Welcome to the 2013 Suppliers’ Update

1. Welcome to the2013 Suppliers’ Update To join the teleconference facility: Dial 1300 300 805 At the prompt: dial 940 109 4557#

2. Introduction Michael Stone 2013 Suppliers’ Update

3. Introduction • Welcome • Participants • Webinar Structure • Presentations • How you can participate • Post-Webinar Participant Feedback • Overview of Program

4. Participants • Australian Red Cross Blood Service • Baxter Healthcare Pty Ltd • Bayer Australia Pty Ltd • Biogen Idec Australia Pty Ltd • Bio-Rad Laboratories Pty Ltd • Biotest AG • CSL Behring (Australia) Pty Ltd • Grifols Australia Pty Ltd • Novo Nordisk Pharmaceuticals Pty Ltd • Octapharma Australia Pty Ltd • Pfizer Australia Pty Limited • Therapeutic Goods Administration • ViroPharma Pty Ltd

5. Webinar Structure • Please hold questions/comments until the end of each presentation, or until the Dialogue Session. • Your participation: • Verbally ask your question via the teleconference facility (please identify yourself first); or • Should you wish to remain unidentified, please send your question/comment to Susan James via the Webex chat facility at the bottom right of your screen. Note: questions/comments submitted via the chat facility will be shared with all participants. • You can communicate with other participants via private chat by selecting names in the participant box (also at the lower right of your screen.

6. Program Overview • Strategic Update Leigh McJamesNBA General Manager • Plasma & Recombinant Products Michael StoneDeputy General Manager, Commercial Contracts & General Counsel • Stewardship and iBlood Peter O’HalloranActing Deputy General Manager, Stewardship • Dialogue Session Michael Stone • Webinar Close • Post-Webinar feedback

8. 2013 Suppliers’ Update

9. Strategic Update Leigh McJames 2013 Suppliers’ Update

10. Structure • Strategic Imperatives • 2013-16 Plan/Program • 2013 in Focus

11. Strategic Imperatives • Improve Patient Outcomes • Financial Sustainability • National Health Reform

12. Future Directions • 2012 • Develop the plan/position the organisation • 2013-16 • Deliver the plan/s

13. The Plan 2013-16 Operational Plan 2013/14

14. 2013 in Focus • Stewardship Program • Blood Service Deed Activities • Commercial/Plasma Activities • Data • ICT • Other

15. Stewardship Program – Implement measures to support Jurisdictions and Health providers to: • Reduce wastage • Improve appropriate use RELEASED MARCH 2013

16. Stewardship (Wastage Reduction and Appropriate Use) • Best Practice Tools (National Reference Set) • Wastage • Patient Blood Management

18. Access via redesigned NBA website through Publications and Resource area

20. Stewardship (Wastage Reduction and Appropriate Use) • Tools (National Reference Set) • Wastage • Patient Blood Management • Promotion/Awareness/Engagement • Private Sector Forum (21 May 2013) • National Symposiums (Sep 2013) • Clinician Conferences (APHA, Surgeons, Anaesthetists, Intensivists)

21. Stewardship (Wastage Reduction and Appropriate Use) • Education and Training • BloodSafe E-Learning • Doctor/Nurse Training Modules • Training Videos • Apps

22. Stewardship (Wastage Reduction and Appropriate Use) • Data • Wastage data and benchmarks to AHP level • Appropriate use data at a macro level in conjunction with ACSQHC • AHP data tools

23. Deed/Fresh • NMF Action Plan • Deed Extension • Handover Plan • Inventory Management Framework • Service Requirements and Standards • Benchmark Deed Costs • Third Party Service Provision • Scope Deed Activities • Governance Review • Substitution and Payment Rules

24. Commercial/Plasma • IVIg Governance • Implement addition of SCIg to Supply List • Fibrinogen/C1 Esterase assessed • CAFA Review • Procurement Strategy Imported Products

25. Data • Wastage • Governance • Haemovigilance • Red Cell linkage • BloodNet Reports • Data definitions • IVIg Report • ABDR Report

