Key points from the evidence

The content of this evidence summary was up-to-date in June 2013. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information.

Summary

Fluticasone furoate/vilanterol (Relvar Ellipta) is a once-daily corticosteroid and long-acting beta2 agonist combination inhaler, which has been submitted for a marketing authorisation for the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) and an exacerbation history despite regular bronchodilator therapy. There are currently no published studies comparing fluticasone furoate/vilanterol with other licensed treatments for COPD, which makes it difficult to assess its place in therapy in the NHS.

Effectiveness

  • No published studies comparing fluticasone furoate/vilanterol with other ICS/LABA combination inhalers licensed for use in COPD.

  • Fluticasone furoate/vilanterol 100/25 micrograms reduced the mean yearly rate of moderate and severe exacerbations, but not exacerbations requiring admission to hospital, compared with vilanterol 25 micrograms alone.

  • Fluticasone furoate/vilanterol 100/25 micrograms improved trough FEV1 after 24 weeks' treatment compared with placebo but not compared with vilanterol alone.

Safety

  • No statistical analysis of safety data from studies is available.

  • Local corticosteroid effects, pneumonia (including requiring admission to hospital) and non-traumatic fractures were seen more frequently with fluticasone furoate/vilanterol 100/25 micrograms than with vilanterol alone.

Patient factors

  • Administration is once-daily using a multi-dose dry powder inhalation device (the Ellipta device). The 2 combination inhalers in the same class currently licensed for use in COPD are for twice-daily use.

Cost

  • Cost has yet to be determined.

Key points

Fluticasone furoate is a once-daily inhaled corticosteroid (ICS) and vilanterol is a once-daily inhaled long-acting beta2 agonist (LABA). A combination multi-dose dry powder inhalation device (the Ellipta device) containing fluticasone furoate 100 micrograms and vilanterol 25 micrograms has been submitted for a marketing authorisation for the symptomatic treatment of COPD in adults who have an FEV1 (forced expired volume in 1 second) of less than 70% and an exacerbation history despite regular bronchodilator therapy. A regulatory decision is expected in late 2013.

This evidence summary is based on studies that have been published in full. In a pre-specified pooled analysis of 2 randomised, double-blind, parallel group studies (total n=3255), Dransfield et al. (2013) found that fluticasone furoate/vilanterol 100/25 micrograms reduced the mean yearly rate of moderate and severe exacerbations compared with vilanterol 25 micrograms alone in people with COPD and a history of such exacerbations (from 1.11 to 0.81, rate ratio was 0.7, 95% confidence interval [CI] 0.6 to 0.8, p<0.0001). However, there was no statistically significant difference in the mean yearly rate of exacerbations requiring admission to hospital compared with vilanterol 25 micrograms alone.

Kerwin et al. (2013) (n=1030) found that fluticasone furoate/vilanterol 100/25 micrograms was statistically significantly superior to placebo in improving post-dose weighted mean FEV1 (173 ml, 95% CI 123 to 224 ml, p<0.001) and trough FEV1 (115 ml, 95% CI 60 to 169 ml, p<0.001) after 24 weeks' treatment. The lower limit in the confidence interval of trough FEV1 is less than the 100 ml difference in FEV1 considered in the full NICE guideline on COPD to be the minimum clinically important difference. There was no statistically significant difference in trough FEV1 between fluticasone furoate/vilanterol 100/25 micrograms and vilanterol 25 micrograms.

An additional study (Martinez et al. 2013) had the same design as that by Kerwin et al. (2013), but for methodological reasons, statistical analysis of the results for fluticasone furoate/vilanterol 100/25 micrograms could not be performed.

Statistical analysis of safety data was not presented in any of the studies included in this review, which limits the conclusions that can be drawn. Local corticosteroid effects, pneumonia (including pneumonia requiring admission to hospital) and non-traumatic fractures were seen more frequently with fluticasone furoate/vilanterol 100/25 micrograms than with vilanterol alone.

The studies that have been published in full provide no information on the effectiveness of fluticasone furoate/vilanterol compared with available inhalers licensed for use in COPD. A further 12-week phase III trial (trial reference NCT01342913) comparing the spirometric effects of fluticasone furoate/vilanterol 100/25 micrograms once daily with fluticasone propionate/salmeterol 500/50 micrograms (Seretide 500 Accuhaler) twice daily has not yet been published in full. The exact dose equivalence between fluticasone furoate and fluticasone propionate (the currently licensed fluticasone salt) is not known (GlaxoSmithKline: personal communication May 2013).

The cost of the product has yet to be determined, so cost comparisons with other inhaled therapy licensed for use in COPD cannot be made at present. The exact place in therapy of fluticasone furoate/vilanterol is also difficult to assess, but if a UK marketing authorisation is granted it will represent an additional treatment option alongside existing inhaled therapies licensed for use in COPD.

Key evidence

Dransfield MT, Bourbeau J, Jones PW et al. (2013) Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. The Lancet Respiratory Medicine 1: 210–23 doi:10.1016/s2213-2600(13)70040-7

Kerwin EM, Scott-Wilson C, Sanford L et al. (2013) A randomised trial of fluticasone furoate/vilanterol (50/25 micrograms; 100/25 micrograms) on lung function in COPD. Respiratory Medicine 107: 560–9

Update

The following information has become available since this ESNM was produced.

January 2014: Availability of fluticasone furoate/vilanterol (Relvar Ellipta) combination inhaler

Relvar Ellipta 92 micrograms/22 micrograms which is licensed for the treatment of chronic obstructive pulmonary disease and asthma was launched in the UK in January 2014. Relvar Ellipta 184 micrograms/22 micrograms is also available for the treatment of asthma. See ESNM34: Asthma: fluticasone furoate/vilanterol (Relvar Ellipta) combination inhaler for more information.

The Ellipta device contains 30 inhalations for 30 days of treatment. The cost of the Relvar Ellipta 92/22 microgram strength inhaler is £27.80. The cost of the Relvar Ellipta 184/22 microgram strength inhaler is £38.87. Costs (excluding VAT) taken from MIMS, October 2014.

About this evidence summary

'Evidence summaries: new medicines' provide summaries of key evidence for selected new medicines, or for existing medicines with new indications or formulations, that are considered to be of significance to the NHS. The strengths and weaknesses of the relevant evidence are critically reviewed within this summary to provide useful information for those working on the managed entry of new medicines for the NHS, but this summary is not NICE guidance.