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NICE: ‘Great uncertainty’ lingers over COPD drug


The National Institute of Health and Clinical Excellence (NICE) in England and Wales has concluded there is great uncertainty about the effect of roflumilast on reducing the rate of exacerbations as an add-on to triple or dual therapy for people with severe chronic obstructive pulmonary disease (COPD).

As a result, NICE’s new draft guidance recommends setting up a trial to assess its clinical effectiveness for this indication. It also recommends that roflumilast should be compared with theophylline in people for whom this drug might be suitable.

NICE has not yet published final guidance to the National Health Service (NHS); final guidance is expected in January 2012.

There are currently one million people with COPD in England and Wales, and it is estimated that almost 200,000 would be eligible for treatment with roflumilast by 2015. Likely treatment duration would be many years.

“The independent appraisal committee concluded that roflumilast was most likely to be used in addition to triple therapy, but the committee was concerned about the lack of clinical evidence available on the use of roflumilast in that way,” said Professor Carole Longson, NICE Health Technology Evaluation Centre Director.

“As there was great uncertainty about how well the treatment works alongside triple therapy, the committee could not establish that it would be good value for money.

“As a result, the committee discussed whether it was appropriate to recommend the set up of a research trial to determine the clinical effectiveness of roflumilast on top of triple or dual therapy.

“In this case, the committee felt that the benefits and costs of carrying out the research would be favourable to the NHS.

“While we recognise it is important for people with severe COPD to have a range of options, NICE has to ensure that the NHS provides treatments which are effective and value for money. We hope a clinical study would generate robust evidence so that we can be clear about the benefits roflumilast brings for these patients.

“We encourage Merck, Sharp & Dohme, patient organisations and other relevant third parties to comment on this preliminary recommendation during this public consultation period so that they can contribute to the development of this guidance.”


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