Presentation (CTI)

OBJECTIVES: To compare Canada's Temporary Access Process (pTAP) and Time-Limited Reimbursement Recommendation (TLR) with analogous rapid access pathways in the UK (Cancer Drugs Fund (CDF)/ Early Access to Medicines Scheme (EAMS)), European Union (EMA Adaptive Pathways), and Australia (TGA Provisional Registration/PBAC), focusing on evidence requirements, approval timelines, negotiation mechanisms, and reimbursement outcomes.
METHODS: We conducted a cross-jurisdictional analysis using data from HTA decisions, regulatory documentation, literature, and managed access agreement databases. Reference cases such as epcoritamab (Epkinly) in Canada and historical CDF exits in the UK, provided submission-to-listing timelines to quantify access acceleration versus standard pathways. For EU and Australian pathways, programme-level evidence and regulatory documentation were used in the absence of comparable individual product benchmarks.
RESULTS: Canada's pTAP is the only framework that fully integrates HTA recommendations with payer negotiation. In the Epkinly case, first provincial listing was achieved in 306 days (~275 days faster than the ~581-day oncology norm). The UK CDF converted 84% of 26 MAAs to routine commissioning. However, only 43.6% of its data collection agreements addressed all uncertainties identified at entry, leaving residual re-appraisal risk. EU Adaptive Pathways offer an iterative evidence approach but are undermined by fragmented payer landscapes - the upcoming EU HTA Regulation mandating joint clinical assessments may partially address this. Australia's TGA provisional approval allows market entry approximately two years earlier than standard, but this acceleration is not mirrored in PBAC review, creating a misalignment that is absent in the Canadian model.
CONCLUSIONS: Rapid access pathways vary in how they integrate regulatory, HTA, and payer processes. Canada's pTAP and TLR is distinctive, though its narrow eligibility limits its scale. Manufacturers with multi-jurisdictional launches must design evidence generation plans to meet multiple re-assessment timelines in parallel. Better alignment between regulatory acceleration and HTA/payer timelines remains a critical unresolved challenge across jurisdictions.