STRUMENTI E METODOLOGIE PER LA VALORIZZAZIONE DELL’INNOVAZIONE

Pascale Brasseur Chair of Eucomed HTA Working Group

• • • • • •

Agenda HTA Key principles Specificities of Medical Devices Ad-hoc process for Medical Devices?

Collaboration Conclusion

Health Technology Assessment

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."

Key Princinples for conducting HTA

• • • •

Key Princinples 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

Medical Device Industry’s position

The Purpose of HTA

Health technology assessment should be used to support patient access to innovative technologies by promoting the use of technologies that are clinically and cost effective. Conversely, HTA should be used as a mechanism to support disinvestment in current services and technologies which are cost ineffective, thus creating ‘headroom’ for new technologies when they become available...

HTA should not be positioned as an additional

barrier to regulatory approval. The focus of regulatory approval for CE marking (safety, quality and performance) and HTA (clinical and cost effectiveness) are fundamentally different.

HTA for Medical Devices

Clinical Studies with Medical Devices



RCTs difficult to undertake

 What do we really compare? Different devices/procedures or different level of expertise?

  Is blinding ethical if requires a sham procedure?

Is randomization possible if patients are aware of a less invasive procedure?

Source : Ergina P et al, Surgical Innovation and Evaluation 2- Challenges in evaluating surgical innovation Lancet – Vol. 374 – September 2009

Learning Curve

Source : Ergina P et al, Surgical Innovation and Evaluation 2- Challenges in evaluating surgical innovation Lancet – Vol. 374 – September 2009

Other specificities of Medical Devices

 Devices change rapidly  Miniaturisation, micro-systems  relevance of operator skills, learning curve  statistical aspects  Digitisation, visualisation, imaging  additional benefit of more precise images and details  Use of new materials, biomarkers  Long term of safety of new materials  Information technology, telemetry  Impact on organisation of health care services  Other sources of evidence such as well designed comparative and non comparative observational studies must be considered

Specific assessment process

“In this report, we proposed the framework for a future procedure for the assessment of new and emerging technologies in Belgium, in particular for new implants and invasive devices, within the current existing legal possibilities of the health insurance law. In the first place, the availability of procedures in other countries was investigated. The international overview of the available procedures demonstrates that the managed uptake of new and emerging technologies is in a relatively initial stage, with UK and Australia providing the relatively most advanced procedures.”

Specific assessment process

http://ec.europa.eu/enterprise/sectors/medical-devices/files/exploratory_process/final_report_en.pdf

Background The medical devices industry constitutes a key sector for healthcare. It is one of the most innovative sectors, improving and saving lives every day by providing innovative solutions for diagnosis, prevention and treatments. The medical devices industry is also a major employer in Europe. However these companies face challenges of national, European and international dimensions that may have an impact on their innovation capacity and their competitiveness. These difficulties might have consequences on the health of European citizens.

An exploratory process on the future of the medical devices sector has been put in place over the second semester 2009 to map the existing public health and industrial challenges in the sector and investigate possible topics of reflection at the European level. This process will provide for industry, users, and consumers of medical devices with an opportunity to share existing challenges Objective

The objective of the exploratory process on the future of the medical devices sector is to gather at the end of the process an

overview of existing public health and industrial challenges, to identify current dynamics of the industry and highlight key topics of interest at the European level

which should result in a set of

suggested themes of potential further reflection

to be adopted by the members of the exploratory process

Members

The exploratory process is chaired by the Commission services. The membership represents both private and public health interests with the involvement of the following stakeholders:                      

EUCOMED EDMA

: Trade association representing the medical technology industry : European Diagnostic Manufacturers

COCIR

: European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry

EUROM I

: European Optical Industry committee

EUROM VI

: European Industrial Federation committee on Medical Technology

EHIMA

: European Hearing Instrument Manufacturers Association

EUROMCONTACT

: European contact lens and lens care industry's association

FIDE

: The Federation of the European Dental Industry

CPME

: The Standing Committee of European Doctors

UEMS

: European Union of Medical Specialists

ESC

: European Society of Cardiology

EFORT

: The European Federation of National Association of Orthopaedics and Traumatology

ESR

: European Society of Radiology

HOPE

: The European Hospital and Healthcare

EPF

: The European Patient's Forum

BEUC

: The European Consumers' Organisation

ESIP

: The European Social Insurance Platform

AIM

: Association Internationale des Mutualités

PGEU

Pharmaceutical Group of the European Union

EFCC

: European Federation of Clinical Chemistry and Laboratory Medicine

CED

: Council of European Dentists

EAHP

: European Association of Hospital Pharmacists

Structure

In order to steer the process in a given way, the

heads of the stakeholders organisations

involved are invited twice, to open and to close the exploratory process. In the mean time, the process will be organised around two

discussion sessions

with representatives of the stakeholders organisations involved and experts. In addition to a plenary session, the participants will explore more in depth challenges covered within three distinct work streams.   

