REALITY IN MARKET ACCESS IN GERMANY AND FRANCE – COMPARATIVE ANALYSIS OF ADDED BENEFIT DECISIONS ON INNOVATIVE PHARMACEUTICAL THERAPIES
Author(s)
Droeschel D1, Chicoye A2, Lepretre M2
1Riedlingen University - SRH FernHochschule Riedlingen, Riedlingen, Germany, 2ESSEC Executive Education, Paris-La Défense, France
OBJECTIVES The German market access system for drugs have been changed significantly in the last years, by introducing a similar focus on benefit assessment as in the French system. The research question remains whether they produce consistent results in terms of additional benefit (AB) for pharmaceuticals which have passed the assessment in both systems. METHODS The G-BA and IQWiG as well as the Transparency Commission (TC) databases were searched systematically to identify those products, which have been processed in both systems between Jan 2011 and Dec 2013. For further comparison a data grid consisting of 26 items for evaluation has been developed including study comparator, primary clinical endpoints, health related quality of life inclusion. RESULTS Overall, 140 new therapies have been assessed in France by TC, and 80 in Germany by the G-BA. According to inclusion criteria, 44 products could be identified which have passed through both systems including 7 orphan drugs. Thirteen products (30 %) had no AB granted by both Agencies, whereas 9 (20%) were in both cases granted with a minor AB, (assuming that “minor” values are equivalent between the two systems), amounting to 22/44 cases with a similar resolution. Five cases (11%) showed a discrepancy in added benefit, all times TC = no and G-BA = yes. However, varying magnitudes appeared to be the greatest difference (n = 17 (39%) remaining drugs), conditioned by lacking concordance of both scale grade systems. CONCLUSIONS Decisions of the agencies in both countries show partial heterogeneity in driving criteria like benefit levels (ASMR and AB). Although the evidence package for initial assessment in both countries is largely similar, preliminary results suggest their contextualization and scales are different. Further analysis based on results of the grid is needed to better assess criteria leading to different benefit levels and their reimbursement impact.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP218
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases