Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence for a drug once further trials are conducted.
CADTH conducts health technology assessments (HTAs) for Canada’s federal, provincial, and territorial public drug programs (with the exception of Quebec) to guide their drug reimbursement decisions.
As we reported, CADTH previously published a guidance document for consultation in early April 2023, setting out the end-to-end process of its proposed time-limited recommendations procedures. CADTH received feedback from more than 30 groups, including industry associations, drug manufacturers, consulting firms, patient and clinician organizations, and public drugs plans.
CADTH Time-Limited Reimbursement Recommendations
A time-limited recommendation is a recommendation to publicly fund a drug for a certain period of time. Drugs are only eligible for the time-limited reimbursement recommendation if all of the following criteria are satisfied:
- Notice of Compliance with Conditions (NOC/c). The drug has been or is undergoing review through Health Canada’s advance consideration process under the NOC/c policy, or the approval is accompanied by terms and conditions. An NOC/c means that a manufacturer is approved to market a drug subject to the condition that it will undertake further studies to verify the drug’s clinical benefit(s).
- Evidence-generation plans. A phase III clinical trial is being planned and/or conducted in the same patient population included in the original submission to CADTH. The study will be completed within three years from the target expert committee meeting date.
- Evidentiary gaps. The evidence-generation plans described in Health Canada’s qualifying notice must address any important evidence gaps identified by CADTH’s expert committee.
- Reassessment commitment. The drug sponsor commits to file a future reassessment of its additional evidence once the phase III evidence has been generated. CADTH will then reach a final reimbursement recommendation.
To enter the pathway, sponsors must submit an advance notification form addressing the eligibility criteria. CADTH will then conduct a preliminary screening to determine a product’s eligibility. Eligible applicants will be offered a 1.5 hour presubmission meeting with CADTH to discuss any evidentiary gaps and their plans to address same.
The time-limited reimbursement recommendation process may eventually be expanded to make such recommendations available for more types of drugs. CADTH will evaluate the process after the first three to five recommendations have been issued, or after 18 months, whichever is soonest. The pathway will remain available during that evaluation period.
The pan-Canadian Pharmaceutical Alliance (pCPA) recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP), which will inform the negotiation process and potential product listing agreements (PLAs) for drug products. The pTAP follows CADTH’s time-limited recommendation pathway.