Relvar Ellipta (fluticasone furoate/vilanterol)
Relvar Ellipta (fluticasone furoate/vilanterol) combines inhaled steriods with a long-acting beta-2-agonist (LABA) and is indicated for asthma in adolescent patients (>12 years) and adults as well as adult patients with COPD. The recommended standard dose is one inhalation of Relvar Ellipta 92/22 micrograms once daily.
The combination product provides significant improvement of the lung function in both asthma and COPD patients, but no clinically relevant improvement of health-related quality of life or dyspnoea has been shown. The effect on severe asthma exacerbations is limited compared with fluticasone furoate monotherapy, whereas the effect on moderate/severe COPD exacerbations is assessed to be clinically relevant compared with vilanterol monotherapy. Very common adverse events for both diseases include headache, nasopharyngitis and upper respiratory tract infections. Pneumonia was observed as a common adverse event in COPD patients. The single dose regimen can potentially improve patient adherence, but this has not been systematically studied for Relvar Ellipta.
When combination therapy is indicated, it is IRF’s overall assessment that Relvar Ellipta does not demonstrate any significant therapeutic improvements in asthma/COPD treatment and that less expensive alternatives are available depending on the severity of the disease and dosage requirements. IRF assesses that there are considerable class effects within the steroid and LABA groups, and consequently asthma or COPD patients should always be treated with the cheapest drug analogues in the cheapest inhalation system.
Relvar Ellipta was marketed on 20 January 2014 and general reimbursement is currently granted.