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Kosten-Nutzen-Analyse neuer Lipidsenker

Cost-benefit analysis of new lipid-lowering agents

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Zusammenfassung

Trotz optimaler medikamentöser Therapie inklusive eines Statins und Ezetimib sind Patienten mit einer atherosklerotischen kardiovaskulären Erkrankung einem hohen Risiko für kardiovaskuläre Folgeereignisse ausgesetzt. Dyslipidämien stellen hierfür eine zentrale und kausale Ursache dar, mit einer häufigen Verfehlung der in Leitlinien empfohlenen Zielwerte. Zur Behandlung dieses residuellen Risikos stehen zunehmend neue lipidsenkende Substanzen zur Verfügung. Um ihre Anwendung angesichts teils hoher Therapiekosten zu rechtfertigen, sind Kosten-Nutzen-Analysen notwendig. Wichtige Kenngrößen in der Evaluation einer Kosteneffizienz sind QALY („quality adjusted life years“) und die ICER („incremental cost effectiveness ratio“). Grenzwerte der ICER, unter der eine Therapie als kosteneffektiv bewertet wird, variieren je nach Gesundheitssystem. Der Einsatz der PCSK9(Proproteinkonvertase Subtilisin/Kexin Typ 9)-Inhibitoren Alirocumab und Evolocumab wird als kosteneffektiv insbesondere bei den Patienten angesehen, die einen hohen LDL(„low-density lipoprotein“)-Cholesterin(LDL-C)-Wert vor Therapiebeginn oder ein hohes individuelles kardiovaskuläres Risiko gemäß dem Vorliegen definierter Risikokriterien aufweisen. Ähnliches gilt für die PCSK9-siRNA („small interfering RNA“) Inclisiran. Die Gabe von Bempedoinsäure wird insbesondere bei Patienten mit Statinintoleranz als kosteneffektiv gewertet. Die Gabe von Icosapent-Ethyl wird insgesamt als kosteneffektiv gewertet, die Datenlage hinsichtlich der genauen placebokontrollierten Wirksamkeit ist jedoch noch inkonklusiv.

Abstract

Patients with atherosclerotic cardiovascular disease have a high risk for subsequent cardiovascular events despite optimal drug treatment including statins and ezetimibe. Dyslipidemia represents a central and direct cause of this, with a frequent failure to achieve the target values recommended in the guidelines. New lipid-lowering substances are increasingly becoming available for treatment of this residual risk. Due to their high cost, cost-effectiveness analyses are required in order to justify their use. Important variables when considering the cost-effectiveness of a drug are quality adjusted life years (QALY) and the incremental cost-effectiveness ratio (ICER). The lower bounds of the ICER determining the cost-effectiveness of a treatment vary between healthcare systems. The proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab are deemed to be cost-effective particularly in patients with high levels of low-density lipoprotein cholesterol (LDL-C) prior to treatment or with a high cardiovascular risk as determined by the presence of defined risk criteria. Similar considerations apply to the PCSK9 small interfering RNA (siRNA) inclisiran. Administration of bempedoic acid is deemed cost-effective especially in patients with statin intolerance. Eicosapentaenoic acid is deemed cost-effective overall, although the data with respect to the exact placebo-controlled efficacy are still inconclusive.

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Authors and Affiliations

  1. Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Deutschland

    Christopher Blaum,  Natalie Arnold &  Christoph Waldeyer

  2. Deutsches Zentrum für Herz-Kreislauf-Forschung e. V. (DZHK e. V.), Standort Hamburg/Kiel/Lübeck, Hamburg, Deutschland

    Natalie Arnold &  Christoph Waldeyer

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  1. Christopher Blaum
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Correspondence to Christoph Waldeyer.

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Interessenkonflikt

C. Blaum und N. Arnold geben an, dass kein Interessenkonflikt besteht. C. Waldeyer erhielt Vortrags- und Beratungshonorare von Amgen, AstraZeneca, Daiichi Sankyo, Novartis und Sanofi. Er erhielt wissenschaftliche Fördermittel von Pfizer im Rahmen des ASPIRE Cardiovascular Grant Award.

Für diesen Beitrag wurden von den Autoren keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien.

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Blaum, C., Arnold, N. & Waldeyer, C. Kosten-Nutzen-Analyse neuer Lipidsenker. Herz 47, 236–243 (2022). https://doi.org/10.1007/s00059-022-05116-8

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