Wednesday, December 5, 2018

CER: Asthma Biologics Need 50% Cut to Be Cost Effective


Two PBMs' pharmacy chiefs tell AIS Health they agree with a new report by the Institute for Clinical and Economic Review (ICER), which finds that several biologic medications to treat uncontrolled moderate to severe asthma may modestly reduce disease exacerbations and improve quality of life. But the analysis also concludes that because the drugs are costly, the entire therapy class would need price discounts of at least 50% to be considered cost-effective.
The report focuses on the five FDA-approved monoclonal antibody therapies targeting pathways involved in either the allergic or type 2 inflammatory phenotypes of asthma in moderate to severe cases: Genentech's Xolair (omalizumab); GlaxoSmithKline's Nucala (mepolizumab); Teva's Cinqair (reslizumab); AstraZeneca's Fasenra (benralizumab); and Sanofi/Regeneron's Dupixent (dupilumab).
ICER says its review suggests these currently approved biologic medications are safe and effective. Yet, the report states, "None of the drugs prevented most exacerbations requiring systemic corticosteroids or improved average daily quality of life to a degree considered clinically significant. Thus, the net health benefit for all five drugs is at best incremental."
Meanwhile, the per-treatment wholesale acquisition cost among the five products ranges from $878.80 to $4,752.11, according to ICER, with annual treatment prices of between $27,800 and $31,000. "Due to high biologic treatment costs, the cost-effectiveness estimates did not meet commonly-cited cost-effectiveness thresholds," the report concludes.
"The study is well done and we agree with the findings," says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. "Like most biologics with marginal clinical benefit but associated with astronomical cost, theses biologics for asthma are also more of a last effort than they are a viable treatment option. For that reason we follow clinically solid, strict criteria to properly administer these products."
David Lassen, Pharm.D., chief clinical officer of Prime Therapeutics LLC, says the PBM's chief clinical concern with the biologics for asthma with type 2 inflammation is that "there isn't a definitive measure and/or biomarker to determine when and if there is a response to therapy with these products — and when/if therapy should be changed or adjusted."
"Additionally, we are concerned with lack of evidence on the long-term safety of these products," Lassen adds. "We believe more comparative effectiveness data is needed to clinically differentiate these products."

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