Dalbavancin (3) – Xydalba®

Infants from birth to < 3 months of age with acute bacterial skin and soft tissue infections (ABSSSI)

• For the medicinal product Xydalba, containing the active ingredient dalbavancin, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 20 April 2023, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
• Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
• Overall assessment
  • The additional benefit is deemed proven.
• Requirements for a quality-assured application
  • In its resolution pursuant to Section 35a(3), first sentence, of SGB V, the Federal Joint Committee (G-BA) must lay down requirements for the quality-assured application of the reserve antibiotic, taking into account the impact on the resistance situation.
  • Dalbavancin may only be used if there is evidence, or in exceptional cases a strong suspicion, that the infection is caused by methicillin-resistant Staphylococcus aureus (MRSA) and only limited treatment options are available.
  • Qualified consultation shall take place, in accordance with the relevant specialist expertise, with a specialist with additional qualification in infectious diseases, a specialist in internal medicine and infectious diseases, or a specialist in microbiology, virology and infectious disease epidemiology.
  • As a general rule, dalbavancin should not be used as part of a calculated (empirical) treatment regimen.
  • Its strict indication as a reserve antibiotic requires knowledge of the pathogen.
  • Outpatient use: For the appropriate management of MRSA infections and the relevant requirements in clinical practice, please refer to the current recommendations of the RKI.
  • In-hospital management: To ensure compliance with the requirements for a quality-assured application, these must be incorporated into the hospital’s internal regulations and processes.
• Designation of medicinal products containing new INN in accordance with Section 35a(3), fourth sentence, of SGB V
  • – No designation of medicinal products containing new INN active ingredients that can be used in combination therapy in accordance with Section 35a(3), fourth sentence, of SGB V, as the G-BA has decided to grant an exemption for the assessed medicinal product as a reserve antibiotic in accordance with Section 35a(1c), first sentence, of the SGB V.

Courtesy translation only, please refer to the German original.