PHP156 Amnog – Summary of Outcomes of Early Benefit Assessment and Reimbursement Negotiation for New Drugs in Germany

Abstract

The AMNOG has been in place for new drugs in Germany since 01/01/2011. The AMNOG includes early benefit assessment in comparison to one pre-defined ‘appropriate comparator' therapy and negotiation of reimbursement price. The objective of this research was to review and compare the outcomes of all benefit assessments which had had in place a final decision until June 2012. A review based on all published documents of the AMNOG processes (benefit dossiers submitted, IQWiG assessment reports and final G-BA decisions). This investigation focuses on the comprehensive description and comparison of outcomes of assessment and final decision. Until June 10, 2012, a total of n=14 AMNOG processes were finalized. For further 4 processes no dossier was submitted. An additional benefit was partially credited 7 (50 %) out of the 14 new drugs by the IQWiG and 10 (71%) by the G-BA. The IQWiG differentiated 39 subpopulations for separate assessment and the G-BA considered 31 subpopulations in the final decisions. The IQWiG credited 26 out of 39 subpopulations (67 %) with ‘no proof of additional benefit'. A total of 3 (8 %) subpopulations was credited with ‘significant' additional benefit, 2 (5%) with ‘marginal', and 6 (16 %) with ‘additional benefit not quantifiable'. The G-BA finally credited 18 out of 31 subpopulations (58%) with ‘no proof of additional benefit' or ‘less benefit'. A total of 2 (6%) subpopulations were credited with ‘significant additional benefit', 5 (16%) with ‘marginal additional benefit', and 6 (20%) with ‘additional benefit not quantifiable'. The AMNOG evaluation of additional benefit differentiates a high number of subpopulations. Obviously the number of subpopulations and the outcomes varied between IQWiG assessment and final G-BA decision. So far, the majority of subpopulations were credited with ‘no proof of additional benefit'. First results from reimbursement negotiations suggest that this may restrict price agreement.