Transcript 2013 Suppliers’ Update

Welcome to the
2013 Suppliers’ Update
To join the teleconference facility:
1. Dial 1300 300 805
2. At the prompt: dial 940 109 4557#
Introduction
Michael Stone
2013 Suppliers’ Update
Introduction
• Welcome
• Participants
• Webinar Structure
• Presentations
• How you can participate
• Post-Webinar Participant Feedback
• Overview of Program
Participants
•
Australian Red Cross Blood Service
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Baxter Healthcare Pty Ltd
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Bayer Australia Pty Ltd
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Biogen Idec Australia Pty Ltd
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Bio-Rad Laboratories Pty Ltd
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Biotest AG
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CSL Behring (Australia) Pty Ltd
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Grifols Australia Pty Ltd
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Novo Nordisk Pharmaceuticals Pty Ltd
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Octapharma Australia Pty Ltd
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Pfizer Australia Pty Limited
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Therapeutic Goods Administration
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ViroPharma Pty Ltd
Webinar Structure
•
Please hold questions/comments until the end of each presentation, or
until the Dialogue Session.
•
Your participation:
1. Verbally ask your question via the teleconference facility (please identify
yourself first); or
2. 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.
Program Overview
1. Strategic Update
Leigh McJames
NBA General Manager
2. Plasma & Recombinant Products
Michael Stone
Deputy General Manager, Commercial Contracts & General Counsel
3. Stewardship and iBlood
Peter O’Halloran
Acting Deputy General Manager, Stewardship
4. Dialogue Session
Michael Stone
5. Webinar Close
6. Post-Webinar feedback
Q&A
Saving & improving
Australian lives
through a world class
blood supply
2013 Suppliers’ Update
Strategic Update
Leigh McJames
2013 Suppliers’ Update
Structure
 Strategic Imperatives
 2013-16 Plan/Program
 2013 in Focus
Strategic Imperatives
 Improve Patient Outcomes
 Financial Sustainability
 National Health Reform
Future Directions
2012
Develop the plan/position the organisation
2013-16
Deliver the plan/s
The Plan 2013-16
Ministers
Statement of
Expectations
National Wastage
Reduction Strategy
2013-17
Operational Plan 2013/14
National Patient Blood
Management Guidelines
Implementation Strategy
2013-16
National Blood Sector
ICT Strategy 2013-16
JBC Strategic Plan
2013-15
NBA Corporate Plan
2013-16
National Blood Sector
Research & Development
Statement of Priorities
2013-16
National Blood Sector
Data & Information
Strategy 2013-16
National Blood
Education & Training
Strategy
2013-16
Core Business
Supply
Contracts
Risk/NMF
Corporate Governance
2013 in Focus
 Stewardship Program
 Blood Service Deed Activities
 Commercial/Plasma Activities
 Data
 ICT
 Other
Stewardship Program – Implement
measures to support Jurisdictions and
Health providers to:
- Reduce wastage
- Improve appropriate use
Stewardship
(Wastage Reduction and
Appropriate Use)
• Best Practice Tools (National Reference Set)
 Wastage
 Patient Blood Management
Access via
redesigned
NBA website
through
Publications and
Resource area
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)
Stewardship
(Wastage Reduction and
Appropriate Use)
• Education and Training
 BloodSafe E-Learning
 Doctor/Nurse Training Modules
 Training Videos
 Apps
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
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
Commercial/Plasma
• IVIg Governance
• Implement addition of SCIg to Supply List
• Fibrinogen/C1 Esterase assessed
• CAFA Review
• Procurement Strategy Imported Products
Data
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Wastage
Governance
Haemovigilance
Red Cell linkage
BloodNet Reports
Data definitions
IVIg Report
ABDR Report
ICT
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BloodNet
My ABDR
IVIg
Apps
Governance
Electronic Records
Disaster Recovery
Clinical Development
• Patient Blood Management Guidelines (Modules 5 & 6)
• Clotting Factor Guidelines
• Intra-operative Cell Salvage Protocols
• Restrictive use protocols
• Tools
Other
