SBU receives its first EU-level clinical assessment assignment for a medicinal product

“For SBU, this assignment is an opportunity to contribute with the solid expertise in health technology assessment, HTA, that exists within the organisation. Over the past year, we have adapted our internal processes and participated in national and EU-level preparations to be able to work with joint clinical assessments, JCA,” says Susanne Johansson, project manager for the JCA at SBU.

SBU, together with Infarmed, will now lead the EU joint clinical assessment of a medicinal product for the treatment of ovarian cancer. This includes multiple steps from defining the scope of the assessment (the so-called PICO) to completing a JCA report. The work follows a defined process where input from all member states is coordinated at specific stages, and the assessment is expected to continue until December 2026.

The background to SBU’s assignment is the new EU Regulation on Health Technology Assessment (HTAR), which applies from January 2025. SBU participates in the joint EU initiative under the HTA Regulation, which aims to ensure evidence-based, effective, and sustainable HTA evaluations of novel medicinal products and medical devices. Since 2024, SBU has strengthened its collaboration with the Swedish Dental and Pharmaceutical Benefits Agency (TLV), which also takes part in the EU collaboration.

“SBU aims to contribute to high-quality clinical assessments that enable earlier access to effective and evidence-based medicines and medical devices for patients,” says Karin Wilbe Ramsay, also project manager for the JCA at SBU.

More information: SBU and the HTA Regulation