VP40 Increasing Divergence Of IQWiG & G-BA Benefit Assessments Over Time?

Abstract

IntroductionSince 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 resolution. If the G-BA deem a new therapy offers no additional benefit over relevant comparators, it cannot attain premium-pricing through price negotiations. This research compares G-BA and IQWiG assessment outcomes over time.MethodsAll EBA resolutions were extracted from the G-BA website alongside corresponding IQWiG assessments (01/01/2011-19/09/2018) and key information compared. For extracted outcome data, the focus was the subgroup of greatest additional benefit.ResultsOf 261 identified EBAs with both G-BA and IQWiG assessment outcomes published, 59% (155/261) did not differ in their additional benefit. The G-BA concluded on an additional benefit where IQWiG deemed none in 13% (34/261) of cases, which was consistent pre-2015: 13% (11/87) and 2015-onwards: 13% (23/174). Conversely, IQWiG deemed an additional benefit where the G-BA concluded on none in 3% (8/261) of cases, none of which were pre-2015 (0/87) vs. 5% (8/261) for 2015-onwards. G-BA and IQWiG both agreed that additional benefit was offered but differed in its extent in 14% (37/261; in 23 cases: G-BA's rating was lower, 14 cases: G-BA's was higher) with 19% (17/87) pre-2015 vs. 8% (14/174) 2015-onwards.ConclusionsThe G-BA has deviated from IQWiG's initial assessment in around one-third of resolutions, with potential significant rebate negotiation consequences. The divergence in extent of additional benefit (where both agree on additional benefit) appears to be becoming less common over time. However, a slight converse time-trend appears regarding divergence on whether any additional benefit is offered, driven by increased incidence of G-BA deeming no additional benefit contrary to IQWiG. This emphasizes that companies should fully engage with the EBA consultation process post-IQWiG appraisal.