Orphan drugs

Orphan drugs are considered to provide additional benefit by law, as long as sales within 12 months stay below a turnover limit of €30 mio (until 2022: €50 mio) 162 different products comprising 349 resolutions fall into this category. The G-BA only decides on the extent of this additional benefit. Therefore, orphan drugs received the most positive assessment so far from the G-BA: 2.8% of the patient subpopulations were granted a major additional benefit, 12.7% a considerable, 12.9% a minor and 50.6% a not quantifiable additional benefit. No additional benefit was identified in 20.9% of the patient population.