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.
Download detailed advice130KB (PDF)
- Medicine name:
- tobramycin inhalation powder 28mg (TOBI Podhaler)
- SMC ID:
- For the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.
- Pharmaceutical company
- Novartis Pharmaceuticals UK Ltd
- BNF chapter
- Submission type
- Date advice published
- 11 June 2012