Abstract

PurposeNovel pharmaceutical treatments reducing cardiovascular events in dyslipidaemia patients must demonstrate clinical efficacy and cost-effectiveness to promote long-term adoption by patients, physicians, and insurers.ObjectiveTo assess the cost-effectiveness of statin monotherapy compared to additive lipid-lowering therapies for primary and secondary cardiovascular prevention from the perspective of Germany’s healthcare system.MethodsTransition probabilities and hazard ratios were derived from cardiovascular outcome trials for statin combinations with icosapent ethyl (REDUCE-IT), evolocumab (FOURIER), alirocumab (ODYSSEY), ezetimibe (IMPROVE-IT), and fibrate (ACCORD). Costs and utilities were retrieved from previous literature. The incidence of major adverse cardiovascular events was simulated with a Markov cohort model. The main outcomes were the incremental cost-effectiveness ratios (ICER) per quality adjusted life year (QALY) gained.ResultsFor primary prevention, the addition of icosapent ethyl to statin generated 0.81 QALY and €14,732 costs (ICER: 18,133), whereas fibrates yielded 0.63 QALY and € − 10,516 costs (ICER: − 16,632). For secondary prevention, the addition of ezetimibe to statin provided 0.61 QALY at savings of € − 5,796 (ICER: − 9,555) and icosapent ethyl yielded 0.99 QALY and €14,333 costs (ICER: 14,485). PCSK9 inhibitors offered 0.55 and 0.87 QALY at costs of €62,722 and €87,002 for evolocumab (ICER: 114,639) and alirocumab (ICER: 100,532), respectively. A 95% probability of cost-effectiveness was surpassed at €20,000 for icosapent ethyl (primary and secondary prevention), €119,000 for alirocumab, and €149,000 for evolocumab.ConclusionsFor primary cardiovascular prevention, a combination therapy of icosapent ethyl plus statin is a cost-effective use of resources compared to statin monotherapy. For secondary prevention, icosapent ethyl, ezetimibe, evolocumab, and alirocumab increase patient benefit at different economic costs.

Highlights

  • Cardiovascular diseases (CVD) remain the leading cause of death in Germany, accounting for more than 35% of all fatalities [1]

  • This study evaluated the cost-effectiveness of current lipidlowering treatment options for primary and secondary cardiovascular prevention from the perspective of the German healthcare system

  • Results demonstrate that icosapent ethyl plus statin is a cost-effective use of resources (ICER: 18,133 €/quality adjusted life year (QALY))

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Summary

Introduction

Cardiovascular diseases (CVD) remain the leading cause of death in Germany, accounting for more than 35% of all fatalities [1]. For patients with elevated triglycerides and cholesterol, treatment strategies for primary and secondary cardiovascular prevention include lipid-lowering drugs. This study examines the cost-effectiveness of additive lipid-lowering therapies compared to statin monotherapy for primary and secondary cardiovascular prevention from the perspective of the German healthcare system. All lipid-lowering drugs that were approved by the European Medicines Agency (EMA) for primary or secondary cardiovascular prevention in combination treatment with statins after the year 2000 were included. Transition probabilities were derived from cardiovascular outcome trials for icosapent ethyl (REDUCE-IT), evolocumab (FOURIER), alirocumab (ODYSSEY), ezetimibe (IMPROVE-IT), and fibrate (ACCORD) [4,5,6,7, 11]. REDUCE-IT and ACCORD trial analyzed cardiovascular risk protection of icosapent ethyl and fibrate in both primary and secondary prevention. We evaluated the impact of drug pricing on calculated cost-effectiveness ratios (Fig. 1)

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