Patient relevant endpoints in oncology: current issues in the context of early benefit assessment in Germany.

ABSTRACT:

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The German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the Federal Joint Committee (G-BA). Current EBA decisions released have unveiled issues regarding the acceptance of some patient-relevant endpoints as G-BA and IQWiG are grading the endpoints, focusing on overall survival as the preferred endpoint in oncology.A taskforce of experienced German outcomes research, medical, health-technology assessment and biostatistics researchers in industry was appointed. After agreement on core assumptions, a draft position was prepared. Input on iterati

SUBMITTER: Dabisch I 

PROVIDER: S-EPMC3901346 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature