The G-BA assesses the additional benefit (“Zusatznutzen”) a product provides over current treatment availability. The G-BA uses a scale of 4 levels of additional benefit but may also assess the additional benefit as unquantifiable under certain conditions. Companies must submit to the G-BA within three months of gaining marketing authorisation in order for the G-BA to recognise any additional benefit claimed over the appropriate comparator.
The final G-BA resolution, which is released at the end of the assessment procedure, will contain a rating of the drug’s additional benefit. This rating will be the basis of the subsequent price negotiations with the statutory payer groups (“GKV-SV“) and will have a major influence on the reimbursement price of the drug.