Melissa Kampman, Melissa Hunt, Kelly Robinson, Health Canada
The article on oncology drug approvals published in this issue of the journal examined the data and nuances of oncology submissions processed under Health Canada’s Notice of Compliance With Conditions (NOC/c) policy.1 The research was conducted through the collaborative efforts of a multidisciplinary team with input from Health Canada staff. Their contributions aided the analysis and interpretation of the results by providing clarifications and highlighting important specifics related to the NOC/c policy and its application.
While Health Canada's transparency mechanisms typically focus on individual submissions, our examination across all submissions over time provided us with a comprehensive resource. This allowed us not only to observe the extent to which confirmatory studies align with approved indications, but also to understand the impact of our decisions under the NOC/c policy. Notably, the analysis revealed that 82% of these products were included in the National Comprehensive Cancer Network guidelines, offering valuable insight into their standard of care status.
Looking ahead, this study underscores the importance of maintaining mechanisms for reviewing promising new medications. It emphasizes the significance of confirmatory trials, not only to Health Canada but also to health care providers. Real-world evidence may play an important role in supplementing confirmatory studies and providing additional support for the use of these products. We look forward to observing the evolution of this landscape over time.
1.Martin A, Hunt M, Blommaert S, Udayakumar S, Lu B, Chatterjee S, et al. Oncology Drug Approvals Under Health Canada’s Notice of Compliance With Conditions Policy: A Retrospective Cohort Analysis. Can J Health Technol. 2024;4(5). https://canjhealthtechnol.ca/index.php/cjht/article/view/MG0024