CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include:
- improving the appropriate prescribing and use of medications;
- increasing pan-Canadian data collection and expanding access to drug and treatment data, including real-world evidence data; and
- reducing drug system duplication and lack of coordination.
CDA has begun several major initiatives including the below:
- The Target Zero initiative aims to achieve zero days between Health Canada’s regulatory approval of a drug and CDA’s reimbursement recommendation to participating drug plans, to increase patient access. CDA accepts submissions 180 days before Health Canada’s anticipated regulatory decision, which enables a parallel review process.
- CDA is updating its provisional funding algorithm in light of feedback received from the consultation (now closed) on updated procedures for provisional funding algorithms. This process is used to give advice to drug programs when they have indicated a need to harmonize the place in therapy for the funding of the drug under review relative to alternative treatments currently reimbursed by public drug programs.
- CDA is piloting the addition of societal perspectives to economic evaluation of drugs. Applications filed through the complex process (including cell and gene therapies, drugs that are first-in-class, drugs reviewed through Health Canada’s expedited pathways, and drugs that have an undefined place in therapy) on or after October 2, 2024 will need to include societal perspectives (i.e., in addition to health care payer costs, considerations associated with costs that fall outside the health care system will be required), or the sponsor will need to provide a rationale for why one is not included. CDA will also consider societal perspectives for applications filed before October 2, 2024, if they target the December 2024 expert committee meetings. Examples of societal costs include costs incurred by patients taking time off work for treatment and costs to other government sectors.
The CDA also released its Annual Report for 2023-2024, the theme of which is “Partnering for Results,” which focuses on how the strong relationships CDA has created will help the agency inform decisions about the best use of drugs and health technologies in Canada.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.