Analyses show cost-effectiveness, value of oral heart failure medication

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If all eligible patients with heart failure and reduced ejection fraction received sacubitril/valsartan (Entresto) at an optimal level, the U.S. could prevent an estimated 28,484 deaths per year, according to a recent study.

Another analysis based on a simulated model found that sacubitril/valsartan was cost effective for eligible patients. The researchers added that the drug’s incremental cost-effectiveness ratio (ICER) was consistent with other high-value options such as cholesterol-lowering agents and implantable cardioverter-defibrillators.

Both trials were published online in JAMA Cardiology on June 22.

In July 2015, the FDA approved sacubitril/valsartan, a twice-daily oral medication for patients with New York Heart Association (NYHA) class II to IV heart failure. The drug is part of a class of medications known as ARNIs (angiotensin receptor neprilysin inhibitors).

Although the drug was projected to be a blockbuster for Novartis, the company generated only $17 million in sales for sacubitril/valsartan during the first quarter of 2016.

However, in May, major medical societies in the U.S. and Europe gave sacubitril/valsartan a Class I recommendation, which could help increase the sales of the medication. GlobalData, a research and consulting firm, estimates that sales of sacubitril/valsartan could reach $5.1 billion in 2022.

For the recent JAMA Cardiology evaluation on preventable deaths, lead researcher Gregg C. Fonarow, MD, and colleagues estimated that 84 percent of U.S. patients with heart failure and reduced ejection fraction would be candidates to take sacubitril/valsartan. They used data from the PARADIGM-HF trial, the American Heart Association and other sources to develop the estimate.

They found that the number needed to treat one death was 80.3. Further, sensitivity analyses showed that the number of deaths that could be prevented each year with optimal use of sacubitril/valsartan ranged from 18,230 to 41,017.

“These findings have significant clinical and public health implications, providing the first quantification of the magnitude of the survival benefits at the population level that may result from full implementation of ARNI therapy for patients with [heart failure and reduced ejection fraction],” the researchers wrote.

For the cost-effectiveness analysis, lead researcher Thomas A. Gaziano, MD, MSc, and colleagues developed a 2-state Markov model that simulated heart failure using data derived from patients in the PARADIGM-HF trial. In that study, patients were randomized to receive sacubitril/valsartan or enalapril.

The researchers accounted for the costs of the medications and the costs associated with hospitalizations following treatment. The wholesale acquisition cost was $375 per month for sacubitril/valsartan and $0.96 per month for enalapril, while the mean cost of hospitalization was $18,158 for heart failure and $10,467 for non-heart failure.

Based on the model, the researchers estimated that the cost per patient over an average life expectancy would be $83,300 if they receive enalapril and $118,500 if they receive sacubitril/valsartan. After they adjusted for quality of life, they projected that using sacubitril/valsartan would have an ICER of $45,017 per quality-adjusted-life-year (QALY) gained. Meanwhile, sensitivity analyses showed that the ICER ranged from $35,357 to $75,301 per QALY gained.

“The ICER of $45,017 per QALY is not only below standard-accepted levels for evaluations of new therapies and interventions, its value also compares well with other accepted cardiovascular therapies when they were first adopted or approved,” the researchers wrote.