Symbicort OTC application blindsides experts, may start Inhaler Wars

9 minute read

Whether the application is approved or not, it is likely to significantly raise regulator awareness of all the issues currently surrounding mild asthma management.

AstraZeneca has surprised much of the respiratory community by applying to take Symbicort OTC as early as November.

Whether the application is approved or not, it is likely to significantly raise regulator awareness of all the issues currently surrounding mild asthma management.

As if to draw a huge red line under significant and somewhat controversial changes to the Australian Asthma Guidelines and the Australian Asthma Handbook around the treatment of mild asthma, it was revealed on Wednesday that Symbicort manufacturer AstraZeneca (AZ) has applied to reschedule its inhaled corticosteroids/long-acting beta agonist (ICS-LABA) treatment from S4 to S3 (prescription to pharmacist-only).

If successful, the application would put the treatment squarely up against OTC short-acting beta agonists (SABA) – generally Ventolin, made by GSK – and depending on the pricing AZ chose to go with, might entirely wipe out SABAs from the OTC market.

If that happened the irony would be that an increasingly large number of senior respiratory experts in Australia, including some representing the National Asthma Council, view ubiquitous OTC SABA availability as outdated and causing asthma sufferers and the system numerous problems, such as fostering populations of patients who never properly get assessed for asthma and who attempt to manage their asthma via SABAs without ever informing their GP. Use of SABAs more than twice a month is viewed as potentially dangerous, and experts believe that there is a big cohort of asthma sufferers who use OTC SABAs in this way.

But most of these experts aren’t seeing a competing OTC listing of an ICS-LABA, which they generally view as a safer regime for mild asthmatics, as the solution. Not yet anyway.

In its application, AZ put forward some reasonably argued benefits of taking the treatment OTC:

Budesonide/formoterol fix dose combination (FDC) for ‘as needed’ use is well-established and is a recommended alternative reliever therapy option in the Australian asthma guidelines for Steps 2-4. Rescheduling to allow access to patients as a Pharmacist Only Medicine would provide the following benefits:

  • Budesonide/formoterol FDC ‘as needed’ provides a more effective anti-inflammatory reliever alternative to the current OTC reliever which many patients now over rely on as their main treatment option thus helping to reshape behaviour learned over many years. In more recently diagnosed patients, this will also help to avoid the establishment of patient reliance on short acting ?-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. 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.
  • 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. This has the potential to improve asthma outcomes for all patients, not only those who are recommended OTC budesonide/formoterol FDC.
  • 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.

If the changes to the Asthma Guidelines to recommend ICS-LABA as a mainstream early treatment for mild asthmatics was a pebble thrown into what has been a largely calm pond of asthma treatment guidelines for the last 30 years, the AZ OTC application is the equivalent of lobbing a fairly large boulder soon after into the same pond.

As such it has taken quite a few experts in the field, who support the research done by AZ to prove the efficacy of the treatment, and the introduction of it more comprehensively at the GP level, by surprise.

The general view of several experts contacted by The Medical Republic was that such a move was “too soon”, and probably “cart before horse”.

Dr Peter Wark, Professor of Medicine at Newcastle University, and a NAC Asthma Guidelines committee member, told TMR that, having had a day or so to think about it, he thought there was already too much confusion in OTC land around asthma and patient education, and that although ICS-LABA was likely a much safer and appropriate treatment for mild asthmatics to be starting on, there really needed to be a staged process for education, both for patients and GPs before such a step was considered.

“We have problems using SABAs on an as-needed basis as it is,” he said. “There is the wrong price signal being sent, there is the lack of oversight by GPs, all issues that have been long identified. Budesonide-formoterol [OTC] is not likely to be any worse but it certainly could be used inappropriately. It’s possibly better in that it is possibly safer, but in the context of not being supervised and not having somebody properly assessed [by their doctor] to begin with, that is a really big unknown.

“Any medication that is used outside the clinical indications of how we know it works is a risk and will potentially have adverse events.

“I see [OTC ICS LABAs] as a great step forward at this stage. I would prefer to see more controls around SABAs. People need to have an adequate assessment of their asthma and their asthma controls. The majority of them should be using an ICS as a preventer and how much and how often they should use, should be in consultation with their doctor.”

Dr Christine Jenkins, Professor of Respiratory Medicine at UNSW Sydney, expressed a similar concern with rush to take ICS-LABA OTC.

“I believe that we need to move from as-needed SABAs to a more widely adopted as-needed ICS-LABA and there is the good evidence now to support this approach… however, the issue is: will patients use this in preference to, say, going to the doctor, being properly assessed, receiving appropriate education around SABA and all the things that are part and parcel of laying a good foundation for understanding and managing asthma well?

“We are unique in Australia in having OTC SABA, but applying to put something in place instead of that doesn’t seem like the best approach to me. To bypass medical consultation for somebody who has asthma, or believes they have asthma or believes they should take a reliever inhaler, is not a good strategy.

“I strongly support the availability of as needed ICS-LABA but the notion that it should be available OTC troubles me because I feel it would enable patients to bypass appropriate and sensible management and education for their asthma.”

Dr Russell Wiseman, a Queensland GP who is a foundation member of the General Practitioner Asthma Group – National Asthma Council, told TMR that an OTC application now for ICS-LABA was “putting the cart before the horse and I don’t think it would be safe”.

“I spend half of my Wednesdays working in a hospital undiagnosing asthma and COPD or correcting the diagnoses. If someone has arrived at a hospital, with several people along the way failing to work out properly what is going on, the idea of letting a pharmacist make a diagnosis of asthma and dispense this stuff over the counter is crazy.”

So all the experts seem aligned on not moving the newly approved ICS-LABA treatment all the way through to OTC, which might make it hard for AZ to get that application through.

But maybe the marketing strategists at AZ have that figured out already.

Maybe they understand that by attempting an OTC listing of Symbicort, it is going to shine a very big and bright light on what is already OTC: SABAs. All the experts TMR talked to expressed a view that the ease of access and ubiquity of SABAs, although once appropriate many years ago when less was known about asthma activation and prevention, and when there were fewer options available to patients, should no longer be OTC.

So whether AZ gets a listing or not, its boulder into the pond is going to cause waves which will likely wash away some of the lack of awareness and education among GPs on OTC and SABAs, and create some sort of surge or backwash which will lead to GPs more rapidly getting their heads around the ICS-LABA vs SABA debates.

“The listing application is a bit of a win-win for AZ so long as they don’t push it too far,” commented one expert who did not want to be named.

“On the one hand if they get the listing, and price it right, they are going to replace SABA at the OTC level and make a lot of money. And if they don’t, they’ve flushed out most of the issues facing regulators, GPs, and specialists, so they can better map how they do one day make a move into OTC.”

The timing of the AZ listing has the whiff of such a flush-it-all-out strategy about it. It was the same day that NAC formally launched its new guidelines and Asthma Handbook and just days before NAC is running a Q&A on the new guidelines.

We presume that with the AZ application the NAC Guidelines committee is going to prepare themselves for a lot of questions about the application and about SABAs remaining OTC.

If you want to ask any of those questions, you can register for the webinar launch of the NAC New Asthma Handbook HERE.

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