Ozempic’s sister drug has been rejected, and more Aussies are paying for replicas

Australia has refused to subsidise the blockbuster weight-loss drug Wegovy for a second time, delaying its introduction to the country while consumers pursue back-door methods to get their hands on the medication.

The Pharmaceutical Benefits Advisory Committee last month rejected the second application by Danish pharmaceutical giant Novo Nordisk to add Wegovy – which is made from semaglutide – to the Pharmaceutical Benefits Scheme as a treatment for severe obesity.

Wegovy was again rejected from the PBS, meaning its manufacturer needs to decide whether to launch it privately.Credit: Novo Nordisk via AP

Wegovy, which is marketed specifically for weight loss, is a higher-dose version of Ozempic, the diabetes drug that became famous for its weight loss properties through TikTok and Hollywood.

Both products are weekly injections that reduce a user’s appetite by mimicking hormones that cause the body to feel full, and trials sponsored by the company have shown patients lost up to 15 per cent of their body weight. They’ve been touted as revolutionising weight loss, leading Novo Nordisk’s share price to skyrocket and the company’s market value to outgrow that of the Danish economy.

But in Australia, cautious medical regulators and global supply shortages, which began in 2022 and are expected to continue through 2024, have limited the extent to which the drugs are available.

While both products have been approved as safe by Australia’s Therapeutic Goods Administration, only Ozempic is sold in the country or listed on the PBS.

It is subsidised at $30 a month in Australia for type 2 diabetes but is frequently purchased “off-label” – meaning for a purpose for which the drug has not been approved – for weight loss at a higher price, starting from $130.

In a pitch to the Australian government, Novo Nordisk argued that listing Wegovy on the PBS – where it would also be available to eligible patients for $30 a month – would offer a “major treatment option for a significant portion of the overweight and obese Australian population”.

“The potential investment on the PBS into reducing the significant burden of disease and economic burden of obesity could be in the order of multiple billions over the forward estimates,” it said.

But in its decision, the pharmaceutical advisory committee said Wegovy was not cost-effective at the proposed price when considered next to the comparator of a placebo with diet and exercise. It said Novo Nordisk’s economic model was overly simplistic and unreliable, while the company needed to better define which patients should be eligible.

Novo Nordisk now needs to decide if it will launch the product in Australia for private prescriptions.

A spokesman said the company was disappointed. “Novo Nordisk is working hard to make Wegovy available for patients living with obesity as soon as possible. The timing of its availability in Australia is not yet confirmed,” he said.

The decision to knock back Wegovy follows the PBAC’s similar call to reject another hyped weight-loss drug, Mounjaro, from the PBS for diabetes in July last year.

Mounjaro, made from tirzepatide, is an injectable medication made by US pharmaceutical giant Eli Lilly with similar outcomes and side effects to Ozempic and Wegovy. Eli Lilly launched it privately in Australia around October last year but is already suffering supply shortages.

The most common side effects of the drugs are nausea, diarrhoea, constipation and dehydration, although the US Food and Drug Administration last week revealed it was evaluating the risk of more serious side effects including hair loss and suicidal ideation.

Global supply shortages of Ozempic, in particular, have driven Australian vendors – especially telehealth companies that are seeking to capitalise on huge demand – to begin compounding the medication. This means a pharmacist or healthcare practitioner makes the medicine themselves.

The Therapeutic Goods Administration says it is concerned about the sale of compounded weight loss medications to Australians because the products have not been evaluated or tested.

“Novo Nordisk is the only pharmaceutical company with Therapeutic Goods Administration approved products containing semaglutide, identified under the trade names Ozempic and Wegovy,” a statement said.

“We are aware of an emerging trend for telehealth providers to offer compounded semaglutide-like products. Compounded semaglutide-like products are ‘unapproved’ therapeutic goods and have not been evaluated by us for safety, quality and efficacy.

“The compounding of medicines should be reserved for exceptional clinical circumstances.”

It said the medicines could contain undisclosed or harmful ingredients.

A TGA spokesperson said the agency would not comment on whether any investigations were under way.

“It is unlawful for pharmacists to supply medicines that they have compounded prior to receiving a prescription for a named patient, except when practising in a hospital in certain circumstances,” they said.

“Compounding medicines on a commercial-like scale has the potential to adversely affect many patients, as the quality, safety and efficacy of the compounded product has not been subject to the rigorous testing required for the safe supply of registered medicines in Australia.”

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