Artesunat (1) – Artesunate Amivas®

Children from birth and adults with severe malaria (for initial treatment)

• Artesunate for the initial treatment of severe malaria in adults and children has a marketing authorisation as a medicinal product for the treatment of an orphan disease in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999.
• In accordance with Section 35a(1), sentence 11, first half-sentence, of Book V of the Social Code (SGB V), the additional medical benefit is therefore deemed proven by virtue of the marketing authorisation.
• The pharmaceutical manufacturer did not submit a benefit assessment dossier at the relevant time.
• Consequently, the necessary evidence for the benefit assessment pursuant to Section 35a of the German Social Code, Book V (SGB V) was not submitted to the G-BA.
• Pursuant to Section 5(8), second sentence, in conjunction with paragraph 7, first sentence, number 4 of the AM-NutzenV, this therefore results in a non-quantifiable additional benefit, as the required evidence is incomplete.

Courtesy translation only, please refer to the German original.