Presentation (CTI)

Problem Statement: Canada’s Drug Agency’s accelerated access pathways, including Rolling Reviews, Time-Limited Recommendations (TLR), and the PACES (Pharmaceuticals with Anticipated Comparable Efficacy and/or Safety) pathway, are designed to streamline drug evaluations and ensure timely access to essential therapies. As pilot initiatives, these pathways aim to address systemic challenges in the market access landscape, maintain rigorous standards, and align with global efforts to modernize health technology assessments (HTA). Their long-term viability, fairness, and potential for broader application remain key questions.
Description: These accelerated pathways enable earlier evidence submission and simplify the review process, emphasizing efficiency and collaboration across the reimbursement continuum. Rolling Reviews and TLR are aligned with the "Target Zero" campaign to eliminate delays between regulatory approval and reimbursement recommendations. PACES focuses on accelerating reviews for simple, low-risk pharmaceuticals, reallocating resources to complex files while maintaining efficiency. This session highlights insights from Canada's Drug Agency on the pathways’ design and impact, pCPA on pricing and negotiation strategies, and a patient advocate on equity considerations and timely access from a patient advocate’s perspective. Key topics include their influence on collaboration among stakeholders, metrics for success such as time-to-listing and cost-effectiveness, and necessary structural or policy changes to support scalability and permanence.
Lessons Learned: While the pathways have demonstrated potential for improving timeliness and resource allocation, challenges remain in scaling these initiatives, ensuring fairness, and building trust. Metrics for evaluating success require refinement, emphasizing the balance of patient outcomes, cost-effectiveness, and equity.
Stakeholder Perspective: This is presented from multiple perspectives, including policymakers analyzing scalability, payers assessing pricing efficiency, and patient advocates addressing equity and access to therapies. These insights seek to guide the development of sustainable pathways that meet the needs of all stakeholders.