1. Health Technology Assessment
John Wilkinson, Chief Executive

2. Key trends in healthcare
Increase of chronic and
Multiple diseases
Increased focus
on prevention
Increasing expectations
of citizens
Aging population
&
Budget constraints
Shift from public to private
funding
Increasing e-solutions
Shift to community
and homecare
Increased demand of medical
Technology and services
Increasing role of purchasing
& paying institutions
Declining power of
Healthcare Professionals

3. MedTech in Europe? EC Exploratory Process 2010:
2. Encompassing innovation
FINANCIAL CHALLENGES
4. Industrial challenges
Holistic approaches
1. Public health challenges
Patient empowerment
Innovative technologies/products
Involvement for innovation
Scope and role of Medical Devices sector
Global context for research investments
Need for a clear political vision of the role of the medical device sector
in the health of citizens and the economy.
Information to patients and clinical practices
Procurement procedures and reimbursement
Involvement in decisions on access
Public health policies
Research and development
Involvement, education and training of the different actors
3. Value of and access to medical devices
Regulatory framework
Patient Safety & Quality of Care
Public procurement
Late payments
Industrial environment
Market Availability
Measuring value of medical devices technologies
Fight against counterfeit medical devices
Transparency
Inclusion of medical devices within the scope of the national health insurance systems and funding systems
Generation of data
Governance in the evaluation and decision making processes

4. HTA A catalyst for faster uptake?
Europe needs innovation to deliver the expectations of citizens for high quality, sustainable healthcare systems.
Collaboration is needed between all stakeholders to bring this about.

5. HTA ….or a bureaucratic barrier?
Bad HTA means delay, expense and poor decisions that do little to improve performance.
Individual systems with varying needs add cost and little value.

6. Most frequently used definition for HTA
Population
Politics
HTA
Evidence
Summarizes the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Informs the formulation of safe, effective health policies that are patient focused and seek to achieve the best value."

7. Some Progress

8. Cross-border health directive
Sets out to clarify legal status of citizens who seek or need to receive treatment in a member state other than their own
So what has this to do with HTA?

9. Cross-border health directive
Article 14
Sets out good governance principles
Includes stakeholder consultation and participation
Transparency
A legal basis for better exchange of HTA related information
We will be working with other stakeholders to:
Create adequate policies and methodologies
To ensure that the interests of society are well represented rather than this being just a management tool for government

10. HTA and the medical technology industry1.
HTA for medical technology is context specific. Over centralise and it often does not work and certainly stifles innovation in ways of treating patients
Methodologies are challenging. Randomised trials often do not work and cannot be used. 2.

11. HTA and the medical technology industry3.
Timing is critical as these technologies evolve over time and over-zealous use of HTA can kill good technologies
Clinical evidence is essential but the level is related to complexity and risk. Standardised methods of assessment needed to limit costs and wasted duplication 4.

12. HTA and the medical technology industry5.
Industry need to inform the process especially in cases of very new technology. Others need to be involved as well, e.g. patients
Appropriate expertise is needed to design the ways in which different technologies are assessed 6.

13. HTA and the medical technology industry7.
Patients should not wait to be treated with new technologies because of bureaucratic delays in assessment
Formal appeals processes are needed to ensure that adequate scrutiny is consistently applied 8.

14. We need to be ‘smart’ and efficient
HTA needs to be applied to the right technologies at the right time
Methodologies need to be harmonised especially in the case of clinical evidence
Europe has a great deal of world leading experience. Lets make sure that it helps us lead the world in ‘new, efficient and sustainable’ system development

15. Thank you! John Wilkinson Chief Executive john.wilkinson@eucomed.org