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NICE backs Novartis’ Tobi Podhaler in cystic fibrosis

But draft guidance doesn't recommend Forest’s Colobreathe

Novartis’ Tobi Podhaler should be available to cystic fibrosis patients with a lung infection, according to the medicines cost-effectiveness body for England and Wales, but Forest’s Colobreathe’s was unable to secure a similar recommendation.

The National Institute for Health and Clinical Excellence (NICE) said in draft guidance that Novartis’s product, which comprises a dry powder version of tobramycin for inhalation rather than the already available nebulised mist, was an effective use of NHS resources for the treatment of pseudomonas lung infection in people with cystic fibrosis.

This was a conditional recommendation though, based on a patient access scheme, where Novartis would cover part of the drug’s cost. In addition, the Tobi Podhaler should only be available for patients unable to use nebulised colistimethate, or for whom nebulised colistimethate had been ineffective.

The Institute took a less positive stance on Forest’s application for the use of Colobreathe for the treatment of chronic pulmonary infection caused by P. aeruginosa in people with cystic fibrosis.

The NICE committee appraising the drug, which is a dry powder inhaled version of colistimethate sodium, failed to recommend Colobreathe, highlighting the lack of an economic comparison to the already available nebulised form of colistimethate sodium.

However, the committee did take into account an economic comparison between Colobreathe and nebulised tobramycin, but decided that although Forest’s drug was less costly it was also less effective, and therefore should not be available within the NHS. Unlike Novartis, Forest had not offered a patient access scheme as part its application for a NICE recommendation.

Professor Carole Longson, health technology evaluation centre director at NICE, said: “In order for NICE to recommend any drug or technology, we have to be sure that it is both clinically and cost effective.

“Unfortunately in the case of colistimethate sodium DPI, the Committee concluded that there were significant limitations and uncertainty in the evidence available, and was, therefore, not able to recommend it.”

The draft guidance is now available for consultation, with final guidance expected to be published in March, 2013.

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