Abstract 11481: Healthcare Resource Use, Early Benefit and Cost for North American Patients With HFrEF Most Likely to Benefit from Omecamtiv Mecarbil

Introduction: In GALACTIC-HF (NCT02929329), omecamtiv mecarbil (OM) added to guideline directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) reduced the risk of composite first HF event (HFE) or CV death. Increased risk with OM use was seen in patients with both digoxin use plus atrial fibrillation/flutter (AF) together at baseline (dig+AF), but not for patients with either factor alone. A previous analysis of GALACTIC-HF found OM to reduce resource utilization and costs among higher-risk patients with EF≤30% excluding dig+AF, but the impact in the subset within North America (N Am) is unclear. Purpose: To examine resource use, timing, and HFE costs for patients treated with OM in N Am. Methods: We analyzed risk of first and total HFE (hospitalization or IV diuretic use, all adjudicated), and events at 30 days post randomization and later, for the N Am region of GALACTIC-HF. Treatment effect was evaluated in the subgroup of GALACTIC-HF previously identified as most likely to benefit from OM: EF≤30% excluding dig+AF at baseline. We applied US costs per HFE from published studies inflated to 2021 USD, including $17,123 per HF hospitalization. Results: Of 8,232 trial patients, 1,386 (16.8%) were from N Am (1,220 US), of whom 4.6% had baseline dig+AF. In the N Am subgroup of 1,090 (78.6%) with EF≤30% excluding dig+AF, OM reduced risk of first HFE vs placebo (HR 0.81, 95% CI 0.67-0.98, p=0.027); >90% were hospitalizations. OM also reduced total HFE vs placebo (41.30 vs 55.46 per 100 pt-yrs, HR 0.76, 95%CI 0.61-0.94, p=0.010), with an ARR of 14.2 and a NNT of 7. Fewer HFE were seen with OM at 30 days (Incidence Rate Ratio [IRR] 0.56, p=0.035), 90 days (IRR 0.61, p=0.005) and throughout 3 yrs (IRR 0.78, p=0.029), with rising ARR. Cost reductions due to HFE avoided with OM averaged $420 / patient at 30 days, $928 at 90 days, and $6,052 (26.9% reduction) over 3 yrs. Conclusions: Among N Am patients with HFrEF≤30% and without dig+AF in GALACTIC-HF, OM significantly reduced HFEs with corresponding reductions in costs for HFEs. Clinically and statistically significant benefits were apparent within 30 days of OM initiation and continued through the trial. This large group of HFrEF patients may be where the clinical and economic benefit of OM is most evident.