AMNOG – German Regulation in the Past, Present and Future

Introduction of the Pharmaceutical Market Restructuring Act (AMNOG) in 2011 and the resulting requirements for benefit assessment have fundamentally changed the conditions of market access and pharmaceutical pricing in Germany. The aim of this mandatory evaluation of clinical evidence was to limit the cost of pharmaceuticals and tackle the price monopoly of drug manufacturers in Germany.

While this has successfully been achieved, it has also brought with it further implications beyond the immediate German market, particularly for those countries that use Germany as a price reference. The open nature in which the clinical evidence and especially the critical aspects in these assessments is shared publically has potential impact on a product’s value story with payers in many other jurisdictions. As an organization working in this market or utilizing German price points for your market access strategy, it’s critical to understand these interconnections.

Join the presenter for insight on the current German requirements, recent trends in price negotiations, and future direction for the AMNOG assessment.

Key take aways of this program include:

• Understanding of current AMNOG process
• Implications of AMNOG evaluation
• Impact of publically available assessment on value story
• Overview of price discount trends, both average and unique examples
• Future growth beyond current AMNOG framework

Speaker

Dr. Thomas Mittendorf, MBA, PhD, Vice President and Managing Director, Herescon GmbH, an AmerisourceBergen company

Thomas Mittendorf is a health economist as well as Managing Director and co-founder of Herescon GmbH, a research and consulting firm specializing in market access research, health economic evaluation studies, outcomes research, and health technology assessment. He currently focuses on health policy and regulatory issues along with health economic research in different diseases and technologies, including vaccination, oncology, immunology and infectious diseases. His specific focus on inflammatory diseases has led to a substantial number of publications in that area with a track record of over 120 publications in all fields of health related research. Dr. Mittendorf is a former Editor-in-Chief of ISPOR CONNECTIONS, a member of multiple editorial boards, and a regular reviewer for many journals. He is a former Assistant (and later Adjunct) Professor teaching health economics and health system research at the Center for Health Economics at the Leibniz University of Hannover, Germany.

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