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成本效益分析如何为加拿大肿瘤药物的报销决策提供信息?以舒尼替尼作为转移性肾细胞癌一线治疗为例。

How do cost-effectiveness analyses inform reimbursement decisions for oncology medicines in Canada? The example of sunitinib for first-line treatment of metastatic renal cell carcinoma.

机构信息

Department of Health Economics and Outcomes Research, Medical Division, Pfizer Canada, Montreal, Quebec, Canada.

出版信息

Value Health. 2010 Sep-Oct;13(6):837-45. doi: 10.1111/j.1524-4733.2010.00738.x. Epub 2010 Jun 7.

Abstract

BACKGROUND

Canadian oncology decision-makers have reimbursed cancer drugs at incremental cost-effectiveness ratios (ICER) higher than those considered acceptable in other therapeutic areas. Sunitinib is a multitargeted receptor tyrosine kinase inhibitor, indicated for metastatic renal-cell carcinoma (MRCC) of clear cell histology. Canadian decision-makers evaluated sunitinib funding in the presence of important data limitations (including interim analysis of a surrogate outcome) and in the context of a high ICER.

METHODS

First, a description was presented of the cost-effectiveness analysis submitted for sunitinib reimbursement decision-making in Canada before conclusive survival evidence had been available. Second, sunitinib access decisions and the oncology drug reimbursement literature were reviewed to explore the interpretation of sunitinib perceived value in the context of the decision-making framework in Canada.

RESULTS

The economic evaluation yielded an ICER of $144K/quality-adjusted life-year gained for sunitinib compared with interferon-alfa. This high ratio was not an insurmountable barrier to access in Canada because all provinces now reimburse sunitinib for first-line treatment of MRCC. In this particular instance, payers were receptive to immature survival data but substantial progression-free gains, for patients with a relatively rare cancer and few treatment options.

CONCLUSION

This demonstrates that the cost-effectiveness ratio is only one of many factors that affect an access decision in oncology.

摘要

背景

加拿大肿瘤学决策者在报销癌症药物时,其增量成本效益比(ICER)高于其他治疗领域被认为可接受的水平。舒尼替尼是一种多靶点受体酪氨酸激酶抑制剂,适用于透明细胞组织学的转移性肾细胞癌(MRCC)。加拿大决策者在存在重要数据限制(包括替代终点的中期分析)的情况下,以及在高 ICER 背景下,对舒尼替尼的资金进行了评估。

方法

首先,在获得明确的生存证据之前,介绍了在加拿大提交的舒尼替尼报销决策的成本效益分析。其次,回顾了舒尼替尼的准入决策和肿瘤药物报销文献,以探讨在加拿大决策框架下对舒尼替尼的感知价值的解释。

结果

与干扰素-α相比,舒尼替尼的经济评估得出的 ICER 为 144K 美元/质量调整生命年。在加拿大,由于所有省份现在都将舒尼替尼用于 MRCC 的一线治疗,因此这个高比率并不是获得药物的不可逾越的障碍。在这种特殊情况下,对于患有相对罕见癌症且治疗选择有限的患者,支付方愿意接受不成熟的生存数据,但可以获得实质性的无进展生存获益。

结论

这表明,成本效益比只是影响肿瘤学准入决策的众多因素之一。

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