tobramycin inhalation powder 28mg (TOBI Podhaler)

following a full submission:

tobramycin inhalation powder, hard capsules (TOBI Podhaler®) is accepted for use within NHS Scotland.

Indication under review: Suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Tobramycin inhalation powder (TOBI Podhaler®) has demonstrated non-inferiority to tobramycin inhalation solution (via a nebuliser) measured by relative change in FEV1 % predicted over three treatment cycles in a phase III, open-label, randomised study.

This preparation offers an alternative to nebulised tobramycin. The company did not make a case for cost-effectiveness relative to other nebulised antimicrobials.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tobramycin inhalation powder (TOBI Podhaler®). This SMC advice is contingent upon the continuing availability of the patient access scheme in Scotland.