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EUnetHTA 21 Launches Joint Scientific Consultations for Regulators, HTAs, and Sponsors
Thomas Kühler
Sanofi R&D

lobal Forum recently published a piece on Health Technology Assessment (HTA) in the EU and how a regulation that had been the subject of protracted negotiations for close to three years eventually seemed to have been cleared for final adoption. The aim of this regulation is to secure timely patient access to novel therapies, to avoid duplicative HTA-assessment work at the Member State level, and to provide the sector with a predictable and consistent HTA process. A few formal steps remained, the most important one being the adoption of the regulation at a Council Meeting, which happened in a Council vote on November 9, 2021.

The EUnetHTA network was established many years ago to create an effective and sustainable structure for HTA across Europe. It has now launched the EUnetHTA 21 initiative and will run a pilot jointly with the European Medicines Agency (EMA) to address methodological issues concerning the implementation of the regulation. In this pilot, EUnetHTA and the EMA invite industry to apply for the first four (out of a total of eight) slots for Joint Scientific Consultations (JSC), or what used to be called Parallel Consultations or Early Dialogues. The timing of when the remaining four slots will be released has not yet been communicated.

In these consultations, medicine developers, regulators (the EMA), and HTA bodies from the different Member States meet to discuss the (sponsor’s) development plan so that, to the widest extent possible, the evidence that will be generated meets the needs of the different decision-makers in terms of quality and appropriateness of the data produced (for example, the choice of comparators, outcomes, quality of life, patient cohorts, etc.). The objective is to enable a development plan that fulfills the evidence requirements of both regulators and HTA bodies at the same time. These consultations render nonbinding advice, but the possibility of early and constructive dialogue has over time become an important step in enabling swift patient access to new therapeutics in the EU.

The call for applications to the four slots remains open from November 8 through December 7, 2021, and the selection of products will take place two weeks after the end of the call period with the aim to start the JSCs in January 2022. All applications for products that meet the qualification criteria will be taken into consideration, but it is unclear which selection criteria will be applied beyond the ones communicated if there are more applications filed than the four (or eight) available slots.

The following criteria have been specified:

  • Unmet medical needs (no treatment or only unsatisfactory treatment available)
  • First in class
  • Potential impact on patients, public health, or healthcare systems
  • Significant cross-border dimension
  • Major European Union-wide added value
  • Union clinical research priorities
  • Targets a life-threatening or chronically debilitating disease
  • Breakthrough technology (chiefly defined as clinical evidence indicating that the drug may demonstrate a substantial improvement in practicality or convenience or efficacy over available therapy/ies)

Another criterion is that the product cannot have entered phase 2 or 3 clinical trials.

The JSC Committee for Scientific Consistency and Quality, which comprises delegates from AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NoMA (Norway), and TLV (Sweden), is responsible for the selection process.

Sponsors should submit the completed application form to the EUnetHTA 21 JSC Secretariat at