European health technology assessment

In Germany, the early benefit assessment of drugs has been in place since 2011, covering almost all new drugs and therapeutic indications. It serves as a basis for price negotiations and creates transparency regarding the evidence. It has been accepted by all stakeholders for years.

However, there are differences between European countries in the way drugs are assessed for reimbursement decisions after approval. For example, differences exist in the scope of the assessment, the comparator, or the decision horizon. These differences are due to variations in healthcare systems, funding, and the legal basis of individual countries.

To promote the quality and efficiency of health technology assessment (HTA) within EU member states, Regulation (EU) 2021/2282 established a legal framework for collaborative HTA. This regulation establishes the basis for European cooperation in HTA. The topics of this cooperation are:

• Joint clinical assessments (JCAs) of drugs and medical devices (Class IIb, III) / in vitro diagnostics (Class D)
• Joint scientific consultations (JSCs)
• Identification of emerging health technologies (EHTs)
• Voluntary cooperation (e.g., for the assessment of non-clinical aspects such as cost assessment)

The now formalized European HTA cooperation evolved from previously voluntary structures. Between 2006 and 2021, the first joint scientific standards were developed, albeit without legally binding force. The Institute for Quality and Efficiency in Health Care (IQWiG), the German HTA agency, played an active role in this initial phase of cooperation.

Europe-wide HTA (EU-HTA) has been introduced in stages since the beginning of 2025: In January 2025, assessments of oncology drugs and advanced therapy medicinal products (ATMPs) were started. Orphan drugs will be added in 2028, and from 2030 onwards, all newly approved drugs will undergo joint assessment at a European level. From 2026 onwards, selected high-risk medical devices will also undergo such an assessment.

The HTA Coordination Group (HTACG) of the member states is the decision-making body for the EU procedure. The content work is carried out in the subgroups. The European Commission (DG SANTE) acts as the secretariat for the procedure.

JCAs form the core of European HTA activity. The assessment of a new drug compared with the current standard of care is carried out within the framework of predefined research questions. These questions are referred to as “PICOs” or “assessment scope”.

“PICO” stands for “population”, “intervention”, “comparator” (i.e. comparator therapies) 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 definition of these questions depends on factors such as the legal context, relevant healthcare practices and the availability of comparator therapies. For instance, a drug that is eligible as a comparator in Germany may not be reimbursed in another country, meaning it cannot be included in a PICO. Consequently, several PICOs may be identified in a European assessment.

Two HTA agencies from two European countries always collaborate on a JCA, with one acting as assessor and the other as co-assessor. This collaboration includes finalizing the assessment scope and assessing the supporting evidence. As an experienced HTA agency, IQWiG already works as an assessor or co-assessor on JCAs.

The JCAs are intended to inform and underpin national decision-making processes, but not to replace them. They describe only the available evidence, i.e., the relative effects and their degree of certainty. The assessment of the added benefit of new drugs continues to be carried out at the national level. If a European dossier is available, the pharmaceutical company can refer to it in the German procedure without having to resubmit the documents. However, member states may request and carry out additional clinical analyses for the national HTA process.

In Germany, this means that, following the JCA, an assessment is still carried out as part of the AMNOG procedure, which is based on the Act on the Reform of the Market for Medicinal Products. This includes a decision on added benefit by the Federal Joint Committee (G-BA), the highest decision-making body in the German healthcare system. This is because amendments to the legal basis in the German Pharmaceutical Benefit Assessment Ordinance clarified that the core elements of the national procedure — transparency, opportunity to comment, adherence to deadlines, appropriate comparator therapy and assessment criteria — remain unchanged.

The gradual introduction of JCAs at the European level will result in JCAs coexisting with subsequent national and purely national assessments in Germany. Additionally, all drugs that have already undergone national assessment and for which a new therapeutic indication is approved will continue to be assessed exclusively at the national level. This coexistence is expected to last for 15 years. To ensure fairness, it is crucial that the assessment criteria are consistent in both cases.