A493 introduced for the treatment of HIV (25%) and asthma/ COPD (25%), type-2 diabetes mellitus (19%) and HCV (13%) as well as for the treatment of essential hypertension (6%), eye disease (6%) and stomach cancer (6%). Most of these products could be grouped into Category A (new substance plus generic substance) and Category E (already G-BA-assessed substance plus generic substance) (both N= 5). There was no product in Category F (two or more already G-BA-assessed substances). It was evident that the G-BA decision was different among the categories of the FDC. ConClusions: New FDC are not common in the EBA. There is a tendency in which indication FDC products are more common. The type of combination, i.e. combination with or without generic substance, as well as the existence of a specific level of evidence, i.e. direct comparator study vs. bioavailability study only, were key drivers for a successful early benefit process.
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