The TGA reiterated its recommendation that Australia continues to have a shortage of Ozempic, saying in a short statement:
It sounds simple, and it would be if only the Ozempic prescription problem were black and white and extremely simple, but unfortunately it is not. Those using Ozempic, both those who meet the standards and those who do not, are finding it difficult to maintain supplies, leading to confusion and frustration. Those who do not meet the criteria may be shamed and told they are not qualified if they try to access it.
First, a disclaimer: I am not a medical professional. I do not offer medical advice. I do not endorse any therapy or treatment (off-label or off-label). As someone with T1D, I am inherently interested in access to technology and medicines that make our lives better. And I am interested in (and believe in) the off-label use of technology and pharmaceuticals because using various off-label treatments has significantly improved my diabetic life and overall health. Masu). And just in case you need attention, almost all diabetics act outside the norm in some way. If you don't believe me, ask your diabetic patient when was the last time they changed their lancet.
And just a quick reminder: I don't work for an Australia-based diabetes organization, so this article may not be in line with anything they say or don't say. It is not related to or involved in any way. This is me, an Australian punter with T1D, sharing my thoughts. (As I've already done in over 2,000 posts here.)
Well, without further ado, I will express my thoughts and complaints regarding the latest information regarding the Ozempic shortage issue.
In Australia (and elsewhere, but limited by Australian prescribing rules since I live here), the TGA has indicated that Ozempic is used for (sorry the wording): TGA needs to come back to me and prescribe a little) #LanguageMatters Update):
“Treatment of adults with poorly controlled type 2 diabetes as an adjunct to diet and exercise:
- As monotherapy when metformin is not tolerated or contraindicated.
- In addition to other medications for the treatment of type 2 diabetes.
For people who meet these criteria, Ozempic is prescribed using a PBS prescription. That means the cost per pen is $31.60 ($7.30 for discount cardholders).
Does this mean only this cohort can be prescribed Ozempic? No, it is not. Off-label prescriptions are not that uncommon (not just Ozempic, I might add). For those who do not meet the eligibility criteria, Ozempic is prescribed using a private prescription and costs approximately $140 per pen.
Is Ozempic prescribed off-label?Of course it is. This is increasingly the case.
Anecdotally, I have heard from many T1D patient friends in Australia and especially the US who use Ozempic as part of their diabetes management arsenal. Over the past few years, I have heard dozens of talks at conferences where the management of T1D is moving further and further away from carbohydrate-centricity, and is focusing on insulin resistance, lipids, blood pressure, heart and kidney health. The approach is to focus on combinations of drugs to address the problem. That makes sense. Because people in high-income countries have access to highly sophisticated hybrid closed-loop systems that can significantly increase TIR and easily achieve HbA1c targets, many of us are wondering what adjunctive therapies support broader health. I'm trying to figure out if it's possible. GLP-1 has been shown to have CVD and renal protective effects, which many T1D patients would like to take advantage of. Speaking at this year's Australian Diabetes Conference, EASD Director Professor Chantal Mathew said: “These drugs are organ-protective drugs.”
The TGA announcement fails to recognize that Ozempic is used for purposes other than weight loss, and that it may be beneficial for T1D patients.
But let's look beyond my own T1D bias for a moment. Many people with T2D who do not meet the criteria set by the TGA benefit greatly from Ozempic. Not only have they been denied access to medicines at PBS prices, but they have also been denied supplies altogether for not meeting standards. However, many people are worried that if they stop using Ozempic, their blood sugar levels will go out of range and meet the criteria. This cohort feels completely lost, unsupported in the use of medications that dramatically improve their blood sugar levels and overall health. A quick look at online diabetes groups shows conversations about this happening every day.
And stepping outside the realm of diabetes, people living with obesity who have been told over and over again to lose weight to improve their health may find that Ozempic is one of the modifiable risk factors for T2D. I've found myself having great success in dealing with one. This is a classic example of damned if they do, damned if they don't. The group was told to lose weight, but the supporting equipment was then taken away from them and they were slammed on the knuckles for trying to access it.
We understand that there is a shortage, but with that comes priority groups. But it seems strange to completely ignore and not acknowledge that there are other groups that benefit from Ozempic. So is ignoring the challenges these groups face in trying to access medicines, including stigma, shame, and prejudice. prescribed by a medical professional. In fact, some might think this shows a clear lack of understanding of the community's needs and experiences.
postscript
I understand that Wegovy is available in Australia and can be used by people for whom Ozempic is not indicated. Wegovy's cost is at least twice that of Ozempic, which would put it out of reach for people who are already expected to pay Ozempic the price of a personal prescription.
It is perhaps also worth mentioning that the use and approval of adjunctive therapies, including GLP-1, in T1D is not new and is well documented in the consensus report by the ADA and EASD on the management of adult T1D. As is often the case, regulators are taking their time in reaching medical consensus.
