Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) and the glucagon-like peptide-1 receptor agonist (GLP-1RA) semaglutide represent 2 landmark innovations in cardiometabolic care. These agents, tested in rigorous randomized clinical trials, offer proven and substantial clinical benefit, PCSK9i through potent low-density lipoprotein cholesterol (LDL-C) reduction and reductions in atherosclerotic cardiovascular disease (ASCVD) events, and semaglutide through weight loss, reductions in kidney events, reductions in cardiovascular risk in patients with diabetes, ASCVD, and overweight/obesity, and heart failure with preserved ejection fraction.
Yet, despite compelling clinical trial evidence for efficacy and safety, each therapy’s initial market entry and uptake was stifled, not by lack of need or effectiveness, but by a common barrier: cost. High pricing rendered both therapies cost-ineffective by conventional standards and of low value limiting access and utilization.
Both therapies faced pricing that rendered their value questionable by conventional cost-effectiveness standards, limiting uptake despite efficacy and safety signals.