Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada - Record of Decisions

• Record of Decisions - August 23, 2017
• Record of Decisions - September 12, 2017

Meeting Objectives:

1. Endorse Terms of Reference
2. Validate Work and Research Plans
3. Clarify Roles and Responsibilities

Participants

Panel Members	Secretariat	Observers
Dr. Penny Ballem (Chair) Dr. Francine Décary (Deputy Chair) Dr. Patrick Robert (Special Advisor) Dr. Merlyn Sayers (Special Advisor)	Dr. Marie-Anik Gagné Connie Berry Dr. Vicky Hogan Dr. Chris Gravel Robyn Cummings	Cindy Moriarty, Executive Director, HPSID (for part) Liz-Anne Gillham-Eisen, Director, HPFB

Item

1. Welcome and introductions

• Cindy Moriarty welcomed all panel members on behalf of Health Canada.
• Dr. Ballem welcomed all to this important work to ensure that Canadians are well served. She invited members and secretariat to introduce themselves.

2. Approval of Agenda

Decision: Agenda was approved.
Action*: Draft French and English List of Acronyms.

3. Orientation and Background to Initiation of Panel

• Dr. Ballem invited all members to comment on the background information provided. Questions the Panel should strive to answer included: Where are Best Practices to manage the use of Ig? Who do we need to speak to?
• Discussion followed on the importance of reviewing demand factors, utilization practices, and characteristics of blood and plasma donors. The following actions for the secretariat were decided:

Actions:

• Research demographics of plasma and blood donors and their behavioral differences.
• Obtain background about prior Canadian plasma collection initiatives.

4. Endorsement of Terms of Reference

Decision: Terms of Reference were unanimously endorsed.

5. Research Plan Discussion

• Dr. Ballem invited members to comment on proposed questions and add any missing questions.
• Panel members discussed a number of topics, including the global plasma market, the track record of market forecasts, and emerging research findings. Some international differences in concepts of self-sufficiency, Ig usage practices (e.g. different ITP therapies), economic influences on patient treatment (i.e. who pays), and use of recovered plasma in manufacturing were identified.  

Actions:

• Review potential impact on supply and demand of relevant trade agreements.
• Review emerging plasma donor recruitment practices of organizations that collect both plasma and blood donations, e.g. recruitment primarily from deferred donors. Research plasma donation frequency guidelines and related factors affecting cost-effectiveness.  
• Follow up on individuals, organizations, and jurisdictions identified as potential key informants.
• Research concept of jurisdictional vs regional plasma self-sufficiency.
• Compare per capita plasma collection in Canada to other jurisdictions.
• Consider how blood operators are adjusting their business models to adapt to reduced demand for whole blood collections (e.g., diversification of business).
• Review R&D programs to assess the prospects for replacement of Ig products.
• Identify different relationship models among plasma collectors/ fractionators/distributors in different jurisdictions.
• Review regulatory data on prior supply challenges/shortages of plasma derived products. (e.g. withdrawals, manufacturing interruptions).

Stakeholder Engagement

• Members discussed the range of stakeholder groups, what they might contribute to the work of the Panel, and how they might be engaged.

Decisions: 

• Drs. Ballem and Décary will host two teleconference meetings, one with patient groups and another with stakeholder groups. Prior to their participation, all participants will be invited to submit a 2-3 page document answering some key questions.
• Dr. Ballem will ask that the Panel’s work be added to an upcoming Conference of Deputy Ministers agenda. All Panel members wish to participate in that briefing.
• CBS and Héma-Québec will be invited to meet the Panel briefly during the September 12 Panel teleconference and to present to the Panel on October 23 or 24.  
• To invite the following to present to the October meeting: National Advisory Committee on Blood and Blood Products, PPTA, CPR, Green Cross.

Actions:

• Prepare and organize the requests and invitations noted above.

6. Roles and Responsibilities

Decisions:

• Correspondence to stakeholders will be coordinated through the Secretariat and sent on behalf of Chair or Director.
• Panel Chair and Secretariat will coordinate updates to ensure progress is made and reported.

