following an abbreviated submission:
fluticasone furoate / umeclidinium / vilanterol (as trifenatate) (Trelegy® Ellipta®) is accepted for restricted use within NHS Scotland.
Indication under review: maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.
SMC restriction: in patients with severe COPD (forced expiratory volume in one second [FEV1] <50% predicted normal).
Trelegy Ellipta costs less than inhalers containing fluticasone furoate / vilanterol (as trifenatate) 92 micrograms /22 micrograms and umeclidinium 55 micrograms administered separately.
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Medicine details
- Medicine name:
- fluticasone furoate / umeclidinium / vilanterol (Trelegy Ellipta)
- SMC ID:
- 1303/18
- Indication:
- Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.
- Pharmaceutical company
- GlaxoSmithKline UK Ltd
- BNF chapter
- Respiratory system
- Submission type
- Abbreviated
- Status
- Restricted
- Date advice published
- 12 February 2018
In November 2018 the marketing authorisation for fluticasone furoate / umeclidinium / vilanterol (Trelegy Ellipta®) was extended to include use in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist. This change will not be assessed by SMC. The restriction for SMC advice 1303/18 is still valid.