Balijepalli Chakrapani, Gullapalli Lakshmi, Joshy Juhi, Rawson Nigel Sb
Pharmalytics Group, Vancouver, BC V6B 2Z4, Canada.
Canadian Health Policy Institute, Toronto, ON, Canada.
J Comp Eff Res. 2024 May;13(5):e230178. doi: 10.57264/cer-2023-0178. Epub 2024 Apr 3.
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.
自2020年末以来,加拿大卫生药品和技术局(CADTH)一直将每质量调整生命年(QALY)50,000加元的阈值用于肿瘤学和非肿瘤学药物。当应用于肿瘤学产品时,该阈值被认为会对加拿大获取这些药物的时间产生更大影响。我们研究了2020年1月至2022年12月期间CADTH审查的肿瘤学药物降价对与泛加拿大药品联盟进行接触和谈判时间的影响。总体而言,103项评估报告了CADTH为达到报销成本效益阈值而建议的降价数据。在这些评估中,57%(59/103)的建议包括降价幅度超过标价的70%。8%(8/103)即使降价100%也不具有成本效益。在47项有明确益处的评估中,21项(45%)CADTH建议至少降价70%。降价至少70%与降价幅度大于70%的评估相比,价格谈判的中位时间(不包括接触时间)分别为2.6个月和4.8个月。这项研究表明,药物申办方的增量成本效益比(ICER)与CADTH修订后的ICER之间存在差异,导致降价以达到每QALY 50,000加元的阈值。对于具有明确临床益处的提交材料,与CADTH指出临床益处存在不确定性的提交材料相比,接触的中位时长(2.5个月对3.3个月)和谈判的中位时长(3.1个月对3.6个月)略短。这项研究表明,将每QALY 50,000加元的阈值用于肿瘤学产品可能会影响及时获得救命药物。