Reason for request
Inclusion on the list of medicines approved for hospital use.
Complicated skin and skin structure infections
The actual benefit of this medicinal product is not sufficient to justify its being reimbursed by National Health Insurance in view of the existing treatments.
Community acquired pneumonia
The actual benefit of this proprietary product is substantial, in view of its effect on the pneumococcus (the main microorganism involved in pneumonia), including strains resistant to penicillin and macrolides, provided that the contra indications and special warnings and precautions for use are adhered to.
Improvement in actual benefit
In view of the following :
- the non-optimal level of evidence in regard to the demonstration of efficacy and tolerance in severe community acquired pneumonia requiring hospitalisation in an intensive care/critical care unit,
- the reservations regarding cardiac tolerance, particularly prolongation of QT,
- and doubts over whether the results of the clinical trials can be carried over into real life,
the Committee is of the view that the proprietary product IZILOX does not bring an improvement in actual benefit (IAB V) in the management of “ community acquired pneumonia ”.