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Empagliflozin in Heart Failure With Preserved Ejection Fraction

Compared in a cost-effectiveness analysis with standard of care for heart failure with preserved ejection fraction (HFpEF), empagliflozin provided low economic value because of its lack of effect on mortality and small benefit on quality of life, researchers conclude. The data come from the EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction) trial. The authors point out that the study’s inclusion and exclusion criteria limited the number of participants with NYHA class IV heart failure and speculated that “empagliflozin could provide intermediate value for super-utilizers—patients with the highest admission rates, longer hospital stays, and often disproportionate burden of illness due to medical and/or social complexity.”

A Markov model was used to estimate treatment efficacy, event probabilities, and utilities from EMPEROR-Preserved and published literature. The main outcome measures were hospitalizations for heart failure, life-years, quality-adjusted life-years (QALYs), lifetime costs, and lifetime incremental cost-effectiveness ratio. The 5,988 patients included in the analysis had a mean age of 72 years, NYHA class II to IV heart failure, and a left ventricular ejection fraction greater than 40%.

The results showed the following: “At the Federal Supply Schedule price of $327 per month, empagliflozin yielded 0.06 additional QALYs and $26,257 incremental costs compared with standard of care, producing a cost per QALY gained of $437,442. Incremental costs consisted of total drug costs of $29,586 and savings of $3,329 from reduced hospitalizations for heart failure. Cost-effectiveness was similar across subgroups. The results were most sensitive to the monthly cost, quality-of-life benefit, and mortality effect of empagliflozin. A price reduction to $153 per month, incremental utility of 0.02, or 8% reduction in cardiovascular mortality would bring empagliflozin to $180,000 per QALY gained, the threshold for intermediate value. Using Medicare Part D monthly pricing of $375 after rebates and $511 before rebates, empagliflozin would remain low value at $509,636 and $710,825 per QALY gained, respectively. Cost-effectiveness estimates were robust to variation in the frequency and disutility of heart failure hospitalizations.”

Source: JAMA Internal Medicine