Eszopiclon (1) – Lunivia®

Benzodiazepine-related agents, Group 1, in Stage 2

• The legal consequence of the company’s decision not to submit a dossier at the relevant time is the determination that the additional benefit is not proven.
• The pharmaceutical manufacturer has not claimed any therapeutic improvement, including due to minor side effects, or any pharmacological-therapeutic non-comparability.
• In its deliberations on establishing the additional benefit of eszopiclone and on updating the fixed-amount group ‘Benzodiazepine-related medicinal products, Group 1’ in Stage 2, that the additional benefit of eszopiclone 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, eszopiclone is to be included in the fixed-amount group ‘Benzodiazepine-related agents, Group 1’ in Tier 2 in accordance with Section 35a(4), first sentence, in conjunction with Section 35(1), second sentence, number 2 of the SGB V (formation of fixed-amount groups).

Courtesy translation only, please refer to the German original.