IL-4 inhibitors — Blue Cross Blue Shield of Texas

Initial criteria

• The patient has submitted supporting clinical or compendia evidence demonstrating generally safe and effective use; acceptable study designs include randomized, double-blind, placebo-controlled clinical trials
• Non-oncology compendia evidence accepted: DrugDex level 1, 2A, or 2B; AHFS-DI supportive narrative text; Oncology compendia accepted: NCCN 1 or 2A; AHFS-DI supportive narrative text; DrugDex level 1, 2A, or 2B; Clinical Pharmacology (supportive text); LexiDrugs evidence level A; or supportive peer-reviewed literature

Reauthorization criteria

• Patient previously approved through prior authorization process for the requested agent AND
• ONE of the following:
• A. Diagnosis: moderate-to-severe atopic dermatitis AND BOTH: 1. Clinical benefit with requested agent AND 2. Continuation of standard maintenance therapies (e.g., topical emollients, good skin care) in combination
• OR B. Diagnosis: moderate-to-severe asthma AND BOTH: 1. Improvements or stabilization from baseline shown by ONE of: increased % predicted FEV1, decreased inhaled corticosteroid dose, decreased systemic corticosteroid need, or decreased hospitalizations/ER visits; AND 2. Patient currently treated within past 90 days and compliant with asthma control therapy (ICS, ICS/LABA, LTRA, LAMA, theophylline)
• OR C. Diagnosis: COPD AND BOTH: 1. Clinical benefit with requested agent AND 2. Patient currently treated within past 90 days and compliant with COPD inhaled maintenance therapy (ICS/LAMA/LABA triple therapy or LAMA/LABA dual therapy)
• OR D. Diagnosis: CRSwNP AND BOTH: 1. Clinical benefit with requested agent AND 2. Continuation of standard nasal polyp maintenance therapy (e.g., saline irrigation, intranasal corticosteroids such as fluticasone, mometasone, Sinuva)
• OR E. Diagnosis: Other than AD, asthma, COPD, or CRSwNP AND clinical benefit with requested agent
• AND Prescriber is a specialist in area of diagnosis (e.g., dermatologist, allergist, immunologist, pulmonologist, gastroenterologist, otolaryngologist) OR has consulted such specialist
• AND ONE of the following regarding concomitant therapy: A. Not used in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR B. If combined, then prescribing information does not limit such use AND there is supporting evidence for combination therapy (clinical trials or guidelines supplied)
• AND Patient does not have any FDA-labeled contraindications to the requested agent

Approval duration

12 months