following a resubmission:
roflumilast (Daxas®) is not recommended for use within NHS Scotland.
Indication under review: for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in one second [FEV1]) post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
The addition of roflumilast, compared with placebo, to combination inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) treatment did not reduce the annual rate of moderate or severe COPD exacerbations in two double-blind, randomised studies of COPD patients with severe airflow limitation and history of at least two moderate or severe exacerbations in the previous year.
The submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC.
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Medicine details
- Medicine name:
- roflumilast (Daxas)
- SMC ID:
- 635/10
- Indication:
- For maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in one second [FEV1]) post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
- Pharmaceutical company
- AstraZeneca UK Ltd
- BNF chapter
- Respiratory system
- Submission type
- Resubmission
- Status
- Not recommended
- Date advice published
- 11 September 2017