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 a draft review report is issued by Canada’s Drug Agency (CDA-AMC). 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. 

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. Manufacturers must honour the result of HTA recommendations for the respective jurisdictions to which they apply.
5. Manufacturers must adhere to the timelines in the ENP. The negotiation must conclude by the time the final HTA recommendation is published.
6. If the CDA-AMC and/or INESSS provide a negative reimbursement recommendation, the pCPA reserves the right to withdraw from the negotiation.
7. 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 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. There may be some instances where the pCPA, at its discretion, will initiate a standard negotiation.
   If a Project Orbis submission was made to Health Canada, the pCPA and public drug plans require the manufacturer of that product to follow the principles and conditions outlined above. 

Evaluation

We’ll begin to evaluate the ENP once a minimum of 10 files has been completed, or within 2 years. 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

Once the CDA-AMC provides the draft review report, the pCPA sends an acknowledgement letter to the manufacturer letting them know that the drug is now under consideration for negotiation through the ENP.

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:

1. Engage in negotiations
2. Place the file on hold; or
3. Close the file and not negotiate.

If a manufacturer declines to participate in the ENP, we may close the file without negotiating.

*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. 

ENP negotiations proceed as follows:

• The manufacturer confirms its participation in the ENP within 5 business days of receiving the 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 our 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 our response, the manufacturer responds again either to accept our 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 ENP.

We aim to finalize ENP negotiations within 65 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’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. 

Note: A file cannot be completed until the final HTA reimbursement recommendation is published. If the negotiation concludes before that, we won’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 draft review report
2 - Consideration	Engagement/Close/Hold Letter	≤ 25 business days from CDA-AMC draft review report
3 - Negotiation	Proposals/Counterproposals	≤ 65* business days from LOE
4 - Completion	LOI/Close letter

^*The outcome of the negotiation and LOI (if applicable) will not be 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’ll be tracking instances where we collectively deviate from these timelines and gathering 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).