医学辅助生殖的经济评估：方法学系统评价。

Department Public Health and Primary Care, Faculty of Medicine, KU Leuven, Leuven, Belgium (AVM, JL); Research Group Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Belgium (TD); Department of Obstetrics, Gynecology and Reproductive Sciences Yale School of Medicine, New Haven, CT, USA (TD); Global Medical Affairs Fertility, Research and Development, Merck Healthcare KGaA, Darmstadt, Germany (TD). The review was written at the Leuven Institute for Healthcare Policy. It was presented at the ESHRE 38th Annual Meeting (Milan 2022). The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Astrid Van Muylder and Jeroen Luyten have no conflicting interests to declare. The participation of Thomas D'Hooghe to this publication is part of his academic work; he does not see a conflict of interest as Merck KGaA was not involved in writing this article. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: We acknowledge an internal funding from KU Leuven for this study. The funding agreement ensured the authors' independence in designing the study, interpreting the data, writing, and publishing the report. The following authors are employed by the sponsor: Astrid Van Muylder and Jeroen Luyten.

Med Decis Making. 2023 Oct-Nov;43(7-8):973-991. doi: 10.1177/0272989X231188129. Epub 2023 Aug 24.

BACKGROUND

Medically assisted reproduction (MAR) is a challenging application area for health economic evaluations, entailing a broad range of costs and outcomes, stretching out long-term and accruing to several parties.

PURPOSE

To systematically review which costs and outcomes are included in published economic evaluations of MAR and to compare these with health technology assessment (HTA) prescriptions about which cost and outcomes should be considered for different evaluation objectives.

DATA SOURCES

HTA guidelines and systematic searches of PubMed Central, Embase, WOS CC, CINAHL, Cochrane (CENTRAL), HTA, and NHS EED.

STUDY SELECTION

All economic evaluations of MAR published from 2010 to 2022.

DATA EXTRACTION

A predetermined data collection form summarized study characteristics. Essential costs and outcomes of MAR were listed based on HTA and treatment guidelines for different evaluation objectives. For each study, included costs and outcomes were reviewed.

DATA SYNTHESIS

The review identified 93 cost-effectiveness estimates, of which 57% were expressed as cost-per-(healthy)-live-birth, 19% as cost-per-pregnancy, and 47% adopted a clinic perspective. Few adopted societal perspectives and only 2% used quality-adjusted life-years (QALYs). Broader evaluations omitted various relevant costs and outcomes related to MAR. There are several cost and outcome categories for which available HTA guidelines do not provide conclusive directions regarding inclusion or exclusion.

LIMITATIONS

Studies published before 2010 and of interventions not clearly labeled as MAR were excluded. We focus on methods rather than which MAR treatments are cost-effective.

CONCLUSIONS

Economic evaluations of MAR typically calculate a short-term cost-per-live-birth from a clinic perspective. Broader analyses, using cost-per-QALY or BCRs from societal perspectives, considering the full scope of reproduction-related costs and outcomes, are scarce and often incomplete. We provide a summary of costs and outcomes for future research guidance and identify areas requiring HTA methodological development.

HIGHLIGHTS

The cost-effectiveness of MAR procedures can be exceptionally complex to estimate as there is a broad range of costs and outcomes involved, in principle stretching out over multiple generations and over many stakeholders.We list 21 key areas of costs and outcomes of MAR. Which of these needs to be accounted for alters for different evaluation objectives (determined by the type of economic evaluation, time horizon considered, and perspective).Published studies mostly investigate cost-effectiveness in the very short-term, from a clinic perspective, expressed as cost-per-live-birth. There is a lack of comprehensive economic evaluations that adopt a broader perspective with a longer time horizon. The broader the evaluation objective, the more relevant costs and outcomes were excluded.For several costs and outcomes, particularly those relevant for broader, societal evaluations of MAR, the inclusion or exclusion is theoretically ambiguous, and HTA guidelines do not offer sufficient guidance.

背景

医学辅助生殖（MAR）是健康经济评估极具挑战性的应用领域，涉及广泛的成本和结果，长期积累并涉及多个利益相关方。

目的

系统地回顾 MAR 的已发表经济评估中纳入了哪些成本和结果，并将其与卫生技术评估（HTA）的规定进行比较，后者针对不同的评估目标规定了应考虑哪些成本和结果。

数据来源

HTA 指南以及对 PubMed Central、Embase、WOS CC、CINAHL、Cochrane（CENTRAL）、HTA 和 NHS EED 的系统检索。

研究选择

MAR 的所有经济评估，发表时间为 2010 年至 2022 年。

数据提取

一份预先设定的数据收集表格总结了研究特征。根据 HTA 和不同评估目标的治疗指南，列出了 MAR 的基本成本和结果。对每项研究纳入的成本和结果进行了审查。

数据综合

综述共确定了 93 项成本效益评估，其中 57%表示为每活产成本，19%表示为每妊娠成本，47%采用临床视角。很少采用社会视角，只有 2%使用了质量调整生命年（QALY）。更广泛的评估忽略了与 MAR 相关的各种相关成本和结果。有几个成本和结果类别，现有的 HTA 指南并未就纳入或排除提供明确的指导。

局限性

排除了发表于 2010 年之前的研究和未明确标记为 MAR 的干预措施的研究。我们关注的是方法，而不是 MAR 治疗的成本效益。

结论

MAR 的经济评估通常从临床角度计算短期的每活产成本。从社会角度使用更广泛的成本效益比（BCRs）或 QALY，考虑与生殖相关的全部成本和结果，虽然稀缺但往往不完整。我们提供了 MAR 的成本和结果摘要，以指导未来的研究，并确定需要 HTA 方法学发展的领域。

重点

MAR 程序的成本效益评估可能极其复杂，因为涉及广泛的成本和结果，原则上涉及多个世代和多个利益相关方。我们列出了 MAR 的 21 个关键成本和结果领域。对于不同的评估目标（由经济评估类型、考虑的时间范围和视角决定），需要考虑其中的哪些成本和结果。已发表的研究主要从临床角度在非常短期的时间内评估成本效益，表现为每活产成本。缺乏更广泛视角、更长时间范围的全面经济评估。评估目标越广泛，排除的相关成本和结果就越多。对于几个成本和结果，特别是 MAR 的更广泛的社会评估相关的成本和结果，纳入或排除在理论上存在歧义，HTA 指南没有提供足够的指导。