[Involvement of scientific societies in early benefit assessment: Simulated participation or valuable additional...

The German framework of early benefit assessment (EBA) of drugs also provides for the participation of scientific medical societies. The aim of their inclusion is to assure that care providers can critically assess all aspects of the EBA and provide insights into relevant aspects regarding the provision of care. This study systematically reviews the frequency of participation of the scientific medical societies (FGs) and the Drug Commission of the German Medical Association (AkdÄ) within the scope of the EBA. In addition, the positioning of AkdÄ/FG is compared to the Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Joint Committee (G-BA) with a focus on antidiabetic drugs and cancer drugs.

A literature analysis was performed based on the comprehensive documentation of benefit assessments published by G-BA. All proceedings of antidiabetic drugs and cancer drugs were included, for which a decision was published by August 6, 2015. In addition, statements of FGs or AkdÄ were identified by an exploratory literature review and included in the analysis. The statements considered were assessed with regard to three categories: (1) additional benefit, (2) appropriate comparator (ZVT) and (3) suitability of the endpoints. For each procedure and category, it was assessed whether there was agreement or disagreement between IGWiG/G-BA and AkdÄ/FGs statements. Regarding the additional benefit, a deviating position was further differentiated according to the level of additional benefit (higher/lower). Afterwards, the proportion of favorable and unfavorable positions was calculated, stratified by FGs and AkdÄ and, separately, for proceedings of antidiabetics and cancer drugs.

The literature review revealed 41 proceedings of cancer drugs and 21 proceedings of antidiabetic drugs which were included in the analyses. Statements by AkdÄ/FGs were identified in 90 % of the proceedings for antidiabetic drugs and in 98 % of the proceedings for cancer drugs. In general, the AkdÄ was more often in agreement with the IQWiG than with the FGs' positions. In addition, a different position was more frequent in the proceedings concerning antidiabetic drugs than in the proceedings concerning cancer drugs. Furthermore, the G-BA decision was more frequently in line with the AkdÄ position than with the FGs' position, and this applies to both indications.

There was a high willingness to participate in the commenting procedure of the EBA. At the same time, the analyses revealed partially heterogeneous positions, both between FGs/AkdÄ and IQWiG/G-BA, as well as between FGs and AkdÄ. The results thus emphasize the need for such discussions within the framework of the EBA.