Roflumilast was first reviewed by NICE in 2012, but limited data meant it was recommended only for patients taking part in clinical trials. Since then, evidence from the new REACT and RE2SPOND trials has highlighted the drug's effectiveness in treating COPD symptoms.
NICE says adults are eligible for treatment only if:
- Their COPD is considered severe, defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 50% of predicted normal, and
- The patient has had 2 or more exacerbations in the previous 12 months despite triple inhaled therapy with a long-acting muscarinic antagonist, a long-acting β2 agonist and an inhaled corticosteroid.
Roflumilast is an orally administered PDE4 inhibitor that reduces both the systemic and pulmonary inflammation associated with COPD. Treatment must be initiated by a respiratory consultant.
'This is welcome news from NICE for those patients with severe COPD who continue to have exacerbations despite optimal inhaled triple therapy,' said Wisia Wedzicha, Professor of Respiratory Medicine at Imperial College London.
'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'.
NICE believes that approximately 122,000 adults in England will be eligible to receive roflumilast.