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New HTA Decisions in France
March 2021
Drug name
FETCROJA® (cefiderocol)
Company
Shionogi SAS
Decision date
20/01/2021
Therapeutic area
Infections
Therapeutic sub area
Infections: general and other
Official notice date
26/01/2021
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
Minor improvement (IV)
Indication
FETCROJA® is indicated as a last resort for the treatment of adult patients with multidrug-resistant aerobic Gram-negative bacteria infections (especially in cases of Enterobacteriaceae and Pseudomonas aeruginosa, with a KPC-type resistance mechanism, oxacillinase or metallo-ß-lactamases [NDM, VIM, IMP]) and when recourse to the other available options is not possible.
Decision (SMR)
Insufficient to justify reimbursement
Decision (ASMR)
Indication
FETCROJA® is indicated for the treatment of other infections caused by aerobic Gram-negative bacteria in adult patients for whom the treatment options are limited, including infections with Acinetobacter baumannii or Stenotrophomonas maltophilia.
Decision Type
New technology assessment
Summary
The committee consider the actual benefit of FETCROJA® to be 'important' in the indication of the Marketing Authorization. The committee consider the actual benefit of FETCROJA® to be insufficient to justify reimbursement in the treatment of other infections caused by aerobic Gram-negative bacteria in adult patients for whom the treatment options are limited, including infections with Acinetobacter baumannii or Stenotrophomonas maltophilia. FETCROJA® provides a minor improvement in actual benefit (ASMR IV) as a last resort in the treatment of adult patients with multidrug-resistant aerobic Gram-negative bacteria infections (especially in cases of Enterobacteriaceae and Pseudomonas aeruginosa, with a KPC-type resistance mechanism, oxacillinase or metallo-ß-lactamases [NDM, VIM, IMP]) and when recourse to the other available options is not possible.