ICER Releases Draft Scoping Document on Biologics for Asthma

The Institute for Clinical and Economic Review (ICER) released a draft scoping document on new biologics for severe asthma. Public comment on the draft is open until June 5. The review will focus on adults and children 6 years and older with moderate to severe uncontrolled asthma and evidence of Type 2 inflammation.

Severe asthma is defined as asthma that requires either oral corticosteroids for more than half of the year or the combination of high-dose inhaled corticosteroids and a long-acting beta agonist or other controller medication (leukotriene inhibitor/theophylline) to maintain control. Uncontrolled asthma is defined by at least 1 of the following: frequent exacerbations, serious exacerbations, or airflow limitation.

The assessment will consider 5 monoclonal antibodies that alter the pathways involved in the type 2 inflammatory phenotype of asthma. About half of individuals with severe asthma exhibit the Type 2 phenotype with increases in T helper 2 cells, increased signaling in the interleukin (IL)-4, IL-5, and IL-13 pathways, and increased eosinophils in both the blood and airways.

The asthma drugs to be reviewed are:

• Omalizumab (Xolair, Genentech/Novartis)
• Mepolizumab (Nucala, GlaxoSmithKline)
• Reslizumab (Cinqair, Teva)
• Benralizumab (Fasenra, AstraZeneca)
• Dupilumab (Dupixent, Sanofi/Regeneron), which is not yet approved for asthma

ICER said its value framework includes both quantitative and qualitative comparisons across treatments to ensure that the full range of benefits and harms when making decisions about the clinical and economic value of the interventions. The review will include outcomes such as:

• Health-related quality of life
• Asthma symptom control
• Days in school
• Days at work
• Asthma exacerbations
• Emergency department visits
• Hospitalizations
• Steroid-related complications
• Mortality

The comparators of interest will be daily inhaled corticosteroids plus at least 1 additional controller therapy, or daily inhaled corticosteroids plus at least 1 additional controller therapy and 1 of the other biologics listed.

As is customary in ICER reviews, the analysis will assess the cost-effectiveness of each intervention added to standard of care as compared to standard of care alone. The incremental costs per outcomes will be looked at from a health system perspective.