Reason for request

Reevaluation and new indication

  • Key points

Favourable opinion for reimbursement in the MA indications only as a last resort for the treatment of patients with P. aeruginosa infections susceptible to the ceftolozane/tazobactam combination and for whom recourse to other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) cannot be envisaged in the event of resistance.

Unfavourable opinion for reimbursement in the other clinical situations.

  • What therapeutic improvement?

Moderate therapeutic improvement in the treatment of P. aeruginosa infections susceptible to ceftolozane/tazobactam and for whom recourse to other beta-lactams and/or 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 ceftolozane/tazobactam combination should not be used as an alternative to carbapenems for the treatment of 3GC-resistant enterobacteria.

ZERBAXA (ceftolozane/tazobactam) is a last resort treatment reserved for patients with P. aeruginosa infections susceptible to ceftolozane/tazobactam and for whom recourse to other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) cannot be envisaged in the event of resistance.

  • 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 ZERBAXA (ceftolozane/tazobactam):

  • remains substantial in the marketing authorisation indications only as a last resort for the treatment of patients with P. aeruginosa infections susceptible to the ceftolozane/tazobactam combination and for whom recourse to other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) cannot be envisaged in the event of resistance;

 

 

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

 

 


Clinical Added Value

moderate

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


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Évaluation des médicaments