Canada’s Intellectual Property Firm

CADTH proposals to enhance drug review processes

Authored byKatie Lee

The Canadian Agency for Drugs and Technologies in Health (CADTH) held consultations which ended April 14, 2022 on two new proposals: (1) a proposed process for non-sponsored reimbursement reviews and (2) a streamlined process for drug class reviews.

The proposal for non-sponsored reimbursement reviews is intended to apply to scenarios where a sponsor is unwilling or unable to file an application (examples given are drugs approved for small patient populations, drugs nearing the end of their exclusivity (such as patent protection), or drugs not approved by Health Canada for a particular clinical indication but are known to be used in Canadian clinical practice).

The proposal for new streamlined drug class reviews would provide a new Streamlined Drug Class Review process that is more efficient and expands CADTH’s ability to flexibly deliver evidence and analysis, for example, by creating a process that allows CADTH to leverage existing published evidence where a new meta-analysis or economic analysis is not required.

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 technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.