Reserve antibiotic cefiderocol: G-BA ensures use within narrow limits

06.05.2022 12:09

Reserve antibiotics can be the last treatment option for an infection with multi-resistant bacteria. For the first time, the Federal Joint Committee (G-BA) has defined quality assurance requirements for the use of a reserve antibiotic - cefiderocol - which ensure responsible and targeted use. This is intended to prevent new resistance from developing against the antibiotic and the loss of reserve status.

The requirements approved for cefiderocol concern pathogen detection, the composition of so-called antibiotic teams in the hospital and the reporting of resistance and therapeutic use to databases of the Robert Koch Institute (RKI). The G-BA had previously checked whether the manufacturer's technical information was already sufficient.

Cefiderocol – protecting reserve status through close deployment

The antibiotic cefiderocol (Fetcroja®) is approved for the treatment of adults suffering from infection caused by aerobic gram-negative pathogens and for whom only limited treatment options are available. At the pharmaceutical company's request, the G-BA recognized the antibiotic as a reserve antibiotic.

In addition to the specialist information, medical institutions must, among other things, note the following:

• Before use, the pathogen that caused the infection must be identified and checked to see whether it responds to other antibiotics, except in very exceptional cases. If another antibiotic is an option, cefiderocol must not be used.
• The requirements for the appropriate use of cefiderocol must be taken into account in the clinic's internal processes. The drug commission of a hospital is responsible for the integration. In-house antibiotic stewardship programs (SECTION) are recommended for implementation.
• The treatment facility or clinic must have a local clearance policy for the use of cefiderocol.
• In order to be able to assess the Germany-wide resistance and consumption situation for cefiderocol as well as possible, the relevant information on resistance and consumption should be sent to the systems AVS (Antibiotic Consumption Surveillance), ARS (Antibiotic Resistance Surveillance) or ARVIA (ARS and AVS – Integrated analysis) of the RKI. This applies no later than six months after the decision comes into force.

When it came to the requirements for a quality-assured application, the G-BA relied, among other things, on one RKI statement, which was created in agreement with the Federal Institute for Drugs and Medical Devices.

The decision comes into force on May 5, 2022.