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Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 
• By Eliza Slawther

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

The PICO framework used for EU-level HTA assessments might be unsuitable for vaccines (Shutterstock)
Key Takeaways
  • The framework used to evaluate products under the EU Health Technology Assessment (HTA) Regulation might pose unique challenges for vaccines, industry warns.
  • A senior figure from GSK explained why member states may struggle to identify the correct population for a given immunization.
  • Industry group Vaccines Europe is pushing for policymakers to address these challenges before the regulation applies to vaccines in 2030.

EU-level joint clinical assessments (JCAs) will apply for vaccines under the HTA Regulation from 2030, but manufacturers are concerned that the framework

JCAs, which are similar to national relative efficacy comparisons, involve companies answering questions in their dossiers known as PICOs

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