OBJECTIVES : Since the enactment of the AMNOG in 2011, pharmaceutical companies are required to prove the benefit of newly approved drugs including new area of application compared to the standard of care in Germany. This benefit is evaluated by G-BA/IQWiG. The aim of this study was to investigate the effect of the benefit assessment on the negotiated reimbursement price with the GKV-SV.

METHODS : A database containing all evaluated AMNOG dossiers from 2011 until the end of April 2019 was analysed. Information on G-BA assessments and decisions on added benefit were extracted. Prices at the time of launch including alterations were obtained from Lauer-Taxe^®. Benefit assessments were qualitatively and quantitatively analysed for predictors of assessment outcome, major pitfalls and impact on price negotiations.

RESULTS : In total, 391 concluded benefit assessments were published including 763 subpopulations, mostly in the field of oncology (247), metabolic (167) and infectious diseases (134). Approximately 37% of the assessed subpopulations received an added benefit whereas 59% received no added benefit. Other outcomes were a lesser benefit or discontinued procedures. In the subsequent price negotiations, a proven added benefit allowed the manufacturer to negotiate higher reimbursement prices. In contrast, for drugs with no added benefit the appropriate comparator determines the upper limit for the negotiated price.

CONCLUSIONS : Since 2011 benefit assessments have become a key component in pricing of new drugs in Germany. It is important to be in line with G-BA/IQWiG regulations as well as to provide sufficient evidence to receive an added benefit, which in turn positively influences price negations. No added benefit leads to a lower price and in worst case, results in market withdrawal.