Dalbavancin (2) – Xydalba®

Adults and children aged 3 months and over with acute bacterial skin and soft tissue infections (ABSSSI)

• The additional benefit is deemed proven.
• 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 Book V of the Social Code (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).
• Requirements for a quality-assured application
  • 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.
  • Should pathogen testing reveal that the pathogen is susceptible to other antibiotics (without reserve status), treatment must be de-escalated accordingly to avoid unnecessary use of the reserve antibiotic.
  • For the appropriate management of MRSA infections and the relevant requirements in clinical practice, please refer to the current recommendations of the RKI.
  • With a view to the future assessment of the resistance situation, the use of a standardised system is necessary. The RKI’s ARS system aggregates data on antibiotic resistance across Germany and also forms the basis for Germany’s participation in international surveillance systems. For this reason, efforts should be made to ensure that the laboratory serving the practice participates in this system.
  • To implement the requirements for a quality-assured application, it is necessary that these be incorporated into the clinic’s internal regulations and processes.
  • The reporting of consumption and resistance data on dalbavancin to the aforementioned systems must be ensured within six months of this resolution coming into force.

Courtesy translation only, please refer to the German original.