The first triple therapy inhaler for COPD containing a LAMA, LABA and inhaled steroid has been recommended for PBS listing.
At its December 2017 meeting the Pharmaceutical Benefits Advisory Committee recommended an Authority Required (Streamlined) listing for GSK’s Trelegy Ellipta inhaler, which contains umeclidinium and vilanterol with fluticasone.
The dry powder inhaler is indicated as a once-daily treatment for patients with moderate to severe COPD (FEV <50% predicted) and frequent exacerbations despite regular maintenance treatment.
The committee said it made the recommendation for PBS listing based on evidence showing a potential modest benefit of triple therapy over LAMA/LABA dual therapy inhalers in some COPD patients.
However the additional benefits would have to be balanced against possible increased harms from more prolonged inhaled corticosteroid use, the committee added.
As part of its recommendation, the PBAC advised that Trelegy should not be priced substantially higher than current LAMA/LABA dual therapy inhalers if it was to be cost effective.
It also flagged that the PBS listing of a triple therapy inhaler might encourage inappropriate use earlier in the COPD treatment pathway or inappropriate use in patients with asthma.
“This inappropriate use may grow the triple therapy market, and PBAC therefore advised that a risk sharing arrangement would be appropriate to contain total cost,” it recommended.
Trelegy is already registered in the US and in the EU as maintenance treatment for people with moderate to severe COPD that is not controlled by dual therapy inhalers. Manufacturer GSK this week applied to extend the indication in the EU to patients at risk of COPD exacerbations.