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Final draft guidance from the National Institute for Health and Clinical Excellence (NICE) on the use of roflumilast (Daxas, Merck Sharp & Dohme) recommends setting up a clinical trial to establish how effective it is for adults with severe chronic obstructive pulmonary disease (COPD), associated with chronic bronchitis, as an add-on to bronchodilator treatment for people with a history of frequent exacerbations.
Roflumilast is most likely to be used in addition to triple therapy, but there was no direct clinical trial evidence related to roflumilast used in this way.
NICE concluded that it is therefore not possible to know whether roflumilast is a cost-effective use of NHS resources.
For that reason, NICE’s independent Appraisal Committee concluded that a clinical trial providing robust data about its clinical and cost effectiveness at this point in the treatment pathway would be beneficial for the NHS.
The trial will be designed to consider how well roflumilast works, and its cost-effectiveness, as an add-on to triple or dual therapy.
There are currently one million people with COPD in England and Wales, and it is estimated that almost 88,000 would be eligible for treatment with roflumilast by 2015. Likely treatment duration would be many years.
Commenting on NICE’s final draft recommendation, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The Committee noted that, in usual practice, roflumilast was most likely to be used in addition to triple therapy, but there were no directly relevant clinical trial data on this treatment regimen for the Committee to consider.
“There are a lot of people with COPD, and those likely to be treated with roflumilast could receive treatment for a long time.
“This meant that a high degree of uncertainty about the clinical and cost effectiveness was not acceptable to the Committee.
“For this reason, the Committee has recommended a clinical trial of roflumilast in the same combination in which it would be used in clinical practice.
“It felt, on balance, the benefits and costs of conducting the research were justified.
“A new clinical trial is a good opportunity to gather robust evidence to help inform future clinical practice.”
The final draft guidance is now with interested third parties, who have the opportunity to appeal against it and highlight any factual errors.
If NICE does not receive any appeals then final guidance will be published in January 2012.