Frequently Asked Questions: Time-Limited Recommendations

What type of drug reimbursement recommendations can we issue?

We can issue the following drug reimbursement recommendations:

• reimburse
• reimburse with conditions
• do not reimburse
• time-limited reimbursement (new).

Why are we introducing time-limited reimbursement recommendations?

We are introducing time-limited reimbursement recommendations to advance our key ambition to enable future-ready care. By establishing this new category, we are demonstrating the role of health technology assessment (HTA) to enable the appropriate adoption of innovation while maintaining a view of the evolving evidence 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.

The alignment of our reimbursement process with Health Canada’s NOC/c policy will help to ensure that HTA and regulatory pathways are working in parallel to 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 create 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.

What is a time-limited reimbursement recommendation?

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

Time-limited recommendations are currently distinct from our other led initiatives related to real-world evidence or post-market drug evaluation.

Which drugs are eligible for a time-limited reimbursement recommendation?

The types of drugs eligible for a time-limited reimbursement recommendation 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 which are expected to address the evidence gaps identified by our expert committee
• a reassessment commitment by the drug sponsor in accordance with the timeframes specified in the procedures for time-limited recommendations.

Why is this recommendation category only available for certain drugs and not all drugs that are submitted to us?

Our time-limited recommendation category aims to align our reimbursement review with Health Canada’s Notice of NOC/c policy. The objective of this regulatory pathway is to provide access to promising new drugs for people with serious, life-threatening, or severely debilitating disease. However, at the time of approval, there may be uncertainties about the clinical benefit or economic value these drugs bring to patients and health systems.

Our initial eligibility criteria for time-limited recommendations acknowledges this context and provides 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 include additional application types.

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.

What is the process for filing an updated submission for reassessment?

Drug sponsors should follow our Procedures for Time-Limited Reimbursement Recommendations for complete guidance on the process, including associated application fees.

Are aligned reviews between Health Canada and health technology assessment organizations eligible for the time-limited reimbursement recommendation category?

Yes. A drug sponsor may file a submission for an aligned review that is eligible for a time-limited reimbursement recommendation. For information, please consult the Review Phase section of our Procedures for Time-Limited Reimbursement Recommendations.

Will we accept real-world evidence as part of the drug manufacturer’s submission for reassessment after a time-limited reimbursement recommendation has been issued?

The focus of the reassessment application must be on the updated data from the phase III trial. Consideration may be given to include other study designs on a case-by-case basis (e.g., real-world evidence generated to address additional gaps in the evidence). However, this evidence must be provided in addition to the phase III trial data and will not be accepted as a substitute for the phase III trial evidence. 

What processes do other health technology assessment agencies in other jurisdictions have in place for how they conduct and deliver time-limited recommendations?

Some countries have developed health technology assessment processes to manage the challenges of uncertainties in the clinical and economic evidence that are identified in a conditional regulatory approval. Our Overview of Health Technology Assessment Processes for Time-Limited Recommendations is an Environmental Scan that provides insight into global processes to conduct and deliver time-limited recommendations.