NICE wants more data on Daxas

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today issued final draft guidance on the use of US drug giant Merck & Co’s Daxas (roflumilast) recommends setting up a clinical trial to establish how effective it is for adults with severe chronic obstructive pulmonary disease, 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, the agency notes. It is therefore not possible to know whether roflumilast is a cost-effective use of National Health Service resources. For that reason, the 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 should be designed to consider how well roflumilast works, and its cost-effectiveness, as an add-on to triple or dual therapy. According to the NICE, roflumilast is priced at £37.31 ($58.30) for a 30-tab pack and £113.14 for a 90-tab pack (excluding VAT). There are currently 1 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.