支付意愿阈值对肿瘤药物降价建议的影响:加拿大药品和卫生技术局进行的评估回顾

IF 1.9 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Journal of comparative effectiveness research Pub Date : 2024-04-03 DOI:10.57264/cer-2023-0178
C. Balijepalli, L. Gullapalli, Juhi Joshy, Nigel S. B. Rawson
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引用次数: 0

摘要

自 2020 年底以来,加拿大药品和卫生技术局(CADTH)一直对肿瘤和非肿瘤药物采用每质量调整生命年(QALY)50,000 加元的阈值。据推测,如果将这一阈值用于肿瘤产品,则会对在加拿大获得这些药物的时间产生较大影响。我们研究了降价对 2020 年 1 月至 2022 年 12 月期间由 CADTH 审查的肿瘤药物的参与时间和与泛加拿大制药联盟谈判时间的影响。总体而言,103 项评估报告了加拿大卫生部建议的降价数据,以达到报销的成本效益阈值。在这些评估中,57%(59/103)的建议降价幅度超过清单价格的 70%。8%(8/103)的评估即使降价 100%,也不符合成本效益。在 47 项有明确效益的评估中,21 项(45%)"计算机辅助设计与制造 "建议降价至少 70%。降价至少 70% 与降价超过 70% 的评估中,价格谈判的中位时间(不包括参与时间)分别为 2.6 个月与 4.8 个月。这项研究表明,药物申办者的增量成本效益比(ICER)与 CADTH 修订后的 ICER 之间存在差异,导致降价幅度达不到 50,000 美元/QALY 临界值。与 CADTH 认为临床效益不确定的申请相比,临床效益明确的申请的参与时间中位数(2.5 个月对 3.3 个月)和谈判时间中位数(3.1 个月对 3.6 个月)略短。这项研究表明,对肿瘤产品使用每 QALY 50,000 美元的阈值可能会影响及时获得挽救生命的药物。
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The impact of willingness-to-pay threshold on price reduction recommendations for oncology drugs: a review of assessments conducted by the Canadian Agency for Drugs and Technologies in Health
Since late 2020, the Canadian Agency of Drugs and Technologies in Health (CADTH) has been using a threshold of $50,000 (CAD) per quality-adjusted life-year (QALY) for both oncology and non-oncology drugs. When used for oncology products, this threshold is hypothesized to have a higher impact on the time to access these drugs in Canada. We studied the impact of price reductions on time to engagement and negotiation with the pan-Canadian Pharmaceutical Alliance for oncology drugs reviewed by CADTH between January 2020 and December 2022. Overall, 103 assessments reported data on price reductions recommended by CADTH to meet the cost–effectiveness threshold for reimbursement. Of these assessments, 57% (59/103) recommendations included a price reduction of greater than 70% off the list price. Eight percent (8/103) were not cost-effective even at a 100% price reduction. Of the 47 assessments that had a clear benefit, in 21 (45%) CADTH recommended a price reduction of at least 70%. The median time to price negotiation (not including time to engagement) for assessments that received at least 70% vs >70% price reduction was 2.6 vs 4.8 months. This study showed that there is a divergence between drug sponsor's incremental cost–effectiveness ratio (ICER) and CADTH revised ICER leading to a price reduction to meet the $50,000/QALY threshold. For the submissions with clear clinical benefit the median length of engagement (2.5 vs 3.3 months) and median length of negotiation (3.1 vs 3.6 months) were slightly shorter compared with the submissions where uncertainties were noted in the clinical benefit according to CADTH. This study shows that using a $50,000 per QALY threshold for oncology products potentially impacts timely access to life saving medications.
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来源期刊
Journal of comparative effectiveness research
Journal of comparative effectiveness research HEALTH CARE SCIENCES & SERVICES-
CiteScore
3.50
自引率
9.50%
发文量
121
期刊介绍: Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate, and for the presentation of new findings and research methodologies. Through rigorous evaluation and comprehensive coverage, the Journal of Comparative Effectiveness Research provides stakeholders (including patients, clinicians, healthcare purchasers, and health policy makers) with the key data and opinions to make informed and specific decisions on clinical practice.
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