HTA in Europe

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HTA in Europe

• Pascale Brasseur
• Health Economics Reimbursement Director,
• Cardiovascular, Medtronic International Sa
• Chair of Eucomed HTA Working group

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12 categories as per Global Medical Device
Nomenclature
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Proposed clustering for funding
reimbursement purposes

Category Imedical aids
Category IIIassistance forprofessionals
Category II artificial body parts
standard products which are prescribed and given
to an individual patient
medical devices which stay ator in the patient
(e.g. knee endoprostheses, stents) only one
component of a broader service package to
implant or adapt the (hardware) product to the
individual patient
technical equipment supporting professionals in
diagnostics and/or treatment with two-stage
financing

• IIIa investment
• IIIb refinancing via use (diagnostics/treatmen
  t)

• incontinence pads

• knee (endo-)prostheses
• ICD
• coronary stents

• endoscope (for e.g. gastroscopy)
• operating room equipment
• imaging devices X-ray, CT, MRI

implants
Source Prof. R. Busse presentation for Med Tech
week October 2008
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Decisions on coverage of medical devices

Category Imedical aids
Category IIIassistance forprofessionals
Category II artificial body parts
standard products which are prescribed and given
to an individual patient
medical devices which stay ator in the patient
(e.g. knee endoprostheses, stents) only one
component of a broader service package to
implant or adapt the (hardware) product to the
individual patient
Large emphasis onHTA, typically
forindication/service/productcombination
technical equipment supporting professionals in
diagnostics and/or treatment with two-stage
financing
Service(not product)is focusof HTA
LittleHTA

• IIIa investment
• IIIb refinancing via use (diagnostics/treatmen
  t)

Limitations toparticular patients, productsor
service providerspossible

• knee (endo-)prostheses
• ICD
• coronary stents

implants
Source Prof. R. Busse presentation for Med Tech
week October 2008
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Increasing Number of HTA Agencies ...
HTA capacity building handbook EUnetHTA WP 8
(Dec. 2008)
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HTA for Medical Devices
Source HTA capacity building handbook EUnetHTA
WP 8 (Dec. 2008)
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Example Horizon Scanning in Italia
Source Dott. Tom Jefferson Aggiornamento
delle Segnalazioni Seminario conclusivo COTE
17 November 2009
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Emerging themes around HTA

• Various levels in one system
• Harmonization
• Collaboration
• Rapid reviews
• Conditional coverage/risk sharing
• Value-based pricing
• Relevant data
• Indirect and multiple treatment comparisons
• Patient/Citizen involvement
• Disinvestment
• Impact of HTA agency activity

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(No Transcript)
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Differences / similarities between HTA agencies
Source Neumann et al , Are Key Principles for
improved health technology assessment supported
and used by HTA organizations? International
Journal of Health Technology Assessment in Health
Care 261 (2010), 7178.
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Differences / similarities between HTA agencies
Source Siebert et al, Methods, procedures, and
contextual characteristics of HTA and health
policy decision making Comparison of HTA
agencies in Germany, UK, France and
Sweden International Journal of Health Technology
Assessment in Health Care 253 (2009) ,
305-314
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Differences / similarities between HTA agencies
Source of Evidence Used in the Assessment of
Interventional Procedures
Source Plumb et al, How guidance on the use of
interventional procedures is produced in
different countries An international
Survey International Journal of Health Technology
Assessment in Health Care 252 (2009) ,124-133
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Differences / similarities between HTA agencies
Source Siebert et al, Methods, procedures, and
contextual characteristics of HTA and health
policy decision making Comparison of HTA
agencies in Germany, UK, France and
Sweden International Journal of Health Technology
Assessment in Health Care 253 (2009) ,
305-314
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Assessment vs Appraisal
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Factors influencing policy-making
HTA and Health Policy Making in Europe, EUnetHTA
WP 6 in collaboration with WHO European
Observatory
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Conditions for reasonable decision making
Source Dissemination of HTAs Health
Technologies and Decision Making - OECD 2005
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Factors that facilitate decision implementation
Decision Making and Implementation Health
Technologies and Decision Making - OECD 2005
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Barriers to decision implementation
Decision Making and Implementation Health
Technologies and Decision Making - OECD 2005
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Networking small cooperative frameworks
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and the EUnetHTA Joint Action
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Joint Action - Background

• A Joint Action is a tool within the EU Health
  programme, which is co-funded by the EC once
  approved, based on a detailed application process
  (Deadline for the application was 20/05/09)
• EU Member States met on 20/02/2009 and 15/04/09
• 3 year-project, which transitions EUnetHTA to the
  EU HTA network mentioned in Article 17 of
  Cross-Border Directive (now Art. 14)
• Also follows up on High Level Pharma Forum
• Almost all EU Member States will be involved
• Prof. Kristensen (Project Leader of EUnetHTA ) to
  coordinate the application and the project.

