levofloxacin (Quinsair)

following a full submission under the orphan equivalent process:

levofloxacin (Quinsair®) is accepted for restricted use within NHS Scotland.

Indication under review: the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.

SMC restriction: for use as a third line treatment option after colistimethate sodium (first line) and tobramycin (second line).

In a phase III open-label randomised study, levofloxacin was non-inferior to another inhaled antimicrobial for change in lung function, measured by relative change in forced expiratory volume in one second (FEV1) percent predicted.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of levofloxacin. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.