ASSESSING THE UTILIZATION OF EARLY ACCESS PATHWAYS AND IMPLEMENTATION OF TIME-LIMITED REIMBURSEMENT AND TEMPORARY ACCESS PROCESS IN CANADA
Author(s)
Brenda Rattanavong, PharmD1, Mandeep Kaur Bhatia, M. Pharm2, Tyler Malloch, MSc2, Liga Bennetts, PhD1;
1Amaris Consulting, Montreal, QC, Canada, 2Amaris Consulting, Toronto, ON, Canada
1Amaris Consulting, Montreal, QC, Canada, 2Amaris Consulting, Toronto, ON, Canada
OBJECTIVES: To accelerate review processes and timely access to promising new therapies, CDA introduced time-limited recommendations (TLRs), complemented by pCPA’s Temporary Access Process (pTAP). To understand utilization and impact of these programs, we reviewed Canadian HTAs and pricing negotiations of products that received an NOC/c designation from Health Canada (HC) following the introduction of the TLR/pTAP process.
METHODS: HTA reports of products that received an NOC/c designation from HC from September 2023 (TLR process introduction) to December 2025 were retrieved from CDA and INESSS. Product information, trial design, and final HTA agency decisions were extracted. Potential for meeting TLR eligibility criteria was also assessed. Status of pCPA negotiations for submissions were also retrieved.
RESULTS: As of 31-Dec-2025, Enhertu® and Epkinly™ were the only products to enter the early access process and receive a TLR and pTAP agreement. While Epkinly™ received a positive recommendation from INESSS and is reimbursed by public drug programs across Canada, Enhertu® received a negative recommendation from INESSS and is not listed in Quebec and PEI public drug plans. Apart from Epkinly™ and Enhertu®, 13 drug submissions received an NOC/c designation from HC from September 2023 to December 2025, of which 8 were submitted to CDA for review. Among the completed reviews (N=5), four received a positive CDA recommendation. One submission (Talvey™) received a negative CDA recommendation due to uncertainties around clinical benefit demonstrated in the Phase 1/2 single-arm trial submitted. When assessing for TLR eligibility, the product appeared to have met the criteria for undergoing the early access process.
CONCLUSIONS: Early access pathways present opportunities for accelerated access to promising therapies. However, utilization of these processes has been limited, with only two products that underwent these processes since introduction. Products receiving an NOC/c designation from HC meeting the TLR eligibility criteria should consider submitting through the early access process.
METHODS: HTA reports of products that received an NOC/c designation from HC from September 2023 (TLR process introduction) to December 2025 were retrieved from CDA and INESSS. Product information, trial design, and final HTA agency decisions were extracted. Potential for meeting TLR eligibility criteria was also assessed. Status of pCPA negotiations for submissions were also retrieved.
RESULTS: As of 31-Dec-2025, Enhertu® and Epkinly™ were the only products to enter the early access process and receive a TLR and pTAP agreement. While Epkinly™ received a positive recommendation from INESSS and is reimbursed by public drug programs across Canada, Enhertu® received a negative recommendation from INESSS and is not listed in Quebec and PEI public drug plans. Apart from Epkinly™ and Enhertu®, 13 drug submissions received an NOC/c designation from HC from September 2023 to December 2025, of which 8 were submitted to CDA for review. Among the completed reviews (N=5), four received a positive CDA recommendation. One submission (Talvey™) received a negative CDA recommendation due to uncertainties around clinical benefit demonstrated in the Phase 1/2 single-arm trial submitted. When assessing for TLR eligibility, the product appeared to have met the criteria for undergoing the early access process.
CONCLUSIONS: Early access pathways present opportunities for accelerated access to promising therapies. However, utilization of these processes has been limited, with only two products that underwent these processes since introduction. Products receiving an NOC/c designation from HC meeting the TLR eligibility criteria should consider submitting through the early access process.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA36
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas