How do you submit an HTA dossier that carries the added benefit through G-BA, IQWiG, NICE or HAS?

An HTA dossier is not measured by its data quality but by its fit with the prescribed comparator therapy. In the AMNOG procedure under SGB V §35a, the G-BA sets the appropriate comparator therapy, and the added benefit must be demonstrated precisely against that regimen. This entails a strict sequence: first the likely zVT is established, then the choice of patient-relevant endpoints per the IQWiG methods paper, then the study design, and only after that the dossier. Reverse this chain and lock the study design first, and you may end up building the evidence against the wrong comparator. That is the most expensive mistake in the procedure, because it can no longer be corrected during the writing phase.

The second bottleneck lies in translating between the different assessment worlds. A NICE submission centers on cost-effectiveness, AMNOG on the extent and probability of added benefit per patient group, and under Regulation (EU) 2021/2282 the Joint Clinical Assessment consolidates the PICO questions across several Member States. For high-risk-class medical devices in the inpatient setting, AMNOG does not apply in any case; instead, SGB V §137h applies with its own logic. We build the evidence synthesis so that it supports the broadest comparison requirement, and adapt only the argumentation per body rather than starting over for each procedure. Ahead of submission, the mock review reveals where a reviewer will call the added benefit into question, while the answer still belongs in the dossier and not only in the oral hearing.