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roflumilast (Daxas)

Advice

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.

Drug Details

Drug Name: roflumilast (Daxas)
SMC Drug ID: 635/10
Manufacturer: AstraZeneca UK Ltd
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.
BNF Category:
Submission Type: Resubmission
Status: Not Recommended
Date Advice Published: 11 September 2017

Archived Advice

Full submission 11 October 2010

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