The pan-Canadian Pharmaceutical Alliance (pCPA) introduced its proposed pCPA Temporary Access Process (pTAP) and invited stakeholders’ input on the process, its principles and conditions by August 18th, 2023.
The proposed pTAP and its associated principles are intended to inform pCPA negotiations and product listing agreements for products that have received a time-limited reimbursement recommendation from the Canadian Agency for Drugs and Technologies in Health (CADTH) – a new process expected to be implemented in fall 2023.
Early insights from PDCI suggest the pTAP principles – as proposed – would place significant risk on manufacturers. Specifically, if a permanent agreement cannot be reached following the CADTH reassessment, manufacturers would be required to assume funding for patients beyond the term of temporary public funding.
Background: Earlier this year, CADTH consulted stakeholders on its proposed approach for time-limited reimbursement recommendations. CADTH’s proposal detailed its eligibility requirements and process to issue an initial time-limited recommendation, then reassess additional evidence to issue a final recommendation. Eligible drugs included those undergoing Health Canada’s NOC/c regulatory approval process, and which have a Phase III clinical trial scheduled for completion within 3 years.