Combination inhaler PBS listed for mild asthma

female pharmacist prescription script dispensary

Symbicort is now PBS-listed for any form of asthma severity – mild, moderate or severe. So how should this change your conversations with patients asking for an OTC blue puffer?

From today (1 June), Symbicort Turbuhaler 200/6 and Symbicort Rapihaler 100/3 will be reimbursed through the PBS for patients 12 years and over with any form of asthma severity – mild, moderate or severe.

The listing means healthcare professionals will be able to prescribe Symbicort anti-inflammatory reliever as needed (PRN) for patients with mild asthma, without daily maintenance treatment, through the PBS.

Symbicort, taken as needed, is already listed in combination with Symbicort maintenance treatment in moderate-to-severe asthma.

The indication for Symbicort to be used PRN for patients with mild asthma was approved by the TGA in September last year.

Recommendations for use of as-needed combination treatment for mild asthma are supported by two open-label, randomised controlled trials in adults, published in the NEJM and The Lancet, and results from double-blind trials published in the NEJM here and here.

Based on the evidence, the Global Initiative for Asthma (GINA) now recommends patients receive a corticosteroid-containing treatment, either symptom-driven (in mild asthma) or daily, to reduce risk of severe exacerbations and asthma-related death.

GINA no longer recommends treatment of asthma in adults and adolescents with short-acting β2-agonist (SABA) such as Ventolin alone.

It says that while treatment with regular daily low-dose ICS, with as-needed SABA, is highly effective, adherence with ICS is poor.

“In adults and adolescents with mild asthma, treatment with as-needed low-dose ICS-formoterol reduces 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,” the group says in its 2020 report.

Consultant pharmacist Debbie Rigby told AJP the listing creates an opportunity for pharmacists to shift the conversation with patients to future risk rather than just relieving their current symptoms.

“The shift from over-reliance on relievers such as salbutamol to as-needed anti-inflammatory relievers like Symbicort for adults with mild asthma has been described as the most radical change in asthma management for adolescents and adults in the last 30 years,” said Ms Rigby.

“The listing of Symbicort as an anti-inflammatory reliever on the PBS creates an opportunity for pharmacists to discuss asthma control and future risk of exacerbations with customers requesting an over-the-counter blue puffer.

“For people just relying on Ventolin for symptom control, especially OTC use without a regular check-up by their GP, we can talk about the benefits of not only helping their immediate symptoms, but also impacting on the underlying inflammation in the lungs and reducing the risk of a severe exacerbation.

“About 70% of Australians living with asthma have mild asthma, but they are still at risk of exacerbations requiring emergency care or even dying from asthma. About one-third of exacerbations requiring a visit to the emergency department are in patients with mild asthma; and 15% to 20% of adults dying from asthma are largely asymptomatic in the preceding three months.”

While cost may be seen as a barrier, long-term cost of Symbicort is likely to be less when compared with that of daily ICS with SABA as-needed, Ms Rigby added.

“Many people buy [Ventolin] every few months or even monthly. On an annual basis, the cost of Symbicort used as-needed may be less than relying on OTC salbutamol,” she said.

In a preview of an updated approach in the Australian Asthma Handbook (Version 2.1), released on Monday, the National Asthma Council Australia addresses the use of a low dose inhaled corticosteroid and rapid onset reliever on an as-needed basis for patients with mild asthma, based on the latest evidence.

The full update will be published in the coming weeks.

“Very few adults and adolescents with asthma can maintain good asthma control relying solely on a short-acting reliever and nearly all adults with asthma will have better health outcomes and quality of life through use of a preventer that contains an inhaled corticosteroid, which addresses the underlying lung inflammation,” said Professor Amanda Barnard, Chair of the Guidelines Committee.

“We welcome the new listing of low dose Symbicort (budesonide/formoterol) as a subsidised medicine under the PBS for as-needed only use by adults and adolescents with mild asthma for its potential to facilitate the use of preventer medication by people who may otherwise over-rely on their reliever.

“However, it’s important to note that short-acting relievers such as salbutamol remain an essential rescue medicine for their role in management of acute asthma and community first aid,” added Professor Barnard. “They still provide safe relief of symptoms when used with a regular inhaled corticosteroid preventer.”

Associate Professor John Blakey, a respiratory physician and Adjunct Clinical Associate Professor at Curtin University, told AJP he welcomes changes that are likely to increase the proportion of people with asthma that are taking preventative treatment.

“Hundreds of thousands of people with asthma in Australia experience avoidable harm because they are not taking preventative therapy for asthma. Reliance on SABA alone has been very common for many years despite the availability of a variety of medications and devices and a very strong evidence base for their use,” he said.

“The current guidance suggests very few people should be on SABA alone, but that’s not what is happening across the country. I therefore welcome changes that are likely to increase the proportion of people with asthma that are taking at least some preventative treatment.

“I don’t see as-needed combination therapy as a direct replacement for all regimes including regular inhaled corticosteroids. Individuals who have an established and effective routine of taking their ICS should not be encouraged to change.”

A/Prof Blakey said uncertainty remains over whether as-needed combination therapy is potentially superior to regular ICS and SABA in the long term, as concordance with regular treatment may be expected to fall off.

“We await that real-world evidence. At present, it is reasonable to include them as approximately equivalent alternatives for mild asthma and to leave the shared decision to the prescriber and patient,” he said.

Note: This article was edited at 10.20am to include updated information on the Australian Asthma Handbook

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  1. Bruce ANNABEL

    Suffering from asthma all my life and I was astonished to learn from my GP sometime last year that I didn’t need Ventolin because I was using Symbicort 200. Having been using Ventolin for about 50 years (and it’s predecessor) it was an astounding revelation and resulted in me not using Ventolin before going for a run, a ride or a swim squad. The GP pointed me to the research and reminded me of an article I had read entitled ‘Blue Death’ in AJP explaining it. Pharmacists have a critical role advising patients suffering from asthma about this revelation and I’m delighted too see the subject reported again in AJP. Thank you.

    • Debbie Rigby

      Great real-life experience Bruce – thanks for sharing.

      (I’m not making comment here on you personally.)

      Inhalation of SABAs e.g. Ventolin prior to exercise or when exercise-induced bronchoconstriction (EIB) has occurred, reduces or even prevents EIB. However, during continuous or frequent use the protective effect diminishes with time and does not offer the same protection after a few weeks of treatment as after the first dose. Tachyphylaxis to the protective effect has been demonstrated. On demand budesonide/formoterol has been shown to be superior to on-demand SABA in reducing EIB. For people with mild asthma and EIB, budesonide/formoterol prn 3-4 doses per week before exercise is sufficient to provide good asthma control, and at a substantially (2.5-fold) lower total ICS dose than regular ICS + prn SABA.

      Many people inhale Ventolin before exercise as routine. However evidence indicates that treatment with budesonide/formoterol on demand provides better protection for occasional, unplanned exercise than SABA on demand as monotherapy.

      For people with moderate-to-severe asthma, maintenance and reliever therapy (i.e. Symbicort SMART) prevents exacerbations and EIB more effectively than regular ICS/LABA plus SABA as reliever.

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