Ivermectin (1) – Soolantra®

adult patients for the topical treatment of inflammatory lesions associated with (papulopustular) rosacea

• No dossier had been submitted by the pharmaceutical manufacturer at the relevant time.
• Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment has been carried out as to whether the active ingredient ivermectin has any additional benefit, no additional benefit or a minor additional benefit compared with the appropriate comparator therapy, and that the additional benefit of ivermectin in relation to the appropriate comparator therapy is deemed not proven.
• As the required proof has not been submitted, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code).
• Appropriate comparator therapy
  • The appropriate comparator therapy for the topical treatment of (papulopustular) rosacea is: azelaic acid or doxycycline (oral) or metronidazole (topical).

Courtesy translation only, please refer to the German original.