EU Health Tech Assessments: Majority Favor Continuing Beyond 2020

Regulatory NewsRegulatory News | 15 May 2017 |  By 

A majority of respondents to a European Commission questionnaire, including pharmaceutical and medical device companies, says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020.

The results, revealed in a EC report on Monday, found that almost all respondents (98%) consider it useful to compare whether new health technologies work better, equally well or worse than existing ones, as part of guidance to decision makers.


HTAs help European national authorities measure the added value of a new health technology in comparison to existing technologies or the current standard of care. The goal of HTAs, according to the EC, is to support decision makers at national, regional or local levels to ensure that patients are treated with the best available treatments while health budgets are kept under control.

Last October, the commission launched a consultation to consider the future of HTA collaboration, seeking more information on the extent and impact of the current diversity of the national HTA systems, the scope for joint work on the EU level, its use in national decision-making and feasibility, as well as studies that are being launched to support the impact assessment with data.

The consult gathered 249 responses, 63 from individuals and 186 from administrations, economic stakeholders, associations or other organizations from 21 EU member states and Switzerland.


A large majority of the respondents (87%) consider that EU cooperation on HTA should continue beyond 2020, and a majority believe that such information on comparing new health technologies to previous ones should be accessible to doctors (95%) and patients (84%).

“Representatives of pharmaceutical industry point out that, HTA procedures are very diverse across EU, and this diversity constitutes a hurdle for companies, as they have to adapt to various national requirements. It was underlined that there are differences regarding the starting moment (e.g. before or immediately after marketing authorisation is granted or at later stage) and length of the HTA procedures, scope of HTA (i.e. all vs a selection of medicinal products), type of assessment carried out on a regular basis (e.g. only relative effectiveness assessments/REA vs sequential clinical and economic assessments vs full HTA), data accepted (e.g. only published vs non-published data), opportunity for early dialogues, level of engagement with stakeholders, availability of relevant documents and background information, and finally the purpose and weight of assessments (e.g. recommendation vs binding opinion for pricing and reimbursement decisions),” the report says.

“Due to these differences, most of the big pharmaceutical companies have national affiliates who engage with national authorities, preparing the documentation requested by HTA and pricing and reimbursement bodies.”

Respondents from the medical technology industry, meanwhile, “note that currently HTA has limited role in market access and the role and timing of HTA for medical technologies is country specific. They deplore the lack of established HTA processes and expectations for medical technologies (i.e. HTA processes and methodologies are considered ‘pharma-biased,’ not always addressing the particularities of the medical technologies' sector), variable timelines and in some Member States disconnection between HTA outcomes and patient access to the technology assessed. Moreover, it was stressed that compulsory HTA for all medical technologies may become a market barrier with major implications on the development of new products.”

Pharmaceutical and device companies also weighed in on the differences in national HTA methodologies for clinical and economic assessments.

In relation to the potential funding mechanisms of the future EU cooperation on HTA, 53% point toward a mix of contributions from EU budget, industry fees and member state contributions.

The Commission said in the report that it will duly consider the views expressed by stakeholders in this open public consultation, and will be attached to an impact assessment report on the strengthening of EU cooperation on HTA beyond 2020.

Strengthening of the EU cooperation on Health Technology Assessment


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