Early negotiation process

1. The pCPA recognizes the need for a unique process 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 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.

1. Drug products eligible for consideration under ENP must:  
   • Have been submitted to Project Orbis for regulatory approval.
   • Have been issued a Notice of Compliance or Notice of Compliance with conditions or be undergoing Health Canada regulatory review.
   • Have been submitted for an HTA to CDA-AMC and INESSS.
2. A submission to Project Orbis doesn’t guarantee the pCPA will engage in ENP negotiations. If either the manufacturer or the pCPA decline to use the ENP, this will be reflected in the negotiation database. 
    

A total of 108 participants, including clinicians, patient groups, and industry partners, participated in virtual sessions for the ENP and targeted negotiation process (TNP) in November 2025. An online survey was also used to gather input from interested parties, and the pCPA received 55 written submissions. Both opportunities were designed to gather specific perspectives on the benefits and challenges of the ENP and the TNP.

What we heard

All parties expressed eagerness and support for efforts to accelerate timelines for coverage of new drugs, and there was widespread support for starting negotiations earlier. 

Feedback also included concerns and suggestions for improvement. The pCPA has gathered these into the following key themes:

Mandatory participation 

The ENP was designed to apply to all Project Orbis drugs. Industry partners expressed a desire to work together on options for an opt-in model based on mutual agreement, as well as more clarity on what would happen if a manufacturer declined to participate in the ENP. 

Expansion to other drug therapies 

Many clinicians and patient groups shared the desire to expand the ENP to additional drug categories, including drugs that have been approved through Health Canada Priority Review. 

Flexibility in number of offers 

Respondents noted the efficiency and predictability of the ENP. They also highlighted concerns regarding the set number of offers outlined in the process, suggesting 2 offers may not be enough for complex files. Some manufacturers also mentioned challenges with the time-bound approach.

Clarity of principles 

Some respondents requested clarification of language in the principles, specifically the requirement for manufacturers to “honour” health technology assessment (HTA) recommendations. 

It was noted that terms such as “good faith” and “strong value” were applied only to the behaviour of manufacturers, rather than to both the pCPA and manufacturers. 

Alignment with Canada’s Drug Agency (CDA-AMC) and the Institut national d’excellence en santé et en services sociaux (INESSS)

Respondents indicated a desire for clarity on how the pCPA would respond to instances where the HTA processes of the CDA-AMC and INESSS led to different conclusions. Concerns were raised regarding the requirement to submit to both the CDA-AMC and INESSS simultaneously, noting potential administrative and operational challenges for manufacturers. 

Evaluation 

Some respondents expressed a desire for the evaluation process to begin sooner, with feedback indicating a rolling evaluation or interim reports would be preferred for continuous improvement. It was also suggested that the evaluation should include a formal feedback mechanism for partner groups. 

As well, respondents said they wanted to better understand the metrics that will be used to evaluate the success of the ENP. 

Communication 

There was a common suggestion for a publicly accessible dashboard that identifies what drugs are following the ENP and TNP. 

Updates based on partner feedback

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 included:

• 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’s 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.

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. 

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

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 a final HTA reimbursement recommendation is published.

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’ll inform the manufacturer at the letter of engagement (LOE) stage, and the decision will be reflected in our negotiation database.
 

The negotiations lead(s) reaches out to the manufacturer to outline next steps and initiate negotiations.

ENP 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 a letter of intent (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, and both negotiating parties play a critical role in meeting timelines. See Timelines below for more information.
 

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 can’t 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”.

* 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. Later phases are joint targets shared with manufacturers. We track timeline deviations, gather feedback from participants, and use the data to improve process efficiency. Check out our performance dashboard for our latest timeline metrics.