Imipenem / Cilastatin / Relebactam (3) – Recarbrio®

• Clinical trials
  • 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 the German Social Code, Book V (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.

a) Paediatric patients under 18 years of age 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/relebactam, 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 (G-BA) 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) Paediatric patients under 18 years of age with bacteraemia for which a link to HAP or VAP exists or is suspected

• 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 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 to have been proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).

c) Paediatric patients under 18 years of age 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 in accordance with 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.