Cefiderocol (2) – Fetcroja®

Adults with infections caused by aerobic Gram-negative pathogens for which only limited treatment options are available

• For the medicinal product Fetcroja, containing the active ingredient (INN) cefiderocol, 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 October 2021, 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).
• Additional benefit of the medicinal product
  • Adults with infections caused by aerobic Gram-negative pathogens for which only limited treatment options are available. 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) has, in accordance with Section 35a(1c), eighth sentence, of SGB V, laid down requirements for the quality-assured application of the reserve antibiotic, taking into account the impact on the resistance situation.
  • Indications for use
  • The requirement that cefiderocol may only be used in adults for the treatment of infections caused by aerobic Gram-negative pathogens where only limited treatment options are available follows directly from the authorised therapeutic indication (Section 4.1 of the SmPC).
  • Qualified consultation must be carried out, 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-drug-resistant pathogens.
  • Indications for pathogen identification
  • As a general rule, cefiderocol must not be used as part of a calculated (empirical) treatment regimen. The authorised therapeutic indication requires knowledge of the pathogen.
  • Should pathogen identification reveal that the pathogen is susceptible to other antibiotics (not classified as reserve antibiotics), treatment must be de-escalated accordingly to avoid unnecessary use of the reserve antibiotic.
  • Indications for implementation
  • The respective Medicines Commission is responsible for integrating this into processes. For implementation, evidence-based antibiotic stewardship teams (see S3 guideline ‘Strategies for Ensuring the Rational Use of Antibiotics in Hospitals’, 2018 update) are particularly suitable.
  • In accordance with Section 23(4) of the Infection Protection Act, the healthcare 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 cefiderocol is used should be encouraged to participate in these systems.

Courtesy translation only, please refer to the German original.