As previously reported, in the spring, the Canadian Agency for Drugs and Technologies in Health (CADTH) consulted on a process for time-limited reimbursement recommendations. The pan-Canadian Pharmaceutical Alliance (pCPA) has recently released a set of principles and conditions for its Temporary Access Process (pTAP) to inform the negotiation process and potential product listing agreements for any drug products that follow CADTH's process, which the pCPA advises CADTH will introduce in the fall of 2023.
Time-limited reimbursement recommendations are "temporary reimbursement recommendations that will be contingent on a future reassessment within a specific time period, where future evidence is expected to address any uncertainty identified in the initial CADTH assessment."
Eligibility criteria
Both the proposed CADTH process and pTAP have the following eligibility criteria:
- the drug is undergoing or has completed a review for a Notice of Compliance with conditions (NOC/c) (CADTH would align with any confirmed revisions to the NOC/c process in Canada 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 drug 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 evidence-generation plans described in Health Canada's qualifying notice are expected to address the gaps in the evidence identified by CADTH's expert committee.
pTAP principles and conditions
The pTAP principles and conditions outline the pCPA's approach to a temporary access process with drug manufacturers for public funding during the evidence-generation period.
Highlights of principles include:
- Participation in pTAP is required if a manufacturer participates in the CADTH time-limited recommendation pathway.
- Manufacturers will be required to abide by the timing and expectations set out by both the CADTH time-limited recommendation process, including a final CADTH recommendation, and by the pTAP.
- For Quebec, file admissibility and evaluation of promising therapies will be under the sole responsibility of the Institut national d'excellence en santé et en services sociaux (INESSS), and the drug manufacturer's data submission (both initial and re-evaluation) must be carried out simultaneously both to INESSS and CADTH.
- Drug manufacturers will be required to provide coverage for any patient started on medication during the temporary period where for any reason public funding is not continued beyond the temporary period.
Highlights of conditions include:
- A time-limited recommendation from CADTH does not guarantee pCPA will agree to temporary access, as pCPA will assess each file individually.
- The manufacturer will assume funding for patients who started on the drug during the interim period in the following situations:
- Manufacturer fails to comply with CADTH reassessment;
- CADTH's final recommendation is to not reimburse;
- CADTH provides a final recommendation to reimburse, but pCPA negotiations do not result in a long-term agreement between pCPA and the manufacturer; or
- CADTH's final recommendation further restricts criteria which results in patients becoming ineligible for public funding.
- If CADTH has issued a time-limited recommendation for a product, pCPA and public drug plans require the manufacturer of that product to abide by the pTAP principles and conditions.
The pCPA has invited input on the pTAP principles and conditions through its online questionnaire until Friday, August 18, 2023.
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.
