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FDA Approves Entresto for the Treatment of Heart Failure
Citation: Annals of Long-Term Care: Clinical Care and Aging. 2015;23(8):47
Entresto has been approved by the FDA to help fight heart failure. The drug is a tablet pill manufactured by Novartis and has been shown to reduce the rate of cardiovascular death and hospitalization due to heart failure (https://1.usa.gov/1Uxv4Dv).
Heart failure is a pervasive condition in the United States, contributing to about 5.1 million deaths per year and costing a collective $32 billion.1,2 One in every nine deaths in 2009 included heart failure as a contributing cause.1 Symptoms occur when the heart cannot pump enough blood and oxygen to support the other organs within one’s body and is most often seen in those with high blood pressure, diabetes, or coronary heart disease.
Entresto was evaluated under the FDA’s priority review program, which provides fast-track reviews for drugs that are intended to treat a serious condition and may offer significant treatment upgrades from other available products. Entresto was studied in a trial of more than 8000 participants and was associated with greater reductions in the rates of hospitalization and death in conditions with and relating to heart failure compared with another drug, enalapril. Patients also received a number of other treatments while on Entresto. Side effects noted during the study included low blood pressure, high potassium levels, and poor function of the kidneys. Angioedema, an allergic reaction usually presenting as swelling of the lips or face, was also reported. African-American patients and those with a prior history of angioedema have higher risks of this adverse event. Entresto should not be considered for patients who may be pregnant.
Novartis is offering a pay-for-performance plan for Entresto, in which insurers will pay an initial fee for the drug followed by a second, higher fee if the drug proves to be successful. Therefore, the cost of the drug to patients and insurers will relate to how the drug performs in each individual case. The move comes at a time when pharmaceutical companies are experiencing pricing backlash from consumers as drug prices continue to rise. —Sean McGuire
References:
1. Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127:e6–e245.
2. Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933–944.
