Benefit Assessments

On November 11th 2010, the German Bundestag has issued a law for the Reform of the Market for Medicinal Products (German Gesetz zur Neuordnung des Arzneimittelmarkts, AMNOG). This law represents a new regulation for the pricing for newly approved pharmaceuticals or for new indications of currently approved pharmaceuticals. It regulates the reimbursability via the statutory health insurance.

The results of benefit assessment of newly approved pharmaceuticals according to § 35a SGB V (social security code, book V) by the Joint Committee (German Gemeinsamer Bundesausschuss [G-BA]) and the Institute for Quality and Efficiency in Health Care (German Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) support the decision-making process for the pricing of pharmaceuticals in Germany.

Since January 1st 2011, pharmaceutical companies must provide a comprehensive dossier of benefit assessment for any new pharmaceutical at the time of market launch or of approval of new indications for currently approved pharmaceuticals.

This dossier of benefit assessment must be written according to exact parameters given by the G-BA and consists of 5 modules, including the following contents:

  • method of action
  • approved indications
  • target populations
  • appropriate comparison therapies
  • therapy costs
  • extraction of pivotal studies

Our Service

MEDAHCON provides services tailored to the goal of completing a dossier of benefit optimized for your product and for submission to the G-BA.
To this end, our service portfolio includes:

  1. complete development and writing of all modules required for a dossier of benefit, including
    • compilation of all documents required for submission
    • formal check for completeness of contents
  2. editing and optimization of the texts for submission to the G-BA
  3. professional translations tailored to the requirements of a dossier of benefit, from English to German and vice versa
  4. consultation for your strategy pertaining structure and formulation of argumentation and of contentual focus


Our experience concerning the support for the development of assessments of benefit include the following fields of indications:

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