OBJECTIVES: In Germany, the G-BA decides on the added benefit of pharmaceuticals. This rating is the most important factor for the subsequent price negotiations. The G-BA’s rules of procedure (chapter 5 sect. 14 VerfO) allow manufacturers to request a re-assessment based on “new scientific evidence”, which – if accepted – would consequently lead to a re-negotiation as well. This precedence analysis aims at identifying the evidence level required for a re-assessment in general, for an improved benefit rating and ultimately the impact regarding the negotiations with the GKV-SV.

METHODS: Using a comprehensive database, all benefit re-assessments according to ch. 5 sect. 14 VerfO and their respective previous assessment(s) were analyzed regarding the respective methodology, G-BA rating(s) and rationale(s) as well as the impact on the reimbursed costs of the drug. The used database is based on publicly available data, combining all dossier assessments in Germany and IQWiG/G-BA rulings with GKV-SV price negotiation outcomes (LAUER-TAXE®).

RESULTS: Within 17 re-assessments until May 2022, in 11 cases data from new RCTs were submitted. A higher benefit was granted for 5/17 drugs. Out of these 5, 4 were based on new RCTs, while one was based on a more recent study data cut. In 5 procedures, the manufacturers succeeded in reducing the previously negotiated rebates, although in 1/5 the benefit rating was not improved. In the remaining 12 procedures, compared to their first assessment, the rebate increased.

CONCLUSIONS: A re-assessment due to new scientific evidence gives the opportunity to achieve a lower rebate if the submitted evidence is of high quality and/or specifically addresses the G-BA’s initial criticism. However, since in several reassessments the negotiated rebate increased, an upfront anticipation of the outcome of the G-BA and GKV-SV interactions is essential to prevent effort and waste in resources or, in the worst case, a higher rebate.