Targeted negotiation process

1. If the manufacturer’s drug product was submitted through the PACES review pathway at CDA-AMC, the manufacturer is expected to participate in the TNP.  
2. The pCPA may notify manufacturers to participate in the TNP for selected files that didn’t undergo a CDA-AMC PACES review.
3. Manufacturers will be notified in the letter of engagement (LOE) that the pCPA has selected their file for the TNP.
4. Québec’s participation in TNP negotiations is contingent on the recognition of therapeutic value by the Institut national d'excellence en santé et services sociaux (INESSS).
5. 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.
6.  Manufacturers must make simultaneous HTA submissions to both the CDA-AMC and INESSS.
7. All parties must adhere to the timelines in the TNP.
8. 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 TNP negotiation, the file will be closed.
9. If the manufacturer does not agree to negotiate through the TNP, the pCPA may, at its sole discretion:
   1. Close the file without negotiation;
   2. Agree to negotiate through standard negotiation; or
   3. Return the file to Phase 2 of the pCPA process (consideration) and reprioritize the file accordingly.   

* There may be circumstances in which the pCPA selects the standard negotiation process for a PACES file. If this occurs, the manufacturer will be informed at the LOE stage, and the decision will be reflected in the negotiation database.

Drug products eligible for consideration under the TNP must:

• Follow the PACES pathway from the CDA-AMC; or   
• Be assessed as a non-complex drug negotiation; or 
• Be drugs that are comparable to others already available in the market.

* A drug that followed the PACES pathway from the CDA-AMC is not guaranteed to be negotiated through the TNP. There may be some instances where the pCPA, at its discretion, initiates a standard negotiation.  If either the manufacturer or the pCPA decline to use the TNP, 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 early negoation process (ENP) and 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:

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 some changes to the language used in the proposed TNP principles, to improve clarity.

We will begin to evaluate the TNP by December 2027. Metrics may include:

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

The results of this evaluation will inform future decisions, such as eligibility criteria. 

Once the CDA-AMC or INESSS publishes a final reimbursement recommendation for a drug, the pCPA sends a letter of acknowledgement to the manufacturer letting them know that the drug is now under consideration for negotiation. 

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 through either the TNP or standard negotiation process;
• Place the file on hold; or
• Close the file without negotiating. 

If a manufacturer declines to participate in the TNP the pCPA may, at its sole discretion, agree to negotiate through a standard negotiation process or close the file without agreement. 

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

TNP negotiations proceed as follows:

• The manufacturer confirms its participation in the TNP within 5 business days of receiving the letter of engagement (LOE).
• The pCPA presents desired terms within 5 business days of the manufacturer confirming they have received the LOE.
• Within 10 business days of receiving the pCPA’s first offer, the manufacturer responds either to accept and proceed with a letter of intent (LOI) or to present their own first offer.
• Within 10 business days of receiving the manufacturer’s first offer, the pCPA responds either to accept the offer and proceed with an LOI, to present a counteroffer, or to decline the offer. 
• Within 10 business days of receiving the pCPA’s response, the manufacturer responds again either to accept the pCPA’s counteroffer and proceed with an LOI or to present their second offer.
• Within 10 business days of receiving the manufacturer’s second offer, the pCPA responds either to accept the offer and proceed with an LOI, to provide feedback, or 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. Negotiations typically take place via teleconference, and the frequency of meetings follows the steps outlined in the TNP.

We aim to finalize TNP negotiations within 65 business days from the LOE. However, many factors can impact negotiation timelines, and both negotiating parties play a critical role in meeting timelines. See the Timelines section below for more information.
 

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

TNP 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.

* First HTA reimbursement recommendation, either the CDA-AMC or INESSS

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.