TDA User Group and ABPI Position.

1
TDA User Group and ABPI Position.

• Julia Earnshaw
• Chair of TDA User Group and Director, Health
  Outcomes, GSK UK
• 14.02.05

2
Industry User Group the links
Drug Review Bodies
User Group (Operational)
Access to Medicines Project Team
ABPI Members
3
Industry User Group Objectives

• Share information and provide feedback
• Inform process improvement and methodology
• Prevention and early resolution of problems
• Develop constructive relationship
• Efficiency (single focus for important issues)
• Peer support

4
Membership of the TDA User Group

• The membership of the group should comprise of
  those operating in Wales and those actively
  involved in HTA submissions
• Julia Earnshaw - GSK (Lead)
• Rick Greville - ABPI
• Debbie Stephenson -Lilly
• Mike Baldwin Sanofi-Aventis
• Alison Edwards - AstraZeneca
• Jenny Snell - Amgen
• Jeremy Way - Novartis
• Richard Evans - Janssen-Cilag
• Jeremy Felvus - Pfizer
• Len Gooblar - Abbott
• Bernard Holton - MSD

5
Objectives of the User Group in Wales

• On behalf of the Access Strategy group of the
  ABPI to consolidate experiences and issues of the
  TDA process amongst companies to share best
  practice and to establish key issues and areas of
  concern
• To propose improvements to facilitate the
  development of a process learning from
  experiences with other national HTA bodies
  (NICE/SMC)
• To provide an interface at an operational level
  between industry and appropriate bodies in Wales
  to develop a constructive and effective
  relationship that will facilitate the above and
  provide an effective two-way communication
  channel.

6
Summary Industries Initial Perspective on TDA
Process

• Acknowledged the need of the NHS in Wales to have
  a consistent view on their use of new medicines.
• Process that is used needs to be clear and
  transparent and based on a careful and timely
  analysis of all the evidence.
• Whilst accepting this was a new and evolving
  process the industry had concerns in how the
  process was working.
• Via the TDA User Group and WIG we hoped that it
  would be possible to develop a process that was
  satisfactory to all parties.

7
Regular Meetings with WMP

• Identified agenda of areas of concern
• Regular informal meetings initiated (monthly)
• Subset of User Group met with
• Phil Routledge Director of WMP
• Karen Samuels Programme Manager WMP
• Ruth Lang Office Manager WMP
• Frank and open discussion of the areas of concern
  trying to learn from others experience and
  suggest realistic solutions.
• Solutions to AWMSG steering group/AWMSG as
  appropriate for agreement.

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Industries Perspective on TDA Process In Wales

• The Process
• Confidentiality
• Communication
• Decision Making
• Consistency
• Appeals

9
Summary

• Built up a good relationship with WMP during
  meeting process.
• Significant changes have been made to the process
  meeting most of our initial objectives.
• Some outstanding areas remain plus reality of
  new process proof of the pudding
• ABPI policy reviewed and agreed November 04.
  Industry should begin to engage in the process.
• The recent changes to the process are the first
  steps in a process of continuous improvement and
  are such that the ABPI can now offer guarded
  advice to member companies to make product
  submissions to AWMSG.

10
Next Steps

• Expansion of process to all products?
• Monitoring implementation of new process and
  resolving issues
• Consideration of appeals process
• Impact of changes in relationship with NICE
• Implementation of decisions impact on
  prescribing