The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added benefit” to “less benefit than the appropriate comparator,” and impact price negotiations beyond the first year on the market. Using data on drugs that entered the market from 2012 to 2016, we evaluated benefit assessment findings, subsequent drug exits, and their correlates. We considered 171 drug-indication pairs, corresponding to 138 different drugs. Of these, 66 drug-indication pairs (55 different drugs) were found to have any additional benefit. Almost all drugs with any positive benefit assessment (98%) remained on the market, while drugs without a positive benefit assessment were over ten times more likely to exit (25% vs. 2%). U.S. policymakers considering how to address rapidly increasing drug costs may draw valuable lessons from the German experience.
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Vincent Dessain, a Belgian national, is the Executive Director of the Europe Research Center (ERC). Vincent has extensive management and business education experience. He is a co-author of two books in finance, a book chapter on intercultural management and a co-author of a wide variety of articles in academic journals, case studies and course development notes (cases can be found on https://cb.hbsp.harvard.edu/ or here). He is a frequent guest speaker invited by academia, business and government to speak on topics in management and education.
Prior to his appointment at the Europe Research Center, he was Senior Director of Corporate Relationships at INSEAD in Fontainebleau and elected as the representative of the INSEAD administration on the School’s Board of Directors. Earlier in his career, Vincent has been active as a management consultant with Booz-Allen & Hamilton in New York and Paris. His field of consulting was international market entry strategies, financial products, strategy, negotiation and implementation of cross border alliances, financial restructuring, mergers and acquisitions. He has also been active as a Foreign Associate with the law firm Shearman & Sterling in New York in Banking and Finance and as an Advisor to the President of the College of Europe in Bruges, Belgium.
Vincent speaks five European languages (French, English, German, Dutch and Italian). He holds a law degree from Leuven University (Belgium), a Business Administration degree from Louvain University (Belgium), an MBA from Harvard Business School (Boston, USA), and a PhD in management and communication from Université Paris VIII, France, on corporate social responsibility.