Orphan Drugs in the German Early Benefit Assessment– Real World Versus G-Ba Bureaucracy
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چکیده
منابع مشابه
Orphan drugs assessment in the centralised procedure.
On the basis of the author's experience as member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and in order to facilitate the access of new orphan drugs to the patients, some suggestions were given. Among these the following should be taken into account by the regulatory bodies: 1) conditional approval or approval under exceptional circumst...
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15 صفحه اولG-Ba Does not Adjust Evidence Requirements in Early Benefit Assessment in Cases of Pre-Defined, Efficacy-Based Cross-Over Decisions in Oncology Trials.
BACKGROUND In Germany, a comparative effectiveness assessment in the form of an early benefit assessment (EBA) is mandatory for new medicines.1–3 The G-BA (Federal Joint Committee) is charged with evaluating a medicine’s additional benefit.1,4 Besides the extent of additional benefit versus an appropriate comparator, the quality of the evidence base, i.e. the evidence level, is evaluated in the...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2013
ISSN: 1098-3015
DOI: 10.1016/j.jval.2013.08.941