New Biological Therapies for Asthma: Do the Benefits Justify the Cost?
- Aruni S. Arachchige Don, PhD, Senior Consultant, Defined Health
- Ed Saltzman, Executive Chairman, Defined Health
- Dr. John Oppenheimer, FACAAI, MD, Director of Clinical Research at Pulmonary and Allergy Associates and Clinical Professor of Medicine at UMDNJ-Rutgers
GSK’s Nucala (mepolizumab), the first anti-IL-5 monoclonal antibody was launched in the US in January 2016 for use in severe, uncontrolled asthma at a price of $32,500/year, according to a recent Institute for Clinical and Economic Review (ICER) report. Teva promptly followed with Cinqair (reslizumab/IL-5), which was FDA approved on March 23, 2016 as an add-on for treatment of inadequately controlled severe asthma (also being reviewed by the EMA). Teva plans to launch the drug in the US in the 2Q of 2016, and has not yet announced a price. Other cytokine targeted biologics are in late phase development, including AstraZeneca’s benralizumab (IL-5) and tralokinumab (IL-13), Roche’s lebrikizumab (IL-13), and Sanofi/Regeneron’s dupilumab (IL-4).
While these new agents clearly represent a therapeutic advance, the introduction of expensive biologics into the asthma market also present unprecedented challenges for health care delivery systems, physicians, payers and patients. Only one biologic therapy has been previously developed and launched for asthma patients, the anti-IgE antibody, Xolair, and evidence that the drug is used disproportionately to the extent of its benefit is mounting. Moreover, Xolair, while expensive, is priced at roughly a third of the cost of the newer biologics.
The new biologics are targeted for a small subset of 5-10% of the broader asthma population (300MM people worldwide and 24MM or 8% of the US population) that account for 60% of the associated healthcare costs in asthma. Unfortunately, the newer biologics target the same overlapping patient population of steroid non-responders, and there is little guidance from developers or validated biomarkers to suggest which of these patients will benefit. Empirical therapy with drugs this costly is unlikely to be welcomed by payers, especially since a meaningful number of “non-responders” to first line therapy fail due to non-compliance. Complicating the matter is a recent cost-effectiveness analysis conducted by ICER, which concluded that Nucala should in fact be priced in the range of $7,800-12,000.
In this webinar, Defined Health and Dr. John Oppenheimer, FACAAI, MD, Director of Clinical Research at Pulmonary and Allergy Associates and Clinical Professor of Medicine at UMDNJ-Rutgers discuss the evolution of the use of biological therapies for management of steroid non-responsive asthma.