EUnetHTA 21 Launches Joint Scientific Consultations for Regulators, HTAs, and Sponsors

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Writing in the December edition of DIA’s Global Forum magazine, Thomas Kühler updates his August piece on the progress towards a unified HTA system in Europe and the objectives of the recently launched EUnetHTA 21 initiative.

 

Global 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.

 

Read the full article here and read PharmaBoardroom’s interview with EUnetHTA Chair Niklas Hedberg here


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