From Molecules to Markets
Broadening the Focus of Cardiovascular Innovation
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- heart failure
- medication adherence
See Article by Sangaralingham et al
On July 7, 2015, sacubitril/valsartan became the first angiotensin receptor-neprilysin inhibitor approved by the US Food and Drug Administration for use among patients with symptomatic heart failure with reduced ejection fraction (HFrEF). This expedited approval was based on the results of the PARADIGM-HF trial (Prospective Comparison of ARNI with ACE-I to Determine Impact on Global Mortality and Morbidity in Heart Failure) that showed that among patients with New York Heart Association class II–IV heart failure and ejection fraction ≤40%, treatment with sacubitril/valsartan rather than 10 mg twice daily of enalapril produced a 17.7% reduction in the composite end point of cardiovascular mortality and hospitalizations for heart failure. The study demonstrated a remarkable 19.4% reduction in death from cardiovascular causes and 17.9% reduction in heart failure hospitalizations among patients receiving sacubitril/valsartan compared with those receiving enalapril.1 Sacubitril/valsartan is the first new-in-class medication to demonstrate a mortality benefit in patients with HFrEF since the early 2000s.2 In this issue of Circulation: Heart Failure, Sangaralingham et al3 describe the early experience with sacubitril/valsartan among patients enrolled in private or Medicare Advantage insurance plans. Although slow uptake is par for the course for a first-in-class drug, this study reveals a disappointingly low prescription rate of sacubitril/valsartan among patients with HFrEF in the first 18 months after approval, and a high discontinuation rate among patients who initiate the drug. This disconnect between strong clinical data and low real-world uptake warrants further exploration.
Sangaralingham et al analyzed the OptumLabs database, a large collection of medical and pharmaceutical claims data, to evaluate prescription practices, drug costs, and medication use in individuals with HFrEF. In their cohort of 102 247 individuals with HFrEF (identified by International Classification of Diseases, Ninth Revision, codes), only 2244 (2.2%) filled a …