OBJECTIVES: The G-BA drug benefit assessment in Germany is evidence-based and can result in major, significant, marginal, non-quantifiable, no, or even less added benefits. Additionally, the G-BA can restrict the period of validity of its resolutions and request the submission of new evidence. This study explored the number of assessments with non-quantifiable resolutions and the set time limits relative to the clinical evidence, in order to evaluate the likelihood of getting time limitations and their implications on price discounts.

METHODS: Information on G-BA resolutions with non-quantifiable outcomes was retrieved from a database of AMNOG dossiers published until 24 March 2017. The results identified as non-quantifiable were classified as orphan drug (OD) or non-OD assessments; information on time limits and clinical evidence was extracted.

RESULTS: