AUTHOR=Wills Allison 

TITLE=Expanding the eligibility criteria for drugs in Canada’s time-limited health technology assessment and temporary drug access processes will further accelerate access to new medicines

JOURNAL=Journal of Pharmacy & Pharmaceutical Sciences

VOLUME=Volume 27 - 2024

YEAR=2024

URL=https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2024.13694

DOI=10.3389/jpps.2024.13694

ISSN=1482-1826

ABSTRACT=Canada’s Drug Agency (CDA-AMC) and the pan-Canadian Pharmaceutical Alliance (pCPA) have introduced new processes to balance timely patient access with decision-making for drugs showing early promise with high evidence uncertainties. In September 2023, CDA-AMC launched a time-limited reimbursement recommendation (TLR) category aimed at providing earlier access to new treatments for severe, rare, or debilitating illnesses. Concurrently, pCPA developed principles for a Temporary Access Process (pTAP) to guide negotiations for drugs following the TLR pathway. Drug eligibility for TLR and pTAP includes having a Notice of Compliance with Conditions (NOC/c) from Health Canada and a phase III clinical trial completion within three years.
As of mid-2024, one drug, epcoritamab for diffuse large B-cell lymphoma, has successfully navigated this new pathway, which significantly accelerated time to listing. Despite this progress, current eligibility criteria may limit the broader impact of TLR and pTAP, as few drugs qualify. Future refinements could include broader eligibility criteria, such as NOC/c expansion to allow for other drug files, incorporating greater flexibility into the Phase III clinical trial requirements, and accepting real-world evidence (RWE) as a supplement to clinical trial data.
Overall, the TLR and pTAP pathway represents a significant advancement in Canada’s approach to health technology assessments and drug reimbursement, promising timelier access to innovative treatments. Continued evaluation and adaptation of these processes will be crucial in ensuring their use, and their impact on timely patient access, with the expansion of drug eligibility criteria a logical next iteration.