Nihar Desai, MD, MPH, discusses the results of a study presented at AHA 22 examining the potential impact of omecamtiv mecarbil use on outcomes and healthcare resource utilization based on data from the GALACTIC-HF trial.
Leveraging data from the GALACTIC-HF trial, a new analysis is shedding light on the potential impact of an approval and uptake of omecamtiv mecarbil as well as a potential patient population who might benefit most from use among patients with heart failure in North America.
Presented at the American Heart Association’s 2022 Scientific Sessions, results of the study demonstrate use of omecamtiv mecarbil was associated with a significant reduction in heart failure events, with corresponding reductions in costs for such events, among a population of North America patients with heart failure with reduced ejection fraction and without digoxin and atrial fibrillation.
Led by Nihar Desai, MD, MPH, associate professor of medicine at Yale School of Medicine, the current research endeavor was launched with the intent of examining resource use, timing, and heart failure event costs for patients treated with omecamtiv mecarbil based on the results and population used int the GALACTIC-HF from North America. With this in mind, investigators designed their study to estimate the risk of first and total heart failure events and events at 30 days post-randomization and later, with the treatment effect based on a subgroup of patients from the GALACTIC-HF trial considered most likely to benefit from omecamtiv mecarbil, which was patients with an ejection fraction of 30% or less not receiving digoxin and without a diagnosis of atrial fibrillation at baseline. For cost, investigators applied US costs per heart failure event from previously published studies, with adjustment for inflation to 2021 USD.
From the 8232-patient trial, 16.8% (n=1386) were from North America, with 1220 of these from the US. Among these patients, 4.6% had baseline digoxin use and atrial fibrillation and 78.6% had an ejection fraction of 30% or less and were not receiving digoxin or have a diagnosis of atrial fibrillation at baseline. In the subgroup of those without baseline digoxin use or atrial fibrillation, use of omecamtiv mecarbil was associated with a reduced risk of first heart failure event and total heart failure events compared with placebo therapy, with an ARR of 14.2 and an NNT of 7.
Investigators also noted fewer heart failure events were seen with omecamtiv mecarbil use 30 days (IRR, 0.56; P=.035), 90 days (IRR, 0.61; P=.005), and at 3 years (IRR, 0.78; P=.029). Further analysis suggested cost reductions observed as a result of heart failure events avoided with omecamtiv mecarbil use $420 per patient at 30 days, $928 per patient at 90 days, and $6,052 per patient over 3 years, which investigators pointed out was a reduction of 26.9% at 3 years.
To learn more about the study design, results, and potential implications for use of omecamtiv mecarbil if approved in February 2023, our editorial team sat down Desai at AHA 22 and that conversation is the subject of the video found below.
This study, “Healthcare Resource Use, Early Benefit and Cost for North American Patients With HFrEF Most Likely to Benefit from Omecamtiv Mecarbil,” was presented at AHA 22.