Drug assessment: department tasks

The department’s main task is to assess the benefits and harms of drugs approved in Germany. For this purpose, drugs are compared with other drugs and with non-drug interventions. The aim of these comparisons is to determine which treatment option has which advantages and disadvantages for patients.

Staff members produce

Early benefit assessments (dossier assessments)

Early benefit assessments are based on dossiers submitted by pharmaceutical companies to the Federal Joint Committee (G-BA). The results are published as dossier assessments. These early assessments follow the provisions of the Act on the Reform of the Market for Medicinal Products (AMNOG), which became effective in 2011.

Benefit assessments (reports, rapid reports)

These assessments are based on IQWiG‘s own systematic searches for published and unpublished studies. The results are published as reports or rapid reports.

Reports on routine practice data collection (RPDC)

In the case of drugs for rare diseases (orphan drugs) and drugs with special marketing authorization, the G-BA can request the responsible pharmaceutical company to collect and analyse routine practice data. This serves to improve the evidence base for the assessment of the added benefit of a drug. For this purpose, IQWiG is commissioned by the G-BA to develop a concept for an RPDC. If the G-BA requests an RPDC on the basis of IQWIG’s concept, the pharmaceutical company must prepare study documents (study protocol and statistical analysis plan) for the RPDC. These are reviewed by IQWiG, as are interim analyses during the RPDC.

European Health Technology Assessments (EU-HTAs)

From January 2025, EU-HTAs (Joint Clinical Assessments, JCAs) for certain drugs will be carried out in a coordinated way across Europe. Based on European legislation and common methods, IQWiG will work together with other European HTA agencies to prepare JCAs.

Other tasks include

• further development of methods for assessing the benefits and harms of drugs,
• collaboration in international working groups (e.g. in the SISAQoL project or with regulatory authorities [EMA and FDA] and other HTA agencies), and
• dissemination of assessment methods and results, as well as other new scientific knowledge arising from the department's work, through presentations and publications.