比较制造商提交的和泛加瘤药物审查重新分析的新型瘤药物增量成本效益比。
Comparing Manufacturer Submitted and Pan-Canadian Oncology Drug Review Reanalysed Incremental Cost-Effectiveness Ratios for Novel Oncology Drugs.
机构信息
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON M4N 3M5, Canada.
Department of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.
出版信息
Curr Oncol. 2021 Jan 20;28(1):606-618. doi: 10.3390/curroncol28010060.
BACKGROUND
To determine the magnitude of difference between manufacturer-submitted and pan-Canadian Oncology Drug Review (pCODR) calculated incremental cost-effectiveness ratios (ICERs), incremental cost (ΔC), and incremental effectiveness (ΔE); to examine whether there is a significant difference in the proportion of ICERs deemed cost-effective; to evaluate trends in the ICERs over time; and to identify methodological issues in manufacturer-submitted economic models.
METHODS
Economic guidance reports for all drug indications submitted from July 2011-November 2018 were extracted from the pCODR database. Cumulative distribution plots were constructed to compare the manufacturer-submitted economic values with both the pCODR lower- and upper-reanalyzed estimates. The proportion of drug reviews considered cost-effective at varying willingness-to-pay (WTP) thresholds by the manufacturer and pCODR were calculated. Manufacturer changes in ICERs over time from 2012 to 2018 were determined. Recurring methodological issues with manufacturer submissions were tallied.
RESULTS
There were 73 unique indications that were included. Manufacturer-submitted ICERs were consistently lower than pCODR estimates for most indications. Manufacturer-submitted ICERs were generally more cost-effective over a range of WTP thresholds. From 2012 to 2018, manufacturer and economic guidance panel (EGP) lower limit reanalyzed ICERs did not change significantly over time. However, EGP upper limit re-analyses did show decreasing cost-effectiveness (increasing ICERs). The two most common issues identified in the manufacturer-submitted models were related to survival time horizon and utility estimates.
CONCLUSIONS
Manufacturers tend to overestimate the cost-effectiveness of their therapies when submitting economic models to pCODR. Although certain methodological issues are still common in manufacturer-submitted models, revision rates are high for most issues raised by pCODR.
背景
确定制造商提交的增量成本效益比（ICER）、增量成本（ΔC）和增量效果（ΔE）与全加癌症药物审查（pCODR）计算值之间的差异幅度；检验认为成本效益的 ICER 比例是否存在显著差异；评估随时间推移的 ICER 趋势；并确定制造商提交的经济模型中的方法学问题。
方法
从 pCODR 数据库中提取了 2011 年 7 月至 2018 年 11 月提交的所有药物适应证的经济指导报告。构建累积分布图以比较制造商提交的经济价值与 pCODR 的重新分析下限和上限估计值。计算制造商和 pCODR 在不同意愿支付（WTP）阈值下认为成本效益的药物审查比例。确定制造商从 2012 年到 2018 年的 ICER 随时间的变化。总计制造商提交的常见方法学问题。
结果
共有 73 个独特的适应证被纳入。对于大多数适应证，制造商提交的 ICER 始终低于 pCODR 估计值。在一系列 WTP 阈值下，制造商提交的 ICER 通常更具成本效益。从 2012 年到 2018 年，制造商和经济指导小组（EGP）下限重新分析的 ICER 随时间没有显著变化。然而，EGP 上限重新分析确实显示出成本效益降低（ICER 增加）。在制造商提交的模型中发现的两个最常见的问题与生存时间范围和效用估计有关。
结论
当向 pCODR 提交经济模型时，制造商往往会高估其疗法的成本效益。尽管制造商提交的模型中仍然存在某些方法学问题，但 pCODR 提出的大多数问题的修订率都很高。
Zotero 插件