Meropenem / Vaborbactam (1) – Vaborem®
Acterial infections, several therapeutic indications
Characteristics
| Start date | 01.11.2024 – Marketing authorisation: 20.11.2018 |
|---|---|
| Resolution | 17.04.2025 |
| INN | Meropenem/Vaborbactam |
| Brand name | Vaborem® |
| Pharm. company | Berlin-Chemie AG |
| G-BA Procedure ID | D-1134 |
| ATC code | J01DH52 Carbapenems (J01DH) |
| 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, 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, K65.09, K65.8Chronic proliferative peritonitis, K65.9Bacterial peritonitis NOS, K75.0Abscess of liver, K80.40Calculus of bile duct with cholecystitis, unspecified, without obstruction, K81.0Abscess of gallbladder, N39.0Urinary tract infection, site not specified, N41.3Prostatocystitis, N73.0Abscess of broad ligament, N73.3Female acute pelvic peritonitis, N73.4Female chronic pelvic peritonitis, N73.5Female pelvic peritonitis, unspecified, O08.0Genital tract and pelvic infection following ectopic and molar pregnancy, 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, T81.4Infection following a procedure, T83.5Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system, T85.71Infection and inflammatory reaction due to peritoneal dialysis catheter |
| Alpha-ID codes (AIS) | I117481Pneumonia caused by gram-negative aerobic bacteria, 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, I5800Bile duct stone with cholecystitis, I64838Septic pleuropneumonia, I71293Sepsis caused by gram-negative pathogens, I7138Bacterial cystitis, I7148Nonspecific urethritis, I7256Acute pelveoperitonitis in women, I7259Chronic pelveoperitonitis in women, I7260Pelveoperitonitis in women, I7735Infection of the reproductive organs after abortion, 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, I87853Small bowel diverticulitis with perforation, I87924Colonic diverticulitis with perforation and bleeding, I87926Small bowel diverticulitis with perforation and bleeding, I87976Intestinal diverticulitis with peritonitis, I88033Intestinal diverticulitis with peritonitis with bleeding, I88416Diverticulitis of the small intestine and colon with peritonitis, I88417Diverticulitis of the small intestine and colon with peritonitis with bleeding, I88696Non-obstructive chronic pyelonephritis, I89137Postpartum infection of the urogenital tract, I89303Intra-abdominal abscess after medical procedures, I95572Ureteral constriction with infection, I96489Meningitis caused by gram-negative bacteria, I97005Pyelonephritis with obstruction, I97652Bacteremia due to staphylococci, I97654Bacteremia due to gram-negative bacteria, I97875Spontaneous bacterial peritonitis |
| Therapeutic area | Infectious diseases Bacterial infections, 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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Vaborem is indicated for the treatment of the following infections in adults: – Complicated urinary tract infection (cUTI) including pyelonephritis – Complicated intra-abdominal infection (cIAI) – Nosocomial acquired pneumonia (HAP: hospital-acquired pneumonia) including – Ventilator-associated pneumonia (VAP)
Treatment of patients with bacteraemia associated or suspected to be associated with any of the above infections. Vaborem is also indicated for the treatment of infections caused by aerobic Gram-negative organisms in adults with limited treatment options. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with complicated urinary tract infection (cUTI), including pyelonephritis | |
| b) | Adults with complicated intra-abdominal infection (cIAI) | |
| c) | Adults with nosocomial acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) | |
| d) | Adults with bacteraemia associated with complicated urinary tract infection, including pyelonephritis, with complicated intra-abdominal infection or with nosocomial pneumonia, including ventilator-associated pneumonia, or if a corresponding association is suspected | |
| e) | Adults with infections caused by aerobic gram-negative organisms 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 urinary tract infection (cUTI), including pyelonephritis
- The additional benefit is deemed proven.
- For the medicinal product Vaborem, containing the combination of active substances meropenem andVaborbactam, 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 7 March 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).
b) Adults with complicated intra-abdominal infection (cIAI)
- The additional benefit is deemed proven.
- For the medicinal product Vaborem, containing the combination of the active substances meropenem andvaborbactam, 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 7 March 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 hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
- The additional benefit is deemed proven.
- For the medicinal product Vaborem, containing the combination of active substances meropenem andvaborbactam, 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 7 March 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).
d) Adults with bacteraemia occurring in connection with a complicated urinary tract infection, including pyelonephritis, a complicated intra-abdominal infection or nosocomial pneumonia, including ventilator-associated pneumonia, or where such a connection is suspected
- The additional benefit is deemed proven.
- For the medicinal product Vaborem, containing the combination of active substances meropenem andVaborbactam, 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 7 March 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).
e) Adults with infections caused by aerobic Gram-negative organisms for which treatment options are limited
- The additional benefit is deemed proven.
- For the medicinal product Vaborem, containing the combination of active substances meropenem andvaborbactam, 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 7 March 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).
Courtesy translation only, please refer to the German original.
Associated procedures
| Meropenem / Vaborbactam (1) | Vaborem® | Berlin-Chemie AG | Acterial infections, several therapeutic indications | 1,294–1,405 | 100% additional benefit considered proven |
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