Early Negotiation Process (ENP)

Our Early Negotiation Process (ENP) is a new pathway designed to support timely public coverage for certain cancer drugs. As 2 in 5 Canadians are expected to be diagnosed with cancer in their lifetime, we appreciate the need for new cancer drugs to reach patients in a timely manner.

Through the ENP, the negotiations process for drugs that are part of Project Orbis will begin when Canada’s Drug Agency (CDA-AMC) or the Institut national d’excellence en santé et en services sociaux (INESSS) accept a submission. This is months earlier than the pCPA’s standard negotiation process, which begins when a final health technology assessment (HTA) reimbursement recommendation is released. In fact, compared to the median 2024 timelines, the ENP is anticipated to save up to 6 months compared to the standard process.

Process updates based on partner feedback

We’re grateful to everyone who provided their thoughts on our new ENP and revised Targeted Negotiation Process (TNP) in fall 2025. Based on what we heard, we made several revisions to the proposed ENP to ensure the process fits the needs of our partners.

Notable updates include:

• Participating in the ENP for Project Orbis drug files is optional. Manufacturers may choose a standard negotiation instead (starting after the publication of final HTA reimbursement recommendations).
• There is no limit to the number of offers that can be exchanged during the negotiation timeframe.
• The ENP will be initiated when the CDA-AMC or INESSS receives a submission for a Project Orbis drug. This allows the process to begin sooner and provides a longer negotiation period than in the initial ENP design.

Read the full “What we heard” summary below to learn about the insights that were shared with us during the consultation period.

Principles

1. The pCPA recognizes the need to establish a unique process that provides the ability to expedite pCPA negotiations for select drugs.
2. If the manufacturer’s drug product was reviewed under the Project Orbis initiative, the manufacturer is expected to participate in ENP.
3. Manufacturers must make simultaneous HTA submissions to both Canada's Drug Agency (CDA-AMC) and Institut national d'excellence en santé et services sociaux (INESSS).
4. Public drug plans will reference and apply the health technology assessment (HTA) decision from the appropriate HTA body, and apply the recommended criteria at their discretion.
5. All parties must adhere to the negotiation timelines.
6. If the CDA-AMC and/or INESSS provide a negative reimbursement recommendation, the pCPA reserves the right to withdraw from the negotiation.
7. All parties negotiate in good faith. The pCPA requires cost-effective pricing, aiming to provide strong value. If mutually agreed upon terms are not reached within the ENP negotiation, the file will be closed.
8. The pCPA will make consensus-based decisions to accept or close files. All participating pCPA jurisdictions will align on the outcome.
9. The pCPA will continue to work collaboratively with CDA-AMC and INESSS.

Conditions

1. Drug products eligible for consideration under ENP must have:
   • Been submitted to Project Orbis for regulatory approval.
   • Been issued a Notice of Compliance or Notice of Compliance with conditions or is currently undergoing Health Canada regulatory review.
   • Been submitted for an HTA to CDA-AMC and INESSS.
2. A submission to Project Orbis does not guarantee the pCPA will engage in ENP negotiations.

Evaluation

We’ll begin to evaluate the ENP once a minimum of 10 files has been completed, or within 2 years (by December 2027). Metrics may include:

• The number of files entering and completing the ENP
• Agreement rates compared to standard negotiations
• Negotiation timelines compared to standard negotiations
• Feedback from partner surveys on process clarity and value

Results of the evaluation will be used to inform decisions such as criteria, and eligible drug therapies.

The process

Initiation

Within 10 business days of the CDA-AMC or INESSS accepting a submission for a Project Orbis drug, the pCPA sends an acknowledgement letter to the manufacturer to:

1. Let them know their drug meets the conditions for negotiation through the ENP.
2. Offer an opportunity to meet with the pCPA to answer any questions related to the ENP pathway

If a manufacturer declines to participate in the ENP, the file doesn’t undergo an expedited negotiation, and this decision is reflected on the pCPA’s website. The pCPA reassesses the file for standard negotiation after the final HTA reimbursement recommendation is published.

Consideration

In this phase, we gather additional information or clarification from partners, including:

• The manufacturer
• CDA-AMC and INESSS
• Clinicians
• Patient groups
• Jurisdictional review committees
• Others as required

Once this phase is complete, we send a letter to the manufacturer to let them know if we’ll engage in negotiations.

* There may be circumstances in which the pCPA selects the standard negotiation process for a Project Orbis file. If this occurs, we will inform the manufacturer at the letter of engagement (LOE) stage.

Negotiation

The negotiation team reaches out to the manufacturer to outline next steps and initiate negotiations.

The ENP resembles a standard negotiation process but starts earlier. These negotiations proceed as follows:

• Both parties exchange offers over the course of 75 business days.
• To begin, the pCPA presents desired terms within 5 business days of issuing the LOE.
• The pCPA requires up to 10 business days to respond to a manufacturer’s offer.The manufacturer’s last offer must be presented to the pCPA no later than day 65 of the negotiation process.
• Within 10 business days of receiving the manufacturer’s last offer, the pCPA responds either to 1) accept the offer and proceed with an LOI; 2) to provide feedback; or 3) to decline and close the file without agreement.

Negotiation leads from the pCPA and the manufacturer work together to determine the negotiation format as appropriate, including when and how often to meet. Negotiations typically take place via teleconference.

We aim to finalize ENP negotiations within 90 business days from the LOE. However, many factors can impact negotiation timelines. See Timelines below for more information.

Completion

Once terms are mutually agreed upon, the pCPA creates an LOI detailing the agreement.

ENP files may be closed without agreement. If mutually agreed upon terms are not reached, we send a letter to the manufacturer letting them know that the negotiation is closed. The manufacturer may later submit an unsolicited offer to reinitiate negotiations.

Note: A file cannot be completed until the final HTA reimbursement recommendation is published. If the negotiation concludes before that, we don’t announce negotiation outcomes or execute the LOI (if applicable) until the HTA is published. A successful ENP negotiation is conditional on obtaining a final HTA recommendation to reimburse. ENP negotiations will be suspended for files where the final HTA recommendation type is “Do not reimburse”.

Timelines

Phase	Deliverable	Target completion time
1 - Initiation	Acknowledgment Letter	≤ 10 business days of CDA-AMC or INESSS acceptance of submission report
2 - Consideration	Engagement/Close/Hold Letter	≤ 25 business days from CDA-AMC draft review report
3 - Negotiation	Proposals/Counterproposals	≤ 90* Business Days from LOE
4 - Completion	LOI/Close letter

* The outcome of the negotiation and LOI (if applicable) is not announced until the final CDA-AMC reimbursement recommendation is published.

The pCPA is accountable for timeliness in the initiation and consideration phases, but progress in the later phases is dependent on all negotiating parties. As such, these should be considered joint targets. We track instances where we collectively deviate from these timelines and gather feedback from participants to further improve process efficiency.

Next steps

Once the terms of the LOI have been fully executed, it’s the responsibility of the individual public drug plans and the manufacturer to transfer the terms into a product listing agreement (PLA).