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ZERBAXA (ceftolozane/tazobactam) - Traitement des infections chez les enfants (de la naissance à moins de 18 ans)

Opinions on drugs - Posted on Jan 09 2023

Reason for request

New indication

Key points

Approval of reimbursement as for adults, in the marketing authorisation indications only as a last resort for the treatment of children (from birth to under 18 years) infected with ceftolozane/tazobactam-susceptible P. aeruginosa and for whom it is not possible to envisage the use of other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) in cases of resistance.

Disapproval of reimbursement for other clinical contexts.

Therapeutic improvement?

As for adults, therapeutic improvement in the treatment of ceftolozane/tazobactam-susceptible P. aeruginosa infections, for which it is not possible to envisage the use of other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) in cases of resistance.

Role of medicinal product in therapeutic strategy?

In June 2019, HAS drafted guidelines to specify the role of carbapenems and their alternatives in the treatment of enterobacteria and P. aeruginosa infections in adults. In the marketing authorisation indications, the use of antibiotics in children is largely extrapolated from the outcomes observed in adults. The treatment is based on antibiotics suitable for the identified or probable bacteria.

Role of the medicinal product

As for adults, it is recommended not to use the ceftolozane/tazobactam association as an alternative carbapenems for the treatment of C3G-resistant enterobacteria.

ZERBAXA (ceftolozane/tazobactam) is a last-resort treatment reserved for children from birth and aged under 18 years infected with ceftolozane/tazobactam association-susceptible P. aeruginosa and for whom it is not possible to envisage the use of other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) in cases of resistance.


Clinical Benefit
Substantial

Considering all of these elements, the Committee deems that the clinical benefit of ZERBAXA (ceftolozane/tazobactam) is significant in the marketing authorisation indications only as a last resort for the treatment of children aged from birth to under 18 years infected with ceftolozane/tazobactam-susceptible P. aeruginosa and for whom it is not possible to envisage the use of other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) in cases of resistance.
Insufficient

Considering all of these elements, the Committee deems that the clinical benefit of ZERBAXA (ceftolozane/tazobactam) is insufficient to justify public funding in the other contexts.

Clinical Added Value
moderate

Considering:

  • the medical need for new antibiotics for the treatment of enterobacteria resistant to third-generation cephalosporins (C3G), and carbapenemase-producing bacteria at the top of WHO priorities (critical priority),
  • its in vitro activity on Pseudomonas aeruginosa and on extended-spectrum beta-lactamase-secreting enterobacteria (ESBLSE),
  • the experience acquired with ceftazidime, a C3G widely used in the treatment severe nosocomial infections induced by Gram-negative bacteria with a strong suspicion of aeruginosa,
  • limited data in children and adolescents suggesting comparable efficacy to that described in adults,
  • that the ceftolozane/tazobactam association is one of the rare current antibiotics active on aeruginosa strains resistant to other beta-lactams,

the Committee deems that, as for adults, ZERBAXA (ceftolozane/tazobactam) provides moderate clinical added value (CAV III) in children aged from birth to under 18 years infected with ceftolozane/tazobactam-susceptible P. aeruginosa and for whom it is not possible to envisage the use of other beta-lactams and/or carbapenems (meropenem or imipenem-cilastatin) in cases of resistance.

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