Ceftolozan / Tazobactam (6) – Zerbaxa®
Bacterial infections, multiple indications
Characteristics
| Start date | 01.05.2022 – Marketing authorisation: 25.07.2022 |
|---|---|
| Resolution | 03.11.2022 |
| INN | Ceftolozan/Tazobactam |
| Brand name | Zerbaxa® |
| Pharm. company | MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-815 |
| ATC code | J01DI54 Other cephalosporins and penems (J01DI) |
| ICD-10 codes (AIS) | J14Pneumonia due to Hemophilus influenzae, J15.0Pneumonia due to Klebsiella pneumoniae, J15.1Pneumonia due to Pseudomonas, J15.5Pneumonia due to Escherichia coli, J15.6Pneumonia due to other aerobic Gram-negative bacteria, J15.8Pneumonia due to other specified bacteria, J15.9Pneumonia due to gram-positive bacteria, J18.0Bronchopneumonia, unspecified organism, J18.1Lobar pneumonia, unspecified organism, J18.2Hypostatic bronchopneumonia, J18.8Other pneumonia, unspecified organism, J18.9Pneumonia, unspecified organism, J69.0Pneumonitis due to inhalation of food and vomit, J85.1Abscess of lung with pneumonia, J95.4Chemical pneumonitis due to anesthesia, N15.10, N15.9Renal tubulo-interstitial disease, unspecified, N28.88, N30.0Acute cystitis, N30.1Interstitial cystitis (chronic), N30.2Other chronic cystitis, N30.3Urethrotrigonitis, N30.80, N30.88, N30.9Cystitis, unspecified, N34.0Urethral abscess, N34.1Nongonococcal urethritis, N34.2Meatitis, urethral, N39.0Urinary tract infection, site not specified, N41.3Prostatocystitis, O23.0Pyelonephritis in pregnancy, O23.1Infections of bladder in pregnancy, O23.2Infections of urethra in pregnancy, O23.3Infections of other parts of urinary tract in pregnancy, O23.4Unspecified infection of urinary tract in pregnancy, O23.9Genitourinary tract infection in pregnancy NOS, O86.2Urinary tract infection following delivery, O86.3, T83.5Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| Alpha-ID codes (AIS) | I110677Hypostatic pneumonia, I119205Pneumonia caused by gram-negative bacteria, I17772Lobar pneumonia, I19728Kidney infection, I20451Reflux pyelonephritis, I21370Pneumonia, I21736Prostatocystitis, I21834Pyelonephritis, I21837Acute bacterial pyelonephritis, I21841Recurrent pyelonephritis, I22426Trigonum cystitis, I22581Bronchopneumonia, I22589Ureteral infection, I22701Urethral abscess, I22872Urethritis, I23169Acute cystitis, I23174Chronic cystitis, I23178Chronic interstitial cystitis, I24324Pyonephrosis, I28449Mendelson syndrome, I5039Pneumonia caused by Haemophilus influenzae, I5040Pneumonia caused by Klebsiella pneumoniae, I5041Pneumonia due to Pseudomonas, I5046Pneumonia caused by Escherichia coli, I5058Bacterial pneumonia, I5288Lung abscess with pneumonia, I64838Septic pleuropneumonia, I7138Bacterial cystitis, I7148Nonspecific urethritis, I7831Infection of the urogenital tract during pregnancy, I7832Kidney infection during pregnancy, I7840Urinary bladder infection during pregnancy, I7843Urethra infection during pregnancy, I78857Aspiration pneumonitis, I8335Postpartum infection of the urinary tract, I88696Non-obstructive chronic pyelonephritis, I89137Postpartum infection of the urogenital tract, I95572Ureteral constriction with infection, I97005Pyelonephritis with obstruction |
| DDD | 3 g P |
| Therapeutic area | Infectious diseases Antibiotikatherapie, Complicated intra-abdominal infections (cIAI), Nosocomial pneumonia (HAP) |
| Reason for procedure | Initial assessment – Reserve antibiotic |
| Regulatory status | Reserve antibiotic |
| Therapeutic indication of the resolution |
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Zerbaxa is indicated for the treatment of the following infections in adult and pediatric patients: Complicated intra-abdominal infections; Acute pyelonephritis; Complicated urinary tract infections. Zerbaxa is also indicated in adults for the treatment of the following infection in adult patients (18 years of age and older): Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with complicated intra-abdominal infections | |
| b) | Adults with acute pyelonephritis | |
| c) | Adults with complicated urinary tract infection | |
| d) | Adults with hospital-acquired pneumonia, including ventilator-associated pneumonia |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
| Reason for dividing into subpopulations (G-BA) | Other |
- 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.
Associated procedures
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