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Cross-border Directive

• Proposal for a Directive on the application of
  patients rights in cross-border healthcare
• The aim of this proposal is to establish a
  general framework for provision of safe, high
  quality and efficient cross-border healthcare in
  the European Union and to ensure free movement of
  health services and a high level of health
  protection, whilst fully respecting the
  responsibilities of the Member States for the
  organisation and delivery of health services and
  medical care.

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EU Legislative Process
COM Draft proposal
July 2008
EP 1st reading
April/May 2009
Council Common Position
June 2009
EP 2nd reading
Spring 2010
January 2011
Council Adoption
Spring 2010
February 2011 ?
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Legal basis for HTA collaboration between Member
States
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EUnetHTA JA Work Packages
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EUnetHTA Executive Committee

• CVZ, College voor zorgverzekeringen, Netherlands
• (EUnetHTA Joint Action WP5 Lead Partner term
  2010-2012)
• HAS, Haute Autorité de santé / French National
  Authority for Health, France
• (EUnetHTA Joint Action WP7 Lead Partner, term
  2010-2012)
• KCE, Belgian Health Care Knowledge Centre,
  Belgium
• (EUnetHTA Joint Action WP6 Lead Partner, term
  2010-2012,)
• NBoH, National Board of Health, Denmark
• (EUnetHTA Secretariat, EUnetHTA Joint Action WP1
  and WP8 Lead Partner (term 2010-2012)
• NETSCC, National Coordinating Centre for HTA,
  United Kingdom
• (EUnetHTA Joint Action WP3 Lead Partner, term
  2010-2012)
• NICE, National Institute for Health and Clinical
  Excellence
• (elected member term 2010-2011)
• NIPH, National Institute of Public Health,
  Slovenia
• (EUnetHTA Joint Action WP2 Lead Partner, term
  2010-2012)
• NOKC, Norwegian Knowledge Centre for the Health
  Services, Norway
• (elected member term 2010-2011)
• SNHTA, Swiss Network for Health Technology
  Assessment, Switzerland
• (elected member term 2010-2011)
• THL/FinOHTA, Finnish Office for HTA, Finland

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EUnetHTA JA 3-year Work Plan
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EUnetHTA JA 3-year Work Plan
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EUnetHTA JA 3-year Work Plan
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15 Key Principles for conducting HTA

• Structure of HTA programs
• the goal and scope of the HTA should be explicit
  and relevant to its use
• HTA should be an unbiased and transparent
  exercise
• HTA should include all relevant technologies
• A clear systems for setting priorities for HTA
  should exist
• Methods of HTA
• HTA should incorporate appropriate methods for
  assessing costs and benefits
• HTAs should consider a wide range of evidence and
  outcomes
• A full societal perspective should be considered
  when undertaking HTAs
• HTAs should explicitly characterize uncertainty
  surrounding estimates
• HTAs should consider and address issues of
  generalizability and transferability
• Processes for conduct of HTA
• Those conducting HTAs should actively engage all
  key stakeholder groups
• Those undertaking HTAs should actively seek all
  available data
• The implementation of HTA findings needs to be
  monitored
• Use of HTAs in Decision Making
• HTA should be timely
• HTA findings need to be communicated
  appropriately to different decision makers
• The link between HTA findings and decision-making
  processes needs to be transparent and clearly
  defined.

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Industry position papers

• Pharma
• http//www.efpia.org/content/default.asp?PageID5
  59DocID1350
• Biotech
• http//www.europabio.org/Healthcare/HC_HTA.htm
• Medical devices http//www.eucomed.be/press//medi
  a/49C306A47FE1424CBCA8ADC185F62554.ashx

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Websites

• HTAi
• http//www.htai.org/
• INAHTA
• http//www.inahta.org
• ISPOR
• http//www.ispor.org/
• WHO Regional Office for Europe - Health
  Evidence Network (HEN)
• http//www.euro.who.int/HEN
• European Observatory on Health Systems and
  Policies
• http//www.euro.who.int/en/home/projects/observat
  ory
• EUnetHTA Joint Action
• http//www.eunethta.net

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Thank you for the attention!Pascale.Brasseur_at_med
tronic.com