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Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions?
Author(s) -
Lipska I,
Hoekman J,
McAuslane N,
Leufkens HGM,
Hövels AM
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.198
Subject(s) - marketing authorization , authorization , health technology , drug approval , prior authorization , business , lead (geology) , actuarial science , risk analysis (engineering) , medicine , pharmacology , political science , computer science , health care , computer security , drug , bioinformatics , geomorphology , law , biology , geology
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.