tedizolid phosphate (Sivextro)

following a full submission

tedizolid phosphate (Sivextro®) is accepted for restricted use within NHS Scotland.

Indication under review: The treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

SMC restriction:

• Use in patients with ABSSSI caused by Gram-positive Staphylococcus aureus (specifically methicillin-resistant Staphylococcus aureus [MRSA] isolates
• Use of tedizolid phosphate is restricted to use as an alternative oxazolidinone antibacterial on the specific advice of local microbiologists or specialists in infectious disease.

In two randomised, double-blind clinical studies, tedizolid phosphate was non-inferior to another oxazolidinone antibacterial in adult patients with ABSSSI.

The presenting company did not submit any evidence for SMC to consider around the use of tedizolid phosphate in “mixed infections”, where the infection involves both Gram-positive and Gram-negative organisms.