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

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ID: 67255
2019
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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.
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stern2019thehealth Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Stern, Ariel D;Pietrulla, Felicitas;Herr, Annika;Kesselheim, Aaron S;Sarpatwari, Ameet;
Journal Health affairs (Project Hope)
Year 2019
DOI
10.1377/hlthaff.2018.05142
URL
Keywords
pharmaceuticals germany comparative effectiveness benefit assessment price regulation

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