Interleukin-4 (IL-4) Inhibitors — Blue Cross Blue Shield of Kansas

Initial criteria

• The patient has an FDA labeled contraindication to ALL long-acting beta-2 agonists (LABA) AND long-acting muscarinic antagonists (LAMA)
• The patient will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested agent
• If the patient has a diagnosis of eosinophilic esophagitis (EoE), the patient weighs ≥ 15 kg
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., AD, CSU, or PN: dermatologist, allergist, immunologist; asthma or COPD: allergist, immunologist, pulmonologist; CRSwNP: otolaryngologist, allergist, pulmonologist; EoE: allergist, immunologist, gastroenterologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• ONE of the following: (A) The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following: (1) The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND (2) There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required)
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• ONE of the following applies:
• A. For moderate-to-severe atopic dermatitis, BOTH of the following: (1) The patient has had clinical benefit with the requested agent AND (2) The patient will continue standard maintenance therapies (e.g., topical emollients, good skin care practices) in combination with the requested agent
• B. For moderate-to-severe asthma, BOTH of the following: (1) The patient has had improvements or stabilization with the requested agent from baseline as shown by ONE of the following: (A) increased FEV1 OR (B) decreased dose of inhaled corticosteroids OR (C) decreased need for systemic corticosteroids OR (D) decreased hospitalizations, need for mechanical ventilation, or emergency visits; AND (2) The patient is currently treated within the past 90 days and is compliant with asthma control therapy (ICS, ICS/LABA, LTRA, LAMA, theophylline)
• C. For COPD, BOTH of the following: (1) The patient has had clinical benefit with the requested agent AND (2) The patient is currently treated within the past 90 days and is compliant with COPD inhaled maintenance therapy (ICS/LAMA/LABA triple therapy, LAMA/LABA dual therapy)
• D. For CRSwNP, BOTH of the following: (1) The patient has had clinical benefit with the requested agent AND (2) The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids such as fluticasone nasal spray, mometasone nasal spray, Sinuva) in combination with the requested agent
• E. For all other indications, the patient has had clinical benefit with the requested agent
• The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with such a specialist
• ONE of the following: (A) The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following: (1) The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND (2) There is support for combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required)
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6 months (AD, asthma, CRSwNP, CSU, EoE, PN); 12 months (COPD, others)