OBJECTIVES: Since 2011, new pharmacological therapies in Germany are subject to an early benefit assessment (EBA) upon launch. The Institute for Quality and Efficiency in Health Care (IQWiG) usually conducts an initial assessment, followed by the Federal Joint Committee (G-BA) issuing a final verdict. If the G-BA deem a new therapy offers no additional benefit over relevant comparators, it is not granted premium-pricing, being subject to reference pricing. This research compares G-BA and IQWiG assessment outcomes.

METHODS: All EBA resolutions were extracted from the G-BA website alongside corresponding IQWiG assessments (01/01/2012-12/31/2016) and key information compared. For extracted outcome data, the focus was the subgroup of greatest additional benefit.

RESULTS: Of 155 identified EBAs with both G-BA and IQWiG assessment outcomes published, 63% (98/155) did not differ in their additional benefit. The G-BA concluded on an additional benefit where IQWiG deemed none in 12% (19/155) of cases. Conversely, IQWiG deemed an additional benefit where the G-BA concluded on none in 5% (6/155) of cases. G-BA and IQWiG both agreed that additional benefit was offered but differed in its extent in 19% (29/155; 19 cases: G-BA’s rating was lower, 10 cases: G-BA’s was higher). In the three cases where IQWiG’s verdict was ‘lesser benefit’, the G-BA ultimately concluded no additional benefit was proven. As for the level of certainty with which additional benefit was demonstrated, in 83% (52/63) the G-BA’s verdict matched IQWiG’s assessment; in 5% (3/63) of cases, the G-BA’s certainty rating was higher, in 13% (8/63) it was lower.

CONCLUSIONS: The G-BA has frequently deviated from IQWiG’s initial assessment, with potential significant pricing consequences. Thus, companies should fully engage with the EBA consultation process post-IQWiG appraisal. As many countries use external reference pricing for price-setting and Germany is one of the most frequently referenced countries, this has global revenue implications.