The MedTech Europe blog

The current voluntary cooperation of Health Technology Assessment (HTA) agencies organized within EUnetHTA indicates that  HTA is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology.

If appropriately performed, in my opinion, Health Technology Assessment  can indeed provide insight into the value of medical technology in real life and daily clinical practice. This value would not only be based on the clinical benefit and direct healthcare cost , but also on benefit to patients,  socio-economic consequences,  the impact  on the sustainability of healthcare systems, and the overall societal well-being. In other words, HTA needs to support finding an answer to the question of value,  the question whether it is worth investing in a technology with public and/or private money.

Important when assessing technology is to consider the uniqueness of healthcare systems in the different EU member states in terms of prioritisation of healthcare to be provided, the structural difference within the systems, their financing models, and differences in treatments offered. This is why national and regional, and even local assessments of the technology are performed to account for this contextual framework. In addition the perspective taken, i.e. informing hospital, regional, national authorities, deciding whether or not to reimburse and if so, to which level, identifying who within the population would benefit the most, determines the type of data and analysis required.

To answer this broad question, a majority of member states unfortunately still perform these assessments  from an Ivory Tower, avoiding to enter into a dialogue with stakeholders such as the patients, the payers, the providers and manufacturers of medical technology, the latter being the main investor in developing the  data and evidence of the outcome of the new technology.
The current EU initiative – described in the cross-border directive 2011/24/EU – of setting up a voluntary network connecting national authorities and  bodies responsible for HTA appointed by member states, will be crucial in shaping the future of medical technology assessment in Europe when it comes to its usability and impact.

The  directive stresses that this network shall be based on [… ] appropriate consultation of stakeholders… (Article 15.1) and Union aid may be granted to the network in order to  […]facilitate the consultation of stakeholders on the work of the network. (art 15.2(e)). Nevertheless, I feel that the governance structure of the current Joint Actions still looks more like an ivory tower instead of a model of dialogue and true involvement with all stakeholders.

Such involvement would, I expect, make sure that the HTA is as efficient and high-quality as can be while ensuring its legitimacy through transparent and open decision-making. A non-binding consultation at the end of a process  will certainly not suffice to reach this objective.

As a representative of the medical device industry, I am also convinced that it is crucial that an HTA intended to support healthcare decision- and policy making must remain independent from all stakeholders’ interests and be based upon high quality data. However, at the same time it is crucial to take into account all the relevant available information, experience and expertise, and different perspectives available within the stakeholders. It is time to put aside the fear of sitting around a table with industry and other stakeholders and have an open, data driven dialogue ensuring informed decision making. I therefore encourage all interested in more dialogue and stakeholder involvement in the upcoming HTA Network, and in HTA in general, to proclaim your wish for a dynamic HTA Network model which:

  • explores the most effective forms of dialogue and involvement of stakeholders
  • acknowledges the different nature of the various stakeholders and the different types of input they can provide both in terms of content and resources
  • sees stakeholders (providers, patients, physicians, payers, industry,…) as a pool of expertise involved in the assessment which provides advice according to the different perspective and experience represented
  • promotes stakeholder involvement on the governance and setting up of quality systems, on strategic issues (e.g. long- and short-term objectives and priorities) and on the operational level;

You can do so by responding to the European Commission’s “Public Consultation on the modalities of stakeholder consultation in the voluntary Health Technology Assessment network” which closes on 1 August.

Only then can HTA and the HTA Network be a useful tool in support of multiple decision maker levels which encourages and rewards innovation with the greatest value to patients, healthcare systems, national and European economies and society.

Yves Verboven
Senior Manager of Economic Affairs

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