Through its latest proposals, BIOTECanada acknowledges and commends the pCPA’s efforts to accelerate timelines so that patients can access high-value medicines sooner. In support of this objective, BIOTECanada has shared the following member input on the pCPA’s proposed Early Negotiation Process (ENP) and Targeted Negotiation Process. We remain engaged and look forward to working with the pCPA Office as it develops and implements these approaches.
Main benefits of the ENP and TNP pathways
BIOTECanada commends the pCPA’s efforts to improve access timelines for innovative products that address high unmet needs. The main benefit of the ENP process is its national approach, which enables expedited access to novel and high-priority products. Products that proceed through ENP should receive an accelerated provincial listing and thus be complemented by provincial acceleration initiatives. Leveraging the draft CDA-AMC review reports allows both the pCPA and manufacturers to review negotiations with clinical and economic guidance as soon as it becomes available. However, this opportunity should extend to all high-value innovative products, including biologics, next-generation therapies such as cell and gene therapies, and treatments addressing high unmet needs, such as drugs for rare diseases. Accordingly, triggering a negotiation at this stage should be applied to standard negotiation processes for all Health Canada Priority Review products at minimum with view to further expansion to a broader definition of high impact products.
The TNP pathway provides clear pCPA response timelines, enabling manufacturers to set expectations and communicate schedules effectively to internal stakeholders.
Drawbacks the Biotech Sector Can Help Solve
The ENP observes the same process as the TNP but is applied to high-value, complex products. The TNP, introduced in January 2021, was designed to address a backlog by providing a structured, streamlined negotiation process for files “on hold” or “in consideration” due to capacity constraints. A critical concern among members is that a process developed for this purpose is now being applied to complex, high-value products. In providing feedback on the TNP, the biotech industry emphasized the importance of limiting its scope to products with clearly defined value, minimal payer uncertainty, and established therapeutic precedents. This approach addressed the backlog while allowing the pCPA to focus standard negotiations on products requiring more detailed and nuanced discussions.
The negotiation approach for the ENP pathway is almost identical to the TNP, which may not be appropriate given that oncology drugs and other high-value products generally involve greater complexity, even if the agreements ultimately reached are often simply structured. These complexities include diagnostic testing, implementation issues, no clear visibility into the place of therapy for oncology products (i.e., provisional funding algorithm developed by CDA-AMC), all of which require sufficient time for meaningful discussions regarding value. When multiple conditions remain open at pCPA’ s final proposal, aligning with the manufacturer’s final response becomes difficult, increasing the risk of file closure if all conditions cannot be met, an issue likely to persist if ENP mirrors TNP. The proposed ENP process may also be insufficient to address bundle indications or incorporate needed innovative pricing constructs. Given the multiple layers of complexity for products in high unmet need areas, the process should not compromise flexibility where required to enable a suitable and informed negotiation. The biotechnology industry encourages a process that is nimble while still aiming for ambitious timelines to bring these high-value products to patients sooner.
These pathways must be voluntary. Given the concerns above, manufacturers must retain the option to pursue a standard negotiation pathway if a simplified process would hinder an informed and mutually beneficial negotiation, including for CDA PACES files in the case of TNP. Under the current proposal, declining to participate may result in file closure. For smaller companies with limited resources and focused pipelines of innovative products, this requirement creates undue pressure and could limit access to the process. It is critical that this process evolve to be more flexible and adaptive to the needs of innovative products. Companies will be incentivized to launch in a market offering predictable, collaborative, and timely listing processes, particularly as they navigate the evolving expansive global dynamics including the US government’s Most Favored Nation pricing policy.
Balancing Timelines with Flexibility for Informed, Effective Negotiations
The proposed timelines in aggregate are generally reasonable and achievable with appropriate preparation from all stakeholders. However, flexibility must be allowed for more complex files or to resolve implementation issues, with total timelines serving as soft targets rather than strict rules. The timelines for each step will require even more flexibility to work. For the TNP, this may include adding a step when a small gap exists between offers. For the ENP, practical realities, such as HTA reviews or reconsiderations, discordant approaches and significant current timeline differences between the CDA-AMC and INESSS reviews, may limit strict adherence to the proposed timelines. Particularly for complex files, a guideline-based approach rather than a rigid rule is more likely to support successful negotiations.
Strengthening Shared Understanding of ENP and TNP
The ENP process is generally clear; however, several practical improvements could enhance clarity and support a more effective negotiation:
- Providing advanced notice when a file will undergo ENP would be helpful. This approach could also apply to TNP files. Similarly, manufacturers should be notified early if their Project Orbis files will not be included in ENP.
- We recommend a meeting prior to setting the pCPA mandate to discuss each party’s considerations. Incorporating these into the mandate would increase the likelihood of a successful outcome within the accelerated timeline.
- Acceleration can still be achieved by aligning with the pCPA’ s current target of 90 days from the letter of engagement. Either party should have the option to pursue the standard negotiation pathway once the CDA-AMC provides the draft review report.
- For files that do not conclude successfully under ENP, there should be an option to continue negotiations via the standard process rather than closing without agreement.
- Exceptions to timelines may be required for ENP files with added complexities; however, both parties should operate in good faith to minimize the number of exceptions.
Additional clarity would be helpful regarding how the pCPA will approach substantive changes between draft and final CDA-AMC reports and recommendations. For oncology products, it would also be valuable for provisional funding algorithms developed by CDA-AMC to be incorporated into pCPA discussions as early as possible to reduce uncertainty and clarify the product’s place in therapy.
It is unclear what is meant by the option for pCPA to “provide feedback” and how negotiations would proceed under this scenario. Further explanation of the nature and purpose of this feedback, which appears in both pathways, would be beneficial. It would also be important to confirm whether the feedback period may include an additional offer from either party and whether it will be made public if a manufacturer declines a TNP or ENP.
The pCPA’ s openness to innovative agreement structures would also support a clearer understanding of its approach to ENP product selection.
Collaborating to Build and Improve Early Negotiation Pathways
While meeting established timelines is a valuable metric to monitor, the ultimate measure of success will be the negotiation outcomes achieved through these processes and resulting improved timelines for access. Ensuring that outcomes for products under these pathways remain comparable to those reached through standard negotiations will be essential in defining what success looks like and how it should be measured.
The pCPA should regularly publish transparent summaries of progress and outcomes on its website. These could include cumulative time saved relative to standard negotiations, as well as the proportion of drugs selected for ENP compared to those eligible but not selected.
With respect to this consultation, industry will be interested in transparent visibility into what feedback was received and how the pCPA plans to incorporate it to refine the current proposal.
BIOTECanada highly commends the pCPA’s intent to accelerate its timelines and processes with the goal of bringing high-value medicines to patients sooner. The recommendations, clarification questions, and proposed practical improvements outlined above would all benefit from further discussion with the pCPA. An enhanced engagement approach for this promising initiative would help ensure its success. BIOTECanada remains open to collaboration and proposes re-establishing the industry–pCPA working group to further elaborate on these ideas. Regular engagement with this group and public reporting on key metrics, such as the number of files completed by therapeutic area, analysis of timelines, and identification of process challenges with proposed solutions, would provide meaningful insights and support continuous improvement.
BIOTECanada would like to thank the pCPA for this opportunity to provide feedback on these initiatives and look forward to engaging with the pCPA on the evolution of these processes.