Value Dossier
The Value Dossier is requested in Germany for any new product at time of market launch or for marketed drugs which are still under document protection. The objective is to document the “additional therapeutic benefit” vs. an “appropriate standard therapy” as platform for price negotiations. The content of the Value Dossier is linked to the Regulatory File. Therefore, it is mandatory that all regulatory actions have to be carefully considered vs. its impact on the value dossier and vice versa.
The dossier consists of 5 modules with a couple of hundred pages at least, including a minimum of 50 tables per indication, and references (similar to a regulatory file). Information from Regulatory-, Medical‑, and Access-sources has to be aligned and included. The objective is to prove the efficacy of the drug regarding the efficacy parameters set by G-BA as well as its statistical significance in the cohort defined by the regulatory label and/or sub-populations thereof which could benefit most. It is also requested to quantify the number of patients in Germany for the defined cohorts and the number treated.
We support you with:
- Project planning
- Drafting and/or reviewing the Value Dossier modules
- Technical compilation of the dossier incl. hyperlinking
- Scientific Advices/Hearings with IQWiG and/or G-BA