Market Access

Strategic planning of the 'story line' for the derivation of additional benefit in the whole process (advice meeting, dossier, written statement, oral hearing and price negotiations)
Advice with respect to the composition and the content of the benefit dossier and the written statement.
Advice with respect to further analyses beyond the results of the study reports. Analyses for special populations

Assessment of existing indirect treatment comparisons, metaanalyses and network metaanalyses with respect to suitability for the use in the benefit derivation.
Participation in oral hearings.
Support and advice in the compilation of written statements concerning assessments of competitive products in the context of benefit dossiers.
Support in the price negotiations with regards to the clinical evidence as used by G-BA to derive the added benefit.
Training with respect to statistical aspects in the AMNOG process and the compilation of the dossier.

Preparation of statistical analysis plans for additional analyses.
Full analysis of all endpoints and subgroups with respect to dossier requirements, delivery of tables for Module 4 in German language and appropriate format to be copied directly in Module 4
Realisation of metaanalyses, indirect treatment comparisons and network metaanalyses.
Review of external statistical analyses.
Compilation of the methods section for the assessment of the validity of the evidence as well as the information synthesis and analysis.
Compilation of the results section for the medical benefit and additional benefit for the selected endpoints (chapter 4.3).
Compilation of the chapter concerning the potential for bias in the main text and in appendix 4F of modul 4.
Compilation of the chapter concerning the concluding assessment of the additional benefit (chapter 4.4).
Compilation of the methods of the included studies (appendix 4E).
Review and quality assurance of externally prepared chapters in module 4.