Currently, reserve antibiotics are excluded from a benefit assessment by the G-BA.
The G-BA decides whether to accept a new antibiotic onto the reserve antibiotics list. In May 2022, the G-BA reviewed cefiderocol and has decided for the first time to put strict quality assurance requirements in place.
G-BA assessment of reserve antibiotics
A manufacturer can request that their antibiotic is excluded from the regular early benefit assessment, if it is a reserve antibiotic, i.e.
- it is effective against severe infections caused by multi-resistant bacterial pathogens
- it is used in strictly defined indications
- there are only limited alternative therapy options.
The additional benefit of reserve antibiotics is deemed proven. The G-BA does not assess the extent of the additional benefit and the therapeutic significance.
However, to ensure a strict indication for the use of the antibiotic, the G-BA can restrict the use of the antibiotic.
Fetcroja® (cefiderocol)
The antibiotic cefiderocol is approved for the treatment of adults infected by aerobic gram-negative pathogens for whom available treatment options are limited.
At the request of the manufacturer, the G-BA recognized the antibiotic as a reserve antibiotic. However, to ensure its responsible and targeted use, the G-BA put strict quality assurance measures in place in May 2022. This should avoid the development of new resistances against the antibiotic, so that it can maintain its “reserve antibiotic” status.
The G-BA had previously checked the requirements of the SPC. However, they concluded that specific requirements for cefiderocol are needed in addition to the SPC:
- Except for in specific cases, hospitals or clinic must identify the causative pathogen of the infection before cefiderocol use. They also must check whether the infection responds to other antibiotics first. If another antibiotic is an option, they should not use cefiderocol.
- Internal hospital processes must consider the specifications for the appropriate use of cefiderocol. The drug commission of a hospital is responsible for this integration. The G-BA recommends in-house Antibiotic Stewardship (ABS) programs for the 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 use for cefiderocol, hospitals must send the relevant information on resistance and use to the AVS (antibiotic use surveillance), ARS (antibiotic resistance surveillance) or ARVIA (ARS and AVS – Integrated analysis) systems of the Robert Koch Institute (RKI).
The G-BA based these requirements on comments from the RKI and BfArM.
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