A significant step in the new EU HTA process: first assessment completed

The subject of the first joint clinical assessment (JCA) was the anticancer drug tovorafenib for the treatment of paediatric low-grade glioma. For Germany, the Institute for Quality and Efficiency in Health Care (IQWiG) acted as the co-assessor. It produced the report in collaboration with the National Centre for Pharmacoeconomics in Ireland.

“We are proud to have been directly involved right from the very first report. The collaboration with our Irish colleagues, and indeed at the European level as a whole, was excellent,” said Beate Wieseler, Head of IQWiG’s Drug Assessment Department. “Working together was very valuable; we were able to learn a great deal from one another and, at the same time, demonstrate that the new EU HTA process works.”

As a next step, the joint report will now be forwarded to the European Commission for a procedural review; only once this has been completed, will the report be published. And what will happen in Germany after that? The EU report will be used for the assessment in the national AMNOG process (the Act on the Reform of the Market for Medicinal Products; the early benefit assessment), and the manufacturer may refer to the European dossier in this context. As tovorafenib is an orphan drug – that is, a drug used for the treatment of rare diseases – the assessment is carried out by the Federal Joint Committee (G-BA).

IQWiG is currently involved on behalf of Germany in numerous other European assessments. An overview of the various projects can be found on our website.