PBS tightens up on FDC inhaler use in child asthma


By Mardi Chapman

14 Jun 2018

The PBS restriction level for fixed dose combination inhaled corticosteroid (ICS)/long acting beta-antagonist (LABA) inhalers for childhood asthma is to be increased to Authority Required (Streamlined), the Pharmaceutical Benefits Advisory Committee (PBAC) has signalled .

The move is a reiteration of the PBAC’s 2017 recommendations aimed at curbing inappropriate first line use of fixed dose combination inhalers for COPD and asthma.

As reported in the limbic last year, the recommendations arose from the Post-market Review of Chronic Obstructive Pulmonary Disease (COPD) Medicines and were supported by other advice.

The review found there was a high rate of initiation to the ICS/LABA combinations inconsistent with clinical guidelines.

“The PBAC recommended in its advice to the Minister to increase the PBS restriction level to Authority Required (STREAMLINED) for ICS/LABAs inhalers that have dual listings on the PBS for the treatment of COPD and asthma,” their August 2017 meeting reported.

Subsequently at their March 2018 meeting, PBAC has revisited the issue with a focus on asthma in children.

The Committee considered an evaluation report conducted three years following the 2014 Post-market Review of Pharmaceutical Benefits Scheme Medicines Used to Treat Asthma in Children.

The PBAC noted that use of fixed dose combination ICS/LABA inhalers in children was unacceptably high with no evidence of clinical benefit associated with its use versus first line treatment with ICS alone.

Its Drug Utilisation Sub Committee (DUSC) review found that, of those children who initiated ICS/LABA, 64% had no prior dispensing of ICS or oral corticosteroids, contrary to PBS restrictions.

“DUSC referred to the stepped approach to adjusting asthma medication in children, as outlined in the 2014 Australian Asthma Handbook, and noted that only a small proportion of children with asthma require an ICS/LABA combination,” it concluded.

“Noting that the report also confirmed that 95% of ICS/LABA prescriptions are written by General Practitioners, the PBAC recommended that the evaluation report be forwarded to the Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine and NPS MedicineWise to inform educational programs for General Practitioners on the rationale for the restriction changes.”

The limbic understands the PBAC has since advised the RACGP of their findings.

The recommendations have not yet been enacted on the PBS schedule but implementation of the change is anticipated in the next few months.

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