Imipenem / Cilastatin / Relebactam (2) – Recarbrio®

Bacterial infections, multiple indications

Characteristics

Start date 01.05.2022
Resolution 03.11.2022
INN Imipenem/Cilastatin/Relebactam
Brand name Recarbrio®
Pharm. company MSD Sharp & Dohme GmbH
G-BA Procedure ID D-814
ATC code J01DH56 Carbapenems (J01DH)
ICD-10 codes (AIS) A41.58, A49.9Bacterial infection, unspecified, A49.9Bacterial infection, unspecified, G00.9Meningitis due to gram-negative bacteria, unspecified, J15.4Pneumonia due to other streptococci, J15.5Pneumonia due to Escherichia coli, J15.6Pneumonia due to other aerobic Gram-negative bacteria, J15.6Pneumonia due to other aerobic Gram-negative bacteria, J15.8Pneumonia due to other specified bacteria, J15.9Pneumonia due to gram-positive bacteria, J18.0Bronchopneumonia, unspecified organism, J18.1Lobar pneumonia, unspecified organism, J18.2Hypostatic bronchopneumonia, J18.8Other pneumonia, unspecified organism, J18.9Pneumonia, unspecified organism, J69.0Pneumonitis due to inhalation of food and vomit, J85.1Abscess of lung with pneumonia, J95.4Chemical pneumonitis due to anesthesia
Alpha-ID codes (AIS) I117481Pneumonia caused by gram-negative aerobic bacteria, I5039Pneumonia caused by Haemophilus influenzae, I5040Pneumonia caused by Klebsiella pneumoniae, I5041Pneumonia due to Pseudomonas, I5042Pneumonia due to staphylococci, I5044Pneumonia caused by group B streptococci, I5045Pneumonia due to streptococci, I5046Pneumonia caused by Escherichia coli, I5058Bacterial pneumonia, I5288Lung abscess with pneumonia, I64838Septic pleuropneumonia, I71293Sepsis caused by gram-negative pathogens, I78857Aspiration pneumonitis, I96489Meningitis caused by gram-negative bacteria, I97651Bacteremia due to streptococci, I97652Bacteremia due to staphylococci, I97654Bacteremia due to gram-negative bacteria
DDD 2 g P
Therapeutic area Infectious diseases Antibiotikatherapie, Nosocomial pneumonia (HAP)
Reason for procedure New therapeutic indication – Reserve antibiotic
Regulatory status Reserve antibiotic

Therapeutic indication of the resolution

Recarbrio is indicated for:

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

Treatment of bacteremia for which there is or is suspected to be an association with HAP or VAP in adults.

Treatment of infections with aerobic Gram-negative pathogens in adults with limited treatment options.
Subpopulation Indication Comparator
a) Adults with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
b) Adults with bacteraemia for which there is an association with HAP or VAP or suspected
c) Adults with infections due to aerobic gram-negative pathogens with limited treatment options

Studies and Results

No. of studies
(best subpopulation) 		0 (no data submitted)
Study design
(best subpopulation) 		no data submitted (Dossier: Other)
Reason for dividing into subpopulations (G-BA) Other

a) Adults with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)

  • The additional benefit is deemed proven.
  • For the medicinal product Recarbrio, containing the combination of active substances imipenem/cilastatin/ relbactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).

b) Adults with bacteraemia that is known or suspected to be associated with HAP or VAP

  • The additional benefit is deemed proven.
  • For the medicinal product Recarbrio, containing the combination of active substances imipenem/cilastatin/ relebactam, an exemption from the obligation to submit evidence pursuant to Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • If the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic in accordance with Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).

c) Adults with infections caused by aerobic Gram-negative pathogens for which treatment options are limited

  • The additional benefit is deemed proven.
  • For the medicinal product Recarbrio, containing the combination of active substances imipenem/cilastatin/ relebactam, an exemption from the obligation to submit evidence pursuant to Section 35a(1), third sentence, numbers 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).

Courtesy translation only, please refer to the German original.

Associated procedures



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