Advice

following a re-submission considered under the orphan process

aztreonam lysine (Cayston®) is accepted for restricted use within NHS Scotland.

Indication under review: Suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged six years and older.

SMC restriction: When inhaled colistimethate sodium and inhaled tobramycin are not tolerated or not providing satisfactory therapeutic benefit (measured as ≥2% decline in forced expiratory volume in 1 second [FEV1]).

Aztreonam lysine has demonstrated superiority in improving lung function and respiratory symptoms in one active-controlled study and two 28-day placebo-controlled studies in patients with cystic fibrosis and chronic Pseudomonas aeruginosa infection.

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

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

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Medicine details

Medicine name:
aztreonam lysine (Cayston)
SMC ID:
753/12
Indication:
Suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged six years and older.
Pharmaceutical company
Gilead Sciences Ltd
BNF chapter
Infections
Submission type
Resubmission
Status
Restricted
Date advice published
12 January 2015