ICER Report Estimates 50% Discount for Asthma Biologics to Be Cost-Effective

Severe asthmatics comprise a small (5%-10%) subset of the 26.5 million adults and children with asthma, but they account for approximately 50% of all asthma-associated costs. There are 5 FDA-approved monoclonal antibody treatments that affect the pathways involved in either the allergic or type 2 inflammatory phenotypes of asthma, and these 5 drugs are the focus of a new report from the Institute for Clinical and Economic Review (ICER).

In addition to treatment with inhaled corticosteroids and long-acting beta agonist therapy, patients with severe asthma are often treated with oral corticosteroids. About half of patients with severe asthma exhibit the type 2 phenotype with increases in T-helper 2 cells, which secrete interleukin (IL)-4, IL-5, and IL-13, which increase proliferation, survival, and recruitment of eosinophils and increase levels of immunoglobulin E (IgE).

The report, “Biologic Therapies for Treatment of Asthma Associated with Type 2 Inflammation: Effectiveness, Value, and Value-Based Price Benchmarks,” concludes that all 5 drugs modestly reduce asthma exacerbations and improve daily quality of life (QOL). However, the treatments’ net prices seem way out of alignment with these incremental clinical benefits, according to the report. “The entire therapy class would need to see price discounts of at least 50% to reach commonly cited thresholds for cost-effectiveness,” says David Rind, MD, chief medical officer of ICER.

The report focuses on the following 5 biologic medications currently approved for uncontrolled moderate to severe asthma:

• Dupilumab (Dupixent)
• Omalizumab (Xolair)
• Mepolizumab (Nucala)
• Reslizumab (Cinqair)
• Benralizumab (Fasenra)

The review concludes all 5 drugs are safe and effective and they all reduced the number of asthma exacerbations compared with placebo and modestly improved day-to-day QOL. A cost-effectiveness model was used to compare the 5 drugs, each to standard of care, for the treatment of moderate to severe uncontrolled asthma with evidence of type 2 inflammation in adults and children 6 years and older. Data from randomized clinical trials were used in the review, with a focus on clinical benefits (asthma exacerbations, emergency department visits, hospitalizations, and QOL) as well as potential harms (severe adverse events (AEs), AEs leading to discontinuation of therapy).

Among the key findings of the report:

• The available evidence provides moderate evidence that dupilumab, reslizumab, and benralizumab each provide an equivalent or better net benefit when used as an add-on maintenance treatment to standard of care.
• There is a high degree of certainty that both omalizumab and mepolizumab provide a small net benefit when added to standard of care.
• The evidence is insufficient to compare the clinical effectiveness of each treatment to the others.
• Patients value that dupilumab may be self-administered at home, whereas the other 4 biologics require administration by a healthcare professional. Omalizumab and reslizumab each carry a Black Box warning concerning anaphylaxis.
• Economic analyses assessing long-term cost-effectiveness found that all 5 medications far exceed commonly cited thresholds of $50,000-$150,000 per quality-adjusted life year (QALY) gained: $374,000 per QALY for dupilumab $325,000 per QALY for omalizumab $344,000 per QALY for mepolizumab $391,000 per QALY for reslizumab $371,000 per QALY for benralizumab

The report concludes that to align costs with the added benefits for patients, the current net prices of these treatments would need to be discounted between 50% and 79%.

The most important insight gained from speaking with patients was their desire to be able to perform their day-to-day tasks. Symptom relief, asthma control, and QOL matter much more than a reduction in asthma exacerbations. A majority of patients with severe asthma report having symptoms more than once per day and being burdened and frightened by their symptoms. They fear side effects of corticosteroids and want to minimize their use of both systemic and inhaled corticosteroids.

The most important factors for choosing a therapy for patients was found to be effectiveness and then cost. While effectiveness and cost were the most important factors for patients when choosing a therapy, effectiveness weighed more among the patients surveyed: an average of 82% responded that effectiveness was a key criterion, while an average of 52% cited cost as a key criterion.