The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a consultation document for a Proposed Process for Time-limited Reimbursement Recommendations. The time-limited reimbursement recommendations would be contingent on a future reassessment with further evidence about the comparative clinical benefit and cost-effectiveness of the drug or drug regimen under review.
According to CADTH, the initiative for time-limited reimbursement recommendation will help ensure timely access to promising new therapies and would better align with conditional regulatory approval, including Health Canada's initiatives on agile licensing of drugs.
Feedback should be provided using the feedback template by 5:00 pm ET on May 1, 2023.
Innovative Medicines Canada (IMC) released a report, Innovative Access Arrangements and Managed Entry—What Canada Can Learn From Europe, which outlines various arrangements made for reimbursement of drugs in Italy, England and Spain, and what lessons Canada could take from such arrangements. CADTH's proposed time-limited reimbursement recommendation is an example of one of the arrangements discussed in the IMC report: coverage with evidence development, where the price and reimbursement terms for a drug are subject to review based on post-marketing trials or real-life data. As previously reported, IMC published an Innovative Agreements Framework describing various types of innovative agreements for drug reimbursement.
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.
