In a major change for corticosteroid/LABA inhalers for COPD, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended removal of the requirement for patients to have a FEV1 less than 50% of predicted normal prior to therapy.

At its March meeting the PBS gatekeeper made the recommendation in response to an application for the triple therapy fluticasone furoate with umeclidinium and vilanterol, (Trelegy).  The Committee said the extension of the existing listing should also apply to all inhaled corticosteroid /LABA fixed dose combination products for COPD on the PBS and as such recommended that flow-on restriction changes to these products were appropriate.

In other PBAC recommendations, the CF treatment tezacaftor with ivacaftor (Symdeko) was recommended for listing on the PBS for patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene and who have at least one RF mutation in the CFTR gene.

In addition, the PBS listing for ivacaftor (Kalydeco) should be extended to include patients aged 12 to 24 months, the Committee recommended.

The PBAC accepted a claim of superior efficacy for Symdeko compared with best supportive care (BSC) in the short-term on the basis of studies that showed an increase from baseline in per cent predicted forced expiratory volume in one second (ppFEV1) for patients treated with tezacaftor with ivacaftor compared with BSC of 6.8% after 8 weeks of treatment, which was maintained for an additional 16 weeks of treatment. The PBAC also noted that studies showed an improvement in quality of life.