Zusatznutzens

Zusatznutzens denotes the additional therapeutic value a new medicinal product provides compared with the standard therapy for a defined patient group. It covers improvements in efficacy, safety, and patient-relevant outcomes beyond what is already available.

In Germany, the concept is central to the AMNOG framework established in 2011. After a drug is authorized, its Zusatznutzens is assessed by IQWiG (Institute for Quality and Efficiency in Health Care). The result informs the G-BA's decisions on reimbursement and price negotiations with statutory health insurers.

Assessment is based on comparative clinical trials and, where applicable, real-world data. Endpoints may include overall survival, symptom relief, quality of life, functional status, and reductions in adverse effects. The added benefit is typically classified into levels such as no added benefit, minor, moderate, or substantial, with criteria defined by policy.

Impact and limitations: A positive Zusatznutzens can support higher reimbursement or faster access, while absence of an added benefit can constrain pricing. The process depends on the quality and relevance of evidence and may be revised as new data emerge.

Critics point to complexity, variability in assessments, and delays. The concept remains a key instrument in evaluating the value of new medicines and shaping access and pricing within the German statutory health-care system.