CADTH consultation on time-limited reimbursement initiative, and IMC report on what Canada can learn from Europe

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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.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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