Wait list for weight loss as Ozempic replicas banned in four months

Australians taking replica versions of Ozempic and Mounjaro have been told to make a back-up plan with their doctor as the government prepares to ban imitations of the popular weight loss drugs in four months.

The major Australian telehealth businesses selling compounded weight loss drugs – which means a pharmacist has made the medicine themselves– said on Wednesday that they were disappointed Health Minister Mark Butler had this week announced an all-out ban on their products rather than taking other steps to guarantee quality and safety.

The Novo Nordisk drug Ozempic.Credit: Bloomberg

People with diabetes and other users were also worried that they would have no way to get the medication, given global supply shortages of the injections made by pharmaceutical giants Novo Nordisk and Eli Lilly are expected to continue until next year.

The federal government estimates at least 20,000 people have been using compounded weight loss medications, although Mark Fitzgibbon, the chief executive of health insurer NIB, said it was closer to 70,000. Midnight Health, which is owned by NIB, has 10,000 customers who use compounded Mounjaro replicas.

“We think a more appropriate policy objective is to crack down on the operators that can’t guarantee quality assurance, rather than a blanket ban,” Fitzgibbon said. “The reality is that the current guidelines allow for drugs to be compounded in exceptional circumstances. There’s no question the current circumstances are exceptional.”

The Woolworths-backed site Eucalyptus said none of its patients had reported unexpected serious adverse outcomes since it started selling compounded Ozempic replicas six months ago.

“Eucalyptus had previously commissioned extensive independent laboratory testing to review the safety and quality of the compounded product. And we reiterate that there were already stringent regulatory controls applicable to compounding pharmacies,” its clinical director, Matt Vickers, said.

“We remain of the view that a more nuanced approach could have addressed the concerns surrounding compounded semaglutide [the active ingredient in Ozempic], in order to not disrupt patient treatment.”

Eucalyptus customer Elyse, who lost 28 kilograms while taking compounded semaglutide, says the proposed ban will only create greater anxiety.

Elyse, a former Eucalyptus customer from Newcastle who did not give her surname to protect her privacy, stopped using replica Ozempic four months ago after being on the weight loss drug for about a year. She said making the compounded medicine unavailable was deeply disappointing.

“[The compounded drug] made me not feel guilty about using it, and taking away the pens from people who should take first priority [is deeply disappointing]. This is a medication I’ve relied on to get to a point where I’m happy with myself … It will cause distress and anxiety for a group that gets so much benefit from it.”

Health Minister Butler defended his decision to ban the compounds on the basis these were “powerful new drugs that have a significant impact on the body”.

“I know there are thousands of patients who have been lured into this market. I want to give them time to go and consult with their doctor,” he said.

“But I want to be really clear: this is an unacceptable safety risk. This is an abuse of the compounding exception that’s always existed in our medical system to allow doctors and pharmacists to make a one-off decision.

“What we’ve seen over the last several months is that exception, essentially, exploited by some businesses who have set up large-scale manufacturing operations, where there’s no line of sight on safety, at all.”

He has broad support from the health sector, including GPs, the Medical Board of Australia, Diabetes Australia, the Eating Disorders Alliance of Australia and state and territory health departments.

Elizabeth Deveny, chief executive of the Consumers Health Forum, said she welcomed the ban because of concerns about safety and quality issues.

“But what we have also been hearing from consumers for a very long time now is that there is absolutely a supply issue which is impacting those people who legitimately need it,” she said.

“We realise that today’s announcement may worry some people and our advice is for people who are using an Ozempic-like product to speak to their GP and pharmacist now to plan options for what happens after October.”

Ozempic and Mounjaro, known as GLP-1 receptor agonists, are regular injections that reduce a user’s appetite by mimicking hormones that cause the body to feel full.

Ozempic is subsidised at $31.60 in Australia for type 2 diabetes but is frequently bought “off-label” – meaning a purpose for which the drug has not been approved – for weight loss at a higher price, from about $140 a month. Mounjaro is not available on the Pharmaceutical Benefits Scheme but sells for between $315 and $645 a month.

Between 20 and 40 per cent of Australian Ozempic users have used it off-label, Novo Nordisk’s general manager for Oceania, Cem Ozenc, told federal parliament’s diabetes inquiry in March.

Global supply issues remained the major challenge for boosting Australians’ access to the drug, he said.

“What we are doing every day is building manufacturing sites like there’s no tomorrow ... But, as you can imagine, the manufacturing process is complex and it will take time,” he said.

“We are already increasing the supply of Ozempic to Australia. We doubled it last year and it’s still increasing this year, yet it’s still not enough. Unfortunately, that won’t change this year. Next year, we will see how that goes, but I do expect that there will be a similar challenge.”

Supply problems have also stopped the company from launching its other product, Wegovy, in Australia. Wegovy includes a higher dose of semaglitude and is approved for obesity.

“It’s very frustrating – I acknowledge that – because this is a treatment that many millions of Australians are anticipating and that’s also causing a lot of turmoil in the market. But we are working very hard to bring it to Australia,” Ozenc said.

“Once Wegovy has been launched in this country, there will be two treatments for two types of patients, and I guess that will at least lessen that problem a little bit.”

NIB boss Fitzgibbon said there was huge demand but supply would eventually catch up. He thought more products would soon enter the market and competition would drive prices down.

“This is a transient issue and the market left to its own devices will correct it in time – I think, sooner rather than later. We welcome the fact that we’ve got until October to deal with this issue and we’re hopeful that by the end of this year, the supply of manufactured products will catch up with demand.”

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