BioCentury
ARTICLE | Clinical News

Bronchitol mannitol regulatory update

October 29, 2012 7:00 AM UTC

The U.K.'s NICE issued new draft guidance recommending Bronchitol mannitol from Pharmaxis as an add-on therapy to best standard of care in cystic fibrosis patients, but in a narrower CF population than the one the committee rebuffed earlier this year. The committee now recommends Bronchitol in CF patients for whom treatment with recombinant human deoxyribonuclease (rhDNase) or osmotic agents like hypertonic saline are not appropriate, and who have rapidly declining lung function defined as a >=2% annual decline in forced expiratory volume in 1 second (FEV1). NICE said that after reviewing responses received during consultation on the initial guidance, the committee concluded that Bronchitol would be cost effective in the subgroup, with an incremental cost-effectiveness ratio (ICER) under £30,000 ($48,105) per quality-adjusted life year (QALY) gained. Final guidance is expected next month. Earlier this year, NICE recommended against Bronchitol in all CF patients because there were gaps and uncertainties in the evidence for the drug's effectiveness compared with hypertonic saline. The agency also questioned the long-term effect of Bronchitol on lung function (see BioCentury, June 4). ...