| Literature DB >> 26250656 |
I Lipska1, J Hoekman2, N McAuslane1, H G M Leufkens2, A M Hövels2.
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.Mesh:
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Year: 2015 PMID: 26250656 DOI: 10.1002/cpt.198
Source DB: PubMed Journal: Clin Pharmacol Ther ISSN: 0009-9236 Impact factor: 6.875