Think twice about initiating GLP-1 receptor agonists until supply problems are sorted out, TGA and experts warn.
No matter your stance on how diabetes and weight-loss drug semaglutide (Ozempic, Novo Nordisk) should be used, now is a bad time to start patients on it.
Dulaglutide (Trulicity, Eli Lilly) has been the latest domino to fall in the diabetes medicine shortage saga, with the TGA warning that there may not be enough supply in the country to fill all scripts until early 2023.
The dulaglutide shortage comes after a spike in demand following the semaglutide shortage, which forced many type 2 diabetes patients to switch brands.
The semaglutide shortage was largely caused by non-diabetics using the drug off label for weight-loss.
Although the message to prioritise the medicines for patients with type 2 diabetes was eventually made clear, by that point stock levels had already dropped significantly.
“Even doctors who are thinking of prescribing them for people with diabetes, for example, are being advised to use other agents,” Melbourne endocrinologist and obesity researcher Dr Priya Sumithran told The Medical Republic.
“It’s not that the ongoing shortage is just because people are using it off label, it’s in shortage now for all the uses.”
Dr Sumithran emphasised that the reason people were prescribing these medicines, on label or off, were because they were good, effective medicines.
“They’ve been prescribed in a situation where they are really considered to be the best option to improve that person’s health,” she said.
Both drugs are glucagon-like peptide 1 receptor agonists and are only TGA-approved for lowering blood sugar and cardiovascular disease risk in adults with type 2 diabetes.
The only other GLP-1 agonist available in Australia, exenatide (Byetta, AstraZeneca), has to be administered twice-daily, as opposed to the once-weekly injections of dulaglutide and semaglutide.
Semaglutide products, in particular Ozempic and Wegovy (Novo Nordisk), have a cult online following and are indicated overseas for weight loss in people with a high BMI.
A trial of 200 overweight teenagers in the US found that, in the space of a year, three quarters of the participants on Ozempic lost at least 5% of their bodyweight, compared to 18% who received placebo.
Dr Terri-Lynne South, chair of the RACGP specific interest group on obesity management, said that while semaglutide was one of the most effective weight loss treatments to hit the market for some time, it would only ever be one aspect of a broader management plan.
“Obesity is such a chronic complex disease, [weight loss] is only one part of a lot of things,” she told TMR.
Whether or not doctors personally agree with the medicine being prioritised for people with type 2 diabetes, prescribing off label in the current supply environment may just lead to more issues for the patient.
“To get someone started on something that is extremely helpful and then for them not to be able to get it or to have patchy supply really disrupts the holistic care that should be part of treating a chronic complex condition,” Dr South said.
She also acknowledged that it could be tough for GPs to respond when patients present and directly ask for a certain medication.
In light of the shortage, the TGA has temporarily green-lit an alternative supplier of a dulaglutide product registered overseas.
The company which holds the supply approval, Medsurge Healthcare, said it had applied for its overseas-registered dulaglutide to be added to the PBS but is still awaiting approval.
Until that approval comes through, the TGA warned that the medicine may be “may be considerably more expensive” than Trulicity.
The regulatory body, along with the RACGP and AMA, continues to recommend that the limited semaglutide stocks be prioritised for people with type 2 diabetes, and that doctors monitor their patients’ access to both medicines.
“This is especially important as we approach the holiday season, when the supply of Trulicity may be at its lowest and medical services will be limited for several weeks,” it said.
