Ceftazidim / Avibactam (2) – Zavicefta®
Bacterial infections, several therapeutic indications, from birth to < 3 years
Characteristics
| Start date | 15.11.2024 – Marketing authorisation: 21.10.2024 |
|---|---|
| Resolution | 15.05.2025 |
| INN | Ceftazidim/Avibactam |
| Brand name | Zavicefta® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-1130 |
| ATC code | J01DD52 Third-generation cephalosporins (J01DD) |
| ICD-10 codes (AIS) | A41.58, A49.88, G00.9Meningitis due to gram-negative bacteria, unspecified, J15.6Pneumonia due to other aerobic Gram-negative bacteria, J15.6Pneumonia due to other aerobic Gram-negative bacteria, J15.8Pneumonia due to other specified bacteria, J15.9Pneumonia due to gram-positive bacteria, N13.61, N13.62, N13.63, N13.64, N13.65, N13.66, N13.67, N15.9Renal tubulo-interstitial disease, unspecified, N28.88, N30.0Acute cystitis, N30.1Interstitial cystitis (chronic), N30.2Other chronic cystitis, N30.3Urethrotrigonitis, N30.88, N30.9Cystitis, unspecified, N34.0Urethral abscess, N34.1Nongonococcal urethritis, N34.2Meatitis, urethral, N39.0Urinary tract infection, site not specified, N41.3Prostatocystitis, T83.5Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| Alpha-ID codes (AIS) | I117481Pneumonia caused by gram-negative aerobic bacteria, I15694Urinary tract infection n.e.c, I19728Kidney infection, I20451Reflux pyelonephritis, I21736Prostatocystitis, I21834Pyelonephritis, I21837Acute bacterial pyelonephritis, I21841Recurrent pyelonephritis, I22426Trigonum cystitis, I22589Ureteral infection, I22701Urethral abscess, I22872Urethritis, I23169Acute cystitis, I23174Chronic cystitis, I23178Chronic interstitial cystitis, I5039Pneumonia caused by Haemophilus influenzae, I5040Pneumonia caused by Klebsiella pneumoniae, I5041Pneumonia due to Pseudomonas, I5046Pneumonia caused by Escherichia coli, I5058Bacterial pneumonia, I71293Sepsis caused by gram-negative pathogens, I7138Bacterial cystitis, I7148Nonspecific urethritis, I88696Non-obstructive chronic pyelonephritis, I95572Ureteral constriction with infection, I96489Meningitis caused by gram-negative bacteria, I97005Pyelonephritis with obstruction, I97654Bacteremia due to gram-negative bacteria |
| Therapeutic area | Infectious diseases Complicated intra-abdominal infections (cIAI), Nosocomial pneumonia (HAP) |
| Reason for procedure | New therapeutic indication – Reserve antibiotic |
| Regulatory status | Reserve antibiotic |
| Therapeutic indication of the resolution |
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"Zavicefta is used in paediatric patients from birth to less than 3 months of age for the treatment of the following infections – Complicated intra-abdominal infections (cIAI) – Complicated urinary tract infections (cUTI), including pyelonephritis – Nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP). Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative pathogens in paediatric patients from birth to less than 3 months with limited treatment options." |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Children from birth to < 3 months with complicated intra-abdominal infections (cIAI) | |
| b) | Children from birth to < 3 months with complicated urinary tract infections (cUTI), including pyelonephritis | |
| c) | Children from birth to < 3 months with nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP) | |
| d) | Children from birth to < 3 months with infections due to aerobic Gram-negative pathogens with limited treatment options |
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) | Indications |
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.
Associated procedures
| Ceftazidim / Avibactam (2) | Zavicefta® | Pfizer Pharma GmbH | Bacterial infections, several therapeutic indications, from birth to < 3 years | 10–27 | 100% additional benefit considered proven | |
| Ceftazidim / Avibactam (1) | Zavicefta® | Pfizer Pharma GmbH | Bacterial infections, multiple indications | 2,600–6,600 | 100% additional benefit considered proven |
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