The TGA has knocked back an application to allow OTC sales of combination budesonide/formoterol inhalers for as-needed reliever therapy in people with mild asthma.
In rejecting the application for pharmacy sales, the TGA acknowledged there was evidence that a combination of long-acting beta-agonist (LABA) with inhaled corticosteroid (ICS) was potentially safer for as-needed use in asthma than current sales of a short-acting beta agonist (SABA) alone.
However it said it relied on submissions from professional groups such as the National Asthma Council which said it was still too early to allow unsupervised access to ICS/LABA inhalers without medical supervision.
The TGA noted that there was potential benefit from providing easier access to low dose ICS/LABA inhalers to people with asthma, which was a treatment option adopted in the Australian Asthma Handbook in September 2020
As-needed low dose budesonide/formoterol has been shown to reduce the risk of severe exacerbations by about two-thirds compared with SABA-only treatment and is non-inferior to daily low dose ICS for severe exacerbations.
However, the TGA’s Advisory Committee on Medicines Scheduling considered that downscheduling the combination inhalers to OTC status would create a risk of inappropriate use for conditions outside of asthma. The committee was also not confident in the ability of pharmacists to provide adequate management of asthma and its symptoms, including monitoring and follow up.
The National Asthma Council and Asthma Australia opposed the re-scheduling, saying it was too early to allow unsupervised use of the new treatment option. They said there were many unanswered questions and critical issues around the sales of as-needed ICS-LABA combination inhalers as relievers, such as how to ensure that people with more severe forms of asthma would not buy and use them unsupervised in place of their regular prescription.