Aztreonam / Avibactam (1) – Emblaveo®

a) Adults with complicated intra-abdominal infections (cIAI)

• The additional benefit is deemed proven.
• For the medicinal product Emblaveo, containing the combination of active substances aztreonam andavibactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of Book V of the Social Code (SGB V) was granted by resolution of 4 April 2024, 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) Adults with nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP)

• The additional benefit is deemed proven.
• For the medicinal product Emblaveo, containing the combination of active substances aztreonam andavibactam, 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 4 April 2024, 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).

c) Adults with complicated urinary tract infections (cUTI), including pyelonephritis

• The additional benefit is deemed proven.
• For the medicinal product Emblaveo, containing the combination of active substances aztreonam andavibactam, 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 4 April 2024, 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).

d) 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 Emblaveo, containing the combination of active substances aztreonam andavibactam, 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 4 April 2024, 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).

Courtesy translation only, please refer to the German original.