Presentation to NHS Industry Forum The Industry Perspective on the Therapeutic Development Assessmen

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Presentation to NHS Industry Forum - The Industry
Perspective on the Therapeutic Development
Assessment Process in Wales

• Julia EarnshawDirector of Health Outcomes, GSK
• Leader of ABPI TDA User Group
• 21st April 2004

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Objectives of todays presentation

• To clarify the role and objectives of the TDA
  User Group
• To clarify industrys perspective on the current
  TDA process
• To discuss potential options to address areas of
  concern

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Key areas of activity which were an initial
concern with NICE
Clarity/Consistency of Process
KEY AREAS
Communication
Quality
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Industry User Group the links
Drug Review Bodies
User Group (Operational)
ABPI Members
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HTA 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

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Objectives of the TDA User Group in Wales

• To consolidate experiences and issues of the TDA
  process amongst ABPI members 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.
• NOT
• Other broader responsibilities of the AWMSG

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Membership of the TDA User Group

• The membership of the group should comprise
  those operating in Wales and those involved in
  HTA submissions across the UK.

• Jeremy Way - Novartis
• Jenny Snell - Amgen
• Jeremy Felvus - Pfizer
• Len Gooblar - Abbott
• Bernard Holton - MSD

• Julia Earnshaw - GSK (Lead)
• Rick Greville - ABPI
• Debbie Stephenson -Lilly
• Mike Baldwin - Aventis
• Alison Edwards - AstraZeneca
• Richard Evans - Janssen-Cilag

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Industrys Current Perspective on TDA in Wales

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

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The process

• Is all information essential? - e.g. Form A
• Inconsistent use of Form B
• Need for assessment to be based on all available
  data
• Inconsistent reference to industry data in Form B
• Lack of clarity on how evidence has informed
  decision making
• Use of revised SMC form to avoid duplication
• Limited opportunity to comment on independent
  report or correct factual inaccuracies
• Role of medical experts
• Lack of patient involvement

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Transparency/Confidentiality

• AWMSG operates with a principle of transparency
• However considerable sensitivity particularly
  pre-launch
• ABPI negotiated agreement with SMC on how this
  could be addressed
• Similar agreement in Wales could minimise issues
  with confidential data - whilst ensuring reviews
  based on all evidence not just that in public
  domain
• Opportunity for confidential discussion at AWMSG?
• Need for some detailed information not to be on
  web-site.

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Agreement between the Association of the British
Pharmaceutical Industry (ABPI) and the Scottish
Medicines Consortium (SMC) on guidelines for the
release of company data into the public domain
during a medicine appraisal

• Principles
• 1. SMC and ABPI acknowledge that while it is in
  the interests of patients generally for all
  relevant information about products being
  appraised to be put into the public domain the
  rights of the owners of the data must also be
  respected
• 2. SMC has made a commitment not to release into
  or use in the public domain any information
  provided to it during a technology appraisal
  prior to the launch of the product(s) into the UK
  market
• 3. Any reference in this Agreement to abstracts
  shall assume the adoption of the CONSORT rules
  for trial reporting and abstracts in relation to
  clinical trials, and an equivalent standard for
  reporting economic models
• 4. In circumstances that warrant publication of
  data regarded by the data owner as confidential,
  or the non-publication of data normally available
  for publication in accordance with these
  guidelines, both parties will negotiate in good
  faith to seek to find a mutually acceptable
  solution, recognising the need for SMC to support
  its recommendations with evidence and the data
  owners right to determine a global publication
  strategy..
• 5. It is recognised that in all cases the data
  owner retains the right to make a final decision
  in relation to the release of information into
  the public domain.
• It is acknowledged that the principles in this
  document apply to licence extensions as well as
  new chemical entities

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What does the SMC agreement suggest should be in
the public domain?

• Published information
• Quotes from unpublished data where release date
  is more than 12 months after sign off of the
  study report. Detailed information not put on
  web-site.
• Economic models available for independent review
  but not on web site
• Price/SmPC/EPAR - after product launch

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Communication

• Clarifying scope of review in advance
• Industry to provide list of publicly available
  information
• Improved written confirmation of decisions
  throughout the process
• Retain opportunity for informal communication
• Opportunity for WMP and TDA User Group to address
  issues on an ongoing basis

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Industrys Current Perspective on TDA in Wales

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

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Summary Industrys Perspective on TDA Process

• Need for a process that is clear and transparent,
  based on a careful and timely analysis of all the
  evidence and doesnt unreasonably deny patients
  in Wales access to new medicines.
• Whilst accepting this is a new and evolving
  process the industry currently has concerns with
  how the process is working
• Acknowledge the need of the NHS in Wales to have
  a consistent view on their use of high cost new
  medicines
• In the spirit of partnership and with
  constructive dialogue with the TDA User Group we
  hope that it will be possible to develop a
  process that is satisfactory to all parties