OBJECTIVES: Dual branding is a strategy commonly employed where the same molecule (with the same INN) is marketed under various brand names. This approach is typically adopted to establish different price points due to variations in formulation, dosing, or delivery mechanisms for the same or different indications. In this article, we evaluated Health Technology Assessment (HTA) outcomes of the dual-branded products approved by the European Medicines Agency (EMA) in the EU4 (France, Germany, Italy, and Spain) and the UK (United Kingdom).

METHODS: All publicly available records were scanned to identify dual branded products approved by EMA between 2009-2022. A total of six drugs (12 brands) approved by EMA were identified. Data on HTA outcomes were extracted from publicly available sources to compare the HTA outcomes.

RESULTS: The UK leads other countries in terms of reimbursing dual-branded products, followed by France and Italy, where many of these products are reimbursed. Spain and Germany reimburse only a few of these products, implying comparatively stricter HTA assessments. None of the identified dual-branded products were found to have a positive HTA recommendation across all of EU4 and the UK.

CONCLUSIONS: HTA outcomes for dual branded products are highly variable at both indication, product, and country level. Dual branded products offer significant commercial potential and the possibility to price the same product at different price points levels to maximize its value. Understanding of the nuances in each of the markets is key for successful HTA outcomes