The pan-Canadian Pharmaceutical Alliance (pCPA) has 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 following the Canada Drug and Health Technology Agency (CADTH) time-limited recommendation pathway.
CADTH Time-Limited Reimbursement Recommendations
Starting in the fall of 2023, CADTH, which conducts health technology assessments (HTAs) to inform public insurers, will introduce time-limited reimbursement recommendations for certain drug products. The CADTH initiative aims to facilitate access to new therapies for serious conditions/unmet medical need.
Drugs are only eligible for time-limited reimbursement recommendations if all of the following requirements are satisfied:
- Regulatory review status. The drug has been, or is undergoing, review through Health Canada’s advance consideration process under the Notice of Compliance with Conditions (NOC/c) policy, or the approval is accompanied by terms and conditions. CADTH intends to align this process with Health Canada’s proposed agile licensing reforms.
- Evidence-generation plans. A phase III clinical trial is being planned and/or conducted in the relevant patient population at the time of the submission to CADTH, and the study’s findings will be reported within 3 years from the target expert committee meeting date.
- Commitment. The drug sponsor commits to file a future reassessment of additional evidence within a set time frame. The reassessment will address the uncertainty with the comparative clinical benefit and cost-effectiveness for the drug under review.
- Evidentiary gaps. The CADTH expert committee must conclude that the evidence-generation plans described in Health Canada’s qualifying notice will address any important evidence gaps in the comparative effectiveness analysis.
pTAP Principles and Conditions
The pCPA has proposed a series of principles and conditions outlining its approach to a temporary access process that will enable publicly-funded access to patients during the evidence-generation period for a drug. We have highlighted key pTAP principles and conditions below.
- If a manufacturer participates in the CADTH time-limited recommendation pathway, participation in the pTAP is required.
- Drug manufacturers must provide coverage for any patient started on a medication during the temporary period where, for any reason, public funding is not continued beyond the temporary period.
- In the case of Québec, file admissibility and evaluation will be the sole responsibility of the Institut national d’excellence en santé et services sociaux (INESSS), and data submission from manufacturers (for both the initial submission and the re-evaluation) must be simultaneously carried out before both INESSS and CADTH.
pTAP Conditions for Participation
- Eligible drug products must meet the four CADTH criteria described above. A time-limited recommendation from CADTH does not guarantee that the pCPA will agree to temporary access.
- Funding is temporary and subject to the final CADTH reassessment recommendation and final pCPA negotiated agreement, which negotiation can start during the temporary access process.
- Manufacturers must agree to submit for HTA-reassessment – regardless of the outcome of their clinical trial – within the time limit set by CADTH.
The pCPA is inviting stakeholder input on its principles and conditions, to be submitted via a questionnaire on the pCPA website. The deadline to provide input is August 18, 2023.