Canadian Blood Services

1
Canadian Blood Services

• Dr. Graham Sher, CEO
• Canadian Blood Services
• WFH Global Forum, Montréal
• 2005-09-26

2

• Overview
• Background and trends
• CBS Strategic Plan for Plasma Protein Products
• Surplus proteins from Canadian plasma

3

• Background and Trends
• In September 1998, CBS assumed responsibility for
  purchasing and distributing about 30 different
  plasma protein products
• The product list was grandfathered to CBS
• Albumin/pentastarch
• IVIG
• FVIII, FIX, VWF/FVIII
• rFVIIa, porcine FVIII, FEIBA
• Hyperimmunes
• Speciality
• C1-esterase inhibitor, ATIII, fibrinogen, Protein
  C
• FXI, FXIII, prothrombin complex

4

• Background and Trends (Continued)
• Recombinant clotting factors (Factor VIII, IX and
  VIIa) are also part of the CBS product list
• In 2004-2005, half of the CBS budget was for
  plasma protein product costs
• Recombinant proteins accounted for 42 of plasma
  proteins costs in 2004-2005
• Product utilization has continued to increase for
  most product types

5
Background and Trends (Continued) Growth in
Demand for Plasma Protein Products
6

• Background and Trends (Continued)
• CBS and Héma-Québec collect and ship
  approximately 190,000 litres of plasma a year for
  fractionation into IVIG and albumin by Talecris
  (previously Bayer)
• CBS and Héma-Québec plasma is pooled jointly for
  processing
• Canadian plasma currently meets about 24 of IVIG
  needs the balance is provided through
  commercial IVIG (US plasma-derived)

7

• Background and Trends (Continued)
• Global changes have impacted the plasma products
  industry
• Increased use of recombinant FVIII and FIX,
  reduced revenue from plasma-derived clotting
  factors
• Reduced demand and price for albumin
• Fluctuating IVIG supply and pricing
• Plasma collection has been scaled back, and
  throughput reduced by 3 million litres a year

8

• Background and Trends (Continued)
• An already concentrated industry is consolidating
  further
• Top 5 in the industry account for 58 of sales
  globally
• CSL purchased ZLB and Aventis Behring
• Grifols purchased Alpha Therapeutic
• Bayer has sold its plasma business
• American Red Cross has exited contract
  fractionation

9

• Background and Trends (Continued)
• Canada is a small market in the global
  marketplace
• e.g. about 4 of global sales for IVIG
• CBS is the monopoly provider of these products to
  Canadian hospitals
• Security of supply is a safety issue, and a risk
  management approach is warranted

10

• CBS Plasma Protein Products Strategic Plan
• In 2003 CBS initiated the development of a
  strategic
• approach for plasma protein products
• Launch (the Syntegration event) Sept 03
• Drafting of Strategic Plan content Jan-Mar 04
• Consultations with Key Stakeholders Apr-May 04
• Board Approval of Strategic Plan June 04
• Development of Operational Plan (current)
• Endorsement from Corporate Members
• Execution

11

• Strategic Plan (Continued)
• Broad-based consultation in Sept 2003
• Members of CBS Board and CBS Executive Management
  Team
• Provincial and Territorial representatives
• Healthcare professionals
• International experts
• Representatives of patient groups
• Fractionation industry
• Regulatory agencies

12

• Strategic Plan (continued)
• What must CBS do now and over the next 5 years
  to ensure that Canada has access to a safe,
  secure, and cost-effective supply of plasma for
  fractionation, plasma products, and their
  alternatives?
• A draft strategic plan was developed by CBS from
  the advice provided at the broad-based
  consultation
• The draft plan was reviewed by CBS executive
  management and then by CBS Board of Directors

13

• Strategic Plan (Continued)
• CBS also reviewed the draft strategic plan with
• Provincial and Territorial funders
• Canadian Hemophilia Society
• Association of Hemophilia Clinic Directors of
  Canada
• Canadian Immunodeficiencies Patient Organization
• National Liaison Committee
• CBS also met with plasma product manufacturers to
  update information on plasma fractionation and
  industry trends

