OBJECTIVES

: New pharmacological therapies in Germany are subject to an early benefit assessment (EBA) upon launch. If the Federal Joint Committee (G-BA) deem a new therapy offers no additional benefit, it cannot negotiate premium-pricing. The Institute for Quality and Efficiency in Health Care (IQWiG) conducts an initial assessment, followed by a final resolution by G-BA. This research aims to evaluate any correlation between the additional benefit manufacturers claim and the benefit that IQWiG and G-BA report.

METHODS

: All EBAs completed between 01/01/2016-30/05/2019 were extracted from the G-BA website alongside corresponding IQWiG assessments, and manufacturer submissions and key information compared. For extracted outcome data, the focus was the subgroup of greatest additional benefit. Statistical analyses were conducted using Chi-squared tests and logistic regression models.

RESULTS

: 206 EBAs were identified. G-BA reported major additional benefit in 0.5%, considerable in 24%, 14% minor, 18% unquantifiable, 43% not proven, and 1% lesser. The corresponding data for IQWiG was 2% major, 15% considerable, 7% minor, 7% unquantifiable, 44% not proven, 5% lesser, and 17% N/A (orphan drug). The corresponding data for manufacturers were 25% major, 39% considerable, 8% minor, 17%, unquantifiable, 3% not proven, and 9% not specified. Both IQWiG and G-BA were significantly likely to report a lower extent of additional benefit than manufacturer requested (134/172 and 153/206; p<0.01 for both). Manufacturers requesting lesser levels of benefits increased the odds of both GBA and IQWiG recognizing no additional benefits, with IQWiG less so than GBA (Wald tests: =11.4, p=0.077; =26.1, p<0.01, respectively).

CONCLUSIONS

: Manufacturers requesting lower additional benefits obtain less favorable EBAs from both IQWiG and G-BA. Further research is needed to identify whether manufacturers request greater additional benefit for drugs with a stronger supportive data package or whether manufacturer requests for additional benefit independently impact GBA and IQWiG decision-making.