We know how important timely coverage for new drugs is. As one part of the drug reimbursement process, the pCPA is committed to supporting timely drug coverage for people in Canada.
That’s why we’ve improved and added to our negotiation pathway options with the Early Negotiation Process (ENP) and the revised Targeted Negotiation Process (TNP). Both apply nationally, benefitting those enrolled in provincial, territorial, and federal public drug plans across Canada.
Partner feedback
To gather insights and feedback on these expedited negotiation pathways, virtual sessions were held in November 2025 with partners in the drug reimbursement system, including clinicians, patient groups, and industry representatives. An online survey was also used to gather input from interested parties.
Both opportunities were designed to gather specific perspectives on the benefits and challenges of the ENP and the TNP.
- What we heard
A total of 108 participants, including clinicians, patient groups, and industry partners, participated in virtual sessions for the ENP and TNP. As well, the pCPA received 55 written submissions.
All parties expressed eagerness and support for efforts to shorten 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.
- Process updates based on partner feedback
Revisions were made to the ENP to ensure the process fits the needs of our partners, as expressed during the consultation period.
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.
Minor changes were also made to the ENP and TNP regarding the language used in the principles, to improve clarity.