of the following:
Member resides in Ohio AND
Plan is Fully Insured or HIM Shop (SG) AND
No FDA labeled contraindications to the requested agent AND
ONE of the following:
Patient has another FDA labeled indication for the requested agent and route of administration OR
Patient has another indication supported in compendia (DrugDex level 1, 2A or 2B, AHFS-DI supportive narrative, or appropriate oncology compendia) OR
Prescriber submitted TWO major peer-reviewed journal articles supporting the proposed use as generally safe and effective (randomized, double blind, placebo controlled; no case studies)

Previously approved through plan’s Prior Authorization process AND
ONE of the following:
A. Diagnosis of moderate-to-severe atopic dermatitis AND BOTH of the following:
1. Reduction or stabilization from baseline in ONE of the following: affected body surface area, flares, or pruritus/erythema/edema/xerosis/erosions/oozing/lichenification, or decrease in EASI or IGA score AND
2. Continued use of standard maintenance therapies (e.g., topical emollients, good skin care) with requested agent OR
B. Diagnosis other than moderate-to-severe atopic dermatitis AND has had clinical benefit with the requested agent AND
If requested agent is Adbry for atopic dermatitis, then ONE of the following:
Patient age < 18 years OR
Patient initiating therapy OR
Treatment for < 16 consecutive weeks OR
Treatment ≥ 16 consecutive weeks AND:
If weight < 100 kg: achieved clear or almost clear skin and dose reduced to 300 mg every 4 weeks OR not achieved clear/almost clear skin OR support for therapy using 300 mg every 2 weeks OR
If weight ≥ 100 kg
Prescriber is a specialist (e.g., dermatologist, allergist, immunologist) or has consulted a specialist AND
Either not used with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR if used concomitantly, the prescribing information does not limit and clinical evidence supports combination therapy AND
No FDA labeled contraindications to the requested agent

12 months