期刊名称：Farmeconomia. Health economics and therapeutic pathways
印刷版ISSN：2240-256X
出版年度：2015
卷号：16
期号：4
页码：103-110
DOI：10.7175/fe.v16i4.1207
语种：English
出版社：SEEd
摘要：In order to reach the European market, a new drug needs to receive a positive evaluation regarding its quality, safety and efficacy by regulatory health authorities and also obtain a positive HTA appraisal regarding its cost-effectiveness by HTA bodies. Regulators and HTA bodies are collaborating in several projects at European level in order to harmonize the scientific requirements of both evaluations to the maximum extent possible. The comparison of the regulatory evaluation performed by EMA for Kalydeco and the HTA appraisals issued by several EU bodies exemplifies the dilemma between scientific evidence and local economic considerations and the difficulties in the achievement of harmonization and therefore equity in the access to drugs.
其他摘要：In order to reach the European market, a new drug needs to receive a positive evaluation regarding its quality, safety and efficacy by regulatory health authorities and also obtain a positive HTA appraisal regarding its cost-effectiveness by HTA bodies. Regulators and HTA bodies are collaborating in several projects at European level in order to harmonize the scientific requirements of both evaluations to the maximum extent possible. The comparison of the regulatory evaluation performed by EMA for Kalydeco and the HTA appraisals issued by several EU bodies exemplifies the dilemma between scientific evidence and local economic considerations and the difficulties in the achievement of harmonization and therefore equity in the access to drugs.
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