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Archived: roflumilast (Daxas)


following a full submission

roflumilast (Daxas®) is not recommended for use within NHS Scotland.

Indication under review: maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV1] post-bronchodilator <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.

Roflumilast has been associated with improved lung function and reduced the rate of moderate and severe COPD exacerbations compared to placebo in studies of patients representing the licensed population.

The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Drug Details

Drug Name: roflumilast (Daxas)
SMC Drug ID: 635/10
Manufacturer: Nycomed UK Ltd
Indication: Maintenence treatment of severe chronic obstructive pulmonary disease (COPD)
BNF Category:
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 11 October 2010

Current Advice

Resubmission 11 September 2017