Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada: Meeting #4

Record of Decisions

Meeting Objectives:

1. Review new research/issues mini-reports and new consultations
2. Map out consensus thinking of Panel
3. Discuss detailed report outline

Participants

Panel Members	Secretariat	Guests
Dr. Penny Ballem (Chair) Dr. Francine Décary Special Advisors: Dr. Patrick Robert Dr. Merlyn Sayers	Dr. Marie-Anik Gagné Connie Berry Dr. Vicky Hogan Dr. Chris Gravel Robyn Cummings Stacey Spicer Mary-Pat MacKinnon	Lise Cobitz (HC) René Toupin-Piper (SPB – FPT Relations) Michael Davies (ARAD) Marie-Chantal Benda (ARAD) Madeleine Benjamin (ARAD)

Item

Welcome and introductions

Dr. Ballem acknowledged the significant work of the Secretariat and guests in bringing the Panel together for this meeting and in the provision of materials for review. She invited meeting participants to introduce themselves.

1. Approval of Agenda

DECISION: The Panel endorsed the meeting agenda.

2. Endorsement of Record of Decisions of October 23 & 24, 2017 meeting

DECISION: The Panel endorsed the October 23 & 24 Record of Decisions.

Panel members discussed their observations and questions arising from the mini-reports prepared in advance. The Panel reviewed the mini-reports and recorded agreements on evidence and outstanding questions. Staff who authored each mini-report provided detailed answers to content questions from the Panel.

3. Discussion on Plasma Donors

• The Panel reviewed and discussed data on plasma donors in Canada and internationally. Different timing of peak red cell demand in Canada and the US were noted, as well as an increasing hospital demand for O-type blood.
• The Panel discussed the safety of patients and the prevalence of disease in both US and Canadian populations.
• Dr. Sayers mentioned having been told of an expanding market in the US for freeze-dried plasma for military use.

4. Discussion on Utilization

• The Panel reviewed the mini-report on clinical guidelines for four indications across Canada, the US, UK, and Australia. The Panel noted that Canadians prescribe double the amount of Ig for ITP than its counterparts in the UK. Australian’s interpretation of self-sufficiency was discussed.
• The Panel reviewed the Canadian Agency for Drugs and Technologies in Health (CADTH) clinical effectiveness reports for off-label IVIG use. The Panel requested that the Secretariat ask CADTH to complete a clinical appraisal for conditions with sufficient data.

5. Discussion on Economics of Plasma in Canada and the US

• The Panel discussed the financial implications of paid and voluntary donor systems. The Panel reviewed financial data in CBS’s proposed plan and identified areas for further clarification. Michael Davies and his team briefly presented on the economics of plasma collection in both US and Canadian settings. The Panel discussed costing assumptions and implications for different approaches.

6. Discussion on Access to Plasma-derived Products (PDPs)

• The Panel reviewed information on PDPs listed on formularies and preliminary information on potential impact of trade agreements.

7. Discussion on Risk Issues to Self-Sufficiency

• The Panel discussed trends in contract fractionation, a written submission from Green Cross, and an international summary of relevant national legislation.

8. Review Input Received

• The Panel reviewed and discussed input received from the Provincial-Territorial Blood Liaison Committee’s National Advisory Committee on Blood and Blood Products, Health Products and Food Branch (HPFB) Assistant Deputy Minister (ADM) and others.

9. Roundtable

• The Panel outlined areas of consensus for inclusion in the report.

10. Meeting Adjourned

Record of Decisions

Panel Members	Secretariat	Guests
Dr. Penny Ballem (Chair) Dr. Francine Décary Special Advisors: Dr. Patrick Robert Dr. Merlyn Sayers	Dr. Marie-Anik Gagné Connie Berry Dr. Vicky Hogan Dr. Chris Gravel Robyn Cummings Stacey Spicer Mary-Pat MacKinnon	Philippe Hébert, General Manager; Toby Simon, Senior Medical Director; and David Confessore, Senior Director Business Services (CSL Behring) René Toupin-Piper (SPB – FPT Relations) Michael Davies (ARAD) Marie-Chantal Benda (ARAD) Madeleine Benjamin (ARAD)

Guest presentations and discussions

1. CSL Behring presentation (teleconference)

• Participants introduced themselves. CSL walked the Panel through their operations (e.g., # of sites, location, production capacity, collection volume). The Panel and CSL discussed a range of issues, including: plasma collection expansion and whether it could lead to market saturation in the US, differences between blood and plasma collection strategies, toll fractionation experiences, and processes to report biomarkers to authorities. CSL confirmed that Canadian plasma is not mixed with other plasma except in limited and approved circumstances. CSL continues to see Canada as an important market and is pleased to continue working with CBS and Héma-Québec.

2. Panel discussion

• The Panel discussed the draft report outline, the evidence, Panel members’ interpretations of the evidence, areas of Panel consensus and emerging Panel positions, and the workplan and timelines for report development.

3. Roundtable

• The Panel was very satisfied with the amount of research and data presented to them throughout the meeting. They felt that they were provided with adequate information and that they were able to explore issues in great depth and detail.

4. Adjournment

ACTIONS emerging from Dec 7 and 8 meeting: 

• Verify whether freeze-dried plasma is licensed in Canada.
• Determine percentage of plasma and whole blood collected at mobile units in Canada (CSB/HQ) and the US (Red Cross, America’s Blood Centers).
• Describe Canadian regulations for blood and plasma including surveillance. Review Canadian Standards Association regulations for patient safety.
• Organize a call with George Schreiber - Re: residual risk of infectious disease in plasma.
• Report on CBS and HQ data on residual risk of infectious disease in blood and plasma.
• Double check US maximum plasma collections per donor per year (in L).
• Search whether there is comparable data re source plasma donors as is available in CBS 2016 surveillance report.
• Search whether there is evidence that people who donate plasma when young switch to donating whole blood after the age of 35.
• Confirm whether the demand for type O transfusion has increased in Canada.
• Ask CADTH to do clinical appraisal for conditions which have reasonably high incidence rates and sufficient data. 4.5.2-4.5.5  Report back ETA (ideally May/June).
• Review cost of product – (a) if Canadian Blood Operators supplied plasma and (b) if they buy product off the shelf.
• Secretariat to further develop evidence available on other countries’ mechanism to protect security of supply, and whether any have restricted export of plasma unless it is being returned for domestic needs.