pCPA Brand Process Guidelines Webinar
On Friday, June 22nd, 2018 the pan-Canadian Pharmaceutical Alliance Office (pCPAO) hosted an industry consultation session via webinar, on the newly completed pCPA Brand Process Guidelines (“the Guidelines”). The objective of this webinar was to:
- introduce the Guidelines and supportive documents developed by the pCPA; and
- invite industry’s initial feedback.
This edition of MORSE Signals provides an overview of the webinar and outlines key takeaways from the session.
- Imran Ali, Senior Manager, pCPAO
- Sang-Mi Lee, Senior Pharmacist, pCPAO
- pCPA Brand Process Guidelines
- pCPA Brand Process FAQs
- pCPA Letter of Intent (LOI) Template
- pCPA website
The release of the pCPA Brand Process Guidelines is an important milestone in the evolution of the pCPA and brings greater formality, consistency and predictability to the current process. This is seen expressly in the “new” components of the process as outlined below:
- The introduction of the acknowledgement letter allows manufacturers to have certainty that their file is moving into the consideration phase
- Formalization and transparency regarding the “holding” of a file so all stakeholders are aware
- Development of target timelines providing the first key performance metric.
The ability to hold files may be an early signal of how pCPA could “sort” files with slower timelines to reach the negotiation phase for products felt to be of low priority. However, this may also lead to faster initiation of files that may be deemed to be higher priority such as products serving a significant unmet clinical need where there are few options available, or those that may provide significant cost savings to the health care system.
Part One – Brand Process Guidelines Review
In Part One of the webinar, the pCPAO reviewed the Guidelines document, its structure and various components. Additional focus was dedicated to discussing the four general phases of the pCPA process, highlighting areas of increased formalization within these phases, and providing an initial look at the pCPA’s new targeted process timeline.
- Guidelines are subject to change: The Guidelines are intended to serve as a “living document” to be regularly updated in order to promote common understanding of the process. The next version of the Guidelines is anticipated within the next 6-12 months.
- Areas of formalization within the process (“new”):
- Within the Initiation phase, the pCPAO will provide an Acknowledgement Letter to the manufacturer following receipt of an HTA recommendation.
- Within the Consideration phase, the pCPAO may issue a Hold Letter to the manufacturer if the pCPA has decided not to engage in the negotiation for a specific New Drug for an identified period of time.
- New target pCPA timelines: The pCPAO has issued proposed target timelines for the various phases with an aim to move a file from HTA recommendation to negotiation completion within 6 months (see Table 1). It was clearly articulated that these timelines are not currently being met and represent a target for the future.
- Implementation date: The new components of the Guidelines are expected to be implemented in early July 2018, with the performance targets for new files beginning to be tracked at that time.
Table 1. pCPA Target Timeline
|Phase||Associated Deliverable||Target Completion||Frequency of Meeting Target Completion Time|
|1 – Initiation||Acknowledgement Letter||≤ 10 Business Days from HTA recommendation†||100%|
|2 – Consideration||Engagement/Close /Hold Letter||≤ 40 Business Days from HTA recommendation†||Year 1: 80%
Year 2: 90%
|3 – Negotiation||Proposals/ Counterproposals*||≤ 90 Business Days from Engagement Letter||Year 1: 80%
Year 2: 90%
|4 – Completion||LOI/Close Letter*|
|†First HTA Recommendation, either INESSS or CADTH
*Joint targets with industry
Year 1 (commencing within fiscal year 2018/19) and Year 2 (fiscal year 2019/20)
Part Two – Q&A Session
In Part Two of the webinar, attendees were invited to pose their questions. The emerging topics included:
- Reconcilement of differences between INESSS and CADTH recommendations in pCPA negotiations;
- Prioritization or “sorting” of files;
- Reconsideration/appeal process through pCPA;
- Role of the pCPAO in negotiations (as lead or support);
- Revised website timing;
- Position on the PMPRB’s proposal for disclosure of confidential prices;
- Implications of failing to meet the proposed timeline; and
- Opportunity for formal industry engagement with pCPA.
Next Steps: Feedback
- All stakeholders are encouraged to write a letter to provide their feedback – there is no specific deadline for feedback.
- The pCPAO aims to update the FAQ document based on questions they receive through stakeholder input.
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