Abstract
We undertook an analysis of the Canadian Agency for Drugs and Technologies in Health (CADTH)’s health technology assessments (HTAs) of systemic therapies for solid tumour indications to determine if a mechanism to re-evaluate HTA decisions is needed based on the level of certainty supporting the original recommendation. To measure the certainty in the evidence, we analysed if: (1) overall survival (OS) was the primary endpoint in the pivotal trial, (2) median OS was available at the time of the recommendation, and (3) the expert review committee explicitly identified gaps in the evidence. There were 96 drugs approved by Health Canada that met our eligibility criteria between 1 January 2017 and 31 October 2021. Median OS was not estimable at the time of the recommendation in 57% of the positive recommendations, and the uncertainty in the magnitude of clinical benefit was identified by the expert review committee in 21% of the positive recommendations. There is uncertainty at the time of the HTA recommendation for many drugs, and thus a need to implement a process to re-evaluate drugs in Canada to allow patients timely access to promising therapies while ensuring long-term value of therapies to patients and the healthcare system.
Highlights
Every year, new therapies become available to Canadians through the provincial and territorial universal healthcare systems
The list of approvals was limited to drugs listed as “antineoplastic agents” on the Health Canada website to narrow the focus to drugs for oncology indications
Overall survival was an endpoint in 82% of the pivotal trials for drugs with Health Canada approval; of these, overall survival (OS) was the primary endpoint in about 40% (31/78)
Summary
New therapies become available to Canadians through the provincial and territorial universal healthcare systems. As in many other countries, the processes of reviewing drugs for public reimbursement are complex [1,2]. In addition to being complex, Canadian processes are static and do not have agile mechanisms to re-evaluate drugs once they are added to public formularies. Drugs entering the Canadian market require regulatory approval from Health Canada. Health Canada has three review streams: standard review (300-day timeline), a priority review (180-day timeline) [3], and an accelerated review for drugs seeking a Notice of Compliance with conditions (NOC/c) (200-day timeline) [4]. When a drug receives an NOC/c approval rather than a Notice of Compliance (NOC), the manufacturer is required to collect evidence based on the conditions specified by Health Canada and provide them to Health Canada when available
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