Health Technology Assessment

HTA systematically evaluates the relative effectiveness, cost-effectiveness and economic, social and organisational impact of health technologies on the lives of patients, healthcare systems and society. The relative effects of a technology or solution are compared to current practices.

HTA reports aim to inform decision-making on, for example, appropriate use, clinical guidelines or national/regional funding.

MedTech Europe welcomes advances in the assessment of medical technology innovations, and the appropriate rewarding of the value these innovations bring. The assessment of the value of medical technologies should take place using tools that are appropriate to the nature of the sector and its innovation model.

In specific cases, HTA can be used to assess a medical technology, for specific purposes and at specific times and implemented to address the specific country needs. This reflects the decentralised and localised market access model, well-suited for Member States’ decision-making.

*HTAi reference

MedTech Europe’s view on HTA

Fundamental guiding principles of HTA for medical technology and solutions in Europe today shall be: clear purpose of HTA, transparency of the process, appropriate timing and adaptive evidence profile.

At a European level, since years, cooperation in the field of HTA has been ongoing through European joint actions, and the HTA Network within the cross-border Directive to which MedTech Europe has actively participated. As of end of 2021, the Directive had been replaced by a Regulation introducing newly defined cooperation in the field of HTA (HTAR).

Our team supports the creation of an appropriate policy environment and initiatives that:

• Promote timely access to, and funding of, innovation.
• Enable accelerated and equal accessibility of innovative technologies.
• Enhance the use of innovative technologies in healthcare delivery healthcare, to contribute to more sustainable and resilient national health systems.

The road ahead

MedTech Europe will seek to be an active partner throughout the Regulation’s implementation phase (foreseen until 2025) and beyond. As a member of the Stakeholder Network, maintaining a strong voice will involve: interactions with the European Commission, the Coordination Group’s medical technology configuration and respective subgroups, as well as engaging in a dialogue with the relevant stakeholders.

At this time, particular focus will be given to the new EU Regulation on HTA implementation and development of processes and fit for purpose methodologies/guidances. We consider as key factors of success:

• Transparency and clarity in the processes from the TIPS (Technology Identification, prioritisation, selection), the JSC and throughout the assessment process up to the uptake of the report.
• Acknowledgement of shortcomings in the JCA pilots; and the adoption of flexible and innovative methods as an adaptive approach to set high-quality standards to assess, at an appropriate time the value of medical technology innovation along the lifecycle. Hereby, reinforcing the need for a uniquely tailored approach. (see discussion paper)
• A fully inclusive process that involves the experts/expertise(incl. patients, healthcare professionals, HTD, …) from scoping to report finalisation.
• Securing high-quality assessment expertise in the field of medical technology.

At all times, any assessment on health technologies, that is to have true value, will need to have a clear purpose and use in national processes. The JCA reports need to be of added value to support decisions of adoption and investment/funding. Equally important is to have no interference with other legislations, avoiding the risk of ambiguity and duplication.

MedTech Europe’s overarching aim is to make the latest medical technology innovations available to European citizens while mitigating the risk of: delays in access to technologies for patients and healthcare systems; an increased burden for the medical technology industry and deprioritising Europe, as a preferred market to innovate.

A Community of Interest

To be a partner to advances and innovate methodologies,  MedTech Europe is committed to foster the discussion on value frameworks and on innovative methodologies to set high quality standards to assess the value along the lifecycle. We therefore have set-up topic leads groups in the field of Joint Clinical Assessment – full process,  Adaptive Approach to assess medical devices and Digital- AI value assessments. This to provide best available evidence to inform decision making in a context of  uncertainty and availability of evidence.

A discussion paper on setting high quality standard by an adaptive approach to assess the value of medical technologies  is being created  with topics leads of industry and experts in the specific field are welcome to join in the discussion, We therefor seek your view.

Please share your perspective.

Digital – AI assessment

MedTech Europe’s topics leads group compiles information on current value frameworks and conducts reflective analysis.

MedTech Europe engages in the European Task Force initiatives on the harmonisation of evaluation of Digital Medical Devices.