NICE gives green light for Novartis’ Tobi Podhaler and Forest Lab’s Colobreathe

March 27, 2013 | By Márcio Barra

Last week there were a bit of bad news for Novartis, as they saw Afinitor being refused by NICE, the UK price regulatory agency.

But in a final guidance published today, NICE has recommended Novartis’ Tobi Podhaler (tobramycin) and Forest Lab’s Colobreathe (colistimethate sodium), two antibiotics, as options for treating certain lung infections (P. aeruginosa) in people with cystic fibrosis. These two drugs are dry powder versions of already available nebulized products.

This recommendation comes with a caveat though, as Novartis will have to provide the drug with a discount, alongside a Patient Access Scheme and only when nebulized Colobreathe is contraindicated, non-tolerated or shows lack of efficacy in a patient. The previous price without a discount for this drug was £1,790 for 56 days of treatment.

Novartis’ Tobi Podhaler was approved for sale in the US last Friday by the FDA, and it’s being touted as the first powder inhaled antibacterial in the US.

Forest Lab’s Colobreathe recommendation follows the same lines, with a discount and a Patient Access Scheme having to be provided. NICE’s recommendation states that Colobreathe should only be used in cystic fibrosis patients who do not tolerate its nebulized form. Colobreathe is currently priced at £1,936 for 56 days of treatment, and received marketing approval by EMA back in February.

Colobreathe Inhaler

Nebulised colistimethate sodium is the first choice for people with cystic fibrosis and infected with P. aeruginosa. The dry powder version of either drug should be considered when lack of efficacy Nebulised colistimethate sodium is deemed inadequate for safety of efficacy reasons. These are surely good news for the 8,000 people in the UK afflicted with Cystic fibrosis, as their treatment options in case of infection increased.

Sources:

NICE

Online Pharmatimes

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