Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. The G-BA then commissions IQWiG, which uses the dossier to assess whether such an added benefit exists.
In contrast to other work results, the time period to conduct the assessment is stipulated by law: the dossier assessment must be completed within three months after receipt of the manufacturer's dossier.
Production of dossier assessments (simplified):
- Transfer of the dossier by the G-BA: A dossier assessment is always initiated by a commission from the G-BA and the transfer of the dossier.
- Information retrieval and scientific evaluation: On receipt of the dossier at IQWiG, the Institute will start the assessment with regard to the contents of the dossier. The database of the assessment is the manufacturer's dossier. Optionally, the Institute may conduct its own additional search for information. Medical experts and patients are regularly consulted for the assessment.
- Production of the dossier assessment: The process ends with the production of a dossier assessment. In accordance with § 35a Social Code Book (SGB) V, the assessment must be completed three months at the latest after the relevant date for submission of the dossier.