Analysis: New labeling of sacubitril/valsartan could greatly expand eligible patients
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The new FDA labeling expansion of sacubitril/valsartan is positioned to increase the potential HF population eligible for the drug by up to 1.8 million individuals, according to a new analysis.
The findings also suggested that the therapy could potentially prevent or postpone up to 180,000 worsening HF events.
As Healio previously reported, in February, the FDA expanded labeling for sacubitril/valsartan (Entresto, Novartis) for use in individuals with chronic HF with left ventricular ejection fraction lower than normal. With this expanded indication, Muthiah Vaduganathan, MD, MPH, cardiologist at Brigham and Women’s Hospital and instructor in medicine at Harvard Medical School, and colleagues sought to quantify newly eligible treatment candidates, as well as apply treatment effects and the number needed to treat to prevent one worsening HF event from PARAGON-HF trial subgroups that fall under the revised labeling.
Their decision analytical model featured adult patients (n = 559,520) hospitalized from 2014 to 2019 in the Get With The Guidelines-Heart Failure registry and adults self-identifying with HF in the National Health and Nutrition Examination Survey from 2015 to 2018.
The primary outcome was the number of worsening HF events prevented or postponed if eligible patients were treated with sacubitril/valsartan for 3 years.
In all, the study included an estimated 4,682,098 patients (mean age, 66 years), of whom 43% were women and 16% were Black adults. According to the researchers, the potential number of adults projected to be newly eligible varied by the definition of FDA labeling of lower-than-normal LVEF from 643,161 (LVEF defined as 41% to 50%) to 1,838,756 (LVEF defined as 41% to 60%).
Data from the PARAGON-HF trial indicated that the number needed to treat to prevent a worsening HF event ranged from seven to 12 patients, and was consistent regardless of selected LVEF range.
Furthermore, after 3 years of treatment, researchers anticipated that comprehensive sacubitril/valsartan implementation would prevent or postpone up to 69,268 worsening HF events (for LVEF 41% to 50%) to 182,592 worsening HF events (for LVEF 41% to 60%).
“These estimates may help guide economic analyses and possibly encourage payer coverage of this effective therapeutic option,” the researchers wrote. “If prior implementation barriers to sacubitril/valsartan are swiftly overcome, population-level impact on worsening HF events in this high-risk population is certainly possible with a favorable safety/efficacy margin for most individuals. However, challenges based on access, cost and therapeutic inertia should not be underestimated.”
In an accompanying editorial, Clyde W. Yancy, MD, MSc, chief of cardiology, vice dean of diversity and inclusion and Magerstadt Endowed Professor of Medicine Chair at Northwestern University Feinberg School of Medicine and associate director of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital, wrote that the urgent need for effective therapies for HF with preserved ejection fraction cannot be discounted and that it is likely that sacubitril/valsartan is an appropriate new therapy for certain patients with HFpEF.
“Clinical implementation will resolve any residual uncertainties and will test the integrity of this evolved FDA evidence bar,” Yancy wrote. “Unfailingly, the correct approach remains further discovery science, but for now, a new, reasonably evidence-based therapy in HFpEF emerges, and for those patients with both the morbidity and mortality risks of HFpEF, hope is palpable.”
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