26. ICT • BloodNet • My ABDR • IVIg • Apps • Governance • Electronic Records • Disaster Recovery

27. Clinical Development • Patient Blood Management Guidelines (Modules 5 & 6) • Clotting Factor Guidelines • Intra-operative Cell Salvage Protocols • Restrictive use protocols • Tools

28. Other • National Blood Supply Contingency Plan Revision • Research and Development Framework • National Health Reform • IHPA • ACQSCHC

31. 2013 Suppliers’ Update

32. Plasma & Recombinant Products Michael Stone 2013 Suppliers’ Update

33. Current Supply Contracts • Australian Red Cross Blood ServiceDeed of Agreement • Donor recruitment and management, collection, testing and processing of fresh blood products, plasma for fractionation, inventory management and distribution of blood and blood products to AHPs, Transfusion Medicine Service, R&D and Corporate support • Original term: 2006-2009 • Latest extension to 30 June 2014

34. Current Supply Contracts • CSL Australian Fractionation Agreement (CAFA) • Domestic manufacture of all plasma-derived therapies from Australian plasma material (22 products). • Some distribution function (minimal). • Term: 2010-2017 • Mid-Term Review by 30 June 2014

35. Current Supply Contracts • Imported IVIg Products Deeds • Octapharma Australia Pty Ltd(2012-14, option to extend 1 year) • Octagam 5% and 10%, Gammanorm • supply under National Blood Supply (NBS) Arrangements and Jurisdictional Direct Order (JDO) Arrangements • Baxter Healthcare Pty Ltd(2012-14, option to extend 1 year) • Kiovig 10% • supply under NBS and JDO Arrangements • Grifols Australia Pty Ltd(2010-2012, extended 1 year, option to extend 1 further year) • Flebogamma 5% DIF • Supply under JDO Arrangements only • provision included to supply under NBS under exceptional circumstances on request by the NBA

36. Current Supply Contracts • Imported IVIg Products • 2012-13 Market Share (to end April 2013)

37. Current Supply Contracts • Imported Plasma & Recombinants Products (IPRP) Deeds

38. Current Supply Contracts • Imported Plasma & Recombinants Products • rFVIII 2012-13 Market Share (to end April 2013)

39. Current Supply Contracts • Red Cell Diagnostic Reagents Deeds • Term: 07/2011-07/20142 options to extend for further 1-year periods • Suppliers: • Abacus ALS Pty Limited • Bio-Rad Laboratories Pty Ltd • BioCSL • Grifols Australia • Ortho Clinical Diagnostics

40. Current Supply Contracts • Supply Contracts - increased focus on: • KPIs and reporting • Audits • Goods Ordering and Receipt Verification (GORV) Audits • Includes seeking verification from AHPs as well as supplier documentation • In-Country Reserve Stocktakes

41. Procurement Current Contract Timeline

42. Procurement • Research • Gather and collate information that will inform decision to procure • May include: • Clinical/patient stakeholder consultation • Request for Information • Current contract evaluations/reviews • Timing and length of contract • Current pricing – domestic and global • Global trends • New products • Transition issues • Clinical choice • Exposure draft/specifications • WHAT • Policy Parameters • Supply Model • Tender specs Tender • HOW • Tendering approach • Procurement Project • Evaluation Plan & Committee Decision Hybrid Extend Contract extension notices NBA Advisory Board & JBC visibility

43. New Products • Changes to the National Product List • http://www.blood.gov.au/changes-national-product-list • Multi-Criteria Analysis (MCA) • Cycle 1 Evaluations • Cycle 2 Evaluations

44. New Products • The SCIg Experience – What Happened • MCA/Schedule 4 Applications • Cycle 1 Evaluation (NBA) • Cycle 2 Evaluation (MSAC) • JBC decision and parameters

45. New Products • The SCIg Experience – What will Happen Next • Detailed Project Planning and communications currently underway • Hospital-based system • Authorisation arrangements • AHP Eligibility – capacity and capability • BloodNet and NBMS • Demand and Supply

48. 2013 Suppliers’ Update

49. iBlood Update Peter O’Halloran 2013 Suppliers’ Update

50. MyABDR