On June 13, 2018, after considerable time in development, the pCPA released its Brand Process Guidelines for external feedback. The pCPA is interested in receiving feedback from all sectors with a stake in the negotiation process: brand and generic pharmaceutical companies, patient organizations, and other interested parties.

The guidance documents, which can be accessed here on the PDCI website, are intended to facilitate a more structured yet hopefully still flexible process for negotiating with the pCPA jurisdictions. Three key takeaways at this point should be watched closely by pharmaceutical manufacturers:

1. Letter of Intent: Of interest for manufacturers is to review and understand the implications of the pCPA’s proposed “Letter of Intent Template”; it will be important to ensure that the deal examples in the template do not become de facto limited options preferred by the pCPA jurisdictions. This will be particularly important to consider as we see other cost management initiatives potentially limiting the financial headroom for negotiating on further financial discounts. As we hear more about building real-world data and value into negotiations, any templates will need to remain flexible enough to offer guidance while not stifling creative discussions.
2. Pre-Negotiation Engagement: To the credit of the pCPA, it appears outreach and engagement remains open with the FPT jurisdictions prior to formal negotiations; as pharmaceutical manufacturers know, and payers should recognize, maintaining constructive and respectful engagement with various drug programs at points before any negotiations begin, should ensure communication is open, transparent and helpful.
3. Active Negotiation Engagement: On the other end however, the pCPA is including language in its guidance document intended to contain discussions during live negotiations to only the Lead pCPA negotiators and the manufacturer. The pCPA states “During negotiations, discussions are expected to remain between the identified contacts from pCPA and the Manufacturer. In support of efficiency, effectiveness, and integrity of process, negotiations are not to include any undue external influence from political, media, or patient channels.”  While the intent here is most likely to protect the integrity of the negotiation process, which will help build and maintain long-standing and constructive working relations between the pCPA and individual manufacturers, pharmaceutical companies will be wise to ensure the intent of this statement is contained to the “integrity” of negotiation issues, and not to simply limit general constructive engagement during this period.

The pCPA is working to engage with all sectors and has stated in several conferences of late that officials within the pCPA see these Guidelines as “living documents” – in other words they should continue to evolve as the process requires; it is expected the pCPA will continue to seek opportunities for continuous and ongoing dialogue to evolve and adapt the content as required.  The first step in the pCPA dialogue is a Webinar planned for the brand pharmaceutical industry on June 22, 2018 (other consultations are occurring as well). Manufacturers can submit any initial feedback by June 20^th to help inform the Webinar sessions. Opportunities for input will continue after the webinar session.

PDCI continues to review material and issues relating to these Guidance documents and will provide clients with the most current and insightful advice on opportunities and implications for product reimbursement strategies.