First EU HTAs with IQWiG involvement launched

In March 2025, the German Institute for Quality and Efficiency in Health Care (IQWiG) began a joint European health technology assessment (EU-HTA), called a joint clinical assessment (JCA), of tovorafenib. This drug is intended for use in children and adolescents with low-grade malignant glioma, which is a slow-growing tumour of the central nervous system. In this project, the Irish National Centre for Pharmacoeconomics (NCPE) is the assessor, while IQWiG is the co-assessor. The project is expected to be completed in the second quarter of 2026, shortly after the anticipated approval of the drug.

In addition, IQWiG is currently involved in three other JCAs of oncology drugs as an assessor. These assessments are expected to be completed in the third quarter of 2026. The partner organizations in these projects are the Portuguese National Authority of Medicines and Health Products (Infarmed) the Hungarian National Centre for Public Health and Pharmacy (NCPHP), and the Slovenian Public Agency for Quality in Healthcare.

European joint clinical assessments of drugs

Regina Skavron, Head of the Methodology and Coordination of European HTA Division at IQWiG, notes: " Since the beginning of 2025, EU countries have been working more closely together to assess new drugs in the EU-HTA process. The aim is to provide member states with a scientific assessment of the available evidence to inform decisions in their healthcare systems."

EU-HTA is gradually being introduced throughout Europe and forms the core of European HTA activities. In January 2025, the assessment of oncology drugs and advanced therapy medicinal products (ATMPs) was launched. These include gene therapies, for example. In 2028, drugs for rare diseases (orphan drugs) will follow, and from 2030 onwards, all newly approved drugs will undergo a joint assessment at the European level. From 2026 onwards, it is also planned that the assessments will include selected high-risk medical devices.

In each assessment, two HTA agencies from different countries act as assessor and co-assessor, respectively. This collaboration involves finalizing the assessment scope defined by the EU member states and assessing the supporting evidence. The assessment scope is also referred to as PICO - PICO stands for population, intervention, comparator (i.e. comparator therapy) and outcome (i.e. health-related outcomes). As PICO reflects a specific question in a particular member state, it is possible that different states will have different questions. The subject is always the comparison of the new drug with the local standard of care.

JCAs are intended to inform and underpin national decisions, not replace them. They only describe the available evidence. Classification of the results is the responsibility of the national institutions. In Germany, for example, an additional assessment known as a benefit assessment (“Nutzenbewertung”) is conducted as part of the early benefit assessment procedure, which is based on the Act on the Reform of the Market for Medicinal Products (AMNOG). This includes a decision on added benefit by the Federal Joint Committee (G-BA), the highest decision-making body in the German healthcare system.