Is health-related quality of life sufficiently addressed in trials for breast cancer treatments? An assessment based on reimbursement opinions from the French health technology assessment body, 2009–2023

IF 2 Q3 HEALTH POLICY & SERVICES Journal of Cancer Policy Pub Date : 2024-09-10 DOI:10.1016/j.jcpo.2024.100504
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Abstract

Background

Breast cancer treatments can impact the patients’ health-related quality of life (HR-QoL). This criterion is relevant for drug reimbursement decisions. We wanted to assess the usage of HR-QoL in health technology assessments (HTA).

Methods

All HAS (Haute Autorité de Santé, the French HTA body) opinions published between January 1, 2009 and March 31, 2023 for the reimbursement of breast cancer drugs were analysed.

Results

51 distinct appraisals were found during the period, corresponding to 45 product-specific indications, of which 36 (80 %) including clinical studies in which HR-QoL was an endpoint. HAS explicitly rejected HR-QoL data in 25 out of 36 (69 %) indications with such data. Rejections are justified by methodological weaknesses, including lack of adjustment for type I error inflation (n=21 indications), open-label treatment (n=7), lack of a pre-specified clinically relevant HR-QoL threshold (n=6) or missing data (n=6). Regardless of rejection status, HR-QoL results were not mentioned as a determinant of value assessment in 3/36 (8 %) instances (2/25 for rejected data).

Conclusions

HR-QoL data are inconsistently present in HTA assessments of new breast cancer drugs. Their methodological quality often hinders their use in determining the drug’s value.

Policy summary

A rigorous and acceptable comparative experimental framework is expected for HR-QoL assessments. More detail on the precise impact of the absence or presence of HR-QoL data in the determination of the drug’s added value could help understanding how this dimension is influential in the assessments.

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乳腺癌治疗试验是否充分考虑了与健康相关的生活质量?根据法国卫生技术评估机构2009-2023年的报销意见进行评估
背景乳腺癌治疗会影响患者的健康相关生活质量(HR-QoL)。这一标准与药物报销决策息息相关。我们希望评估在卫生技术评估(HTA)中使用 HR-QoL 的情况。方法分析了 2009 年 1 月 1 日至 2023 年 3 月 31 日期间发布的所有 HAS(Haute Autorité de Santé,法国卫生技术评估机构)关于乳腺癌药物报销的意见。结果在此期间发现了 51 份不同的评估意见,对应 45 个特定产品适应症,其中 36 份(80%)包括以 HR-QoL 为终点的临床研究。在有 HR-QoL 数据的 36 个适应症中,有 25 个(69%)的 HAS 明确拒绝接受 HR-QoL 数据。拒绝的理由是方法学上的缺陷,包括缺乏对I型误差膨胀的调整(21个适应症)、开放标签治疗(7个适应症)、缺乏预先指定的临床相关HR-QoL阈值(6个适应症)或数据缺失(6个适应症)。无论否决状态如何,在 3/36 (8 %) 例中(2/25 为否决数据),HR-QoL 结果未被提及作为价值评估的决定因素。这些数据的方法学质量往往妨碍了它们在确定药物价值时的使用。政策摘要:人力资源--生活质量评估应采用严格且可接受的比较实验框架。在确定药物的附加值时,如果能更详细地说明缺乏或存在 HR-QoL 数据的确切影响,将有助于理解这一维度在评估中的影响。
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来源期刊
Journal of Cancer Policy
Journal of Cancer Policy Medicine-Health Policy
CiteScore
2.40
自引率
7.70%
发文量
47
审稿时长
65 days
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