Eravacyclin (1) – Xerava®

Adults with complicated intra-abdominal infections (cIAI)

• The additional benefit is deemed proven.
• For the medicinal product Xerava, containing the active ingredient (INN) eravacycline, 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 21 April 2022, 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
  • The requirement that eravacycline may only be used to treat the infections specified in the therapeutic indications where only limited treatment options are available is set out in this resolution as part of the requirements for a quality-assured application, in order to ensure strict indication criteria for all therapeutic indications in accordance with Section 35a(1c) of the German Social Code, Book V (SGB V).
  • Qualified consultation shall take place, in accordance with the relevant specialist expertise, with a specialist in infectious diseases (internal medicine and infectious diseases, microbiology, virology and infectious disease epidemiology, or a subspecialty in infectious diseases) or, if unavailable, with a specialist from other disciplines who must have appropriate experience in the treatment of infectious diseases caused by multi-resistant pathogens.
  • As a general rule, eravacycline must not be used as part of a calculated (empirical) treatment regimen. The strict indication for its use as a reserve antibiotic requires knowledge of the pathogen.
  • Even in the exceptional cases mentioned, the probability of infection with a multidrug-resistant pathogen from the RKI’s list of pathogens is at least high.
  • 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.
  • Empirical treatment with eravacycline should be as short as possible.
  • To implement the requirements for a quality-assured application, it is necessary for them to be incorporated into the hospital’s internal regulations and processes.
  • The relevant Medicines Committee is responsible for integrating these requirements into the processes.
  • In accordance with Section 23(4) of the Infection Protection Act, the treatment facility is obliged to carry out surveillance of consumption and resistance, although there are no specific requirements regarding the systems to be used.
  • The RKI’s ARS, AVS and ARVIA systems aggregate data on antibiotic resistance and consumption across Germany. ARS also forms the basis for Germany’s participation in international surveillance systems.
  • For this reason, hospitals in which eravacycline is used should be encouraged to participate in these systems.
  • If no participation has taken place to date, data must at least be reported to the aforementioned systems for the reserve antibiotic eravacycline.
  • A transition period until 1 January 2024 is considered appropriate for this purpose.
  • Until participation in the aforementioned systems is established, the consumption and resistance situation must be monitored via the existing systems.

Courtesy translation only, please refer to the German original.