Aztreonam / Avibactam (1) – Emblaveo®
Bacterial infections, several therapeutic indications
Characteristics
| Start date | 01.09.2024 – Marketing authorisation: 22.04.2024 |
|---|---|
| Resolution | 20.02.2025 |
| INN | Aztreonam/Avibactam |
| Brand name | Emblaveo® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-1101 |
| 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, N11.9Chronic interstitial nephritis NOS, N12Tubulo-interstitial nephritis, not specified as acute or chronic, N13.60, N13.61, N13.62, N13.63, N13.64, N13.65, N13.66, N13.67, N13.68, 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, I131040Hydronephrosis with infection of the kidney, I131041Hydronephrosis due to obstruction by stone, with infection of the kidney, I131042Hydroureter with infection of the kidney, I131044Hydronephrosis in ureteropelvic obstruction with infection of the kidney, I131046Hydronephrosis in obstruction due to kidney stone with infection of the kidney, I131047Hydronephrosis in obstruction due to ureteral calculi with infection of the kidney, I13283Urinary bladder abscess, I13588Cystitis, I15694Urinary tract infection n.e.c, I19495Kidney abscess, 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, I24324Pyonephrosis, 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, 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 |
| Therapeutic area | Infectious diseases Bacterial infections, Complicated intra-abdominal infections (cIAI) |
| Reason for procedure | Initial assessment – Reserve antibiotic |
| Regulatory status | Reserve antibiotic |
| Therapeutic indication of the resolution |
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Emblaveo is indicated for the treatment of the following infections in adult patients: – Complicated intra-abdominal infections (cIAI) – Nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP) – Complicated urinary tract infections (cUTI), including pyelonephritis – Emblaveo is also indicated for the treatment of infections due to aerobic Gram-negative pathogens in adult patients with limited treatment options |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with complicated intra-abdominal infections (cIAI) | |
| b) | Adults with nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP) | |
| c) | Adults with complicated urinary tract infections (cUTI), including pyelonephritis | |
| d) | Adults with infections due to aerobic Gram-negative pathogens with limited treatment options 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) Adults with complicated intra-abdominal infections (cIAI)
- The additional benefit is deemed proven.
- For the medicinal product Emblaveo, containing the combination of active substances aztreonam andavibactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of Book V of the Social Code (SGB V) was granted by resolution of 4 April 2024, 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) Adults with nosocomial pneumonia (HAP), including ventilator-associated pneumonia (VAP)
- The additional benefit is deemed proven.
- For the medicinal product Emblaveo, containing the combination of active substances aztreonam andavibactam, 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 4 April 2024, 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) Adults with complicated urinary tract infections (cUTI), including pyelonephritis
- The additional benefit is deemed proven.
- For the medicinal product Emblaveo, containing the combination of active substances aztreonam andavibactam, 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 4 April 2024, 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).
d) Adults with infections caused by aerobic Gram-negative pathogens for which treatment options are limited
- The additional benefit is deemed proven.
- For the medicinal product Emblaveo, containing the combination of active substances aztreonam andavibactam, 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 4 April 2024, 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).
Courtesy translation only, please refer to the German original.
Associated procedures
| Aztreonam / Avibactam (1) | Emblaveo® | Pfizer Pharma GmbH | Bacterial infections, several therapeutic indications | 2,600–6,600 | 100% additional benefit considered proven |
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