Presentation (CTI)

OBJECTIVES: Dual brand strategy defines the idea of launching a pharmaceutical drug (active ingredient) under distinct brand names. According to European pharmaceutical law, duplicating marketing authorization for the same medicinal product, is only possible based on Orphan Designation (OD) or exceptionally. From Market Access perspective, dual branding might result in differentiated pricing. This research aimed at compiling potential examples, where dual branding led to differentiated pricing for pharmaceuticals in Germany with obligation to undergo pricing negotiation according to §35a SGB V AMNOG framework.
METHODS: Manual research based on German Payer Head Association GKV-SV online database of all §130b SGB V negotiations was conducted. Only cases with dual branding for one active ingredient and one pharmaceutical manufacturer were eligible, excluding any co-marketing or licensing. The list of relevant examples was further examined via specialized pricing database (Cellbyte) to analyze price evolution based on historic data as well as up-to-date pricing situation.
RESULTS: Research in GKV-SV database identified N=9 cases, which might be clustered in two categories: (A) brands distinguished by patient population/indication and dosing/regimen/formulation that are not considered bioequivalent (n= 5) and (B) brands considered bioequivalent (n=4). Category (B) relevant examples include lenvatinib (Kisplyx, Lenvima), nintedanib (Ofev, Vargatef), pitolisant (Ozawade, Wakix) and tremelimumab (Imjudo, Tremelimumab AZ). Pricing analysis via Cellbyte research showed only one sustainably differentiated pricing case (Lenvatinib), potentially indicating a deviation from the German mixed-price system, while all other cases showed similar pricing or gradual harmonization over time.
CONCLUSIONS: This research aimed to investigate whether there is evidence for differentiated pricing by dual brand strategy for drugs in Germany within the regular AMNOG framework. Overall, limited examples were found where dual brand strategy was executed. One case showed sustained differentiated pricing, while others converged over time, supporting that indication-based differential pricing is generally not intended under German drug pricing regulation.