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NICE backs two cystic fibrosis treatments for NHS use

Novartis’ Tobi Podhaler and Forest’s Colobreathe recommended at discounted price


Novartis' Tobi Podhaler and Forest Laboratories' Colobreathe have both received backing for use in the NHS in England and Wales to treat lung infections in people with cystic fibrosis.

The final draft guidance from the National Institute for Health and Clinical Excellence (NICE) reaffirms the agency's view that the Tobi Podhaler is a cost-effective use of NHS resources and overturns previous guidance that recommended against the use of Colobreathe.

NICE had previously ruled that there were significant limitations in the evidence provided by Forest for the use of Colobreathe in treating chronic pulmonary infection caused by pseudomonas aeruginosa in people with cystic fibrosis and its benefits did not justify its cost.

However, NICE has now decided to recommend the colistimethate sodium dry powder for inhalation (DPI), albeit for a limited population comprised of people currently benefiting from nebulised colistimethate sodium who are unable to tolerate it twice daily in its nebulised form.

NICE has also now agreed to a patient access scheme with Forest, who will provide the drug at a discounted rate.

The biggest issue with Colobreathe for NICE is the lack of comparison data between the dry powder for inhalation and the nebulised version, which is the preferred comparator for the cost-effectiveness body as it is the standard first-line treatment for the condition.

Novartis' Tobi Podhaler is a dry powder version of tobramycin, which is also already available in a nebulised form that is recommended for patients unable to take nebulised colistimethate sodium as it is either contraindicated, not tolerated or has proven ineffective.

Unlike Forest's dry powder product, the Tobi Podhaler has previously been recommended in draft NICE guidance, with Novartis already agreeing a patient access scheme when providing the drug for use in the treatment of patients with chronic pulmonary infection caused by pseudomonas aeruginosa.

The recommendation is also limited, however, and the Tobi Podhaler should only be used in patients for whom nebulised tobramycin is considered an appropriate treatment, which currently constitutes patients unable to use nebulised colistimethate sodium.

Commenting on the NICE guidance, Novartis said patients will benefit from the improved drug-delivery of the dry powder product, which takes five to six minutes to administer compared to 20 minutes for the nebulised version.

Dr Diana Bilton, consultant respiratory physician, Royal Brompton Hospital, said: “Our experience is that patients really benefit from this antibiotic inhaler in terms of a reduction in treatment burden and being able to get on with life instead of spending time on a nebuliser.”

Final guidance on both products is expected in March, 2013.

25th January 2013

From: Sales



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