The UK’s National Institute for Health and Clinical Excellence (NICE) has issued a qualified recommendation for Forest Lab’s Colobreath colistimethate sodium and Novartis’s TOBI Podhaler tobramycin dry powders for inhalation as options for the treatment of P. aeruginosa lung infections in patients with cystic fibrosis. The recommendation is a final draft; the final guidance is expected in March 2013.
Forest got European marketing approval for Colobreathe in February 2012. The TOBI podhaler has been available in the UK since September 2011.
NICE is recommending Colobreathe as an option for patients who cannot tolerate nebulized colistimethate sodium and when the DPI is provided at a discount. For patients who get an inadequate benefit from nebulized colistimethate sodium or cannot tolerate it, the committee recommends the TOBI Podhaler if the DPI price is discounted.
The committee noted that the Colobreathe DPI is “slightly less effective” than nebulized tobramycin but offers “substantial cost savings.” They found no evidence of any clinical or economic benefit of Colobreathe over nebulized colistimethate sodium. Some evidence indicated that the TOBI Podhaler was slightly more effective and cheaper than nebulized tobramycin, and therefore, “the Committee agreed that it was reasonable to conclude that tobramycin DPI was a cost effective use of NHS resources in people with cystic fibrosis who would otherwise have been treated with nebulised tobramycin.”
NICE Health Technology Evaluation Centre Director Carole Longson commented, “The primary cause of death in people with cystic fibrosis is respiratory failure resulting from chronic pulmonary infection caused by Pseudomonas aeruginosa. We are therefore pleased to recommend both colistimethate sodium and tobramycin dry powders for inhalation as options for treating such infections in people with cystic fibrosis.”
Read the committee’s final appraisal determination.
Read the NICE press release.
