PRO40 Global Access Implications of GermanyÂ’s New GSAV LAW for Orphan Drugs

Abstract

New pharmacological therapies in Germany are subject to early benefit assessments by the Federal Joint Commission (G-BA). If the G-BA deem no additional benefit is offered over an appropriate comparator, premium pricing cannot be negotiated. EMA-designated orphan medicines were guaranteed an additional benefit (if the annual turnover from outpatient treatment sales was below €50 million). In August 2020, the GSAV law came into force, whereby orphan drugs granted a non-quantifiable additional benefit by the G-BA can be subject to post-launch data collection.