Early benefit assessment of drugs: effects on health care in Germany

Established in 2011, the early benefit assessment of drugs according to the Act on the Reform of the Market for Medicinal Products (AMNOG) has meant a paradigm shift for drug supply, because since then manufacturers have to prove the added benefit, i.e. the added value of their new drugs with scientific evidence. Since then, the transparency of the procedure and the assessment results have had a deep impact on the entire health care system in Germany.

The early benefit assessment thus not only achieved its declared main goal, namely to produce sound evidence for price negotiations between representatives of the statutory health insurance (Gesetzliche Krankenversicherung, GKV) on the one hand and the pharmaceutical company on the other. Since then, the procedure has also provided reliable and freely accessible information for health decisions - both at the individual and the epidemiological level.

Thus, the early benefit assessment has had an impact not only on decisions about reimbursement by the statutory health insurance funds, but also on health care itself in the form of medical guidelines, or, with the help of information prepared for the respective target groups, on decision-making in doctor-patient discussions. In their current article in the journal Medical Writing, Michael Köhler and Annette Christoph, both involved in dossier assessments for the early benefit assessment as research associates in IQWiG’s Drug Assessment Department, describe the procedure and its contents in compact form - starting with the standardized manufacturer dossiers and the subsequent dossier assessments by IQWiG up to the resolution at the Federal Joint Committee (G-BA). A case study provides insight into the assessment practice and the result of a benefit assessment by IQWiG.