The Ontario government and the pan-Canadian Pharmaceutical Alliance (pCPA) announced separate initiatives in October 2025, both aimed to accelerate patient access to breakthrough cancer treatments approved through the Project Orbis pathway.
As previously reported, Project Orbis is a global collaborative review program initiated by the U.S. Food and Drug Administration Oncology Center of Excellence to facilitate faster patient access to high-impact cancer therapies. Health Canada has been a partner in Project Orbis since 2019 and took part in the first joint approvals in September 2019.
1. Funding Accelerated for Specific Treatments (FAST) program
On October 7, 2025, the Ontario government announced the launch of a three-year pilot program which will expedite access to 7 to 10 Project Orbis cancer drugs every year by initiating public funding before the conclusion of pCPA negotiations with drug manufacturers.
In Canada’s traditional drug access process, pCPA price negotiations are initiated after a final reimbursement recommendation is published by health technology assessment (HTA) organizations (i.e., Canada’s Drug Agency (CDA-AMC) and in Québec, the Institut national d’excellence en santé et en services sociaux (INESSS)). Following a successful negotiation by pCPA, public drug plans make a final decision to fund a drug.
Under the FAST program, however, the Ontario government will pay for eligible drugs once a positive final recommendation from CDA-AMC is issued. The public funding will continue for an interim period while price negotiations take place. If an agreement with pCPA is not reached and public funding is discontinued after the interim period, drug manufacturers will be responsible for funding the drug for patients who have already started treatment during the interim period.
To be eligible for consideration, a drug must be:
- a Project Orbis cancer drug with a positive final CDA-AMC recommendation;
- manufactured by a company that wants to enter into a Letter of Intent (LOI) and funding agreement with Ontario;
- suitable for the FAST pilot (the ministry will assess each file individually).
The program is estimated to provide eligible patients with coverage to select cancer drugs nine months faster.
2. pCPA Early Negotiation Process (ENP)
On October 21, 2025, the pCPA released details of a new accelerated price negotiation process (Early Negotiation Process, ENP) which is designed for cancer drugs being reviewed under Project Orbis and is anticipated to save up to 6 months compared to the standard negotiation process.
Under the ENP, the price negotiation process will begin when a draft review report is issued by the CDA-AMC and/or INESSS. The intent is to complete negotiations by the time final reimbursement recommendations are published. If the negotiation concludes before then, the pCPA will not announce negotiation outcomes or execute an LOI until the HTA is published.
To be eligible for consideration under the ENP, a drug must have been:
- submitted to Project Orbis for regulatory approval;
- issued a Notice of Compliance (NOC) or NOC with conditions, or currently undergoing Health Canada regulatory review;
- submitted for an HTA to CDA-AMC and INESSS.
The pCPA is currently seeking feedback on the ENP. The survey will close on November 12, 2025.
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 life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.