Details
| Original language | English |
|---|---|
| Pages (from-to) | 1182-1187 |
| Number of pages | 6 |
| Journal | Health affairs |
| Volume | 38 |
| Issue number | 7 |
| Publication status | Published - Jul 2019 |
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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In: Health affairs, Vol. 38, No. 7, 07.2019, p. 1182-1187.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - The impact of price regulation on the availability of new drugs in germany
AU - Stern, Ariel D.
AU - Pietrulla, Felicitas
AU - Herr, Annika
AU - Kesselheim, Aaron S.
AU - Sarpatwari, Ameet
N1 - Funding Information: Ariel Stern is supported by the Kauffman Junior Faculty Fellowship. Aaron Kesselheim and Ameet Sarpatwari are supported by Arnold Ventures. Kesselheim also receives support from the Harvard-MIT Center for Regulatory Science and the Engelberg Foundation. The authors are grateful to Lila Kelso, Melissa Ouellet, and Mats Terwiesch for excellent research assistance and to Victoria Lauenroth for helpful comments.
PY - 2019/7
Y1 - 2019/7
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85069267253&partnerID=8YFLogxK
U2 - 10.1377/hlthaff.2018.05142
DO - 10.1377/hlthaff.2018.05142
M3 - Article
C2 - 31260362
AN - SCOPUS:85069267253
VL - 38
SP - 1182
EP - 1187
JO - Health affairs
JF - Health affairs
SN - 0278-2715
IS - 7
ER -