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NICE wants more clinical data for MSD’s Daxas

UK cost-effectiveness body wants a new trial for the company's COPD drug

MSD's Daxas (roflumilast) should not be used in the UK's NHS according to final draft guidance from the National Institute for Health and Clinical Excellence (NICE).

NICE said it was not possible to know whether the drug was a cost-effective use of NHS resources without direct clinical trial evidence on its use as an addition to triple therapy.

NICE said this was the most likely use for Daxas, which is approved to treat adults with severe chronic obstructive pulmonary disease (COPD).

Specifically, the cost effectiveness watchdog wants MSD to carry out a new clinical trial to establish how effective the drug is in adults with severe COPD, associated with chronic bronchitis, as an add-on to bronchodilator treatment for people with a history of frequent exacerbations.

“There are a lot of people with COPD, and those likely to be treated with roflumilast could receive treatment for a long time,” said Professor Carole Longson, director of the NICE Health Technology Evaluation Centre.

“This meant that a high degree of uncertainty about the clinical and cost effectiveness was not acceptable to the committee.”

MSD's economic model on Daxas' cost effectiveness suggested patients have first-line treatment for one year followed by second-line treatment for their remaining lifetime (up to 29 years).

Longson said the potential costs that the NHS would incur treating the estimated 88,000 people who would eligible for treatment over this extended period of time justified further research from MSD.

Roflumilast is priced at £37.71 for a 30-tablet pack and £113.14 for a 90-tablet pack.

The monthly cost for maintenance in the severe state of the illness was estimated to be £48.33 and £150.05 in the very severe state. The monthly cost of a moderate exacerbation was estimated to be £73.56 and a severe exacerbation was £1346.63.

If NICE's final draft guidance is not appealed it will come into effect in January.

12th December 2011

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