Ceftazidim / Avibactam (1) – Zavicefta®
Bacterial infections, multiple indications
Characteristics
| Start date | 01.05.2022 – Marketing authorisation: 22.10.2020 |
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| Resolution | 03.11.2022 |
| INN | Ceftazidim/Avibactam |
| Brand name | Zavicefta® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-816 |
| ATC code | J01DD52 Third-generation cephalosporins (J01DD) |
| ICD-10 codes (AIS) | A41.58, A49.9Bacterial infection, unspecified, 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, 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) | I117481Pneumonia caused by gram-negative aerobic bacteria, I21495Bacteremia, I21736Prostatocystitis, I21812Infection caused by Pseudomonas aeruginosa, 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, I71293Sepsis caused by gram-negative pathogens, 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, I96489Meningitis caused by gram-negative bacteria, I97005Pyelonephritis with obstruction, I97654Bacteremia due to gram-negative bacteria |
| DDD | 6 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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Zavicefta is used in adults and paediatric patients from the age of 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), Treatment of adult patients with bacteraemia related or suspected to one of the above suspected association with any of the above infections |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Complicated intra-abdominal infections (cIAI) | |
| b) | Adults and paediatric patients from the age of 3 months with complicated urinary tract infections (cUTI), including pyelonephritis | |
| c) | Adults and paediatric patients from the age of 3 months with nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP) | |
| d) | Adult patients with bacteraemia associated with or suspected of being associated with complicated intra-abdominal infections (cIAI). suspected association with complicated intra-abdominal infections (cIAI), with complicated urinary tract infections (cUTI), including pyelonephritis, or with nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP). | |
| e) | Adults and paediatric patients from the age of 3 months with infections caused by 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) | Other |
a) Adult and paediatric patients aged 3 months and over 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, 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).
b) Adult and paediatric patients aged 3 months and over 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 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 proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
c) Adult and paediatric patients aged 3 months and over 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 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).
(d) Adult patients with bacteraemia associated with, or suspected of being associated with, complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), including pyelonephritis, or 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, 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).
e) Adult and paediatric patients aged 3 months and over 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 andavibactam, 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 (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.
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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