IQWiG Annual Report 2016: amount of Addenda in AMNOG processes continues to increase – impact on the benefit assessment not always favorable

Wed, 2017 / 07 / 19

This year’s publication of the Annual Report of the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IQWiQ) confirms that the rapid increase in additional assessments throughout an early benefit assessment, the so-called Addenda, continuous. The IQWiG can be commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) with the preparation of an Addendum if the hearing procedure shows the need for a complementary consultation after the completion of the AMNOG Dossier assessment. This can be due to the submission of further data or information by the pharmaceutical manufacturer or due to the emergence of new questions. In general, the IQWiG takes about two to three weeks to process and close these additional cases.

While only one Addendum out of a total of 25 assessments was prepared in 2012, the Dossier-Addendum-ratio rose to one third in 2013, and exceeded to more than 50% in 2016, with 28 addenda to 50 assessments, not considering orphan drug Dossiers. Taking all additional assessments into account performed since 2012, the IQWiG altered its initial evaluation of the additional benefit in almost one-fourth of all cases. Given that the Institute acknowledged a significant change in the evidential situation in comparison to the Dossier evaluation, the Addendum normally led to an appreciation of the initial recommendation for the additional benefit. In three cases however, the IQWiG downgraded the extent of the additional benefit due to the additional analysis; in two cases, this being Regorafenib and Sacubitril/ Valsartan, the G-BA followed the Institute’s recommendation and legally imposed the downgraded additional benefit in the AMNOG resolution.

Although the high heterogenous nature of the commissioning circumstances of an additional IQWiG assessment doesn’t allow to draw universal valid conclusions about the reasons for the significant increase of Addenda, one however can reason that a relevant aspect is the increasing role of preliminary data in the approval process and the relevance of specific subgroup analyses in the early benefit assessment. Hence, its crucial to point out that the submission of the AMNOG Dossier doesn’t necessarily mean that the pharmaceutical manufacturer have fully exploited their chance to influence the assessment – in a positive as well as negative way. This underlines the necessity of a meticulous preparation of the assessment procedure and especially a diligent compilation of supplementary documents in line with the overall strategic positioning in the AMNOG-process, in order to maximize the chances of a favorable early benefit assessment process.

Please click here to download the IGWiQ Annual Report 2016 in German.