EU HTA regulation update

All you need to know about the new HTA Regulation

In 2021, the adoption of the legislation for joint European Health Technology Assessment (EU HTA) initiated a new era for HTA. The HTA Regulation (HTAR) aims to enable the development of a joint perspective on clinical aspects of drugs, in vitro diagnostics (IVDs) and high-risk medical devices.

The ultimate objective is to improve patient access by reducing duplication of assessment effort, ensuring reproducibility whilst keeping appraisal at Member State (MS) level.

The timeline for drugs to be assessed through the pan-EU lens:

  • 2025: cancer and advanced therapy medicinal products (ATMPs)
  • 2028: orphan drugs
  • 2030: all drugs, IVDs and high-risk medical devices

Collaboration on HTA and harmonization of processes and requirements is valuable, but the shift to a mandatory process requires review and adjustment of current processes and the introduction of new workstreams to meet future HTA requirements. These resources can help you answer some of your questions and identify areas to address.

  • What does HTA mean at the EU level?
  • Key concerns about the new process
  • How to prepare for the future of EU HTA

If you are attending any of the ISPOR conferences this year, drop by the IQVIA booth and talk to an expert. In the meantime, if you have a more pressing question, please contact us!

 

To explore more resources around the value of RWE, please visit our RWE Library

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