A Markov lifetime-horizon model adapted from the VESALIUS-CV trial finds that adding evolocumab to standard therapy in high-cardiovascular-risk patients without prior myocardial infarction or stroke yields an incremental cost-effectiveness ratio (ICER) of $71,162 per QALY gained at the current direct-to-patient price of $3,107 annually. The treatment prevented 0.24 major adverse cardiovascular events and 0.17 revascularization procedures per person lifetime, generating 0.34 incremental QALYs at an incremental cost of $24,430. Across three scenario analyses incorporating societal perspectives and Cholesterol Treatment Trialists' meta-analysis inputs, ICERs ranged from $20,152 to $51,160 — all beneath the conventional $100,000/QALY willingness-to-pay threshold.
This analysis expands the cost-effectiveness case for PCSK9 inhibition beyond secondary prevention, where evolocumab's value was already established. For clinicians, the findings suggest that high-risk primary-prevention patients — a larger, previously undertreated population — may now have an economically justifiable pathway to aggressive LDL-lowering. However, important limitations temper enthusiasm: this is a modeled projection, not a head-to-head economic trial, and Markov models are highly sensitive to input assumptions about long-term mortality benefit extrapolated from finite trial follow-up. The FOURIER-OLE extension data meaningfully drive optimistic outcomes. Critically, this paper is a preprint posted on medRxiv and has not yet undergone peer review, meaning the model parameters and conclusions may shift substantially. Funding from Amgen, evolocumab's manufacturer, also warrants scrutiny of baseline assumptions. Confirmatory independent analyses are essential before broad payer adoption.