Four years have passed since the introduction of the German Act on the Reform of the Market for Medicinal Products (AMNOG). AMNOG was primarily aimed at containing the increasing drug expenditure of the statutory health insurance funds. However, the early benefit assessment of new drugs as stipulated by AMNOG also reveals so far unpublished information from clinical study reports. Researchers from the German Institute for Quality and Efficiency in Health Care (IQWiG) have further examined this issue in an article published in the British Medical Journal. 

Their conclusion: Company dossiers and dossier assessments performed by IQWiG, which are published during the early benefit assessment of new drugs, contain considerably more information than other publicly available documents on clinical studies – especially with regard to patient-relevant outcomes in approved subpopulations. The early benefit assessment of drugs may also be suitable as a model for more transparency in other countries or in other areas, such as the assessment of the benefit of non-drug interventions.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/early-benefit-assessment-increases-transparency-for-study-data.6611.html