Regulatory Focus™ > News Articles > Novartis Cystic Fibrosis Drug Cleared for NHS Use

Novartis Cystic Fibrosis Drug Cleared for NHS Use

Posted 25 October 2012 | By Louise Zornoza

The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has issued a draft guidance recommending the use of Novartis' Tobi Podhaler, an inhaled tobramycin dry powder intended for the treatment of pseudomonas lung infections in persons with cystic fibrosis.

NICE's recommendation comes as Forest Laboratories' competing drug Colobreathe (colistimethate sodium dry powder for inhalation) was not recommended for use by NICE because the agency's preferred economic analysis showed that the drug was not cost effective.

"In order for NICE to recommend any drug or technology, we have to be sure that it is both clinically and cost effective," saud Prof. Carole Longson, director of the agency's Health Technology Evaluation Center (HTEC). "Unfortunately in the case of colistimethate sodium DPI … there were significant limitations and uncertainty in the evidence available, and [NICE] was, therefore, not able to recommend it."

Cystic fibrosis is one of the UK's most common life-threatening inherited diseases, affecting an estimated 8,000 people. The condition affects the internal organs, especially the lungs and digestive system, by clogging them with thick, sticky secretions, making it hard to breathe and digest food.

People with the condition are prone to lung infections by a range of pathogens including Staphylococcus aureus, Haemophilus influenzae, Pseudomonas aeruginosa and Burkholderia cepacia. The condition can also lead to pulmonary disease as well as cystic fibrosis related diabetes, male infertility and it can cause the blockage of small ducts in the liver. At present, there is no cure.

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