NICE has published a Technology Appraisal Guidance (TAG) recommending roflumilast for use within NHS England as an add-on option to treat adults with severe chronic obstructive pulmonary disease (COPD) who continue to experience exacerbations despite triple inhaled therapy.

Roflumilast, as an add-on to bronchodilator therapy, is recommended within its marketing authorisation as an option to treat severe COPD in adults with chronic bronchitis only if the disease is severe, defined as a forced expiratory volume in 1 second (FEV1) after a bronchodilator of less than 50% of predicted normal. Or if the person has had two or more exacerbations in the previous 12 months despite triple inhaled therapy with a long-acting muscarinic antagonist, a long-acting beta-2 agonist and an inhaled corticosteroid.

NICE advises that around 122,000 adults in England will be eligible to receive roflumilast.

Wisia Wedzicha, Professor of Respiratory Medicine, Imperial College London, said: “This is welcome news from NICE for those patients with severe COPD who continue to have exacerbations despite optimal inhaled triple therapy. Exacerbations place a huge burden on patients and are associated with a poor prognosis, reduction in quality of life and increased mortality risk. A new add-on treatment that reduces exacerbations in people with COPD addresses a significant unmet need that will be highly valued by patients.”

The NICE appraisal committee considered evidence for roflumilast submitted by AstraZeneca using pooled analyses from REACT (a multicentre double-blind randomised controlled trial with 1,945 patients, comparing roflumilast plus inhaled combination therapy with oral placebo plus inhaled combination therapy) and RE2SPOND, another multicentre double-blind trial of roflumilast that included 2,352 patients. 

The NICE committee concluded that the company’s pooled analysis provided sufficient evidence of the clinical efficacy of roflumilast compared with placebo in the subgroup of patients with severe COPD having exacerbations despite triple inhaled therapy.

Professor David Halpin, Consultant Physician and Honorary Associate Professor in Respiratory Medicine at the Royal Devon and Exeter Hospital, said: “I am pleased that NICE has approved the use of roflumilast for patients with severe COPD as this drug provides an alternative approach to reducing the occurrence of exacerbations. 

"Exacerbations are significant events in the course of COPD which lead to deterioration in quality of life and drive progression of the disease. The International GOLD Report recommends the use of roflumilast for patients who have chronic bronchitis and who are breathless and at higher risk of exacerbations. This decision by NICE will allow patients in England with severe COPD to benefit from this therapy.”

 The most common adverse reactions associated with roflumilast include diarrhoea, weight loss, nausea, abdominal pain and headache.