Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program
- Canadian regulatory approvals align with FDA decisions, but submission numbers to Health Canada (HC) and Health Technology Assessment (HTA) processes are lower in Canada.
- There is a nearly 3-year delay between Accelerated Approval (AA) and funded access to treatment for Canadians.
- HTA in Canada involves evaluating clinical and cost-effectiveness to optimize health outcomes and resource allocation.
- Delays in Canada are due to regulatory and HTA processes, with factors like uncertainty in comparative clinical benefits contributing.
- Project Orbis and aligned reviews between HC and HTA aim to reduce these delays.
- Despite the longer timelines, access in Canada ensures greater certainty of clinical benefits, cost-effectiveness, and health care system sustainability.
- Collaboration among regulators and health care partners is crucial for improving patient access in Canada.
- Study limitations include inability to determine submission decision-making rationales and factors associated with regulatory and HTA process delays.
For serious or life-threatening diseases such as cancer, there is tension between standard regulatory approval processes and patients’ demand for early access to treatments. To address this issue, the US Food and Drug Administration (FDA) initiated the Accelerated Approval (AA) expedited pathway. AA enables funded drug access through Medicare.
In Canada, a similar expedited Health Canada (HC) pathway exists, but regulatory approval does not guarantee reimbursement. Since 2011, national health technology assessment (HTA) has taken place through the pan-Canadian Oncology Drug Review (pCODR) to facilitate funding decisions. Drug pricing is negotiated at a national level after a positive pCODR recommendation, followed by formulary listing.
We hypothesize that Canadians have delayed and reduced access to FDA AA drugs. This quality improvement study compares FDA AA with Canadian approvals and timelines for hematology and oncology treatments...
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