Tuesday, November 11, 2025 – On October 3rd, the pan-Canadian Pharmaceutical Alliance (pCPA) formally announced two new expedited negotiation pathways – the Early Negotiation Process (ENP) and the Targeted Negotiation Process (TNP).
TNP was initially rolled out during COVID, but has never been fully and formally communicated to the pCPAs core stakeholders. ENP, however, is an entirely new pathway designed to speed up negotiation timelines for promising new cancer therapies that have already received regulatory approval through Project Orbis. We summarize both pathways below:
The Early Negotiation Process (ENP)
ENP is differentiated from pCPA’s standard negotiation process by its early start. Instead of waiting for a final reimbursement recommendation, the ENP allows negotiations to begin as soon as the CDA-AMC draft review report is released. This early start is anticipated to save up to six months compared to the median 2024 timelines for the standard process.
The Targeted Negotiation Process (TNP)
The TNP is designed for non-complex drugs, including those considered comparable to others already on the market. Launched as a pilot in 2021, TNP has been designed to support faster and more efficient negotiations for drugs that have received an HTA review through the CDA-AMC’s “Pharmaceuticals with Anticipated Comparator Efficacy and Safety” initiative, known as PACES. Four years since its launch, TNP has led to successful negotiations that have concluded 30-45% faster than the timelines expected through the organization’s Standard pathway.
ENP & TNP Timelines
The chart below provides a comparison of the ENP and TNP timelines. It’s important to note that with ENP and TNP, manufacturers must make simultaneous HTA submissions to both CDA-AMC and the Institut national d’excellence en santé et services sociaux (INESSS) to ensure alignment with the findings of both major review bodies.
Santis Insights
Reflecting on both the ENP and TNP pathways – and the broader political and policy context surrounding them – 4 key takeaways are important to consider:
- ENP and TNP have been designed to address very different groups of drugs with the same general process. As the table above makes clear, the ENP and TNP pathways start at two different points: for ENP, the “Consideration Phase” starts within 25 business days of the CDA-AMC Draft Review Report; and for TNP it starts within 40 business days of the Final Review Report. Apart from that key difference, however, the ENP and TNP processes are broadly similar – which means the pCPA is confident that it can successfully negotiate complex cancer drugs using essentially the same approach it uses with PACES drugs.
- Following the launch of Ontario’s “FAST” pilot program, ENP is now the second accelerated access initiative to focus on the same group of Project Orbis Drugs. Announced on October 7, Ontario’s Funding Accelerated for Specific Treatments (FAST) pilot program is a 3-year initiative designed to speed up public funding of select high-priority cancer drugs that have secured expedited global regulatory review. ENP targets the same specific medicines, with some important key differences:
- ENP is being rolled out as a permanent negotiations pathway, whereas FAST was announced as a pilot program,
- ENP negotiations commence following a Draft Review Report from CDA-AMC, whereas FAST kicks off following positive final recommendation from the Agency; and
- Any deal reached through ENP is final, and will apply across all participating pCPA jurisdictions, whereas FAST remains an Ontario-only initiative.
- ENP’s expansion beyond Orbis will depend on its initial popularity. More than two years after it was first announced, only two products have moved through the pCPA’s Temporary Access Process (pTAP) – vs. the more than 100 drugs that have moved through TNP. The pCPA is clearly counting on ENP having the same success as TNP, but if the new pathway suffers from the same disinterest as pTAP – or if manufacturers conclude the ENP timelines are too tight to reflect the complexity of Project Orbis drugs – the likelihood of expanding eligibility beyond its initial cancer parameters will be low.
- ENP’s ultimate success will depend on its impact on the timing of PLAs – not LOIs. Industry, clinicians and patient groups are collectively united in their desire for faster access to innovative treatments. If it rolls out as the pCPA hopes, ENP could play a key role in securing Letters of Intent months faster than through a Standard negotiations process. However, ENP’s value will be significantly undermined if individual provinces fail to adopt the same accelerated approach to signing their respective PLAs.
What Happens Next
The pCPA hosted four consultation sessions from November 5 – 7, providing dedicated opportunities for clinicians, industry representatives and patient advocates to have their ENP and TNP questions answered, share their concerns and recommendations, and outline their interest in more engagement and more transparency over the coming months. The pCPA has also released a Stakeholder Survey on its website as a mechanism to gather additional feedback, with responses due on November 12. (Full Disclosure: Santis moderated those sessions and will be synthesizing the forthcoming stakeholder feedback.)
Driving this tight timing is the pCPA’s commitment to publicly releasing a concise What We Heard Report on its website as a key milestone in its goal of formally launching ENP before the new year.
Final Thoughts
In July 2024, Canada’s Premiers came together at their annual Council of the Federation meeting in Halifax and released a public commitment to accelerate access to medicines across the country. Fifteen months later, not one but two accelerated access mechanisms have now been announced – the Government of Ontario’s new FAST initiative and the pCPA’s new ENP pathway. Although it’s too soon to assess the success of either one, the speed of their development reflects a collective acknowledgement by leaders across the pan-Canadian drug access ecosystem that the status quo has to change.
Interested in learning more about pCPA’s expedited negotiation pathways? Contact our Santis Health expert today:
Ross Wallace – ross.wallace@santishealth.ca