Reimbursement Decision Drivers of CAR T-Cell Therapies across the EU-5, Canada and the US - an Insight into Patient Access
Author(s)
ABSTRACT WITHDRAWN
Objective: The chimeric antigen receptor (CAR) T-cell therapies address significant unmet needs in certain hematological malignancies however their cost may pose burden on healthcare systems. Analysis of reimbursement drivers for these approved (CAR) T-cell therapies, Kymriah® (tisagenlecleucel- ALL/DLBCL) and Yescarta® (axicabtagene ciloleucel- DLBCL/PMBCL), can help in preparing appropriate access strategies. This analysis aimed to understand the recent trends of health technology assessment (HTA) decisions for these drugs in the US, Canada and EU-5 nations. Methods: A review of recent HTA decisions in the EU-5 regions, [UK (NICE, SMC, AWMSG), France (HAS), Italy (AIFA), Spain (AEMPS, AETSA) and Germany (G-BA, IQWiG)] the US (ICER, AHRQ) and Canada (CADTH) was done using IQVIA™ ’s proprietary platform ‘HTA Accelerator’ from 01/Jan/2015 to 30/June/2020. Results: 28 submissions [16 Kymriah®; 11 Yescarta®; 1 Kymriah®+Yescarta®] were made to 12 HTA bodies for the scope countries. Positive decisions were given by HAS (n=3), SMC (n=3), CADTH (n=2) and ICER (n=1), based on clinical benefit, cost-effectiveness (CE), high unmet need and innovation. Key drivers for CE were the cost, target population, survival gain, utility gain, life-years gained and safety. With restrictions, G-BA provided temporary decisions with reassessments after deadline (n=4); NICE recommended access via CDF based on key CE drivers (n=3); For Yescarta® only, AIFA decided to re-asses innovative drug status after 1 year. SMC (n=2) provided negative decisions for both based on increased risk of adverse events, non-robust economic analyses, inappropriate target population and comparator. Conclusion: Despite apprehensions on affordability, these therapies gained positive recommendations, while for few regions it was negative, as they proved not to be cost-effective. Additional economic analyses and updated submissions can determine, future reimbursement of these drugs, enabling enhanced patient access.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PRO102
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Cost-comparison, Effectiveness, Utility, Benefit Analysis, Decision & Deliberative Processes, Reimbursement & Access Policy
Disease
Rare and Orphan Diseases