Final NICE guidance on the use of Daxas (roflumilast), Merck Sharp and Dohme’s drug for maintenance treatment of severe chronic obstructive pulmonary disorder (COPD), recommends setting up a clinical trial to test its clinical and cost-effectiveness.
The Appraisal Committee confirmed draft guidance, which was not challenged, on the potential use of Daxas as an add-on to double or triple bronchodilator drug therapy for adults with severe COPD and a history of frequent exacerbations.
It is estimated that 88,000 people with COPD would be eligible for long-term treatment with Daxas in the suggested indication by 2015; however, the lack of relevant direct clinical trial evidence for the drug’s value in this context led the NICE Appraisal Committee to demand more robust data.
Daxas, an oral medication, is a long-acting enzyme inhibitor that targets cells and mediators important whose inflammation is believed to cause COPD.
NICE recommends use of the drug on an ‘only in research’ basis to generate relevant data about its benefits as an add-on to triple therapy (long-acting muscarinic antagonists plus long-acting beta2 agonists plus inhaled corticosteroids) or dual therapy (the first two of these).
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “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.”