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Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions?

Authors :
Lipska, I
Hoekman, J
McAuslane, N
Leufkens, Hgm
Hövels, A M
Innovation and Sustainability
Sub Pharmacoepidemiology
Sub Pharmacotherapy, Theoretical
Innovation Studies
Pharmacoepidemiology and Clinical Pharmacology
Innovation and Sustainability
Sub Pharmacoepidemiology
Sub Pharmacotherapy, Theoretical
Innovation Studies
Pharmacoepidemiology and Clinical Pharmacology
Source :
Clinical Pharmacology and Therapeutics, 98(5), 489. Nature Publishing Group
Publication Year :
2015
Publisher :
Wiley, 2015.

Abstract

An early access pathway of conditional approval for potentially beneficial medicines is available within the European regulatory framework. However, marketing authorization does not necessarily result in recommendations for public funding by health technology assessment (HTA) agencies. As conditional approval goes along with less than complete data on benefits and risks of a treatment option for a high medical need, this raises the question how HTA decision-making is affected by these uncertainties.

Details

ISSN :
00099236
Volume :
98
Database :
OpenAIRE
Journal :
Clinical Pharmacology & Therapeutics
Accession number :
edsair.doi.dedup.....bd62ee5e92330ca9578db4df28f6b913
Full Text :
https://doi.org/10.1002/cpt.198