The Influence of the Claimed Benefit

The benefit claimed in the dossier for the German AMNOG assessment was not confirmed by the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) in 68% of the procedures. The aim of this analysis was to investigate if the downgrade of the benefit was associated with a higher rebate negotiated with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband, GKV-SV).

We performed a database analysis encompassing all G-BA procedures with a claimed added benefit and a negotiated rebate until 05/2022. To enable a comparability of these procedures, we selected for those whose benefit claim is identical for all subpopulations and for all subpopulations in the G-BA decision. We then compared the negotiated rebate on net annual therapy costs (ATC) of products with a downgrade or confirmation of the claimed benefit during the AMNOG process. The results refer to the effect of achieving the claimed additional benefit alone without including other success factors of the price negotiations.

From a total of 381 analyzed AMNOG procedures, only two received an upgrade of the added benefit in all subpopulations, whereas 75 cases reached the claimed added benefit (average rebate on negotiated ATC net 10.19%) and 304 procedures were downgraded by the G-BA (average rebate on negotiated ATC net 17.87%). The negotiated rebate in each benefit-category of procedures with downgrading was slightly higher compared to procedures in which the claimed benefit was confirmed, independent of the dimension of the downgrade. As an exception, the rebates of procedures downgraded to a "non-quantifiable" added benefit are within the same range.

A downgrade of the claimed benefit was associated with a higher rebate on the ATC. As a conclusion, receiving a confirmation of the claimed added benefit by the G-BA likely contributes to a successful price negotiation and therefore it is of importance to set a suitable benefit claim in the dossier.