G-BA entbindet Recarbrio von der Nachweispflicht in Deutschland; Ausnahme für Reserve-Antibiotikum

G-BA entbindet Recarbrio von der Nachweispflicht in Deutschland; Ausnahme für Reserve-Antibiotikum

Justification

Courtesy translation – only the German version is legally binding.

Justification for the Resolution of the Federal Joint Committee (G-BA) on an Amendment of the Pharmaceuticals Directive: Annex XII – Benefit Assessment of Medicinal Products with New Active Ingredients according to Section 35a SGB V Imipenem/ cilastatin/ relebactam (new therapeutic indication: bacterial infections, multiple therapeutic indications, < 18 years)

From 6 August 2026 Contents 1. Legal basis ……………………………………………………………………………………………….. 2 2. Key points of the resolution ………………………………………………………………………… 2

Additional benefit of the medicinal product …………………………………………………… 4 2.1.1 Approved therapeutic indication of imipenem/ cilastatin/ relebactam (Recarbrio) in accordance with the product information ………………………….. 4 2.1.2 Extent of the additional benefit and significance of the evidence ……………… 4 2.1.3 Summary of the assessment …………………………………………………………………. 5 2.2 Number of patients or demarcation of patient groups eligible for treatment ……….. 5 2.3 Requirements for a quality-assured application ……………………………………………… 6 2.4 Treatment costs ………………………………………………………………………………………… 7 3. Bureaucratic costs calculation ……………………………………………………………………. 11 4. Process sequence ……………………………………………………………………………………. 11

Courtesy translation – only the German version is legally binding. 2 1. Legal basis According to Section 35a paragraph 1 German Social Code, Book Five (SGB V), the Federal Joint Committee (G-BA) assess the benefit of all reimbursable medicinal products with new active ingredients. Pursuant to Section 35a, paragraph 1c, sentence 1 SGB V, the Federal Joint Committee shall exempt the pharmaceutical company from the obligation to submit the evidence pursuant to Section 35a, paragraph 1, sentence 3, numbers 2 and 3 SGB V (medical benefit and additional medical benefit in relation to the appropriate comparator therapy) upon request, if it is an antibiotic that is effective against infections caused by multidrug-resistant bacterial pathogens with limited treatment options and the use of this antibiotic is subject to a strict medical assessment of the therapeutic indication (reserve antibiotic). The additional benefit is deemed to be proven if the Federal Joint Committee have decided on an exemption for a reserve antibiotic in accordance with Section 35a, paragraph 1c, sentence 1 SGB V; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee. In the resolution according to Section 35a, paragraph 3, sentence 1 SGB V, the Federal Joint Committee shall specify the requirements for a quality-assured application of the reserve antibiotic pursuant to Section 35a, paragraph 1c, sentence 8 SGB V, taking into account the effects on the resistance situation. Pursuant to Chapter 5, Section 20, paragraph 6, sentence 3 of the Rules of Procedure (VerfO) of the G-BA, the Federal Joint Committee may lay down restrictive requirements for the use of the antibiotic in order to ensure a strict medical assessment of the therapeutic indication, if this is necessary to maintain the reserve status of the medicinal product. With regard to these requirements for a quality-assured application of the reserve antibiotic, the Federal Joint Committee shall obtain a statement from the Robert Koch Institute (RKI), which shall be prepared in agreement with the Federal Institute for Drugs and Medical Devices (BfArM). Pursuant to Section 35a, paragraph 3 SGB V, the G-BA pass a resolution on the benefit assessment, taking into account the requirements for a quality-assured application according to Section 35a, paragraph 1c, sentence 8 SGB V, within three months of publication of the resolution. The resolution is to be published on the internet and is part of the Pharmaceuticals Directive. 2. Key points of the resolution By resolution of 20 January 2022, the Federal Joint Committee decided that the pharmaceutical company is exempted from the obligation to submit evidence in the benefit assessment procedure for the medicinal product Recarbrio with the combination of active ingredients imipenem/ cilastatin/ relebactam according to Section 35a, paragraph 1, sentence 3, numbers 2 and 3 SGB V, since the medicinal product Recarbrio with the combination of active ingredients imipenem/ cilastatin/ relebactam for the treatment of bacterial infections is a reserve antibiotic within the meaning of Section 35a, paragraph 1c, sentence 1 SGB V. The combination of active ingredients imipenem/ cilastatin/ relebactam (Recarbrio) was listed for the first time on 15 June 2021 in the “LAUER-TAXE®”, the extensive German registry of available medicinal products and their prices. On 19 January 2026, imipenem/ cilastatin/ relebactam received marketing authorisation for a new therapeutic indication to be classified as a major type 2 variation as defined according to

