In this exclusive article, Sydney endocrinologist Dr Namson Lau explores how the Ozempic crisis came about, the impact of the extended shortage on the care of patients, and how it is affecting clinicians.
By now, almost all doctors working at the coalface of clinical practice have heard of Ozempic (Novo Nordisk) — the trade name for semaglutide.
Usually, this shortage is expressed by exasperated patients saying “Doc, why can’t I get this drug, and can you help me?”
This article seeks to explore how we got there, and the impact of the extended shortage on the care of patients and the questions it has posed for clinicians.
What is it?
Semaglutide is a potent glucagon-like peptide 1 (GLP-1) receptor agonist compound administered as a weekly subcutaneous injection.
It is listed by the pharmaceutical regulator, the Therapeutic Goods Administration (TGA), as medical therapy, adjunct to lifestyle management, for people with suboptimal control of type 2 diabetes mellitus despite use of other medications.
Ozempic’s initial listing in the Pharmaceutical Benefits Scheme (PBS), which broadly follows the same criteria, took effect on 1 July 2020.
With the increasing rates of type 2 diabetes, the addition of another potent anti-hyperglycaemic such as Ozempic was broadly welcomed by the diabetes community.
However, two years after its listing, in about mid-2022, Ozempicreallyhit the news with a rolling sequence of shortages.
What has been driving this shortage?
The efficacy of GLP-1 receptor agonists for weight loss has been known for some time.
In 2021, the potency of semaglutide as a highly effective medical adjunct to lifestyle management in people with clinical obesity was confirmed.
The average weight loss of –15% (v –2.5% for people on placebo) exceeded that of the other widely used anti-obesity medications and with a side-effect profile that was for the most part tolerable.
The original article, published in the New England Journal of Medicine, has been widely cited in the medical literature, and was well covered in mainstream media.
However, it has been through the dissemination of semaglutide’s impressive weight loss properties by celebrities and those with prominent social media profiles that knowledge of Ozempic went truly viral.
This has fuelled an exponential consumer demand for what has been described by patients as the “miracle weight loss drug” and the “magic skinny pen”.
What has this meant for people living with diabetes and their doctors?
The Ozempic shortage led to downstream impacts on the availability of the other weekly GLP-1 receptor agonist agent dulaglutide(trade name Trulicity; Eli Lilly).
It was also worsened by the planned withdrawal of the remaining daily GLP-1 receptor agonist exenatide (trade name Byetta; AstraZeneca), which has been significant in the lives of many people living with type 2 diabetes.
They faced having to contact multiple pharmacies to try to obtain their medications and, even after all their efforts, to increasingly face being unable to buy their medications.
This disheartening experience has been shared by the hundreds of my own patients and in many conversations I have had over the past near 12 months with specialist and general practitioner colleagues.
For people with type 2 diabetes, the majority experienced increasingly elevated blood glucose levels and worsened glycaemic control and weight regain. For some people, this may well lead to high risk to develop new diabetes-related complications.
Many of my own patients expressed frustration and lost confidence about their ability to live well with the condition.
As clinicians, we had to try to restore our patients’ willingness to engage with their diabetes care, yet faced this with a reduced regimen of agents to use.
I would not be alone in navigating a tricky conversation about adding in older agents with a higher risk of hypoglycaemia and without the metabolic and cardiac risk-reducing properties of the weekly GLP-1 receptor agonists versus just waiting for supply of the GLP-1 receptor agonists to come back, nor wondering if a new script might be more likely to get filled than one written previously.
What about those living with obesity?
This had to be administered daily and was nearly three times the cost of Ozempic, when the latter was prescribed on a private script.
Although the dose of semaglutide in Ozempic is lower than that used in the Step 1 study, that distinction was lost in the increase in off-label Ozempic prescriptions experienced from mid-2022.
However, the resulting shortage has led to debate as to who should receive the agent, with the TGA and professional associations calling on clinicians to prioritise people meeting the PBS criteria for prescribing.
However, what the Step 1 study demonstrated was that beyond lifestyle measures, there really is a role for effective adjunct medical obesity therapies for people living with obesity; even more so if they also had obesity-related metabolic or other complications.
Where are we now?
Although there are signs the shortage of GLP-1 receptor agonists is currently improving, this experience has highlighted to clinicians the hereby underappreciated role of new media to dramatically ramp up knowledge of what were previously niche medications.
This rapid increase in knowledge created massive consumer demand and challenged us to be aware and proactive in discussing these concerns with our patients.
It also reminded Australians of the global nature of the pharmaceutical sector (many of my patients expressed surprise that these agents were not being manufactured locally) and the fragility of the supply chain.
In addition, it raises important questions about the trade-off between equity of access to important medications across differing clinical conditions.
With even more potent agents such as the dual incretin tirzepatide likely to come in the near future, the wide knowledge and prescription of Ozempic and related agents raises a challenging conversation about how society views weight, weight loss and body image.
Dr Namson Lau is a Consultant Endocrinologist affiliated with Royal Prince Alfred and Liverpool Hospitals and conjoint senior lecturer, South West Clinical School, University of New South Wales.
The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.
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