STRUMENTI E METODOLOGIE PER LA VALORIZZAZIONE

DELL’INNOVAZIONE

Pascale BrasseurChair 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

• 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

Key Princinples for conducting HTA

Medical Device Industry’s position

The Purpose of HTA

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

HTA should not be positioned as an additionalbarrier to regulatory approval. The focus of regulatory approval for CE marking (safety, quality andperformance) 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 innovationLancet – Vol. 374 – September 2009

Learning Curve

Source : Ergina P et al, Surgical Innovation and Evaluation 2- Challenges in evaluating surgical innovationLancet – 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

ObjectiveThe 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

BackgroundThe 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

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 : Trade association representing the medical technology industry

EDMA : 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 J oint Action The EUnetHTA J oint 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 J oint 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

Aim Lead partner(s) Associated partners

WP1 Coordination National Board of Health of Denmark

KCE, DIMDI, ISCIII, THL, HAS, AGENAS, CVZ, AHTAPOL, SBU, IPH-RS, NETSCC, LBI

WP2 Dissemination IPH RS - Lead SBU - Co-lead

HVB, NCPHP, MOH Spain, NSPH

WP3 Evaluation WPs NETSCC None WP4 Core HTA THL - Lead

AGENAS - Co-lead LBI, GOG, KCE, DIMDI, IQWIG, SBU, UTA, ISCIII, HIQA, THL, Regione Veneto, SSD/MSOC, AHTAPOL, INFARMED, SBU, HVB, NBOH, IPH-RS, NICE, NOKC

WP5 Relative Effectiveness of Pharmaceuticals

CVZ - Lead HAS - Co-lead

NOKC, SDU, HIQA, AIFA, KCE, IQWIG, GOG, HVB, THL, VEC, AHTAPOL, SSD/MSOC, INFARMED, SBU, ESKI, NICE

WP6 Information Management Systems

KCE - Lead DIMDI - Co-lead

CVZ, EMKI, ESKI, GOG, HAS, HVB, ISCIII, LBI, NETSCC, NIPH, SBU, THL

WP7 New Technologies; Facilitating Evidence Generation and Collaboration on (Pre-coverage) Assessments

HAS - Lead LBI - Co-lead

CZ Ministry of Health, SDU, ISCIII, THL, EMKI, HIQA, AGENAS, AIFA, Regione Veneto, VASPVT, SSD/MSOC, CVZ, AHTAPOL. INFARMED, NETSCC, NICE. NOKC

WP8 Strategy and Business Model Development

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 !