Assessing the Cost-Effectiveness of Sacubitril/Valsartan in Chronic Heart Failure Based on Ejection Fraction

Data from an analysis presented at the American College of Cardiology’s 71st Annual Scientific Sessions details the cost-effectiveness of sacubitril/valsartan (Entresto) in patients with chronic heart failure and an ejection fraction below normal.

Using data from the PARADIGM-HF and PARAGON-HF trials along with Get With the Guidelines-HF Registry, results of the analysis demonstrate sacubitril/valsartan maintains cost-effectiveness and would increase quality-adjusted life years (QALY) at an incremental cost-effectiveness ratio (ICER) similar to that of other pharmacologic interventions in heart failure, with the most benefit observed in those on the lower end of the spectrum of ejection fraction.

With the FDA label for sacubitril/valsartan failing to clearly define ‘below normal’, it has left some in cardiology unsure of the potential benefit in some patients with more elevated ejection fractions. With this in mind, investigators designed their study with the intent of using the language of the FDA label to explore the cost-effectiveness of sacubitril/valsartan at different cost thresholds and across multiple ranges of ejection fraction.

For the purpose of analysis, investigators used a 5-state Markov model to estimate the cost-effectiveness of sacubitril/valsartan against renin-angiotensin system inhibitors using probabilities and risk reductions observed in the PARAGON-HF and PARADIGM-HF trials, with differences in quality of life estimated using Euro-QoL EQ-5D scores. The wholesale acquisition cost of sacubitril/valsartan was estimated at $7092 per year, with sensitivity analyses conducted to reflect changes based on a 50% drop in price and a 20% increase. Investigators noted independent risk estimates were generated in consecutive 5% LVEF increments beginning at 45% and up to 60% and applied to the distribution of patients in the GWTG-HF registry.

Results suggested sacubitril/valsartan was projected to add 0.53 QALYs at an incremental lifetime cost of $40,892 compared with renin-angiotensin system inhibitors, yielding an ICER of $76,952 per QALY, for patients with an ejection fraction below 60%. For patients with ejection fractions at 55% or less, 50% or less, and 45% or less, the ICERS were $67,331, $59,614, and $56,786 per QALY. In a probabilistic sensitivity analysis, results indicated 95% of the values for the ICER of sacubitril/valsartan compared against renin-angiotensin system inhibitors in patients with an ejection fraction of 60% or below occurred between $71,516 and $82,970 per QALY.

With an interest in learning more about the results of this study and how it might inform care, we reached out to study author and Practical Cardiology advisory board member Muthiah Vaduganathan, MD, MPH, a cardiologist at Brigham and Women’s Hospital, for more insight.

This study, “Cost-Effectiveness of Sacubitril/Valsartan in Chronic Heart Failure at Ejection Fraction Ranges Below Normal: A Pooled Analysis from PARADIGM-HF and PARAGON-HF,” was presented at ACC.22.