TGA rejects proposal for OTC sales of budesonide/formoterol inhalers


By Michael Woodhead

8 Feb 2021

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.

“Given we aim to manage asthma as a chronic condition, then it’s unlikely that efforts to remove people from appropriate chronic disease management will be successful,” said the Asthma Australia submission.

“The risk of entrenched counterproductive and unsafe health care access, the potential for regressive behaviours and choices and its potentially disastrous implementation among adolescents are irreconcilable for Asthma Australia under current circumstances.

“Add to these risks logistic and practical concerns raised by consumers around cost, education and support around device use and product expiry and we believe there are too many unanswered questions and unresolved issues for safe and effective implementation at this stage.”

The National Asthma Council submission went further and warned that OTC scheduling would perpetuate the problems created by unsupervised sales of salbutamol inhalers, which allowed asthma patients to obtain treatment without an accurate diagnosis and ongoing medical review from a medical practitioner, and potentially over-rely on SABA in their asthma management.

It said a better solution would be to up-schedule SABA inhalers and require more formal pharmacist oversight in the provision of the medications.

In an interim decision, the ACMS ruled that the current scheduling of budesonide and formoterol under Schedule 4 was appropriate.

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