Abstract 019: Real-World Use of Sacubitril/ Valsartan in Heart Failure in the First Year Following FDA Approval

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Abstract

Background: In July 2015, the FDA approved the use of sacubitril/ valsartan in patients with heart failure (HF) and reduced ejection fraction. It was shown in a large clinical trial to reduce the risk of both hospitalization and death compared with enalapril, and has since received a class I recommendation for use in the 2016 ACC/ AHA HF guidelines. However, the use of sacubitril/ valsartan in a clinical practice has not been described. We aimed to assess the uptake and cost of sacubitril/ valsartan in its first year following FDA approval.

Methods: Using a large U.S. insurance database, we identified privately insured and Medicare Advantage (MA) patients who filled a first prescription for sacubitril/ valsartan between July 1, 2015 and July 31, 2016. We restricted to persons with medical and pharmacy enrollment for 6 months prior to first fill. For reference, we identified all individuals with a diagnosis of HF on a billing claim (ICD9 428.X or ICD-10 I50.X) in the same time period.

Results: There were 314,410 individuals with a diagnosis of HF in the study period. In total, 972 filled a new prescription for sacubitril/ valsartan, and the number of new users steadily increased over time (Figure). The mean age of sacubitril/ valsartan users was 68.1±12.3 years, 32.5% were women, 61.1% were white, and 77% were enrolled in MA plans. Most prescribing clinicians were cardiologists (82.5%). A majority of prescription costs were covered by the health plan (mean $324.05, median $335.38, interquartile range [IQR] $266.56-$370.10). Out-of-pocket (OOP) costs per 30-day prescription filled were variable (mean $101.53, median $45.00, IQR $7.40-$97.49), and were similar in beneficiaries enrolled in MA and commercial plans. By comparison, median OOP costs were $2-4 for lisinopril, losartan, carvedilol, and spironolactone per 30-day prescription.

Discussion: These finding suggest that the uptake of sacubitril/ valsartan has been slow in the first year after FDA approval. While the majority of prescription costs are covered by the health plan, OOP costs are still much higher than other guideline-recommended HF medications. Further studies are needed to determine if uptake of sacubril/ valsartan continues to rise and if the higher prescription cost is associated with lower downstream costs of hospitalization and mortality benefit.

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