CareLit Fachartikel
Multi-dimensional capture of patient-relevant endpoints in regulatory trials and health technology assessments in oncology two years after introduction of the German AMNOG health…
Dintsios, C.; Knoerzer, D.; Dünne, A.; Schwartz, F.; Ruof, J. · Das Gesundheitswesen · 2013 · Heft 8/09 · S. 1 bis 1
Dokument
335689
CareLit-ID
Jahr
2013
Publikation
PDF
nein
Metadaten
DOI
ja
zitierfähig
Bibliografische Angaben
Zusammenfassung
Objectives: With the introduction of AMNOG in January 2011, an early benefit assessment (EBA) was required for new medicines in Germany. EBAs are based on the additional therapeutic benefit of a drug on patient-relevant endpoints (PREs). We compared the acceptance of PREs for oncology in regulatory trials, and in EBAs conducted by German health technology assessment (HTA) bodies. Methods: EBAs on oncology drugs and the respective regulatory trials were reviewed. The Federal Joint Committee (G-BA) website was used to obtain manufacturers‘ value dossiers, Institute for Quality and Efficiency in Health Care (IQWiG)…
Schlagworte
Gesundheit
Pflege
Germany
Deutschland
After
Onkologie
Das Gesundheitswesen
