Ceftazidim / Avibactam (2) – Zavicefta®

a) Children from birth to < 3 months with complicated intra-abdominal infections (cIAI)

• The additional benefit is deemed proven.
• For the medicinal product Zavicefta, containing the combination of active substances ceftazidime/avibactam, 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).

b) Children from birth up to < 3 months of age with complicated urinary tract infections (cUTI), including pyelonephritis

• The additional benefit is deemed proven.
• For the medicinal product Zavicefta, containing the combination of active substances ceftazidime/avibactam, 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 (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) Infants from birth up to < 3 months of age with nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP)

• The additional benefit is deemed proven.
• For the medicinal product Zavicefta, containing the combination of active substances ceftazidime/avibactam, 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).

d) Children from birth up to < 3 months 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 Zavicefta, containing the combination of active substances ceftazidime/avibactam, 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).
• Overall assessment
  • No designation of medicinal products containing new INN active ingredients that can be used in combination therapy in accordance with Section 35a(3), fourth sentence, of the SGB V, as the G-BA has decided to grant an exemption for the assessed medicinal product as a reserve antibiotic in accordance with Section 35a(1c), first sentence, of the SGB V.

Courtesy translation only, please refer to the German original.