14
Strategic Plan (Continued)
Product Selection Process Brands and categories
Utilization Management Monitoring and optimizing
use
Demand Forecasting Projecting requirements
Plasma Products Supply Chain - Seven
Strategic Directions
Canadian Sufficiency in Plasma Products How
much product from Canadian plasma
Collections Collecting the plasma required
Manufacturing Fractionating the plasma into
products
Inventory and Distribution Maintain inventory
levels and ship products to hospitals
15

• Strategic Plan (continued)
• Product Selection Process
• Establishing a decision-making mechanism to add
  or remove products
• Defining roles and responsibilities
• Patient and physician stakeholder participation
• Utilization Management
• Supporting initiatives to ensure optimal product
  use
• Continuing support for product guidelines
  development
• Demand Forecasting
• Projecting product requirements for each province
  12-18 months in advance

16

• Strategic Plan (continued)
• Canadian Sufficiency in Plasma Products
• Defining a target for IVIG made from Canadian
  plasma
• Shifting from self-sufficiency to 40 and
  security of supply
• Collections
• Integrating the plans for plasma collection to
  meet the 40 target with the requirements for red
  cells, platelets and plasma for transfusion

17

• Strategic Plan (continued)
• Manufacturing
• CBS will continue to send plasma for contract
  fractionation
• A longer term objective will be to split the
  plasma fractionation contract between two
  fractionators
• Extracting other proteins from the Canadian
  plasma pool will maximize the benefit to Canadian
  patients
• Examine the possibilities for surplus proteins
  such as factor VIII
• Inventory and Distribution
• Update inventory and distribution management
  software
• Evaluate and optimize inventory targets

18

• Surplus Proteins from Canadian Plasma
• Factor VIII supply and demand in 1993
• 77.8 Million IU FVIII (plasma-derived and
  recombinant) issued in Canada in 1993-1994
• Recombinant FVIII introduced in June 1993
• 21.7 Million IU rFVIII issued that year
• Factor VIII supply and demand in 2004
• 130.2 Million IU rFVIII issued
• 4.3 Million IU plasma-derived Factor VIII (3.2)

19

• Surplus Proteins from Canadian Plasma
• Historically, Canadian plasma has consisted of
• Recovered plasma from whole blood collection,
  frozen within 15 hours (RP-15)
• Recovered plasma from whole blood collection
  frozen within 72 hours (RP)
• Apheresis plasma frozen within 8 hours (Source)
• Currently plasma shipped for fractionation is RP
• Increased time to freezing reflects high
  proportion of mobile clinics in current whole
  blood collection operations
• Apheresis plasma is preferred for transfusion

20
Surplus Proteins from Canadian Plasma
239,000 litres Plasma shipped for Fractionation
in 1993-94
21
Surplus Proteins from Canadian Plasma
192,000 litres Plasma shipped for Fractionation
in 2004-05
22

• Surplus Proteins from Canadian Plasma
• Changes are imminent
• Canadian Blood Services will be switching to the
  buffy coat production method, beginning with a
  pilot project that commences this Fall
• Impact on cryoprecipitate yield and
  characteristics, if any, cannot be established
  until pilot project has begun

23

• Surplus Proteins from Canadian Plasma
• Potential use of Canadian cryoprecipitate
• Continue our discussions with CHS and WFH
• South Africa (National Bioproducts Institute) a
  potential fractionator
• Initial meeting at PPTA Plasma forum in June
• First conference call with all parties in July
• WFH, CHS, WHO, NBI, IPFA, CBS and Héma-Québec

24

• Surplus Proteins from Canadian Plasma
• CBS currently examining
• Legal, liability and ethical questions pertinent
  to Fraction IV and cryo
• Technical cryo manufacture/collection questions
  with Talecris
• Plasma collection constraints (ie. time to
  freezing)
• CBS will continue to explore all options to
  support this initiative.

25

• Thank you.