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ZAVICEFTA (avibactam/ ceftazidime)

β-lactams - β-lactamase inhibitors
Opinions on drugs - Posted on Feb 21 2020

Reason for request

Reevaluation

  • 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 ceftazidime/avibactam 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 or OXA-48 type carbapenemase.

Unfavourable opinion for reimbursement in the other clinical situations.

  • What therapeutic improvement?

Moderate therapeutic improvement in the treatment of enterobacteria infections susceptible to ceftazidime/avibactam 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

The ceftazidime/avibactam combination should not be used as an alternative to carbapenems for the treatment of TGC-resistant enterobacteria and for the treatment of P. aeruginosa infections.

ZAVICEFTA (ceftazidime/avibactam) is a last resort treatment reserved for patients with enterobacteria infections susceptible to ceftazidime/avibactam and for whom recourse to carbapenems cannot be envisaged in the event of resistance, in particular with a KPC or OXA-48 type resistance mechanism.

  • 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 ZAVICEFTA (ceftazidime/avibactam):

  • remains substantial in the marketing authorisation indications only as a last resort for the treatment of patients with enterobacteria infections susceptible to ceftazidime/avibactam 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 or OXA-48 type carbapenemase;

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

Clinical Added Value
moderate

Considering:

  • its in vitro activity on Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE), particularly KPC and OXA-48,
  • experience acquired with ceftazidime, a third-generation cephalosporin (TGC) widely used in the treatment of severe nosocomial infections due to Gram-negative bacteria with high suspicion of aeruginosa,
  • its demonstrated efficacy in moderate to mild complicated urinary tract infections (including pyelonephritis) and complicated intra-abdominal infections, particularly on ceftazidime-resistant strains; and in hospital-acquired pneumonia, including ventilator associated pneumonia,
  • limited clinical data in severe forms and/or forms due to multi-drug resistant bacteria,
  • the fact that the ceftazidime/avibactam combination is one of the few current antibiotics active on certain carbapenemase-producing enterobacteria,

the Committee considers that ZAVICEFTA (ceftazidime/avibactam) provides a moderate clinical added value (CAV III) in the treatment of enterobacteria infections susceptible to the ceftazidime/avibactam 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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