IL-4 inhibitors — Blue Cross Blue Shield of Illinois

Initial criteria

• Supporting evidence submitted as generally safe and effective (randomized, double-blind, placebo-controlled clinical trials or acceptable compendia references).
• Non-oncology compendia allowed: DrugDex level 1, 2A, or 2B, or AHFS-DI with supportive narrative.
• Oncology compendia allowed: NCCN level 1 or 2A, AHFS-DI supportive narrative, DrugDex level 1, 2A, or 2B, Clinical Pharmacology supportive narrative, or LexiDrugs level A, or peer-reviewed literature.

Reauthorization criteria

• Previously approved for the requested agent through plan’s prior authorization process.
• AND ONE of the following:
• A. Atopic dermatitis (AD): patient has had clinical benefit with the requested agent AND will continue standard maintenance therapies (e.g., topical emollients, good skin care practices) in combination with the requested agent.
• B. Asthma: patient has had improvements or stabilization as indicated by ONE of the following: increase in % predicted FEV1 OR decrease in dose of inhaled corticosteroids required OR decrease in need for systemic corticosteroids OR fewer hospitalizations/mechanical ventilation/urgent or ER visits due to exacerbations; AND patient currently treated within past 90 days and compliant with asthma control therapy (ICS, ICS/LABA, LTRA, LAMA, theophylline).
• C. COPD: patient has had clinical benefit with the requested agent AND is currently treated within past 90 days and compliant with COPD inhaled maintenance therapy (ICS/LAMA/LABA triple therapy or LAMA/LABA dual therapy).
• D. CRSwNP: patient has had clinical benefit with the requested agent AND will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids such as fluticasone nasal spray, mometasone nasal spray, or Sinuva) in combination with the requested agent.
• E. Other diagnosis (not AD, asthma, COPD, or CRSwNP): patient has had clinical benefit with the requested agent.
• AND prescriber is a specialist in disease area or has consulted with a specialist.
• AND ONE of the following: patient will NOT use with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR combination use allowed only if prescribing information does not limit combination and clinical support (e.g., trial data) submitted.
• AND patient does not have any FDA-labeled contraindications to the requested agent.

Approval duration

12 months