Targeted Negotiation Process (TNP)

Our Targeted Negotiation Process (TNP) is a streamlined pathway designed for non-complex drug negotiations, including drugs that are comparable to others already available in the market. It launched as a pilot in 2021, and we’re now looking to formalize it and extend it to drugs that are part of the PACES (Pharmaceuticals with Anticipated Comparable Efficacy and Safety) pathway from Canada’s Drug Agency (CDA-AMC).

Based on past observations, the TNP has been shown to be approximately 30-45% faster than a typical negotiation, supporting timely coverage for patients.

Principles

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 did not 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 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. Manufacturers must honour the result of health technology assessment (HTA) recommendations for the respective jurisdictions to which they apply.
6. Manufacturers must make simultaneous HTA submissions to both the CDA-AMC and INESSS.
7. Manufacturers must adhere to the timelines in the TNP.
8. The pCPA requires cost-effective pricing and expects manufacturers to negotiate in good faith, 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:
   • Close the file without negotiation;
   • Agree to negotiate through standard negotiation; or  
   • 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. 

Conditions

1. 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.  

Evaluation

We will begin to evaluate the TNP pathway within 2 years of the public launch. 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. 

The process

Initiation

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

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 through either the TNP or standard negotiation process;
• Place the file on hold; or
• Close the file and not negotiate.

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.  

Negotiation

The negotiation team 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.

The format for negotiations is determined by a combination of factors including the drug, the manufacturer, and the team leading the negotiation. 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. See the Timelines section below for more information.

Completion

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’ll 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.

Timelines

Phase	Associated deliverable	Target completion time
1 - Initiation	Acknowledgment Letter	≤ 10 business days from HTA recommendation†
2 - Consideration	Engagement/Close/Hold Letter	≤ 40 business days from HTA recommendation†
3 - Negotiation	Proposals/Counterproposals	≤ 65 business days from LOE
4 - Completion	LOI/Close letter

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’ll be tracking instances where we collectively deviate from these timelines and gathering feedback from participants to further improve process efficiency. 

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

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).