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HTA in Europe

HTA in Europe. Pascale Brasseur Health Economics & Reimbursement Director, Cardiovascular, Medtronic International Sa Chair of Eucomed HTA Working group. 12 categories as per Global Medical Device Nomenclature . Proposed “clustering” for funding & reimbursement purposes.

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HTA in Europe

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  1. HTA in Europe Pascale Brasseur Health Economics & Reimbursement Director, Cardiovascular, Medtronic International Sa Chair of Eucomed HTA Working group

  2. 12 categories as per Global Medical Device Nomenclature

  3. Proposed “clustering” for funding & reimbursement purposes Category I“medical aids” Category III“assistance forprofessionals” Category II “artificial body parts” 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 standard products which are prescribed and given to an individual patient technical equipment supporting professionals in diagnostics and/or treatment with two-stage financing: • IIIa: investment • IIIb: refinancing via use (diagnostics/treatment) • 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

  4. Decisions on coverage of medical devices Category I“medical aids” Category III“assistance forprofessionals” Category II “artificial body parts” 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 standard products which are prescribed and given to an 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/treatment) Limitations toparticular patients, productsor service providerspossible • knee (endo-)prostheses • ICD • coronary stents implants Source : Prof. R. Busse presentation for Med Tech week October 2008

  5. Increasing Number of HTA Agencies ... HTA capacity building handbook EUnetHTA WP 8 (Dec. 2008)

  6. HTA for Medical Devices Source : HTA capacity building handbook EUnetHTA WP 8 (Dec. 2008)

  7. Example : Horizon Scanning in Italia Source : Dott. Tom Jefferson – Aggiornamento delle Segnalazioni – Seminario conclusivo COTE – 17 November 2009

  8. 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

  9. 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; 26:1 (2010), 71–78.

  10. 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; 25:3 (2009) , 305-314

  11. 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; 25:2 (2009) ,124-133

  12. 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; 25:3 (2009) , 305-314

  13. Appraisal Assessment vsAppraisal

  14. Factors influencing policy-making HTA and Health Policy Making in Europe, EUnetHTA WP 6 in collaboration with WHO European Observatory

  15. Conditions for reasonable decision making Source: Dissemination of HTAs Health Technologies and Decision Making - OECD 2005

  16. Factors that facilitate decision implementation Decision Making and Implementation Health Technologies and Decision Making - OECD 2005

  17. Barriers to decision implementation Decision Making and Implementation Health Technologies and Decision Making - OECD 2005

  18. Networking … small cooperative frameworks

  19. … and the EUnetHTA Joint Action

  20. 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.

  21. 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.

  22. 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 ?

  23. Legal basis for HTA collaboration between Member States

  24. EUnetHTA JA – Work Packages

  25. 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 (EUnetHTA Joint Action WP4 Lead Partner, term 2010-2012)

  26. EUnetHTA JA 3-year Work Plan

  27. EUnetHTA JA 3-year Work Plan

  28. EUnetHTA JA 3-year Work Plan

  29. 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.

  30. Industry position papers • Pharma http://www.efpia.org/content/default.asp?PageID=559&DocID=1350 • Biotech http://www.europabio.org/Healthcare/HC_HTA.htm • Medical devices http://www.eucomed.be/press/~/media/49C306A47FE1424CBCA8ADC185F62554.ashx

  31. 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/observatory • EUnetHTA Joint Action http://www.eunethta.net • EUROSCAN http://www.euroscan.org.uk

  32. Thank you for the attention!Pascale.Brasseur@medtronic.com

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