A trial set out to determine whether empagliflozin can help prevent hospitalizations and extend life for patients with heart failure, while not hurting the US payers’ pockets.
Empagliflozin is a medication indicated for glucose control in patients with type 2 diabetes, but now, a study published in the Journal of the American Heart Association1 explores the drug’s efficiency in not only avoiding hospitalizations caused by heart failure (HF), but in extending and improving quality of life for adult patients in the United States who may have this condition with reduced ejection fraction.
HF is defined by economic burden, high mortality, and morbidity. In fact, National Health and Nutrition Examination Survey data from 2015–2018 indicates that approximately six million Americans aged 20 years or older have HF; due to an aging population, HF’s prevalence is anticipated to increase 46% from 2012 to 2030.
The EMPEROR‐reduced trial (empagliflozin outcome trial in patients with chronic heart failure and a reduced ejection fraction) sought to determine whether the addition of empagliflozin—a sodium-glucose cotransporter 2 inhibitor—to patients’ standard treatment plans produces health benefits at an acceptable cost to payers.
For the trial, investigators simulated data for a population with characteristics equal to the trial population, while the costs and health consequences for the length of the trial were all modeled. Any future costs and benefits were cut at 3% per year, a rate that is on par with the Second US Panel on Cost‐effectiveness in Health and Medicine recommendation.
Based on Kansas City cardiomyopathy questionnaire clinical summary score quartiles and death, investigators developed a five-state Markov cohort model that was able to simulate the lifetime progression of HF with reduced ejection fraction (HFrEF) by taking on the viewpoint of a third-party payer.
The model was able to predict the following from trial data:
Of the patient population, half of them had type 2 diabetes. Those with impaired kidney function could also participate if they had estimated glomerular filtration rate as low as 20 mL/min per 1.73 m2. Further, 62% of participants were 65 years of age or older.
The mean values of the EMPEROR‐reduced intent‐to‐treat population were applied at baseline. Subpopulations based on type 2 diabetes history, kidney impairment, and angiotensin receptor neprilysin inhibitor treatment use were run through the model in scenario analyses. The model also simulated commercially insured patients (less than 65 years old) and Medicare patients (65 years of age or older) populations separately. All patients had the same mean characteristics within each cohort.
Study results showed that the average life expectancy was 0.19 life years more in the base‐case (5.96 versus 5.77 years). There were also 18% fewer hospitalizations for HF and 6% fewer deaths for patients using empagliflozin plus standard of care versus standard care alone.
After adjusting for quality of life, the difference in lifetime health effects was 0.19 quality-adjusted life years, or QALY (4.36 QALYs for empagliflozin plus standard of care [SoC] versus 4.17 QALYs for SoC alone). Mean lifetime costs were $95,075 per patient treated with empagliflozin plus SoC (37% in pharmacy costs and 49% in clinical event management costs) and $78,260 per patient treated with SoC alone (19% in pharmacy costs and 65% in clinical event management costs), with a difference of $16,815 per patient. Compared with SoC alone, the treatment strategy of using empagliflozin added to SoC had an incremental cost‐effectiveness ratio of $87,725 per QALY.
As a result, the investigators concluded that “empagliflozin plus standard of care may prevent hospitalizations for heart failure, extend life, and increase quality‐adjusted life years for patients with heart failure with reduced ejection fraction at an acceptable cost for US payors.”
Reference
1. Reifsnider OS, Tafazzoli, A, Linden S, Ishak J Rakonczai P, Stargardter M, Kuti E.Cost‐Effectiveness Analysis of Empagliflozin for Treatment of Patients With Heart Failure With Reduced Ejection Fraction in the United States. Journal of the American Heart Association. https://www.ahajournals.org/doi/10.1161/JAHA.123.029042