Does Conditional Approval for New Oncology Drugs in Europe Lead to Differences in Health Technology Assessment Decisions?

被引：30
|
作者：
Lipska, I. [1 ]
Hoekman, J. [2 ]
McAuslane, N. [1 ]
Leufkens, H. G. M. [2 ]
Hoevels, A. M. [2 ]
机构：
[1] Ctr Innovat Regulatory Sci, Warsaw, Poland
[2] Univ Utrecht, Div Pharmacoepidemiol & Clin Pharmacol, Utrecht, Netherlands
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS | 2015年 / 98卷 / 05期
关键词：
D O I：
10.1002/cpt.198
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
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.
引用
收藏
页码：489 / 491
页数：3
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