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Telehealth provider defies TGA semaglutide request


Matt Woodley


4/07/2023 5:07:23 PM

Eucalyptus is reportedly offering patients access to the type 2 diabetes-indicated drug for weight loss purposes, despite ongoing supply issues.

Semaglutide packages
Semaglutide has experienced supply issues since May 2022. (Image: AAP)

This article was updated at 8.30 pm on Tuesday 4 July to include comment from Eucalyptus CEO Tim Doyle.

Telehealth providers owned by Australian online healthcare company Eucalyptus have begun prescribing semaglutide (sold as Ozempic) for weight loss, seemingly in contravention of a Therapeutic Goods Administration (TGA) request to avoid ‘off-label’ use of the popular drug.
 
According to the Australian Financial Review, Eucalyptus’ women’s health provider Juniper recently began promoting the drug to eligible customers, while on Monday it also removed a statement from its site confirming that its weight loss medication had been approved for that indication in Australia.
 
The same statement had specifically ruled out prescribing semaglutide, which is not indicated for weight loss in Australia.
 
Eucalyptus CEO Tim Doyle told newsGP the change in approach was due to liraglutide (sold as Saxenda) shortages that first became apparent in May, leading the company to stop taking on new customers and recommend that existing patients cap dosages at reduced levels.
 
‘To ensure continuity of care for tens of thousands of patients we investigated alternative options, including Ozempic,’ he said.
 
‘Ozempic is a cheaper, more effective GLP-1 medication and its supply in Australia has significantly increased in recent months. As a result, Eucalyptus began transitioning eligible patients towards this alternative medication.’
 
Mr Doyle also said that while the ‘initial priority’ had been patients with diabetes or at high risk of diabetes, ‘ample further supply’ means doctors can prescribe semaglutide to eligible patients ‘if consistent with their clinical judgement’.
 
However, Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, is worried that the flow-on effect may exacerbate semaglutide supply challenges that caused major disruption last year and are likely to continue until at least the end of 2023.
 
‘It is clear that the semaglutide supplies currently available in Australia are recommended for people with type 2 diabetes at least until December 2023 to ensure supply is not further interrupted,’ he told newsGP.
 
‘A concern is that an upsurge in off-label use of semaglutide will again impart further hardship on people utilising this drug for type 2 diabetes as stock is only guaranteed for expected use in [this cohort].’
 
Moreover, Dr Deed is also wary about siloing healthcare into commercial disease-focused entities as they may impact on patients’ ability to manage any safety concerns or risks associated with medical advice given in these contexts.
 
‘Obesity management should be provided in the context of a supportive multidisciplinary program,’ he said.
 
‘Services offering unitary approaches to chronic health conditions, such as obesity, that on the face of things seem patient friendly and offer convenience, [may] lack the integration of “whole of health approaches” to the setting in which overweight or obesity arises.
 
‘How much support is actually available to all these patients? How is the intervention integrated into the patient’s health records. Do patient’s get ethically informed that their own GP may and can offer these services?
 
‘[To me], this clearly points to the fact that people need to engage in a supportive primary care model to optimise all health outcomes.’
 
Dr Terri-Lynn South, Chair of RACGP Specific Interests Obesity Management, holds similar concerns.
 
‘The TGA advice has been to try to limit that medication to people with type two diabetes. The RACGP, supported by the Australian Diabetes Society, also came out with a position statement advising members to do the same,’ she told newsGP.
 
‘My concern is that prescribers are doing these online sessions without extensive assessment or knowing the patient and their broader picture of complex obesity as well as their own GP might. They’re also going against what they’ve been advised to do in what is a very difficult situation.
 
‘It’s not illegal for GPs to prescribe medications off-label – we do that with other medications. It’s more of an equity and access issue at this point in time, and [these] prescribers will be going against regulatory advice.’
 
Semaglutide also has a number of potential side-effects, while research has also found that users can regain around two-thirds of any weight lost during treatment within a year of ceasing medication.
 
For those reasons, Dr South said a patient’s regular GP is generally better placed to provide obesity management.
 
‘They understand their patient’s weight or obesity in a holistic context that incorporates extended family history as well as their society, their community, and all of their other concerns, such as their mental health,’ she said.
 
‘Is it genetically driven? Is it a complex obesity that will need lifelong management? If it is, they need to talk to the patient about what that actually looks like, because people who have a certain type of obesity which has been very much driven by their genes will absolutely gain weight when they stop this medication.
 
‘I’m not sure that a prescriber who doesn’t know their patient very well and is interacting via online asynchronous communication is actually giving that sort of assessment and advice, which I don’t think is the best practice.’
 
Eucalyptus Clinical Director and GP Dr Matthew Vickers previously told newsGP that the service provided by Juniper entails more than simply prescribing and that patients receive follow-up care, including safeguards and clinical audits designed to help patients manage potential side effects.
 
The liraglutide supply issues that prompted the initial shift have since been resolved.
 
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Dr Samuel Christopher Ognenis   5/07/2023 1:25:00 PM

Semaglutide is indicated and listed for weight loss in Australia, as this NewsGP article mentions (https://www1.racgp.org.au/newsgp/clinical/semaglutide-supplies-return-to-australia-ahead-of). It is just that the brand Wegovy is not available.

It is a cheaper, evidence-based and more effective option than many other options, and is absolutely essential to treat, to prevent development of T2DM and all manner of other comorbidities.

The TGA does not have jurisdiction here.


Dr Issa Khalil   7/07/2023 4:06:28 PM

With all due respect I think the TGA and RACGP got it all wrong this time.
I have been pushing to get semaglutide approved and if possible PBS listed for the treatment of obesity we know the weight loss is a class effect and goes with both other available GLP-1 analogs it is relatively safe the pancreatitis is rare and the diarrhoea is short lasting it doesn't drop your blood sugar and the effect on appetite is amazing. It has helped many people to lose significant amount of weight.
This class has been around for long time and I remember since 2012 how hard it is to convince diabetic patients to take on injectables whether GLP-1 analogs or insulin and now all of the sudden all diabetes patients want semaglutide?
I think the obesity pandemic should be the priority to treat here not the diabetes and in my opinion if a patient is willing to inject themselves to help with losing weight I am happy to prescribe it to them regardless of what TGA think


Dr Nicola Behne-Smith   14/07/2023 2:09:08 AM

This is a distorted topic. The problem is not the incorrect prescribing as Semaglutide is the leading weight loss medication in effectiveness and yet good safety profile . Obesity is a serious and deadly disease with significant morbidity and mortality. . More so than well controlled diabetes.
The actual problem is YET AGAIN there is a supply problem regarding essential important medications. When will this stop?? When will we STOP relying upon foreign manufacturers and transport and instead enforce pbs listing requirement for local manufacturing of product? All this talk of war , economical al ready waging and Europe and Taiwan flashpoints which result in trade crashing ,… and yet such a clear and present danger to our supply of so many essential supplies and medications is not being addressed and prevented. Instead of the ridiculous wedged fighting amongst ourselves how about we look at the bigger picture and unanimously call for onshore drug manufacturing to be securely funded