7. Work plan Discussion

• Dr. Ballem walked through work plan, emphasizing timelines (i.e., first draft report is required in January 2018).
• All members confirmed their attendance to Panel meetings scheduled until December 2017.

8. Secretariat Update

• Dr. Gagné indicated that following Panel’s approval of the Records of Decision, that these would be posted on the Expert Panel’s website.

Actions:

• Send media summaries and biweekly updates to all panel members.

9. Next Meeting

• September 12 in Atlanta / Teleconference (EDT 07:00-08:15)

10. Roundtable

Note: Roundtable discussion points are captured under Agenda Item #5 above.

11. Closing remarks / adjournment

• Dr. Ballem thanked all Panel members for their time and meaningful discussion.

Meeting adjourned: 15:00

*Unless otherwise indicated, all ACTIONS listed are to be completed by the secretariat.

Meeting Package:

1. Agenda
2. Terms of Reference
3. Background deck
4. Draft research plan
5. Draft stakeholder template
6. Draft work plan

Additional background reading:

• Dublin Consensus conference statements 2010, 2011, 2012
• Risk-Based Decision Modelling Final Report
• CBS Proposal & Select Annexes sent August 4, 2017

Record of Decisions

Meeting Objectives:

1. Open dialogue with Héma-Québec and Canadian Blood Services
2. Plan for October 23 & 24, 2017 meeting

Participants

Panel Members	Secretariat	Guests
Dr. Penny Ballem (Chair) Dr. Francine Décary (Deputy Chair) Dr. Patrick Robert (Special Advisor) Dr. Merlyn Sayers (Special Advisor)	Dr. Marie-Anik Gagné Connie Berry Dr. Vicky Hogan Dr. Chris Gravel	Ms. Smaranda Ghibu, A/Présidente et chef de la direction, Direction générale, Héma-Québec Dr. Graham Sher, Chief Executive Officer, Canadian Blood Services

Item

1. Welcome and introductions

Dr. Ballem opened the meeting with a roundtable.

2. Approval of Agenda

DECISION: The Panel endorsed the meeting agenda.

3. Brief orientation to the Panel for guests

Dr. Ballem oriented guests to the Panel's mandate and outlined information the Panel will be seeking from Canada's two public blood and plasma providers.

In this discussion, it was clarified that item 2 of the Panel mandate will include a review of the impact of both voluntary and paid plasma collections in Canada: the Panel will be examining the pros and cons of a wide range of models.

Information was requested from Héma-Québec and the Canadian Blood Services (CBS) during the discussion including:  

from Héma-Québec:

• A copy of its original complete business plan for expansion of plasma collection
• Data on trends,  any changes to the  whole blood donor base which is thought to be a result of this new program , volume of plasma collected, efficiencies learned
• Details of Héma-Québec's arrangement with its prospective new fractionator
• Information available about Québec initiative to review IVIG utilization practices; overview of how plasma products are paid for (across Héma-Québec, hospitals, Québec government)
• Percentage of Québec plasma donations returning to Canada in the form of plasma-derived products
• Cost for PlasmaVie to collect source plasma per unit
• List of treating physicians and description of clinical and scientific committees that advise Héma-Québec who might engage in the work of the Panel

from CBS:

• A request for a copy of full presentation CBS gave at the IPFA conference
• More details about methodology used to prepare Decision Responses Group (DRG) IG Forecast
  • NOTE: Panel to clarify remaining methodological questions after review of the complete forecast report (200 pages) ( requested from CBS on Sept 15, 2017)
• Summary of utilization control mechanisms used by British Columbia, Ontario, Nova Scotia and data available on the impact of these programs on use of plasma derived products, especially Ig
• Data on impact of Saskatoon's new private sector plasma centre on local CBS whole blood donors, collection volumes and any other demographic shifts in the CBS  donor base
• Data / information available from CBS on their discussions with Grifols and/or CSL about their ability to sustain growth of plasma collection and the impact of plasma collection on whole blood collection; also whether they have similar  data from American Red Cross
• Comment on Canadian practice for deciding what products are distributed through CBS, including rationale for including non-plasma-derived products (e.g. recombinants) while excluding some plasma-derived products (e.g. Alpha-1 Antitrypsin). Please include information about discussions underway with the provinces and territories and Canadian Agency for Drugs and Technologies in Health (CADTH).
• Length of time to amortize capital investment in proposed new plasma centres
• Lists of treating physicians that have advised CBS as part of its product procurement group, and as ad hoc advisors on market trends.

