More Daxas data needed, NICE says

NICE has recommended a further clinical trial to establish how effective MSD’s Daxas (roflumilast) is for adults with severe chronic obstructive pulmonary disease (COPD) in final draft guidance.

Its independent Appraisal Committee concluded further data was required on its clinical and cost effectiveness as an add-on to bronchodilator treatment for people with a history of frequent exacerbations.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says a new trial “is a good opportunity to gather robust evidence”.

The trial should be designed, NICE advises, to analyse how effective  and cost effective Daxas is as an add-on to triple or dual therapy.

The Committee decided that research should aim to generate data around the benefits of Daxas as an add-on treatment to long-acting muscarinic antagonists (LAMA) plus long-acting beta agonists (LABA) plus inhaled corticosteroids (ICS), known as triple therapy, or LAMA plus LABA for those people who are intolerant to, or decline, ICS.

NICE believes that the medication is most likely to be used in addition to triple therapy. However, there was no direct clinical evidence provided by MSD in this way, and no possible way of NICE knowing whether Daxas is a cost-effective use of NHS resources.

There are currently around a million people with COPD in England and Wales. NICE estimates that nearly 90,000 people would be eligible for the treatment by 2015.

“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,” said Professor Longson.

“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.”

If NICE does not receive any appeals to the draft guidance, a final decision will be published in January 2012.