TGA indications for Symbicort Turbuhaler 200/6 and Rapihaler 100/3 have been extended to include the as-needed management of mild asthma in adults and adolescents from the age of 12 years.
The change is supported by growing evidence and international guidance, as reported in the limbic earlier this year, that preventer not reliever-only medications should be the foundation of asthma management even in mild disease.
However the PBAC has yet to make positive recommendations for PBS listing – a submission was rejected in July and will be reconsidered at the November meeting – and the changes have yet to be incorporated into national asthma guidelines.
The announcement of the new indications for budesonide and formoterol coincides with a New Zealand study of as-needed use of the ICS/LABA combination versus maintenance therapy with budesonide and as-needed terbutaline.
The PRACTICAL study, published in The Lancet, randomised 885 adults with mild to moderate asthma to one of the treatment arms for 52 weeks.
It found budesonide-formoterol reliever therapy resulted in fewer severe exacerbations, fewer severe exacerbations requiring an ED visit or hospital admission, and a longer time to a first severe exacerbation than maintenance budesonide plus as-needed terbutaline.
“The timing of inhaled corticosteroid administration is probably a more important determinant of efficacy than the total dose, and a symptom-driven increase in the dose of inhaled corticosteroid in worsening asthma might lead to resolution of an exacerbation before it becomes severe enough for the patient to seek medical review,” the study authors said.
Professor Helen Reddel, from the Woolcock Institute of Medical Research and a co-investigator on the study, highlighted the inclusion of inflammatory markers in the study.
“Baseline inflammatory status did not affect whether or not patients benefited from as-needed budesonide-formoterol. In other words, you don’t need to check someone’s inflammatory status before you can assume they would benefit from reduced exacerbations with the combination,” she told the limbic.
“This is just speculation on my part on what is a fascinating result, but not every exacerbation is going to be eosinophilic. And so this is probably not just about ICS but that some exacerbations may just be associated with bronchoconstriction and may benefit from the formoterol component, which has different characteristics compared with the characteristics of the short-acting beta-agonists.”
Professor Reddel said findings from the PRACTICAL study also supported those of Novel START study published earlier this year which found as-needed budesonide–formoterol was superior to as-needed albuterol for the prevention of exacerbations in patients with mild asthma.
Regarding the TGA approval of Symbicort as-needed for mild asthma, she said it was still important to defer to the national asthma guidelines committee.
“This is an announcement that the TGA have approved it but we still need the guidelines committee recommendations about whether this fits into Australian asthma guidelines and if so where it fits.”
“Let’s wait and see if and where it is positioned in the asthma guidelines.”
“And the other thing is that until it has a [PBS] listing for as-needed use, it would be more costly for concession card holders if they were prescribed this rather than a regular low dose inhaled corticosteroid. Both of these options are very effective for reducing the risk of asthma flare-ups.”
“Overall it’s not a good idea to be suggesting that doctors write private scripts for something that would disadvantage some patients.”