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在加拿大,癌症药物报销中临床、经济、患者价值观和可行性标准的相对重要性:对 2011-2017 年加拿大泛癌种药物评审建议的揭示偏好分析。

The Relative Importance of Clinical, Economic, Patient Values and Feasibility Criteria in Cancer Drug Reimbursement in Canada: A Revealed Preferences Analysis of Recommendations of the Pan-Canadian Oncology Drug Review 2011-2017.

机构信息

Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.

School of Pharmacy, Dalhousie University, Halifax, NS, Canada.

出版信息

Pharmacoeconomics. 2018 Apr;36(4):467-475. doi: 10.1007/s40273-018-0610-0.

Abstract

BACKGROUND

Most Canadian provinces and territories rely on the pan-Canadian Oncology Drug Review (pCODR) to provide recommendations regarding public reimbursement of cancer drugs. The pCODR review process considers four dimensions of value-clinical benefit, economic evaluation, patient-based values and adoption feasibility-but they do not define weights for individual decision criteria or an acceptable threshold for any of the criteria. Given this implicit review process, it is of interest to understand which factors appear to carry the most weight in pCODR recommendations using a revealed preferences approach.

METHODS

Using publicly available decision summaries (n = 91) describing submissions and resulting recommendations 2011-2017, we extracted ten attributes that characterized each submission. Using logistic regression, we identified statistically significant attributes and estimated their relative impact in final recommendations.

RESULTS

Clinical aspects appear to carry the greatest weight in the decision to reject or not reject, along with aspects of patient value (treatments with no alternatives were less likely to be rejected). Cost effectiveness does not appear to play a role in the initial decision to reject or not reject but is critical in full versus conditional approvals. There is evidence of a maximum acceptable threshold of around $Can140,000 per quality-adjusted life-year (QALY) gained.

CONCLUSION

A set of factors driving pCODR recommendations is identifiable, supporting the consistency of the review process. However, the implicit nature of the review process and the difficulty of extracting and interpreting some of the attribute levels used in the analysis suggests that the process may still lack full transparency.

摘要

背景

大多数加拿大省份和地区依赖泛加肿瘤药物评审(pCODR)来提供癌症药物公共报销的建议。pCODR 评审过程考虑了四个维度的价值——临床获益、经济评估、基于患者的价值和采用可行性——但它们没有为个别决策标准定义权重或为任何标准设定可接受的阈值。鉴于这种隐性评审过程,了解哪些因素在 pCODR 建议中似乎具有最大的权重,这是很有趣的,我们可以采用揭示偏好的方法来研究。

方法

使用公开的决策摘要(n=91),描述 2011 年至 2017 年的提交内容和结果建议,我们提取了描述每个提交内容的十个属性。使用逻辑回归,我们确定了具有统计学意义的属性,并估计了它们在最终建议中的相对影响。

结果

临床方面似乎在决定接受或不接受方面具有最大的权重,同时还有患者价值方面的因素(没有替代方案的治疗不太可能被拒绝)。成本效益在最初决定接受或不接受方面似乎没有作用,但在完全批准与有条件批准方面至关重要。有证据表明,每获得一个质量调整生命年(QALY)可接受的最高成本约为 14 万加元。

结论

可以确定一组推动 pCODR 建议的因素,支持评审过程的一致性。然而,评审过程的隐性性质以及在分析中提取和解释某些属性水平的困难表明,该过程可能仍然缺乏充分的透明度。

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