• National Blood Supply Contingency Plan
Revision
• Research and Development Framework
• National Health Reform
– IHPA
– ACQSCHC
Q&A
Thank you
www.blood.gov.au
Saving & improving
Australian lives
through a world class
blood supply
2013 Suppliers’ Update
Plasma & Recombinant
Products
Michael Stone
2013 Suppliers’ Update
Current Supply Contracts
Australian Red Cross Blood Service
Deed 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
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
Current Supply Contracts
Imported IVIg Products Deeds
•
Octapharma Australia Pty Ltd
(2012-14, option to extend 1 year)
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•
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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)
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•
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Kiovig 10%
supply under NBS and JDO Arrangements
Grifols Australia Pty Ltd
(2010-2012, extended 1 year, option to extend 1 further year)
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Flebogamma 5% DIF
Supply under JDO Arrangements only
–
provision included to supply under NBS under exceptional circumstances on request by
the NBA
Current Supply Contracts
Imported IVIg Products
2012-13 Market Share (to end April 2013)
2013-14 YTD - Imported IVIg
(grams Issued to AHPs)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Kiovig
Octagam
Current Supply Contracts
Imported Plasma & Recombinants Products (IPRP) Deeds
Supplier
Products
Contract Term
Bayer Australia Limited
Kogenate FS (rFVIII)
07/2011-07/2014
2 options to extend for further 1-year
periods
Baxter Healthcare Pty Ltd
FEIBA-NF (FVIII inhibitor bypass agent)
Ceprotin (Protein C Concentrate)
pdFVII concentrate
07/2011-07/2014
2 options to extend for further 1-year
periods
Rhophylac (Rh(D) Immunglobulin)
pdFXIII
CSL Behring (Australia Pty Ltd)
(supply pdFXI pending contractual
arrangements)
07/2011-07/2014
2 options to extend for further 1-year
periods
Novo Nordisk Pty Ltd
NovoSeven RT (rVIIa)
07/2012-07/2014
1 option to extend for a further 1-year period
Pfizer Australia Pty Limited
Xyntha (rFVIII)
BeneFIX (rFIX)
07/2011-07/2014
2 options to extend for further 1-year
periods
Current Supply Contracts
Imported Plasma & Recombinants Products
rFVIII 2012-13 Market Share (to end April 2013)
2013-14 YTD - rFVIII
(IU Issued to AHPs)
100%
90%
80%
70%
60%
Kogenate
50%
Xyntha
40%
30%
20%
10%
0%
Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13
Current Supply Contracts
Red Cell Diagnostic Reagents Deeds
Term: 07/2011-07/2014
2 options to extend for further 1-year periods
Suppliers:
• Abacus ALS Pty Limited
• Bio-Rad Laboratories Pty Ltd
• BioCSL
• Grifols Australia
• Ortho Clinical Diagnostics
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
Procurement
Imported IVIg Products Deeds
Octapharma
Baxter
Grifols
Imported Plasma & Recombinants Products (IPRP) Deeds
Red Cell Diagnostic Reagents Deeds
= Extension Option 1
=Extension Option 2
Jan-16
Jul-15
Jan-15
Jul-14
Jan-14
Jul-13
Jan-13
Jul-12
Jan-12
Jul-11
Jan-11
Jul-10
Jan-10
Current Contract Timeline
Procurement
Research
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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
Tender
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•
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Decision
Hybrid
Extend
NBA Advisory Board & JBC visibility
WHAT
Policy Parameters
Supply Model
Tender specs
HOW
Tendering approach
Procurement Project
Evaluation Plan &
Committee
Contract extension notices
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
New Products
The SCIg Experience – What Happened
• MCA/Schedule 4 Applications
• Cycle 1 Evaluation (NBA)
• Cycle 2 Evaluation (MSAC)
• JBC decision and parameters
New Products
The SCIg Experience – What will Happen Next
• Detailed Project Planning and communications
currently underway
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Hospital-based system
Authorisation arrangements
AHP Eligibility – capacity and capability
BloodNet and NBMS
Demand and Supply
Q&A
Thank you
www.blood.gov.au
Saving & improving
Australian lives
through a world class
blood supply
2013 Suppliers’ Update
iBlood Update
Peter O’Halloran
2013 Suppliers’ Update
MyABDR
Dialogue Session
Michael Stone
2013 Suppliers’ Update
Webinar Close
Thank you for your
participation
2013 Suppliers’ Update