Olodaterol (1) – Striverdi Respimat®

Beta-2 sympathomimetics, inhaled and oral, Group 1, in Stage 2

• 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.
• Consequently, in the present classification into fixed-amount groups at Level 2 pursuant to Section 35(1), second sentence, No. 2 of SGB V, where pharmacologically and therapeutically comparable active ingredients, in particular those chemically related substances, are grouped together, there is not only therapeutic but also pharmacological and therapeutic comparability of the active ingredients to be grouped, as required by Section 35a(4) of the German Social Code, Book V (SGB V).
• During its deliberations on determining the additional benefit of olodaterol and on updating the fixed-amount group ‘Beta2-sympathomimetics, inhaled and oral, Group 1’ in Stage 2, that the additional benefit of olodaterol is deemed not proven in accordance with Section 35a(1), fifth sentence, of SGB V, the conditions under Section 35a(4), first sentence, of SGB V are met and, consequently, olodaterol is to be included in the fixed-amount group ‘Beta-2 sympathomimetics, inhaled and oral, Group 1’ in Tier 2 in accordance with Section 35a(4), first sentence, in conjunction with Section 35(1), second sentence, No. 2 of the German Social Code, Book V (SGB V) (fixed-amount grouping).

Courtesy translation only, please refer to the German original.