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[HTA-Perspective: Challenges in the early assessment of new oncological drugs]

Authors :
Claudia, Wild
Anna, Nachtnebel
Source :
Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen. 107(2)
Publication Year :
2013

Abstract

Oncologic drug therapies have gained wide attention in the context of health policy priority setting for serious and socially significant diseases with high human and monetary costs. Due to uncertainties and scepticism about the actual therapeutic importance of newly approved oncology products, an early assessment programme was already established in Austria in 2007. The assessment of new oncology products is thereby faced with special challenges, since study populations are frequently not representative or the study design is laid out in such a manner that a definitive assessment of patient-relevant endpoints is not possible (cross-overs after interim assessments, surrogate parameters as primary endpoints, uncontrolled studies or those with unrealistic comparators, invalidated post-hoc identified biomarkers). On account of these major uncertainties, even the European Medicines Agency (EMA) is already contemplating multi-stage, "adaptive" approvals, and national reimbursement institutions are increasingly working with outcome-oriented, conditional reimbursement. (As supplied by publisher).

Details

Language :
German
ISSN :
22120289
Volume :
107
Issue :
2
Database :
OpenAIRE
Journal :
Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen
Accession number :
edsair.pmid..........ca93ba2ce2969094e5316838592e9362