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Semaglutide unavailable in Australia until April 2023
GPs have been told not to initiate any new patients on either semaglutide or dulaglutide, which will also only have ‘limited availability’.
Semaglutide has been in short supply in Australia since April.
The Therapeutic Goods Administration (TGA) has advised that semaglutide (sold as Ozempic) will be unavailable in Australia until the end of the March 2023.
The weekly GLP-1 receptor agonist (GLP-1 RA) diabetes medication has been in short supply since April, in large part due to its promotion as a weight loss drug on social media platforms like TikTok.
However, while the shortage was originally expected to ease by the end of the year, ongoing demand has led to global supply issues that are also having a knock-on effect on dulaglutide (sold as Trulicity), another one-weekly GLP-1 RA.
That drug is expected to have ‘limited availability’ until at least the end of March 2023, placing pressure on type 2 diabetes patients who use GLP-1 RAs to help manage their condition.
The RACGP has advised GPs not to initiate either medication for new patients until the shortage subsides.
‘While we understand this is a cause of concern, it is important to note that there are other effective diabetes medicines available in Australia for people with type 2 diabetes that contribute to improved health outcomes,’ a college release states.
‘We encourage all GPs to identify and support any person affected by the unavailability of the GLP-1 RA to make an appointment to actively review their diabetes or obesity management.’
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, told newsGP the shortage is a good trigger for GPs to review the college’s type 2 diabetes guidelines.
‘Both diabetes and obesity management require a multimodal and multidisciplinary approach to optimising patient outcomes,’ he said.
‘These drug supply issues are a great opportunity to have patient management reviews, emphasise principles around healthy lifestyle, and review therapies including prescribing options or even de-prescribing if possible.’
Alternative treatment options suggested by the RACGP include:
The twice daily exenatide (Byetta) is not recommended as a potential substitute, as it is
being discontinued and will no longer be available once existing stock runs out, which is predicted to occur next month.
While the increased demand for semaglutide is negatively impacting patients unable to access the medication, it is generating significant profits for its sponsor, Novo Nordisk.
According to the company’s
Q3 financial results, operating profits have increased by 14% at constant exchange rates to 57.7 billion Danish kroner ($11.98 billion) thanks in-part to an 18% sales increase in its diabetes and obesity care products.
The $25.5 billion in revenue generated by these products has been mainly driven by a 44% increase in GLP-1 RA sales.
Obesity care sales also grew by 75% and Novo Nordisk has committed to making all Wegovy dose strengths available in the US towards the end of 2022.
Wegovy is the tradename for semaglutide when sold for the purposes of weight loss, with the main difference being that it currently comes in 0.25–2.4 mg injections, as opposed to Ozempic, which is sold as 0.25–1 mg injections.
A spokesperson for Novo Nordisk has ‘sincerely’ apologised for the supply shortage, which they described as an ‘unfortunate situation’, as well as ‘any inconvenience it may cause’.
‘Whilst we continue to significantly increase our production, our present supply does not always meet this demand in Australia,’ the spokesperson told
newsGP.
‘We understand the uncertainty and concern this is causing for people living with diabetes and the healthcare professionals that support them.
‘This is not something we take lightly, and we are … working around the clock to maximise existing production while investing heavily in new capacity to remedy these shortages.’
Meanwhile, dulaglutide’s sponsor, Eli Lilly Australia, told
newsGP it remains ‘committed’ to people who use the medication and is confident in its mid- and long-term global supply for people with type 2 diabetes.
‘Lilly is in frequent contact with wholesalers, and together we are closely monitoring stock levels,’ the spokesperson said.
‘We are releasing stock to wholesalers as equitably as possible. Lilly anticipates that patients could experience delays of several weeks in having their prescriptions filled, depending on location and wholesaler.
‘We are working diligently to ensure patients and pharmacies are minimally impacted as Lilly continues to invest and add manufacturing and supply capacity around the world.’
Eli Lilly has also benefited financially from the increased demand for semaglutide, with dulaglutide and its new glucose-dependent insulinotropic peptide (GIP)/GLP-1 launch tirzepatide (sold as Mounjaro)
generating $1.85 billion and $187.3 million in Q3 sales respectively.
As reported by AJP, the increased demand for GLP-RAs appears to have taken many by surprise, including the Pharmaceutical Benefits Advisory Committee (PBAC).
When semaglutide was first launched in 2020, the PBAC’s
public summary document only allowed for ‘50,000–100,000 prescriptions for semaglutide in the first year of listing … increasing to over 200,000 in year six’.
It estimated the net cost to the PBS as $10 million in year one, increasing to up to $60 million in year six. However, the PBS reimbursement costs for the drug up to June 30 – the second year it was listed – totalled nearly $90 million, a figure 50% larger than the highest year six estimate.
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diabetes dulaglutide GLP-1 RAs Ozempic semaglutide Trulicity
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