EUnetHTA’s Uncertain Future & the Evolution of European HTA

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The journey of EUnetHTA began back in 2004, when the European Commission and Council of Minsters requested the establishment of a sustainable European network on Health Technology Assessment (HTA) as “a political priority”, work on which was properly initiated in 2005 when a group of 35 organizations came together to establish EUnetHTA, with the mission being to “develop reliable, timely, transparent, and transferable information to contribute to HTA in European countries.”

 

As the current chair of the executive board since 2018, Dr. Niklas Hedberg, who is also chief pharmacist at TLV, Sweden’s pricing and reimbursement agency, explains, “EUnetHTA is both a network and a project, built up of Health Technology Assessment Bodies (HTAs) from across Europe. The network has answered a number of calls from the European Commission (EC) and now counts 83 partners, some of whom have been members since 2006.”

 

The project’s unwieldy name reflects the thorny nature of the challenges it aims to tackle. A seemingly paradoxical demand – fundamental to the project’s work, as Hedberg indicates – is ensuring that EUnetHTA provides actionable insights that do not circumvent or infringe upon national sovereignty, since each EU member makes their own pricing and reimbursement decisions. For instance, one of the key activities of EUnetHTA is the production of joint HTA reports on pharmaceuticals, medical devices and diagnostics.

 

In the fast-developing world of health technologies, especially under the pressure of COVID-19 but already before, there is a need for HTA to be both predictable and flexible

Niklas Hedberg, EUnetHTA

 

Hedberg expresses, “there is a thin line between producing high quality reports that can easily and readily be implemented without making them preempt national decisions. The national decision making must still be national, but the report should be ready and easy to implement. Without this, the value of the joint work becomes questionable.”

 

What complicates the matter further is that for the past three years, EUnetHTA has in a sense been working towards its own demise. In 2017, the European Commission developed a proposal on the future European model for HTA, and as Hedberg anticipates, “it seems that during the end of the German presidency (July-December 2020) and the beginning of the Portuguese presidency (January-June 2021), an agreement will be struck about which HTA regulation Europe will adopt in the future. That means that the project base and the joint action base might eventually come to an end.”

 

But he is hopeful that “the network will remain, where we have a pool of participating agencies, communication and information exchange, interaction, and mutual learning”, adding that “the general idea of a joint work on HTA is not under debate. Almost all partners are agreeing that we should increase our efforts on joint work.”

 

Recapping some of the highlights of EUnetHTA’s work, Hedberg lists, “EUnetHTA has a work package on evidence generation where the HTA bodies have provided an opportunity for early dialogues to the pharma developers. There is also a work stream for post-launch evidence data generation and in this work EUnetHTA has rolled out a number of pilots for evidence generation and has developed a quality tool for evaluating quality and relevance for quality registers.” He also added, from his national perspective, “TLV has worked with RWE for a number of years and we have started to utilise new or untraditional kinds of evidence.

 

Even if EUnetHTA ceases to exist in its current form in a couple of months, the importance of HTA within the EU will not fade, even though Hedberg does not expect the creation of a new EU HTA agency in the model of the European Medicines Agency (EMA). It is also clear that HTA will remain a challenging issue for the bloc, even after the establishment of an EU-wide HTA regulation, since “in the fast-developing world of health technologies, especially under the pressure of COVID-19 but already before, there is a need for HTA to be both predictable and flexible. Unexpected things happen all the time.”

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