On September 28, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) introduced the time-limited reimbursement recommendation category, which aims to provide early access to promising new drugs that target unmet needs of people with severe, rare, or debilitating illnesses, and to increase responsiveness to changes in drug development and regulation. CADTH also published the Procedures for Time-Limited Reimbursement Recommendations guidance document detailing the process for issuing and reassessing recommendations, as well as Frequently Asked Questions.
The new category allows a recommendation to publicly fund drugs for a certain period of time based on the condition that the manufacturer will conduct ongoing clinical studies to address any uncertainty in evidence. Any new evidence will be assessed by CADTH, leading to a final reimbursement recommendation.
As previously reported, CADTH consulted in April 2023 on the process for issuing and reassessing time-limited recommendations, which was developed by CADTH’s expert and advisory committees, Health Canada, the pan-Canadian Pharmaceutical Alliance (pCPA), and other pharmaceutical industry representatives. The pCPA introduced its Temporary Access Process in July 2023, in anticipation of CADTH implementing the present time-limited category recommendation.
Eligible drugs and drug regimens must meet the following eligibility criteria:
- the drug is undergoing or has completed a review for a Notice of Compliance with conditions (NOC/c) (CADTH will align with any confirmed revisions to the NOC/c process based on Health Canada’s initiatives on agile licensing of drugs);
- a phase III trial is being planned and/or conducted in the relevant patient population at the time of the submission to CADTH and the study completion date will not exceed 3 years from the target expert committee meeting date;
- the evidence-generation plans in Health Canada’s qualifying notice are expected to address the gaps in the evidence identified by CADTH’s expert committee; and
- the manufacturer must be willing to commit to file a reassessment application with CADTH in accordance with the time frames specified in the procedures for time-limited recommendations.
The eligibility process may expand based on the initial experiences to extend to more types of drugs. CADTH will evaluate the time-limited recommendation process after 3 to 5 recommendations or after 18 months, whichever is sooner, with the process remaining in place during the evaluation.
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.