Imipenem / Cilastatin / Relebactam (2) – Recarbrio®

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.