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VABOREM

Opinions on drugs - Posted on Feb 21 2020

Reason for request

First assessment

  • Key points

Favourable opinion for reimbursement in the MA indications only as a last resort for the treatment of patients with enterobacteria infections susceptible to the meropenem/vaborbactam combination and for whom recourse to other beta-lactams and carbapenems (meropenem or imipenem-cilastatin) cannot be envisaged in the event of resistance, in particular via the production of KPC-type carbapenemases.

Unfavourable opinion for reimbursement in the other clinical situations.

  • What therapeutic improvement?

Moderate therapeutic improvement in the treatment of enterobacteria infections susceptible to the meropenem/vaborbactam combination and for whom recourse to other beta-lactams and carbapenems (meropenem or imipenem-cilastatin) cannot be envisaged in the event of resistance.

  • Role in the care pathway?

In June 2019, the HAS published guidelines relating to the antibiotic treatment of Enterobacteriaceae and Pseudomonas aeruginosa infections in adults, specifying the role of carbapenems and their alternatives.

Role of the medicinal product in the care pathway

VABOREM (meropenem/vaborbactam) is a last resort treatment reserved for the treatment of patients with enterobacteria infections susceptible to meropenem/vaborbactam and for whom recourse to carbapenems cannot be envisaged in the event of resistance, in particular with a KPC-type resistance mechanism.

VABOREM (meropenem/vaborbactam) should not be used as an alternative to carbapenems for the treatment of TGC-resistant enterobacteria and for the treatment of P. aeruginosa infections.

  • Special recommendations

Given the product characteristics and the need to restrict its use to a last resort treatment only in order to preserve it, the therapeutic decision should be taken with the help of an antibiotic expert, with systematic reassessment 48 hours after the start of treatment.

 


Clinical Benefit

Substantial

the clinical benefit of VABOREM (meropenem/vaborbactam) in the MA indications is:

  • substantial only as a last resort for the treatment of patients with enterobacteria infections susceptible to the meropenem/vaborbactam combination and for whom recourse to other beta-lactams and carbapenems (meropenem or imipenem-cilastatin) cannot be envisaged in the event of resistance, in particular via the production of KPC-type carbapenemases;

 

 

Insufficient
  • insufficient to justify its funding by the French national health insurance system in all other clinical situations.

 

 


Clinical Added Value

moderate

VABOREM provides a moderate clinical added value (CAV III) in the treatment of enterobacteria infections susceptible to the meropenem/vaborbactam combination and for whom recourse to other beta-lactams and carbapenems (meropenem or imipenem-cilastatin) cannot be envisaged in the event of resistance.


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