Eligibility, Clinical Outcomes, and Budget Impact of PCSK9 Inhibitor Adoption: The CANHEART PCSK9 Study

BACKGROUND: The FOURIER (Further Cardiovascular Outcomes Research With PCSK9i [Proprotein Convertase Subtilisin‐Kexin Type 9 Inhibitors] in Subjects With Elevated Risk) trial found a reduction in cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD). Our objective was to estimate the eligibility, clinical outcomes, and budget impact of adopting PCSK9i in a large healthcare system. METHODS AND RESULTS: Ontario, Canada, residents alive in 2011, aged 40 to 85 years, were eligible for inclusion. PCSK9i eligibility was determined on the basis of FOURIER trial definition. Hazard ratios observed in the FOURIER trial were applied to assess the number of events that could be avoided. Budget impact was calculated as the difference between projected costs of treatment adoption and events avoided if PCSK9i were used. Of the 2.4 million included individuals, 5.3% had a history of ASCVD. We estimated that 2.7% of the general population and 51.9% of the patients with ASCVD would be eligible for PCSK9i. Adoption of PCSK9i in all eligible patients with ASCVD was projected to reduce primary events rates by 1.8% after 3 years. Despite cost reduction of $44 million in events, PCSK9i adoption would have a net budget impact of $1.5 billion over 3 years. Potential benefits of PCSK9i varied widely across subgroups, with the largest absolute risk reduction estimated to be 4.3% at 3 years in peripheral artery disease. In this subgroup of 5601 patients, the budget impact of treatment adoption was $116 million. CONCLUSIONS: We estimated that ≈1 in 2 patients with ASCVD would be eligible for PCSK9i. The budget impact of adopting PCSK9i for all patients with ASCVD is substantial. Selective adoption to high‐risk patients will lessen the overall budgetary impact of PCSK9i treatment.