During the discussion, considerations for the Panel were noted as they continue their work:

• Economic dis/incentives and payment systems; concerns about  the lack of  financial capacity of hospitals/health authorities  to purchase alternate drugs to plasma-derived products  (e.g. monoclonals); lack of responsiveness of  provincial formularies to new drugs which could replace the need for some plasma derived products
  • Example: Ongoing use of IVIG for ITP where there may be a non plasma derived product which is now available
• Impact of regulations on plasma collection and processing systems, e.g.  current need for flash freeze process
• Questions in regard to frequency of donation of plasma donors and the broad range set by regulators and practiced by blood operators

ACTION:

• The secretariat to follow-up with Héma-Québec and CBS in writing to confirm all requested information to be provided in advance of the October 23rd meeting.  Copies of the presentations from CBS and Héma-Québec are to be provided to the secretariat one week prior to the October 23rd meeting.

4. Endorsement of Record of Decisions of August 23, 2017 meeting, including:

DECISION: The Panel endorsed the August 23, 2017 Record of Decisions

5. Update on stakeholder engagement to date; update on media tracking to date

An update was provided to members about Requests for Input sent to patient and stakeholder groups. Their written input is due October 6th and will be summarized for members before the October meeting.

ACTIONS:

• Add Drs. Sayers and Robert to the stakeholder and patient group conference calls if they are able to attend
• Send patient and stakeholder group packages to Panel members as an FYI
• Develop and maintain list of acronyms specific to  the plasma and blood sector
• Develop engagement strategy for key healthcare providers to include:  hematologists, rheumatologists, immunologists, neurologists and pediatricians. Look at setting up meeting with physicians groups prior to October 23 and 24 meeting

6. Update on progress on research activity  and availability of documents

A brief verbal update on research activity was provided.

ACTIONS:

• Send copy of reference 12 in the CBS business plan – (Global IVIG Market, 2015) to Panel members
• Determine whether NPlate, Promacta are licensed or in the process of being licensed in Canada.

Request that CADTH update their 2009 report on plasma

7. Risk analysis document

The secretariat reported that its internal report has been prepared and will be circulated to members.

ACTION:

• Send summary of critical appraisal of risk analysis to the panel by September 15, 2017

8. Discuss October 23 and 24 meeting Agenda

Discussion was held about which organizational/industry stakeholders should be invited to participate in the October meeting, taking into account those already met in Atlanta.

DECISION: October meeting invitees to include Grifols, CSL, Green Cross, Therapure, ProMetic, and possibly physician group representatives (if not completed before these meetings)

Questions for Grifols and CSL:

• Impact of plasma collection on whole blood collection
• Projections on paid vs non- paid plasma donors
• Donor demographics

DECISION: CBS and Héma-Québec sessions will be held separately. Each will be asked to limit presentation time to 20 minutes maximum to allow sufficient time for discussion.

9. Roundtable

ACTION:

• Send all revised questions to stakeholders to Panel members for review. Provide a deadline by which to respond
• Schedule a teleconference between Stacy Sime from LifeServe Blood Center and Dr. Décary to enquire on process to triage whole blood and plasma donors as they arrive. Dr. Décary to report back to the Panel

10. Closing remarks / adjournment

Next Meeting: October 23 and 24, 2017 in Ottawa

Meeting Package:

1. Agenda
2. Record of Decision _ August 23, 2017
3. Draft Evidence Gathering Plan
4. Draft Agenda for October 23 & 24, 2017
5. Draft questions for Presenters at October 23 & 24 meeting