Efbemalenograstim alfa (1) – Ryzneuta®

Colony-stimulating factors, pegylated, Group 1, at Level 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.
• In its deliberations on the determination of additional benefit for efbemalenograstim alfa and on the update, including the renaming of the fixed-amount group ‘Colony-stimulating factors, pegylated, Group 1’ to Tier 2, concluded that the additional benefit of efbemalenograstim alfa is deemed not proven in accordance with Section 35a(1), fifth sentence, of Book V of the Social Code (SGB V).

Courtesy translation only, please refer to the German original.