Cefepim / Enmetazobactam (1) – Exblifep®

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

• The additional benefit is deemed proven.
• For the medicinal product Exblifep, containing the combination of active substances cefepime and enmetazobactam, an exemption from the obligation to submit the evidence required under Section 35a(1), third sentence, points 2 and 3 of Book V of the Social Code (SGB V) was granted by resolution of 2 May 2024, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of the German Social Code, Book V (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 hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)

• The additional benefit is deemed proven.
• For the medicinal product Exblifep, containing the combination of active substances cefepime and enmetazobactam, an exemption from the obligation to submit the evidence required under Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 2 May 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).

c) Adults with bacteraemia occurring in association with complicated urinary tract infections (cUTI), including pyelonephritis, or with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), or where such a connection is suspected

• The additional benefit is deemed proven.
• For the medicinal product Exblifep, containing the combination of active substances cefepime and enmetazobactam, an exemption from the obligation to submit the evidence required under Section 35a(1), third sentence, points 2 and 3 of Book V of the Social Code (SGB V) was granted by resolution of 2 May 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).

Courtesy translation only, please refer to the German original.