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New diabetes medication shortage will impact patient care


Matt Woodley


5/07/2022 6:36:38 PM

The semaglutide shortage is having a flow on effect, with dulaglutide now also in short supply until at least the end of August.

Dulaglutide autoinjector.
Unanticipated demand is behind the ongoing dulaglutide shortage in Australia.

An unexpected increase in demand is behind an ongoing shortage of dulaglutide 1.5 mg (sold as Trulicity) in Australia, the drug’s sponsor Ely Lilly has said.
 
While dulaglutide stock is still available in Australia, the company has warned people seeking the medication may encounter ‘temporary delays, interruptions and/or shortages’ at wholesalers and pharmacies until at least 31 August.
 
According to Eli Lilly, the drug’s current limited availability is related to the ongoing semaglutide shortage, which has been brought about primarily by its off label application as a weight loss treatment.
 
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, told newsGP there are ‘no alternatives’ for type 2 diabetes patients impacted by the dual shortages.
 
‘Patient care will be compromised,’ he said.
 
‘Type 2 diabetes patients using these drugs may be using them for specific reasons and alternative agents are clinically difficult to implement quickly when these shortages occur.’
 
A spokesperson for Novo Nordisk, the Australian sponsor of semaglutide (sold as Ozempic), told newsGP intermittent supply issues will continue until at least the end of August.
 
‘We are working hard to satisfy demand to the greatest extent possible,’ they said.
 
‘Our deliveries of Ozempic to Australia this year have significantly exceeded those originally planned, and increasing supply takes time.
 
‘Over the past two months, Novo Nordisk has worked with the TGA to take actions to address the matter, and the support of organisations including the RACGP, AMA, Diabetes Australia and others, has helped people with type 2 diabetes to continue to access Ozempic. 
 
‘Whilst this has helped more people with type 2 diabetes secure access … more time is needed to ensure stable supply.’
 
Meanwhile, Ely Lilly has said new shipments to Australia should be arriving ‘weekly’ and that efforts to replenish the supply chain are ongoing.
 
Both companies and the Therapeutic Goods Administration (TGA) have requested that type 2 diabetes patients be prioritised over other potential recipients of the glucagon-like peptide-1 receptor agonists (GLP-1 RAs).
 
It is a position supported by Dr Deed.
 
‘This all commenced due to a significant upswing in off-label prescribing of semaglutide for management of obesity … at doses well below clinical trial evidence,’ he said.
 
‘Please restrict prescribing to patients with type 2 diabetes and advise other patients with obesity about the TGA-indicated alternatives.
 
‘Think carefully about any off-label prescribing, and have adequate consent and documentation in clinical records.’
 
While semaglutide only has TGA approval for use in diabetes management, the US Food and Drug Administration (FDA) last year ruled that it could be also be used in that jurisdiction for chronic weight management in adults with obesity or overweight with at least one weight-related condition.
 
It is this ruling, combined with social media promotion on platforms like TikTok, that has the resulted in the ‘unanticipated’ demand that is impacting supply.
 
However, it has also raised questions over equitable access to medication.
 
Dr Ella Barclay, Chair of RACGP Specific Interests Obesity Management, told newsGP many patients asking GPs about semaglutide or dulaglutide may not have ever tried previous anti-obesity medications due to financial constraints.
 
Likewise, the once-weekly injection of these medications may also be appealing, compared to alternatives that require daily administration, like liraglutide.
 
So while Dr Barclay understands the call to prioritise semaglutide and dulaglutide for people with diabetes while there is a shortage, she also believes more should be done to support medication access for people with obesity once supply chain issues have been resolved.
 
‘What this whole shortage has highlighted is that access to healthcare should be equal for everyone and we really need to bridge that gap,’ she said.
 
‘Semaglutide is a really, really effective medication for the management of obesity and we know obesity can be a precursor to a number of other chronic health conditions – including diabetes – so I would love to see the TGA approve weight loss as an indication.’
 
Dr Barclay says the STEP 3 trial helped show that there is a ‘really strong biological driver’ behind obesity, which also supports providing greater access to medication that can best help people manage the condition.
 
‘We know that semaglutide is an excellent medication for both the management of diabetes and the management of obesity,’ she said.
 
‘I think we would be doing our patients a disservice if we offered them an inferior medication when we have published evidence showing it isn’t as effective as semaglutide.’
 
For this reason, Dr Barclay would also like to improve patient access to evidence-based weight loss medications via the Pharmaceutical Benefits Scheme (PBS).
 
‘No anti-obesity medications are currently subsidised through the PBS,’ she said. ‘That goes back to access to healthcare and prioritising some conditions over others.
 
‘I’m not on the PBAC [Pharmaceutical benefits Advisory Committee] or part of the approval process. But I think what we’re looking at really is trying to prevent people developing complications from obesity that we know can have significant ramifications on someone’s life and also within the wider health system.
 
‘If we’re trying to be preventive that’s where the benefit lies, in trying to tackle health issues before those complications come about.’
 
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Dr Dusan Sajdak   6/07/2022 7:20:16 AM

Given the spectrum of diseases caused by obesity, why not PBS list Liraglutide for obesity?
Or, given the urgency and severity of the obesity "pandemic", would emergency authorization of WEGOVY (this is semaglutide available in America specifically for weight loss) be an option? The pandemic has authorised the use of antivirals and vaccines for emergency use... so why not apply the same logic?
I see lots of options here from a physician's point of view, but just like always, I'm forced to provide (often) substandard heath care due to bureaucratic processes.
Is there a way we doctors can make decisions (as academics) without the government standing in our way? Just look at America with its abortion law situation... so sad.
I'm up for helping people, I'm struggling to continue doing so. I'm open to any suggestion or ideas.


Dr Dusan Sajdak   6/07/2022 2:15:58 PM

Given the spectrum of diseases caused by obesity, why not PBS list Liraglutide for obesity?
Or, given the urgency and severity of the obesity "pandemic", would emergency authorization of WEGOVY (this is semaglutide available in America specifically for weight loss) be an option? The pandemic has authorised the use of antivirals and vaccines for emergency use... so why not apply the same logic?
I see lots of options here from a physician's point of view, but just like always, I'm forced to provide (often) substandard heath care due to bureaucratic processes.
Is there a way we doctors can make decisions (as academics) without the government standing in our way? Just look at America with its abortion law situation... so sad.
I'm up for helping people, I'm struggling to continue doing so. I'm open to any suggestion or ideas.