Ceftolozan / Tazobactam (6) – Zerbaxa®

• Clinical trials
  • The pharmaceutical manufacturer submitted a dossier in due time on 11 March 2020 in accordance with Section 4(3)(2) of the Medicinal Products Benefit Assessment Regulation (AM-NutzenV) in conjunction with Chapter 5, Chapter § 8(1)(2) of the Rules of Procedure (VerfO) of the G-BA for the combination of active substances ceftolozan and tazobactam in the therapeutic indications of hospital-acquired pneumonia ( HAP), including ventilator-associated pneumonia (VAP) in adults, complicated intra-abdominal infections in adults, complicated urinary tract infections in adults and acute pyelonephritis in adults.

a) Adults with complicated intra-abdominal infections

• The additional benefit is deemed proven.
• For the medicinal product Zerbaxa, containing the combination of active substances ceftolozan andtazobactam, 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).

b) Adults with acute pyelonephritis

• The additional benefit is deemed proven.
• For the medicinal product Zerbaxa, containing the combination of active substances ceftolozane/tazobactam, 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.
• 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 complicated urinary tract infections

• The additional benefit is deemed proven.
• For the medicinal product Zerbaxa, containing the combination of active substances ceftolozan andtazobactam, 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).

d) Adults with hospital-acquired pneumonia, including ventilator-associated pneumonia

• The additional benefit is deemed proven.
• For the medicinal product Zerbaxa, containing the combination of active substances ceftolozan andtazobactam, 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.
• 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.