Our Time-Limited Recommendation Category Aims to Support Earlier Access to Promising Drugs

We have introduced a new type of recommendation. Time-limited drug reimbursement recommendations are a new recommendation category that will aim to help provide earlier access to promising new treatments that target the unmet needs of people in Canada living with severe, rare, or debilitating illnesses.

A time-limited recommendation is a recommendation to publicly fund a drug or drug regimen for a certain period of time. This recommendation is based on the condition the manufacturer will conduct ongoing clinical studies to address uncertainty in the evidence. We will conduct a future reassessment of that additional evidence, which will lead to a final reimbursement recommendation.

New Recommendation Category Responds to Changing Pharmaceutical Landscape

There are a broad array of products coming to market (like biologics, gene therapies, and combination therapies) that are complex and may target smaller patient populations or treat conditions that have limited therapeutic options. Regulators in Canada and globally may grant earlier approval of these products based on less mature evidence and with certain conditions in place. As a result, patients and health systems are looking to access new treatments sooner to harness their potential benefits. We have created the new time-limited reimbursement recommendation category to meet the evolving expectations and needs of policy-makers and to more effectively respond to changes in drug development and regulation.

Criteria for Drugs Eligible for a Time-Limited Recommendation

There are clear criteria to determine which drugs are eligible for the time-limited recommendation category. These drugs will have all of the following:

• a Notice of Compliance with Conditions (NOC/c) from Health Canada (this means approval to market the drug with the condition that the manufacturer will undertake more studies, typically phase III studies, to verify the clinical benefit)
• robust evidence-generation plans for a phase III clinical trial are or will be in place for the same patient population included in the original submission to us and the study completion date will not exceed 3 years from the target expert committee meeting date
• evidence-generation plans described in Health Canada’s qualifying notice that are expected to address the evidence gaps identified by our expert committee
• a reassessment commitment by the drug sponsor in accordance with the time frames specified in the procedures for time-limited recommendations.

The alignment of our time-limited reimbursement recommendation process with Health Canada’s NOC/c policy aims to help ensure that health technology assessment and regulatory pathways are working in parallel. We anticipates that the process may provide patients with earlier access to promising new drugs while creating mechanisms to revisit the clinical and economic evidence as it evolves. This process alignment may also contribute to a more seamless avenue for pharmaceutical companies to bring their drugs to market in Canada and help provincial, territorial, and federal governments make those drugs available to patients more quickly.

“CADTH recognizes the value of innovation and the contributions of the life sciences sector, and we hope this initiative encourages drug manufacturers to bring new drugs to Canada,” said Suzanne McGurn, CADTH President and CEO. “We believe the introduction of time-limited recommendations is another way that health technology assessment can enable the timely and appropriate adoption of innovation and help governments expand access to treatments while managing uncertainty and risk.”

The initial eligibility criteria for time-limited recommendations are a first step for us, the participating public drug programs, the pan-Canadian Pharmaceutical Alliance, and other affected parties to establish and refine the implementation of these recommendations. Based on these initial experiences, the process may be expanded to make time-limited recommendations available for more types of drugs. To ensure that the introduction of time-limited recommendations has the intended impact and meets the needs of stakeholders, we will evaluate the process after the first 3 to 5 recommendations have been issued or after 18 months, whichever is soonest. We expect the time-limited recommendation process to remain in place during the evaluation period.

The time-limited recommendation category builds on our existing recommendation options, which include reimburse, reimburse with conditions, and do not reimburse. Note that a recommendation to reimburse with conditions is a final recommendation that provides implementation criteria on how a drug may be reimbursed.

Consultations Helped Refine the Process

We have published Procedures for Time-Limited Reimbursement Recommendations, a guidance document for manufacturers that describes the end-to-end process for issuing and reassessing recommendations.

The process for time-limited recommendations was developed in consultation with our expert and advisory committees, Health Canada, the pan-Canadian Pharmaceutical Alliance, and representatives of the pharmaceutical industry. The proposed process was published in March 2023 for a 4-week public consultation, and the feedback received was carefully considered and contributed to the final version. We received feedback from more than 30 groups, including industry associations, drug manufacturers, consulting firms, patient and clinician organizations, public drug plans, and other organizations.

For more information about time-limited recommendations, consult our Frequently Asked Questions.