Joint HTA in the EU: the future is shaping up!

HTA moving up the policy agenda in the EU

The HTA collaboration across the European Union is coming to fruition. The recent EU Regulation on joint Health Technology Assessment published in December 2021 created an unprecedented dynamic across the Union.  

Your Decide Hub kept you informed very early on of these new developments (click here to access the news)

So, this is it: joint HTA is possible, leading to more efficient collaboration and an increased quality for all. Of course, it is limited to clinical effectiveness, and will start in 2024.

However, the foundations are there, and trigger new initiatives in this field. But ever since this the Regulation is out, operational collaborations are speeding up to say the least.

EU Consortium of HTA agencies

At the end of 2021 a consortium of 13 HTA agencies won a tender initiated by the European Commission to stimulate experimental collaboration between these HTA agencies. The French health authority (HAS) details the objective of this unprecedented project:

to work on the divergences identified during previous collaborations and to set up a common methodological basis.

 

The tender will provide for the carrying out of 2 joint evaluations on medicinal products and 4 on medical devices to test the new methodological approaches developed.

As a result, the EUnetHTA21 project submitted by the consortium was selected and awarded 2 years’ funding, i.e.  circa € 3 million.

Interested in knowing which Agencies participate in EUnetHTA21? Hereunder is the list also available on the HAS website (click here to be redirected):

G-BA (Gemeinsame Bundesausschuss), Germany,

IQWIG (Institute for Quality and Efficiency in Health Care), Germany,

AIHTA (Austrian Institute for Health Technology Assessment), Austria,

KCE (Belgian Health Care Knowledge Centre), Belgium,

AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), Spain,

HAS (Haute Autorité de santé), France,

NIPN (National Institute of Pharmacy and Nutrition), Hungary,

AIFA (Italian Medicines Agency), Italy,

NCPE (National Centre for Pharmacoeconomic), Ireland,

NOMA (Norwegian Medicines Agency), Norway,

ZIN (National Health Care Institute), Netherlands,

INFARMED (National Authority of Medicines and Health Products), Portugal,

TLV (Dental and Pharmaceutical Benefits Agency), Sweden.

Setting up of the HAG, a leading player on the HTA scene

In parallel, Heads of HTA Agencies met decided to foster stronger and closer collaborations between HTA agencies in the EU space. To this end they created the Heads of Agencies Group (HAG)

which brings together heads of national health technology assessment agencies.

 

A strategic body, the HAG, is called upon to set guidelines for European cooperation, with the EUnetHTA21 Consortium and the Coordination Group of the new HTA regulation which will be set up in early 2022.

This is the future of the HTA landscape that is being sketched out in front of our very eyes. Who has joined the HAG? The Finnish Medicines Agency – FIMEA details membership on their website:

Organisations that have joined the group so far include AEMPS (Spain), AIFA (Italy), AGENAS (Italy), AIHTA (Austria), INFARMED (Portugal), KCE (Belgium), NIPH (Norway), G-BA (Germany), HAS (France), HIQA (Ireland), IQWIG (Germany), FIMEA (Finland), NCPE (Ireland), REDETS (Spain), RER (Italy), RIZIV-INAMI (Belgium), NOMA (Norway), TLV (Sweden) and ZIN (The Netherlands).

European Medicines Agency (EMA) and EUnetHTA21 hand in hand

The last piece in the jigsaw puzzle is the design of a joint work plan between the EMA and the Consortium, announced by the EMA on 12th April.

The Agency underlined that this collaboration yielded effective synergies between regulatory evaluation and HTA and bolstered a medicine life cycle approach that would ultimately benefit patients’ access to medicines across the EU.

The work plan sets clear priorities for 2023 (Click here to download the joint EMA & EUnetHTA21 work plan):

Priority areas in the EMA / EUnetHTA 21 joint work plan include joint scientific consultation for robust evidence generation, generation of patient-relevant data / information to support decision making, and methodologies to engage patients and healthcare professionals.

 

Activities related to the delivery of the service contract will be given high priority and will be actioned by EUnetHTA 21.

If you want to know more, click here to read the statement by the EMA which stirs up hopes for more systemic and integrated public health collaboration withing the European Union.

Back to the roots for HTA?

Perhaps this new dynamic across the EU space is the right time to reflect on the origin, development and success of Health technology assessment which spread across Europe as well as other regions of the world, and is pretty much the talk of the moment.

It is very timely of our friends at HTAi to underscore the reissue of a fundamental article by David Benta and Egon Jonsson on the History of HTA which provides incredibly useful and relevant insight on the topic.

It also delves in the development and growth of the main stakeholders of the HTA area, from HTAi to INAHTA, Euroscan, or WHO for instance.

Click here to download the article.

More HTA?

Since we are on the topic of HTA, you may be interested in one of the highlights of the forthcoming International Conference on Priority Setting in Health which will be held -mostly virtually- in Bergen from 28th to 30th April 2022. Click here to access the free registration form

The plenary session on HTA organized by Decide will feature INAHTA, Africa CDC and WHO discussing the transferability of HTA, its trends and regional development. Do not miss!

Click here to read more about the session content.

Interestingly, the session will be moderated by Dr Melanie Bertram, Head of the Delivery for Impact Unit at WHO and co-editor of the recent WHO “How to HTA guide” with Dr Tessa Edejer, Director of the HGF Department at WHO.

The guide can be downloaded here