Future challenges and opportunities for public health and medical technologies developments

This visionary work stream will provide the overarching high level framework for the discussions. This work stream will consider the future challenges of public health systems and how the medical devices industry could respond to them, with a particular focus on emerging needs (e.g. developing a shared understanding of future healthcare goals), increasing expectations (e.g. overcoming health inequalities), societal changes (e.g. ageing society) and the emergence of new medical technologies (e.g. potential of the e-health technologies).

Balance between the patients' needs and financial sustainability

This work stream will cover all the challenges of access to medical devices for the European citizen . These could include issues such as how to measure appropriately the value of medical devices , how to enhance better access of patients to medical devices looking at the different factors including pricing and reimbursement policies. Challenges of the purchasing systems and payment mechanisms should be looked at in that context.

Competitiveness and Innovation of the medical devices industry

This work stream could investigate what are the global innovation and competitiveness challenges faced by the medical devices industry, including aspects of R&D, emerging technologies and green economy. It could also cover aspects linked to the position of Europe in the world, both in the field of trade and regulatory cooperation. Finally, challenges specifics for SMEs should be looked at.

http://ec.europa.eu/enterprise/sectors/medical-devices/competitiveness/exploratory-process/index_en.htm#h2-objective

EUnetHTA Joint Action

Starting a new phase – European network for HTA Joint Action

The EUnetHTA Joint Action (European network for HTA Joint Action) grant agreement has been signed by the EU Executive Agency for Health and Consumers and the Coordinator (National Board of Health of Denmark) on behalf of 33 partners in 23 EU Member States and Norway and the Joint Action now begins its activities. Focusing on scientific cooperation on HTA in Europe, EUnetHTA Joint Action partners in cooperation with the Commission aim at delivering highest quality, transparency and value added for the EU Member States in its activities and in its governance and organisational processes

EUnetHTA Joint Action

WP

WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8

Aim

Coordination Dissemination Evaluation WPs Core HTA Relative Effectiveness of Pharmaceuticals Information Management Systems New Technologies; Facilitating Evidence Generation and Collaboration on (Pre coverage) Assessments Strategy and Business Model Development

Lead partner(s) Associated partners

National Board of Health of Denmark IPH RS - Lead SBU - Co-lead NETSCC THL - Lead AGENAS - Co-lead CVZ - Lead HAS - Co-lead KCE - Lead DIMDI - Co-lead HAS - Lead LBI - Co-lead KCE, DIMDI, ISCIII, THL, HAS, AGENAS, CVZ, AHTAPOL, SBU, IPH-RS, NETSCC, LBI HVB, NCPHP, MOH Spain, NSPH None LBI, GOG, KCE, DIMDI, IQWIG, SBU, UTA, ISCIII, HIQA, THL, Regione Veneto, SSD/MSOC, AHTAPOL, INFARMED, SBU, HVB, NBOH, IPH-RS, NICE, NOKC NOKC, SDU, HIQA, AIFA, KCE, IQWIG, GOG, HVB, THL, VEC, AHTAPOL, SSD/MSOC, INFARMED, SBU, ESKI, NICE CVZ, EMKI, ESKI, GOG, HAS, HVB, ISCIII, LBI, NETSCC, NIPH, SBU, THL CZ Ministry of Health, SDU, ISCIII, THL, EMKI, HIQA, AGENAS, AIFA, Regione Veneto, VASPVT, SSD/MSOC, CVZ, AHTAPOL. INFARMED, NETSCC, NICE. NOKC National Board of Health of Denmark KCE, DIMDI, ISCIII, THL, HAS, AGENAS, CVZ, AHTAPOL, SBU, IPH-RS, NETSCC, LBI

In Summary

• • • • •

Key principles for the conduct of HTAs:

–

inclusiveness

–

transparency

–

review

–

timeliness HTA is not as an additional regulatory barrier Specificities of medical devices Evaluation of entire treatment pathway Harmonization / collaboration

Grazie per l’attenzione !