Semaglutide supplies return to Australia ahead of schedule

Some patients with type 2 diabetes and a prescription for semaglutide (sold as Ozempic) will be able to access the medication again this month.
 
The Therapeutics Goods Administration (TGA) issued a statement this week announcing that limited supplies of the drug have now commenced distribution in Australia, and that limited quantities will be available at some – but not all – community pharmacies. 
 
‘Supply is expected to improve over the next few weeks, although will remain quite limited for some time,’ the TGA said.
 
‘The arrival time of stock at individual pharmacies will vary as stock is urgently dispatched from Novo Nordisk to pharmaceutical wholesalers around Australia.’
 
To ensure even distribution, the Department of Health and Aged Care has asked wholesalers to apply purchasing limits on pharmacies.
 
The TGA has also confirmed that pharmacies in rural and remote areas will be prioritised during the first few weeks of distribution to address the barriers patients face in these areas, given they have fewer choices of pharmacy at which to fill their prescriptions.
 
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, welcomed the news.
 
‘Finally, we can overcome a real problem that has affected our management of patients with diabetes,’ he said.
 
However, the medicines regulator has noted that the initial supplies of semaglutide ‘will not be enough’ to meet demand from all patients with type 2 diabetes who have a current valid prescription, nor for those taking the drug off-label for other conditions, such as obesity.
 
The TGA has therefore requested that GPs prioritise people using the drug to manage their type 2 diabetes.
 
‘In the current situation, it is strongly recommended that health professionals should allocate supplies to patients using Ozempic for registered indications, particularly those who have not been switched by their doctor to other glucose-lowering medicines,’ the regulator said.
 
‘Prescribers should avoid initiating new patients until supply stabilises and should continue to prioritise supply of Ozempic for people with type 2 diabetes who are current or previous users and for whom other medicines are not suitable.’
 
Dr Deed said this is where clinical judgement is important.
 
‘The supply issues are not completely resolved so we need each prescriber to consider clinical judgement in prescribing this medication, noting it is TGA indicated for the management of adult people with type 2 diabetes in conjunction with some diabetes medications,’ he said.
 
Meanwhile, the TGA has advised that where feasible, GPs are encouraged to liaise with community pharmacies to obtain updates on stock availability to help inform their prescribing decisions.
 
Semaglutide has been included in the Australian Register of Therapeutic Goods and approved for the treatment of type 2 diabetes, as an addition to both diet and exercise.
 
The drug has also been prescribed off-label for other conditions, notably obesity, and has made a name for itself at a ‘miracle’ weight loss drug in Hollywood and through social media influencers, which is believed to have increased global demand and impacted supply.
 
The sought-after medication started to make headlines due to a global shortage, with impacts on the Australian supply chain first seen in early 2022.
 
Semaglutide, which is taken as a weekly injection that is self-administered, helps people with type 2 diabetes to control their blood sugar and in many cases also lose weight. It does so by sending a signal to the pancreas to produce insulin and reduces the movement of food through the digestive system, leading the individual to feel fuller for longer, and suppresses appetite.
 
But the drug is not without side effects, including nausea, bloating and diarrhoea.
 
The TGA has approved a form of semaglutide, sold as Wegovy, specifically  for weight loss, but it is still not available for use in Australia.
 
For GPs who have been prescribing semaglutide off-label to treat conditions such as obesity, while the medicines regulator acknowledges that it is a ‘serious chronic disease that is challenging to manage’, at this stage it is recommending that alternatives be considered as supply is expected to ‘remain unstable for some time’.
 
Considering the current state of limited supply, the TGA has advised that pharmacists should, where possible, allocate the initial limited supplies to patients with type 2 diabetes who have been unable to switch to other medicines.
 
‘Patients who have switched to other glucose-lowering medicines during the shortage but still hold a valid prescription for Ozempic should be referred to their doctor for advice,’ the regulator said.
 
Dr Deed says that like many other GPs, he has witnessed the impact of the shortage on his patients firsthand.
 
‘Personally, I have seen people struggling to achieve goals with what were previously healthy targets both for weight and glucose or having to utilise different medication combinations to address this enforced change,’ the Queensland GP said.
 
‘Diabetes itself is complex enough to live with, without these external factors affecting a desire to stay healthy.’
 
The TGA has said that it will continue to monitor supply and work with stakeholders to update their advice when the situation changes.
 
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