Courtesy translation – only the German version is legally binding. 3 Annex 2, number 2, letter a to Regulation (EC) No. 1234/2008 of the Commission of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334 from 12.12.2008, sentence 7). On 11 February 2026, i.e. at the latest within four weeks of informing the pharmaceutical company about the approval for a new therapeutic indication, the pharmaceutical company submitted the final dossier to the G-BA in due time in accordance with Section 4, paragraph 3, number 2 Ordinance on the Benefit Assessment of Pharmaceuticals (AM-NutzenV) in conjunction with Chapter 5, Section 8, paragraph 1, number 2 of the Rules of Procedure (VerfO) of the G-BA. In this, the pharmaceutical company submitted evidence pursuant to Section 35a, paragraph 1, sentence 3, numbers 1, 4 and 5 SGB V and evidence on the requirements for a quality-assured application of the reserve antibiotic, taking into account the effects on the resistance situation (Chapter 5 VerfO Annex II. 1 Section 1.4). The assessment procedure began on 15 February 2026. The additional benefit is deemed to be proven if the Federal Joint Committee have decided on an exemption for a reserve antibiotic in accordance with Section 35a, paragraph 1c, sentence 1 SGB V; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee. In the resolution according to Section 35a, paragraph 3, sentence 1 SGB V, the Federal Joint Committee shall specify requirements for a quality-assured application of the reserve antibiotic, taking into account the effects on the resistance situation. A draft of the requirements for a quality-assured application of the reserve antibiotic was made available to the RKI for drafting a statement in agreement with the BfArM in accordance with Section 35a, paragraph 1c SGB V. The G-BA commissioned the IQWiG to assess the information provided by the pharmaceutical company in Module 3 of the dossier on treatment costs and patient numbers. The draft of the requirements for a quality-assured application as well as the RKI statement drafted in agreement with the BfArM were published on the G-BA website (www.g-ba.de) together with IQWiG’s assessment of treatment costs and patient numbers, thus initiating the written statement procedure. The oral hearing has been dispensed with since all assessment experts who submitted written statements waived their right to make an oral statement. The G-BA have adopted their resolution on the basis of the dossier of the pharmaceutical company, the draft of the requirements for a quality-assured application prepared by the G- BA taking into account the joint statement of RKI/BfArM, the IQWiG’s assessment of treatment costs and patient numbers (IQWiG 26-06) and the written statements.

Courtesy translation – only the German version is legally binding. 4

Additional benefit of the medicinal product 2.1.1 Approved therapeutic indication of imipenem/ cilastatin/ relebactam (Recarbrio) in accordance with the product information Recarbrio is indicated in paediatric patients from birth for:

Treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP.

Treatment of infections due to aerobic Gram-negative organisms with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Therapeutic indication of the resolution (resolution of 6 August 2026): See the approved therapeutic indication

2.1.2 Extent of the additional benefit and significance of the evidence In summary, the additional benefit of imipenem/ cilastatin/ relebactam is assessed as follows:

a) Paediatric patients aged < 18 years with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) The additional benefit is considered proven. b) Paediatric patients aged < 18 years with bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP The additional benefit is considered proven. c) Paediatric patients aged < 18 years with infections due to aerobic Gram-negative organisms with limited treatment options The additional benefit is considered proven.

Justification: For the medicinal product Recarbrio with the combination of active ingredients imipenem/ cilastatin/ relebactam, an exemption from the obligation to submit the evidence according to Section 35a, paragraph 1, sentence 3, numbers 2 and 3 SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a, paragraph 1c, sentence 1 SGB V. The additional benefit is deemed to be proven if the Federal Joint Committee have decided on an exemption for a reserve antibiotic in accordance with Section 35a, paragraph 1c, sentence 1 SGB V; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee.

Courtesy translation – only the German version is legally binding. 5 2.1.3 Summary of the assessment Imipenem/ cilastatin/ relebactam is indicated in paediatric patients from birth for:

Treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP.

Treatment of infections due to aerobic Gram-negative organisms with limited treatment options. 3 patient groups were formed according to the individual therapeutic indications. The additional benefit of imipenem/ cilastatin/ relebactam is considered proven for every patient group. For the medicinal product Recarbrio with the combination of active ingredients imipenem/ cilastatin/ relebactam, an exemption from the obligation to submit the evidence according to Section 35a, paragraph 1, sentence 3, numbers 2 and 3 SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a, paragraph 1c, sentence 1 SGB V. The additional benefit is deemed to be proven if the Federal Joint Committee have decided