Key result
Icosapent ethyl is cost-effective for primary and secondary cardiovascular prevention in the UK with ICERs of £19,485/QALY and £13,285/QALY respectively, whereas PCSK9 inhibitors require price discounts to achieve cost-effectiveness.
Why the study?
Despite statin treatment, patients with dyslipidaemia and elevated cholesterol and triglyceride levels have high residual MACE risk, requiring new lipid-lowering drugs to demonstrate both MACE prevention and cost-effectiveness.
Are icosapent ethyl, fenofibrate, ezetimibe, evolocumab, or alirocumab in combination with statins cost-effective compared to statin monotherapy for cardiovascular prevention?
Are icosapent ethyl, fenofibrate, ezetimibe, evolocumab, or alirocumab in combination with statins cost-effective compared to statin monotherapy for cardiovascular prevention?
Effect estimate: ICER £19,485/QALY (primary) and £13,285/QALY (secondary) for icosapent ethyl
In the UK, icosapent ethyl, fenofibrate, and ezetimibe are cost-effective add-on therapies to statins for cardiovascular prevention, whereas PCSK9 inhibitors require substantial price discounts to achieve cost-effectiveness.
BACKGROUND: Despite treatment with statins, dyslipidaemia patients with elevated cholesterol- and triglyceride-levels remain at high residual risk for major adverse cardiovascular events (MACE). New lipid-lowering drugs must prevent the occurrence of MACE and exhibit cost-effectiveness for their successful adoption to clinical practice. OBJECTIVE: To assess the cost effectiveness of icosapent ethyl, fenofibrate, ezetimibe, evolocumab, and alirocumab in combination with statins compared to statin monotherapy for cardiovascular prevention from the perspective of UK's National Health Service. METHODS: A Markov model simulated the progression of cardiovascular disease and MACE, including myocardial infarction, stroke, angina pectoris, and coronary revascularisation, in dyslipidaemia patients. The model was populated with cardiovascular outcome trial data for each drug. Cost and utility data were extracted from peer-reviewed literature. The incremental cost-effectiveness ratio (ICER) is reported per quality-adjusted life years (QALY) gained in 2021 Great Britain Pounds (£). RESULTS: For primary cardiovascular prevention, icosapent ethyl increased QALYs by 0.79 and costs by £15,421 compared to statin monotherapy (ICER = £19,485/QALY). Fenofibrate yielded 0.62 additional QALYs at cost-savings of - £6127 (ICER = - £9932/QALY). For secondary prevention, the omega-3 fatty acid icosapent ethyl extended QALYs by 0.98 at costs of £12,981 compared to statin monotherapy (ICER = £13,285/QALY). Fenofibrate added 0.85 QALYs whilst saving - £637 (ICER = - £7472/QALY). Ezetimibe increased QALYs by 0.60 at cost reductions of - £2529 (ICER = - £4231/QALY). PCSK9 inhibitors provided QALYs of 0.53 and 0.86 at costs of £45,279 and £46,375 for evolocumab (ICER = £85,193/QALY) and alirocumab (ICER = £54,211/QALY), respectively. At a willingness-to-pay threshold of £25,000/QALY, there is a probability of 100% for icosapent ethyl (98% in primary prevention) and 0% for PCSK9 inhibitors to be cost effective in secondary prevention. CONCLUSIONS: Icosapent ethyl is cost effective for primary and secondary cardiovascular prevention at an annual price of £2064 in the UK. For PCSK9 inhibitors, price discounts or prescription restrictions are necessary to achieve cost effectiveness.
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Michaeli et al. (2022) studied Dyslipidaemia (n=1,000). Icosapent ethyl, fenofibrate, ezetimibe, evolocumab, or alirocumab in combination with statins vs. Statin monotherapy was evaluated on Incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained (ICER £19,485/QALY (primary) and £13,285/QALY (secondary) for icosapent ethyl). Icosapent ethyl is cost-effective for primary and secondary cardiovascular prevention in the UK with ICERs of £19,485/QALY and £13,285/QALY respectively, whereas PCSK9 inhibitors require price discounts to achieve cost-effectiveness.
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