In October 2025, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Government of Ontario  announced new pathways to accelerate the funding of new drugs for Canadians. Canada currently ranks last among G7 countries in providing patients with timely access to innovative drugs. The pCPA has proposed two new expedited negotiation pathways, one for high-impact cancer drugs and another for non-complex negotiations. In tandem, the Government of Ontario announced a pilot program to fast-track funding for breakthrough cancer drugs.

Background

According to Innovative Medicines Canada (link), Canada ranks last among the G7 countries and 19th out of 20 OECD peer countries in providing timely access to innovative new drugs. It takes, on average, 2 years for such drugs to become publicly funded after Health Canada has approved them. During those 2 years, the manufacturer must navigate a complex path, including:

  • Health technology assessment: Canada’s Drug Agency / l’Agence des médicaments du Canada (CDA-AMC) and l’Institut national d’excellence en santé et services sociaux (INESSS) conduct a health technology assessment (HTA) of the new drug and recommend whether or not to fund it.
  • pCPA negotiations: Relying on the CDA-AMC and/or INESSS recommendation, the pCPA negotiates the new drug’s price on behalf of provincial, territorial, and other public drug plans.
  • Product listing agreements: The terms negotiated by the pCPA must be transferred into product listing agreements between each individual drug plan and the manufacturer, which leads to the drug being listed on public formularies and patients gaining access to treatment.

pCPA: Expedited negotiation pathways

On October 7, 2025, the pCPA proposed two new negotiation pathways: the Early Negotiation Process for cancer drugs and the Targeted Negotiation Process for “non-complex drug negotiations”. If launched, these pathways would join another non-standard pathway launched in 2024, the pCPA Temporary Access Process for drugs conditionally approved by Health Canada (our report here).

Early Negotiation Process: The pCPA has proposed the Early Negotiation Process for new cancer drugs that are: (i) submitted to Project Orbis; (ii) approved or are under review by Health Canada; and (iii) submitted to CDA-AMC and INESSS for an HTA. Project Orbis is a partnership between Health Canada and the US Food and Drug Administration, along with other national regulators, for reviewing high-impact, clinically significant cancer drugs. Under the Early Negotiation Process, the pCPA would start negotiations early—after a draft HTA report rather than the final report—and the negotiations would follow a structured, streamlined process. The negotiations would conclude before the final HTA report is published, with the pCPA reserving the right to withdraw if the final HTA recommendation is “Do not reimburse”.  According to the pCPA, this new pathway could save up to 6 months over its standard pathway.   

Targeted Negotiation Process: The pCPA has proposed the Targeted Negotiation Process for “non-complex drug negotiations, including drugs that are comparable to others already available in the market.”  The new pathway would continue a pilot launched in 2021 and extend it to drugs in the CDA-AMC’s PACES pathway (for pharmaceuticals with anticipated comparable efficacy and safety). Negotiations under the pCPA’s proposed Targeted Negotiation Process would begin after a final HTA report is published and would follow a structured, streamlined process. According to the pCPA, this new pathway is ~30-45% faster than its standard pathway.   

The pCPA is inviting comments until November 12, 2025 on the proposed new pathways.

Ontario: FAST Program

On October 7, 2025, the Government of Ontario announced a new pilot program, the Funding Accelerated for Specific Treatments (FAST) Program, to provide early funding for 7-10 high-priority cancer drugs every year for 3 years.

Eligibility: To be eligible for FAST, a drug must have been: (i) approved by Health Canada and part of Project Orbis (see above); (ii) have a positive, final funding recommendation from CDA-AMC; and (iii) have been deemed suitable by Ontario’s Ministry of Health (Ministry). Factors that may prevent funding under the FAST Program include “the drug is complex” and funding not being “in the public interest”.

Stopgap funding: For eligible drugs, the FAST program will provide public funding during the “interim period” while the pCPA negotiates with the drug manufacturer. The outcome of the pCPA negotiations will determine if public funding is continued. If public funding is not continued, the drug manufacturer must fund the drug for patients who started treatment during the interim period. By providing public funding during the interim period, the Ministry says that Ontario patients will gain access to breakthrough cancer drugs up to 9 months earlier than they otherwise would have.

Links: