Thousands of patients with chronic obstructive pulmonary disease look set to benefit from a drug that is expected to be available for routine use in the NHS by the end of the year, following official approval.
The drug – roflumilast – was previously only sanctioned for use in clinical trials but has now been given the seal of approval by the National Institute for Health and Care Excellence to tackle severe COPD in adults whose symptoms have failed to respond to other treatments.
“New evidence has meant we can now say that roflumilast should be routinely available to patients with severe COPD”
However, the body’s new draft guidance stresses the fact treatment should only be initiated by respiratory specialists because of concern about side effects and “a lack of clinical experience” of using the drug in the UK.
Roflumilast – also known by its trade name, Daxas – is a once-a-day tablet that helps reduce irritation and swelling in the airways of people with COPD.
In 2012 it was only approved for limited use in clinical trials because NICE said there was not enough evidence on how well it worked or the best way to use it.
But after looking at evidence from two new trials, the body said it should be made available for wider use on the NHS.
Evidence from the new trials showed the drug eased COPD symptoms that were not being controlled by inhalers.
The expert committee that reviewed the drug concluded it could be recommended for use in the NHS for treating severe COPD in adults with chronic bronchitis who were still experiencing frequent exacerbations – two or more flare-ups in the past year – despite using inhalers.
However, the committee also stressed the need for expert input and the guidance states treatment “should only be started by a specialist in respiratory medicine”.
”This [approval] will be welcome news for many patients who have severe COPD symptoms that have been difficult to control”
While roflumilast is “generally well-tolerated” side effects can include weight loss and gastrointestinal issues so patients taking the drug need to be carefully monitored.
Another factor behind the need for specialist intervention is that most clinicians in the UK are not as yet familiar with the drug, the guidance said.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said the decision to approve the drug would be welcome news for many COPD patients – with an estimated 122,000 adults in England eligible for the treatment.
“COPD is a chronic lung condition which causes breathing problems and for many, symptoms will only worsen over time,” she said.
“New evidence has meant we can now say that roflumilast should be routinely available to patients with severe COPD.
“This will be welcome news for many patients who have severe COPD symptoms that have been difficult to control,” she added.
The draft guidance is out for consultation until July 6, with the final document expected to be published in the same month – providing there are no appeals.
Roflumilast should be available on the NHS within three months of the final guidance being published.