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RECARBRIO

Opinions on drugs - Posted on Oct 08 2020

Reason for request

First assessment

Key points

Positive opinion for reimbursement in the market authorisation (MA) indications, only as a last resort for patients’ treatment with enterobacteria infections, sensitive to the imipenem/cilastatin/relebactam combination, and for whom recourse to other beta-lactams and carbapenems (meropenem or imipenem-cilastatin) cannot be considered in case of resistance, in particular through KPC-type carbapenemase production.

Negative opinion for reimbursement in other situations.

What therapeutic improvement?

Therapeutic improvement in patient care management.

Role in the care pathway?

In June 2019, the HAS published guidelines relating to antibiotics management therapy 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

RECARBRIO (imipenem/cilastatin/relebactam) is a last resort treatment, in the same way as VABOREM (meropenem/vaborbactam), restricted for patients with enterobacteria infections sensitive  to the imipenem/cilastatin/relebactam combination and for whom recourse to carbapenems cannot be considered in case of resistance, in particular with a KPC type resistance mechanism.

RECARBRIO (imipenem/cilastatin/relebactam) should not be used as an alternative to carbapenems for the treatment of TGC-resistant enterobacteria and for the treatment of P. aeruginosa infections.

It should not be used as probabilistic treatment but solely on the basis of microbiological documentation.

Special recommendations

Given the product characteristics and the need to restrict its use to a last resort treatment only to preserve it, the therapeutic decision should be taken alongside antibiotic experts, with systematic reassessment 48 hours after treatment initiation.


Clinical Benefit
Substantial

The Committee deems that the clinical benefit of RECARBRIO (imipenem/cilastatin/relebactam) is substantial only as a last resort for patients’ treatment with enterobacteria infections sensitive to the imipenem/cilastatin/relebactam combination and for whom recourse to other beta-lactams and carbapenems (meropenem or imipenem/cilastatin) cannot be considered in case of resistance, in particular through KPC-type carbapenemase production.
Insufficient

The Committee deems that the clinical benefit of RECARBRIO (imipenem/cilastatin/relebactam) is insufficient to justify public funding cover in all other clinical situations.

Clinical Added Value
moderate

Considering:

  • its in vitro activity on class A Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL-PE), particularly KPC type;
  • experience acquired with imipenem/cilastatin, a carbapenem widely used in the treatment of severe nosocomial infections due to Gram-negative bacteria;
  • the demonstrated efficacy of the imipenem/cilastatin/relebactam combination in mild to moderate hospital-acquired pneumonia, with a satisfactory safety profile;
  • limited clinical data (RESTORE-IMI-1 study) suggesting high efficacy in patients with carbapenem-resistant enterobacteria infections (CRE), primarily through KPC-type carbapenemase production;
  • the fact that the imipenem/cilastatin/relebactam combination is one of the few current antibiotics active on certain carbapenemase-producing enterobacteria;

the Committee considers that RECARBRIO (imipenem/cilastatin/relebactam), in the same way as VABOREM (meropenem/vaborbactam), provides a moderate clinical added value (CAV III) in the treatment of enterobacteria infections sensitive to the imipenem/cilastatin/relebactam combination and for whom recourse to other beta-lactams and carbapenems (meropenem or imipenem-cilastatin) cannot be considered in case of resistance.

 

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