G-BA extends benefit assessment of reserve antibiotic Recarbrio to children under 18 years of age

The Federal Joint Committee (G-BA) decided on August 6, 2026, to extend the benefit assessment of the reserve antibiotic Recarbrio, containing the active ingredient Imipenem/Cilastatin/Relebactam, to pediatric patients under 18 years of age. The Federal Ministry of Health published the decision to amend the Pharmaceutical Guidelines in the Federal Gazette, official reference BAnz AT 16.09.2026 B1 dated September 16, 2026. The added benefit is considered proven in all three new areas of application.

Amendment of the Pharmaceutical Guidelines according to Section 35a SGB V

The legal basis is Annex XII of the Pharmaceutical Guidelines (AM-RL) for the benefit assessment of medicinal products with new active ingredients according to § 35a of the Fifth Book of the Social Code (SGB V). The guidelines in the version dated December 18, 2008/January 22, 2009 (BAnz. No. 49a dated March 31, 2009) were last amended by the decision of June 18, 2026 (BAnz AT 04.09.2026 B5).

For Recarbrio, the G-BA had already granted an exemption from the obligation to submit evidence by decision on January 20, 2022, as it is a reserve antibiotic within the meaning of § 35a paragraph 1c sentence 1 SGB V. In the case of such an exemption, the added benefit is considered proven; the extent of the added benefit and its therapeutic significance are not to be assessed by the G-BA. At the same time, the committee must establish requirements for quality-assured application that take into account the effects on the resistance situation.

Three new areas of application from birth

The authorization dated January 19, 2026, and the decision dated August 6, 2026, cover the same three areas for pediatric patients from birth:

• Treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
• Treatment of bacteremia for which a connection to HAP or VAP exists or is suspected
• Treatment of infections with aerobic Gram-negative pathogens with limited therapy options

The added benefit of Imipenem/Cilastatin/Relebactam is considered proven in all three constellations. Official guidelines for the appropriate use of antibiotics must be taken into account.

Around 520 to 1,300 children and therapy costs up to over 21,000 euros

The decision quantifies the number of patients eligible for treatment for all three areas of application combined at approximately 520 to 1,300. The announcement specifies the annual therapy costs per patient uniformly for all three areas:

• Imipenem/Cilastatin/Relebactam: €7,065.63 to €21,196.89
• Costs after deduction of legally required discounts, as of Lauer-Taxe: June 1, 2026
• Costs for additional necessary SHI (GKV) services: not applicable

Strict requirements for use in the clinic

Use is permitted exclusively if there is evidence or, in exceptional cases, a strong suspicion that the infection is caused by multi-resistant aerobic gram-negative pathogens and only limited treatment options are available. In principle, the causative pathogen and its sensitivity must be microbiologically proven prior to application; sample collection must take place before the start of therapy, and empirical therapy must generally be adjusted after a maximum of 72 hours.

Prior to use, consultation must be held with:

• a specialist physician with an additional qualification in infectiology
• a specialist physician for internal medicine and infectiology
• a specialist physician for microbiology, virology, and infection epidemiology

If these groups are unavailable, a specialist physician with appropriate experience in the treatment of infections with multi-resistant pathogens must be involved. The clinic must provide a local release regulation, formulate restriction measures in writing, and implement the specifications within the framework of the drug commission as well as the internal antibiotic stewardship program (ABS). Consumption and resistance surveillance according to Section 23 Paragraph 4 of the Infection Protection Act must be ensured via the AVS, ARS, or ARVIA systems; reporting should occur within six months of the resolution coming into force. Furthermore, the principles of antibiotic therapy of the Commission for Anti-infectives, Resistance, and Therapy (ART) at the Robert Koch Institute as well as the summary of product characteristics made freely accessible by the European Medicines Agency (EMA) for Recarbrio must be observed.

Entry into Force and Publication

The resolution comes into force with effect from the day of its publication on the G-BA website on August 6, 2026. The supporting reasons will be published on the G-BA website at www.g-ba.de. The announcement was signed in Berlin on August 6, 2026, by the Federal Joint Committee in accordance with Section 91 SGB V, the Chairperson Dr. Optendrenk.

For hospitals and children’s hospitals, this change means that they can henceforth prescribe the reserve antibiotic for children from birth, but only under documented infectiological consultation, local release reservation, and surveillance obligations. For statutory health insurance, this results in billable annual therapy costs of up to €21,196.89 per child, while the resistance situation remains monitored through mandatory reporting to AVS and ARS.

Source: Bundesanzeiger, BAnz AT 16.09.2026 B1 from September 16, 2026, Announcement of a resolution of the Federal Joint Committee (official reference: BAnz AT 16.09.2026 B1).