meropenem/vaborbactam (Vaborem)

following a full submission:

meropenem/vaborbactam (Vaborem®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of the following infections in adults:
• Complicated urinary tract infection (cUTI), including pyelonephritis
• Complicated intra-abdominal infection (cIAI)
• Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Meropenem/vaborbactam is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

SMC restriction: for adults with confirmed carbapenem-resistant Enterobacteriaceae (CRE), which is involved in the production of Klebsiella pneumoniae carbapenemase (KPC) associated with cUTI (including acute pyelonephritis [AP]), cIAI, HAP (including VAP) and bacteraemia that occurs in association with, or is suspected to be associated with any of the infections previously mentioned. Use should be on the advice of local microbiologists or specialists in infectious disease.

In a randomised, double-blind, phase III study, meropenem/vaborbactam was non-inferior to a beta-lactamase/beta-lactamase inhibitor for the treatment of adults with cUTI, including AP. A smaller, randomised, open-label, phase III study suggested that meropenem/vaborbactam compared favourably with best available therapy for the treatment of adults with infections due to confirmed/suspected CRE.