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肿瘤药物审查时间对公共资金推荐的影响。

Impact of Oncology Drug Review Times on Public Funding Recommendations.

机构信息

Department of Oncology, University of Calgary, Calgary, AB T2N 4N2, Canada.

Faculty of Arts, Department of Psychology, University of Calgary, Calgary, AB T2N 1N4, Canada.

出版信息

Curr Oncol. 2023 Aug 18;30(8):7706-7712. doi: 10.3390/curroncol30080558.

Abstract

New oncology drugs undergo detailed review prior to public funding in a single-payer healthcare system. The aim of this study was to assess how cancer drug review times impact funding recommendations. Drugs reviewed by the pan-Canadian Oncology Drug Review (pCODR) between the years 2012 and 2020 were included. Data were collected including Health Canada approval dates, initial and final funding recommendations, treatment intent, drug class, clinical indications, and incremental cost-effectiveness ratios (ICER). Univariable and multivariable analyses were used to determine the association between funding recommendations and review times. Of the 164 applications submitted, 130 received a positive final recommendation. Median time from Health Canada (HC) approval to final recommendation was longer for drugs indicated for the treatment of gastrointestinal (GI) and lung cancer compared to breast, genitourinary (GU), and other tumours (205 vs. 198 vs. 111 vs. 129 vs. 181 days, respectively; Kruskal-Wallis = 0.0312). Drugs with longer review times were more likely to receive a negative pCODR recommendation, even when adjusting for tumour type, drug class, and intent of therapy (157 vs. 298 days; Wilcoxon = 0.0003, OR 1.002 95% CI [1.000-1.004].). There was no association between funding recommendation and tumour type or class of drug. The exploration of factors associated with variance in review times will be important in ensuring timely patient access to cancer drugs.

摘要

在单一支付者医疗体系中,新的肿瘤药物在获得公共资金之前要经过详细审查。本研究旨在评估癌症药物审查时间如何影响资金建议。研究纳入了 2012 年至 2020 年间由加拿大泛肿瘤药物审查组织(pCODR)审查的药物。收集的数据包括加拿大卫生部批准日期、初始和最终资金建议、治疗意图、药物类别、临床适应证和增量成本效益比(ICER)。采用单变量和多变量分析来确定资金建议与审查时间之间的关联。在提交的 164 份申请中,有 130 份获得了最终的积极建议。与乳腺癌、泌尿生殖系统(GU)和其他肿瘤相比,用于治疗胃肠道(GI)和肺癌的药物从加拿大卫生部(HC)批准到最终建议的中位时间更长(分别为 205 天、198 天、111 天、129 天和 181 天;Kruskal-Wallis 检验=0.0312)。审查时间较长的药物更有可能收到 pCODR 的否定建议,即使在调整了肿瘤类型、药物类别和治疗意图后也是如此(157 天和 298 天;Wilcoxon 检验=0.0003,OR 1.002,95%CI [1.000-1.004])。肿瘤类型或药物类别与资金建议之间没有关联。探索与审查时间差异相关的因素对于确保患者及时获得癌症药物至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f200/10453657/b9284ea974af/curroncol-30-00558-g001.jpg

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