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Health Aff (Millwood). 2019 Jul;38(7):1182-1187. doi: 10.1377/hlthaff.2018.05142.

The Impact Of Price Regulation On The Availability Of New Drugs In Germany.

Author information

1
Ariel D. Stern ( astern@hbs.edu ) is an associate professor of business administration and a Hellman Faculty Fellow in the Department of Technology and Operations Management, Harvard Business School, in Boston, Massachusetts.
2
Felicitas Pietrulla is a student in the Harvard Program in Therapeutic Science, Harvard Medical School, in Boston.
3
Annika Herr is a professor in the Institute of Health Economics, Leibniz University Hannover, in Germany, and a research affiliate in the Department of Economics, Heinrich Heine University Düsseldorf, in Germany.
4
Aaron S. Kesselheim is a professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, both in Boston.
5
Ameet Sarpatwari is an instructor in medicine at Harvard Medical School and assistant director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School.

Abstract

The 2011 German Pharmaceutical Market Restructuring Act subjected brand-name drugs for nonrare diseases to price regulation based on an assessment of their clinical benefit. Indication-specific assessment outcomes range from major added benefit to less benefit than the appropriate comparator(s) and affect price negotiations beyond the first year on the market. Using data on drugs that entered the market in the period 2012-16, 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 added benefit. Almost all drugs with a positive benefit assessment (98 percent) remained on the market, while drugs without a positive benefit assessment were over ten times more likely to exit (25 percent versus 2 percent). US policy makers considering how to address rapidly increasing drug costs may draw valuable lessons from the German experience.

KEYWORDS:

COMPARATIVE EFFECTIVENESS; Germany; Pharmaceuticals; benefit assessment; price regulation

PMID:
31260362
DOI:
10.1377/hlthaff.2018.05142

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