AMNOG – SUMMARY OF OUTCOMES OF EARLY BENEFIT ASSESSMENT AND REIMBURSEMENT NEGOTIATION FOR NEW DRUGS IN GERMANY

Author(s)

Claus V1, Freyer D1, Kotowa W2, Mathes J21Novartis Pharma GmbH, Nuremberg, Germany, 2IGES Institut GmbH, Nuremberg, Germany

OBJECTIVES: 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. METHODS: 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. RESULTS: 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’. CONCLUSIONS: 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.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP156

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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