Could combo asthma inhalers go OTC?

Proposal for combination asthma inhalers to be downscheduled to Pharmacist Only with Appendix M controls for ‘as needed’ use

A request has been made for the TGA to downschedule budesonide-formoterol fixed dose combination (FDC) inhalers to Schedule 3, for use as an anti-inflammatory reliever in people aged 12 years and over who have diagnosed asthma.

The proposed amendment was published on Wednesday, the same day as the launch of the new National Asthma Handbook, which now outlines as-needed low-dose budesonide-formoterol, taken for relief of symptoms, as a treatment alternative to daily maintenance low-dose inhaled corticosteroid preventer for mild asthma.

According to the National Asthma Council Australia, the new recommendation is supported by “strong evidence” from four randomised controlled trials showing combination inhalers not only provide immediate symptom relief, but also reduce the risk of severe flare ups by two-thirds compared with using short-acting relievers alone.

Reduction in risk of severe flare-ups was similar to, or better, than with a daily maintenance low-dose inhaled corticosteroid.

The TGA application calls for an Appendix M entry to be made, requiring the pharmacist on supply to: confirm the patient has a medical diagnosis of asthma; comply with the relevant professional standards; and document the supply.

An Appendix F entry was also proposed, requiring the medicine to have a warning statement that says “this preparation should be part of an overall treatment plan regularly assessed with your doctor”.

Reasons for the downschedule, put forward by the private applicant, include that in more recently diagnosed patients, budesonide/formoterol FDC ‘as needed’ will help to avoid the establishment of patient reliance on short acting β-agonist (SABA).

“OTC budesonide/formoterol FDC ‘as needed’ will provide patients with earlier inhaled corticosteroid (ICS) therapy helping to address the underlying inflammation to prevent exacerbations or asthma deterioration,” said the applicant.

“ICS adherence is also not a concern with this therapy as the budesonide is provided in combination with the reliever.

“The benefits of reducing SABA overreliance and ICS under-utilisation would have indirect benefits with fewer patients with uncontrolled or poorly-controlled asthma, reduced urgent asthma-related healthcare visits and potentially less asthma-related deaths. Thus minimising cost and risk to the community.”

With these proposed changes, consultations between pharmacists and patients with asthma will have an increased focus on the importance of reduction in underlying inflammation, in addition to symptom relief, to prevent exacerbations and maintain control, the applicant submitted to the TGA.

“This has the potential to improve asthma outcomes for all patients, not only those who are recommended OTC budesonide/formoterol FDC, ” it said.

“With patient consent and in accordance with professional practice guidance, pharmacists will follow up with the patient’s medical practitioner as appropriate about the supply of OTC budesonide/formoterol FDC. This will facilitate best practice communication and collaboration between the pharmacist and medical practitioner about the patient’s ongoing asthma management. This is especially important for patients with mild asthma. ”

The Secretary invites public submissions on scheduling proposals referred to the November 2020 meeting of the Advisory Committee on Medicines Scheduling. Submissions on the proposal must be received by close of business 28 September 2020.

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