Does Conditional Approval for New Oncology Drugs in Europe Lead to Differences in Health Technology Assessment Decisions?
Does Conditional Approval for New Oncology Drugs in Europe Lead to Differences in Health Technology Assessment Decisions?
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DOI：
10.1002/cpt.198
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发表时间：
2015-11-01
影响因子：
6.7
通讯作者：
Hoevels, A. M.
中科院分区：
文献类型：
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作者：
Lipska, I.;Hoekman, J.;Hoevels, A. M.
在欧洲监管框架内，有条件批准潜在有益药物的抢先体验途径是可用的。然而，上市许可并不一定会导致卫生技术评估（HTA）机构建议公共资金。由于有条件批准沿着的是关于高医疗需求的治疗选择的益处和风险的不完整数据，这就提出了一个问题，即HTA决策如何受到这些不确定性的影响。
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.