Imipenem / Cilastatin / Relebactam (1) – Recarbrio®

• Based on the criteria set out in Chapter 5, Section 15a of the VerfO for classifying an antibiotic as a reserve antibiotic, and taking into account the criteria for classifying an antibiotic as a reserve antibiotic published by the Robert KochInstitute has published on its website pursuant to Section 35a(1c), fifth sentence, of SGB V, as well as the documents submitted by the applicant, the Federal Joint Committee (G-BA) has decided, to grant the following application by a pharmaceutical manufacturer for exemption of a finished drug from the obligation to submit the evidence required under Section 35a(1), sentence 3, points 2 and 3 of the SGB V:
• Active ingredient (INN): Imipenem-cilastatin-relebactam
• Imipenem-cilastatin-relebactam has marketing authorisation for the treatment of the following infections: - Treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), in adults; - Treatment of bacteraemia that is associated with, or suspected to be associated with, HAP or VAP in adults; - Treatment of infections caused by aerobic Gram-negative pathogens in adults with limited treatment options.
• The therapeutic indication ‘treatment of infections caused by aerobic Gram-negative pathogens in adults with limited treatment options’ constitutes a marketing authorisation for a pathogen-specific indication in accordance with EMA/84491/2018 (Rev. 3) in accordance with criterion 1.1 of the list of indicators.

• The application for exemption from the requirement to submit evidence under Section 35a(1), third sentence, points 2 and 3 of the German Social Code, Book V (SGB V), on the grounds of reserve status under Section 35a(1c) of the German Social Code, Book V (SGB V), is granted, as the information provided by the pharmaceutical manufacturer is sufficient to justify the classification of the active ingredient imipenem-cilastatin-relebactam as a reserve antibiotic in accordance with Chapter 5, Section 15a of the VerfO.
• The pharmaceutical manufacturer states that the spectrum of activity of imipenem-cilastatin-relebactam is directed against the following multi-resistant pathogens on the RKI’s list of pathogens: - Escherichia coli, carbapenem-resistant (CR) -Klebsiella spp., CR -Pseudomonas aeruginosa, CR
• In vitro data have been submitted for this purpose, demonstrating sufficient susceptibility of imipenem- and meropenem-resistant P. aeruginosa to imipenem-cilastatin-relebactam.
• Given the sufficient total number of isolates, the data are considered to be sufficiently meaningful.
• No conclusion regarding efficacy against E. coli, CR and Klebsiella spp., CR can be drawn from the data provided, as only a minor number of isolates are available.
• The factual requirement of efficacy against infections caused by multidrug-resistant bacterial pathogens, for which only limited alternative treatment options are available, is certainly met for the pathogen Pseudomonas aeruginosa, CR, which is included on the RKI’s list of pathogens.
• Due to the pathogen-specific marketing authorisation for patients with limited treatment options and the efficacy against at least one pathogen on the pathogen list, criterion 1.1 of the Robert Koch Institute’s indicator list is fulfilled.
• An assessment of the further criteria 1.2 (in vivo data) and 2.1 (guideline review) is not required in this case.
• The factual requirement that the use of the antibiotic is subject to strict indications is, according to the current assessment, met by the fact that, as stated in the SmPC, the marketing authorisation is restricted to patients with limited treatment options.
• However, this applies only to the therapeutic indication ‘treatment of infections caused by aerobic Gram-negative pathogens in adults with limited treatment options’.
• The Federal Joint Committee (G-BA) therefore reserves the right to lay down further provisions in its resolution pursuant to Section 35a(3) of Book V of the Social Code (SGB V) regarding the requirements for a quality-assured application, including to ensure compliance with the criterion of strict indication.
• The application was therefore to be granted.

Courtesy translation only, please refer to the German original.