Pangaea Express: pCPA Brand Process Guidelines
The pCPA has released its Brand Process Guidelines to formalize the procedure and structure of the product negotiation process. While there are some new initiatives, for the most part, these Guidelines bring transparency to the current process in a “living document” that will continue to evolve with further stakeholder engagement. The pan-Canadian Pharmaceutical Alliance Office (pCPAO), received initial input from stakeholders that helped steer the development of the Brand Process Guidelines and the Office will continue on this path of transparency in the future.
There are 4 distinct phases in the process identified by pCPAO:
- Phase 1 Initiation
- Phase 2 Consideration
- Phase 3 Negotiation
- Phase 4 Completion
As before, the pCPA process begins once CADTH and /or INESSS publish their recommendations. However, now, the pCPAO will issue an “Acknowledgement Letter” to the manufacturer to inform them of the start of the Initiation phase. These Guidelines stress that Manufacturers DO NOT need to notify the pCPAO regarding new CADTH/ INESSS recommendations. The pCPAO will not accept meetings from Manufacturers prior to HTA Review (exceptions include Manufacturers unfamiliar with pCPA who wish to meet regarding process-related questions).
At the end of Phase 2, Consideration, the pCPA may: i) Express interest in opening negotiations, ii) Issue a Hold Letter, or iii) Issue a Close Letter (no negotiation will ensue). While the Hold letter is new, it is bringing more transparency and formality to an ongoing practice. Reasons for a Hold could range from the pCPA awaiting additional HTA information and/or other products relevant to the negotiation. In the event of a Close Letter, manufacturers must go through the pCPAO if interested in pursing negotiations with individual jurisdictions. However, any new proposal must be submitted to the pCPAO and not individual jurisdictions.
Negotiations remain confidential and all sensitive information (pricing, budget impact estimate etc.) will not be disclosed. During the negotiations process, the Manufacturer may ONLY communicate with the Lead jurisdiction and not with any of the other participating jurisdictions.
New target timelines have been introduced. While the pCPA has identified these timelines as “aspirational”, they do acknowledge a need for improvement from the current 10 – 11 month timeframe required for the complete process. The pCPA Brand Process Guideline has identified target completion expectations for Year 1 (2018/19) and Year 2 (2019/20):
- Phase 1 Initiation: Completion of Acknowledgement Letter ≤ 10 business days (from HTA recommendation)
- Phase 2 Consideration: Engagement/ Close/ Hold Letter delivered ≤ 40 business days (from HTA recommendation)
- Phase 3 & 4: Negotiation to Completion ≤ 90 business days from Engagement Letter
The aim is to meet these target completion times for 80% of the time during Year 1 and 90% of the time for Year 2. Except in the case of Phase 1, where pCPA wants 100% of the Acknowledgement Letters to be delivered within the allotted time frame.
In addition to the Guidelines, the pCPA has provided a Template for the Letter of Intent, they will continue to update an FAQ with common stakeholder questions and are in the process of building a website (no timing identified at this point). While there is no formal process for which jurisdiction will take on the role as lead, nor any systemic method for prioritization or “Sorting” products, as a “living document”, the Brand Process Guidelines will continue to evolve as required. Stay tuned for more…..
For more information, please contact Marla Weingarten at email@example.com, Consultant, The Pangaea Group.