Fluticasonfuroat / Vilanterol-Trifenatat (1) – Relvar Ellipta®

Combinations of glucocorticoids with long-acting beta-2 sympathomimetics, Group 1, in Level 3

• The legal consequence of the company’s decision not to submit a dossier at the relevant time is a finding that the additional benefit is not proven.
• The pharmaceutical manufacturer has not claimed any therapeutic improvement, including due to minor side effects, or pharmacological-therapeutic non-comparability.
• In its deliberations on establishing the additional benefit of fluticasone furoate plus vilanterol and on updating the fixed-amount group ‘Combinations of glucocorticoids with long-acting beta-2 sympathomimetics, Group 1’ in Stage 3, that the additional benefit of fluticasone furoate plus vilanterol is deemed not proven in accordance with Section 35a(1), fifth sentence, of SGB V, the requirements under Section 35a(4), first sentence, of the German Social Code, Book V (SGB V) are met and, consequently, fluticasone furoate plus vilanterol is to be classified in the fixed-amount group ‘Combinations of glucocorticoids with long-acting beta-2 sympathomimetics, Group 1’ in Tier 3 pursuant to Section 35a(4), first sentence, in conjunction with Section 35(1), second sentence, No. 2 of the SGB V (fixed-amount grouping).

Courtesy translation only, please refer to the German original.