Abstract
Background: Proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab reduce ischemic events; however, the cost-effectiveness remains uncertain. This study sought to evaluate its economic value in patients with myocardial infarction (MI) from the Chinese healthcare perspective. Methods: A state-transition Markov model was developed to determine the cost-effectiveness of alirocumab for preventing recurrent MI, ischemic stroke and death. Preventative effect of the therapy was gathered from ODYSSEY OUTCOMES trial and absolute reduction of low-density lipoprotein cholesterol (LDL-C) in ODYSSEY EAST trial, respectively. The primary outcome was the incremental cost-effectiveness ratio (ICER), defined as incremental cost per quality-adjusted life-year (QALY) gained. Results: Compared with statin monotherapy, the ICER of alirocumab therapy at its present discounted price [34,355 Chinese yuan (CNY) annually, 33% rebate] based on clinical follow-up efficacy was 1,613,997 CNY per QALY gained. A willingness-to-pay threshold of 212,676 CNY per QALY would be achieved when the annual cost of alirocumab was reduced by 88% from the full official price to 6071 CNY. The therapeutic effect evaluation estimated by the magnitude of LDL-C reduction was superior to the results of clinical follow-up, but this medication was still far from cost-effective. Multiple vulnerable subgroup analyses demonstrated that the ICER for patients with polyvascular disease in 3 vascular beds was 111,750 CNY per QALY gained. Conclusion: Alirocumab is not cost-effective in general MI population based on current discounted price. High long-term costs of alirocumab may be offset by health benefit in patients with polyvascular disease (3 beds).
Highlights
Cardiovascular disease (CVD) plays an increasing role in years of life lost currently, accounting for 40% of deaths in the Chinese population (Zhao et al, 2019)
In the main result applying the hazard ratio (HR) observed in ODYSSEY OUTCOMES to the model, mean costs would be 871,321 Chinese Yuan (CNY) with alirocumab added to statin therapy and 400,705
Discounted net price, therapeutic effect based on HRs of clinical endpoints
Summary
Cardiovascular disease (CVD) plays an increasing role in years of life lost currently, accounting for 40% of deaths in the Chinese population (Zhao et al, 2019). Alirocumab is a fully human monoclonal antibody biological medication that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It has showed powerful effect and safety in lipid-lowering and cardiovascular outcomes improvement in patients with heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk (Kastelein et al, 2015; Farnier et al, 2016). In 2020, alirocumab was approved in priority by Chinese National Medical Products Administration based on Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (ODYSSEY OUTCOMES) trial (Schwartz et al, 2018) This landmark trial demonstrated that the risk of composite primary endpoints reduced by 15% among patients with previous acute coronary syndrome in alirocumab therapy compared with placebo. This study sought to evaluate its economic value in patients with myocardial infarction (MI) from the Chinese healthcare perspective
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