Study – 1 year to be prepared for the new European Regulation on health technology assessment: INSTRUCTIONS FOR USE

Health Technology Assessment (HTA) is a key stage in the process of bringing a drug to market. This process, which is currently carried out at national level, ensures that medicines placed on the market provide sufficient clinical benefit for patients in France. For information, the Haute Autorité de Santé (HAS) issued 461 opinions and decisions on various products in 2023.

This is an important step for the healthcare ecosystem, including national governments, industry players, patients and healthcare professionals, which will be completely transformed from 2025 following the adoption of the European HTA Regulation. This is a subject that has not yet been widely discussed in France, even though it will have major consequences.

Nextep Health is closely monitoring the development of this new process and its implications for all stakeholders. The study produced sets out the main guidelines of the European Regulation and offers advice for healthcare system players involved in HTA, so that they are well prepared for the European HTAs. There is just one year to go before the process applies to oncology products and advanced therapy products. …

We would like to warmly thank Mrs Chantal Bélorgey, Former Advisor to the President, Haute Autorité de Santé and Former Vice-Chair Executive Board, EUnetHTA21, for her expertise and recommendations on this very important subject. Vice-Chair Executive Board, EUnetHTA21, for her expertise and recommendations on this very important subject.

Contact

Dominique Amory – Partner

dominique.amory@nextep-health.com

Sébastien Faure – Partner

sebastien.faure@nextep-health.com

Anaïs Ronchin – Consultante senior

anais.ronchin@nextep-health.com

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