Objectives: Considering still unsolved concerns by some of the German HTA stakeholders towards a EU-HTA in terms of methodology, transparency, comprehensiveness and the obligatory adoption of the assessment on a national level, detailed analyses comparing the status quo of both the EUnetHTA and the national evidence assessment are needed. These analyses would allow judgement on the potential uptake of EUnetHTA assessments and their implications in Germany.

Methods: By means of searches in the databases of EUnetHTA and the Federal Joint Committee (G-BA), all drugs with published dossiers and assessment reports by both EUnetHTA and G-BA were identified and examined with regard to defined structural and content-related comparison criteria.

Results: Until end of June 2020, three procedures have been identified, i.e. polatuzumab vedotin, siponimod and brolucizumab.All assessments have been carried out in a methodically adequate and transparent manner from a German perspective, irrespective of the assigned assessment team. However, the EUnetHTA assigned multiple comparators and direct or indirect evidence was expected to be provided for all of them. In comparison, the G-BA mostly assigned only one comparator. This comparator was also covered by EUnetHTA, but data requirements in Germany were far more extensive in terms of in-depth analyses of safety aspects and subgroups. Interestingly, not all evidence presented in the EU dossier was included in the German dossier, although potentially relevant.

Conclusions: Concerns regarding lack of transparency and methodical standards in EUnetHTA assessments compared to assessments by the German HTA stakeholders seem unwarranted. However, manufacturers not always exhaust potential for synergies. The reason is unclear, but might be justified by the overlapping timelines. Hence, further alignment on the requirements of data presentation and timeline is needed to unleash the full potential of synergies for both the manufacturers during dossier preparation and the national uptake by HTA bodies.