Live Presentation
Speak with Alexandre Couture about his practicum on January 31st from 3:45-4:15pm via this .
Video Presentation
View Alexandre Couture's poster presentation in this video recording:聽
Abstract
Tumour-agnostic therapies are marking a paradigm shift in oncology. The treatment is prescribed based on genetic alterations instead of cancer location. This novel approach is supported by basket trials and immature data which are challenging the current HTA framework. Therefore, despite a lack of standardized terminology, clinical trials, and economic evaluation reports for a specific family of targeted therapy, TKIs, were retrieved to analyze and quantify the barriers to the reimbursement decision-making by insurance and Ministry of Health.聽
A total of 86 clinical trials were found. Many of them share similar characteristics: the studies are at best in phase 2, the sample sizes are small, and there are almost no masking nor randomization. As for the economic evaluations, their presence in the literature is very limited, thus reports from HTA bodies were sought. Five reports were found for the only two TKIs approved in a tumour-agnostic context, Entrectinib and Larotrectinib.聽
The search strategy has been adapted to overcome the lack of proper indexing and the number of results revealed the terminology problem reported in the literature. To take decisions for reimbursement based on the evidence retrieved put at risk of accepting subpar quality. The pharmaceutical companies should wait for further data and include a comparator arm in their studies before submitting their product to HTA agencies. As already highlighted in the literature, both parties should also concert to determine the standards for this new paradigm.聽