Mirzayeh Fashami Fatemeh, Tarride Jean-Eric, Sadeghirad Behnam, Hariri Kimia, Peyrovinasab Amirreza, Levine Mitchell
Health Research Methodology Graduate Program, McMaster University, 1280 Main St West, Hamilton, ON, Canada.
Center for Health Economics and Policy Analysis (CHEPA), McMaster University, 1280 Main St West, Hamilton, ON, Canada.
Pharmacoecon Open. 2024 Nov;8(6):823-836. doi: 10.1007/s41669-024-00511-9. Epub 2024 Aug 5.
Identifying key differences between manufacturers' submitted analysis and economic reanalysis by the Canadian Agency for Drugs and Technologies in Health (CADTH) is an important step toward understanding reimbursement recommendations. We compared economic values reported in manufacturers' analysis with the CADTH reanalysis and also assessed methodological critiques.
Two reviewers extracted data from the clinical and economic reports in publicly available CADTH reports from 2018 to 2022. We used the Wilcoxon rank-sum test to assess the difference between mean economic values, and the Chi-square test to assess the association between the CADTH critique final recommendations.
Of the total submissions, 99.4% included effectiveness critiques, 88.8% included model structure critiques, 69.1% included utility score critiques, and 78.7% included cost critiques. The median incremental cost-utility ratio (ICUR) in the manufacturers' analyses was $138,658/quality-adjusted life-year (QALY), 2.5-fold lower than the CADTH's reanalysis at $380,251/QALY (p < 0.001). The median CADTH reanalysis for 3-year budget impact analysis (BIA) was $4,575,102, which was 27% higher than the manufacturers' submitted 3-year BIA (p < 0.001). CADTH requested a price reduction for 95% of all submissions, and the median price reduction request was 63.5%. In 2021 and 2022, the willingness-to-pay threshold identified in CADTH reports remained constant at $50,000 per QALY gained for all medications.
There was high frequency of CADTH critiques on manufacturers' submissions in all four aspects of economic submissions: effectiveness, cost, utility score and structure. We observed a higher median incremental cost and lower median incremental QALYs in the CADTH reanalysis compared with the manufacturers' submissions. The resulting higher ICUR in the CADTH reanalysis often leads to a recommendation that the manufacturer needs to reduce its price. The 3-year budget impact was higher in the CADTH reanalyses compared with manufacturers' submissions.
识别制造商提交的分析与加拿大卫生药品和技术局（CADTH）进行的经济再分析之间的关键差异，是理解报销建议的重要一步。我们将制造商分析中报告的经济价值与CADTH的再分析进行了比较，并评估了方法学批评。
两名评审员从2018年至2022年公开的CADTH报告中的临床和经济报告中提取数据。我们使用Wilcoxon秩和检验来评估平均经济价值之间的差异，并使用卡方检验来评估CADTH批评最终建议之间的关联。
在所有提交的材料中，99.4%包含有效性批评，88.8%包含模型结构批评，69.1%包含效用评分批评，78.7%包含成本批评。制造商分析中的中位增量成本效用比（ICUR）为138,658美元/质量调整生命年（QALY），比CADTH的再分析低2.5倍，后者为380,251美元/QALY（p < 0.001）。CADTH对3年预算影响分析（BIA）的中位再分析为4,575,102美元，比制造商提交的3年BIA高27%（p < 0.001）。CADTH要求对所有提交材料中的95%进行降价，中位降价要求为63.5%。在2021年和2022年，CADTH报告中确定的支付意愿阈值对所有药物保持不变，为每获得一个QALY 50,000美元。
CADTH对制造商提交材料在经济提交的所有四个方面（有效性、成本、效用评分和结构）的批评频率很高。与制造商的提交材料相比，我们在CADTH的再分析中观察到更高的中位增量成本和更低的中位增量QALY。CADTH再分析中由此产生的更高ICUR通常导致建议制造商需要降低其价格。与制造商的提交材料相比，CADTH再分析中的3年预算影响更高。
