Ozempic arrives back in Australia

The TGA has urged doctors to avoid prescribing it off-label for weight loss until stocks stabilise. Rural and remote areas will be prioritised.

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Relief appears to be in sight for patients who have been unable to fill their scripts for semaglutide –   and for doctors who have been navigating the drug’s shortage since May last year.

However, the TGA has warned that initial supplies would not be enough to meet demand for all patients with “current valid prescriptions for type 2 diabetes nor for those taking it off-label for other conditions” and urged health professionals to avoid prescribing it off-label for weight loss until stocks stabilised.

The TGA announced that limited supplies of semaglutide (Ozempic, Novo Nordisk) “have now commenced distribution in Australia”.

“From late next week there will be limited quantities of Ozempic, which is indicated for certain patients with type 2 diabetes mellitus available at some [but not all] community pharmacies,” the TGA said in a statement.

“Supply is expected to improve over the next few weeks, although will remain quite limited for some time. The arrival time of stock at individual pharmacies will vary as stock is urgently dispatched from Novo Nordisk to pharmaceutical wholesalers around Australia.”

The announcement comes earlier than expected – the TGA had previously published advice on its Medicines Shortage Reports Database that the Ozempic 0.25/0.5mg and 1mg pre-filled injection pens were unavailable with expected supply on 31 March.

The TGA also revealed in its statement that the Department of Health and Aged Care had asked wholesalers supplying pharmacies to apply purchasing limits on pharmacies to help ensure a more even distribution of the stock.

“We have also asked wholesalers to prioritise filling pharmacy orders in rural and remote areas during the first few weeks to assist supply in those areas, noting patients in these areas have fewer choices of pharmacy at which to fill their prescriptions,” it said.

“Initial supplies of Ozempic will not be enough to meet demand from all patients with current valid prescriptions for type 2 diabetes nor for those taking it off-label for other conditions.”

The TGA “strongly recommended” that health professionals allocate supplies to patients using Ozempic for registered indications, particularly those who have not been switched by their doctor to other glucose-lowering medicines.

“The TGA recognises Ozempic has also been used off-label to treat other health conditions such as obesity, which is a serious chronic disease that is challenging to manage,” the TGA said.

“Prescribers treating patients with obesity should continue to consider alternatives to semaglutide because supply will remain unstable for some time.”

Other advice provided to health professionals by the TGA in relation to Ozempic included:

• Patients who have switched to other glucose-lowering medicines during the shortage but still hold a valid prescription for Ozempic should be referred to their doctor for advice;
• Prescribers should avoid initiating new patients until supply stabilises and should continue to prioritise supply of Ozempic for people with type 2 diabetes who are current or previous users and for whom other medicines are not suitable;
• Patients may need to restart treatment with a prescription for semaglutide 0.25/0.5mg 1.34mg/mL pre-filled pen to minimise risk of gastrointestinal side effects.

A spokesman for Novo Nordisk told The Medical Republic that the company had ramped up manufacturing capacity and had been running “all operations 24/7”.

He said the company’s guidance to the TGA has been that stock would be available in the first three months of 2023 and they were “pleased that we have met this commitment”.

“We invested about US$1.6 billion [AUD$2.3 billion] in new lines and facilities in 2022,” he said.

“We will more than double this amount in 2023 investing US$3.6 billion [AUD$5.2 billion] to expand capacity across all relevant production sites.”

The spokesman said Ozempic was not indicated for weight loss, and Novo Nordisk “does not promote or prompt any off-label promotion or prescription of its products.”

The company last year received TGA approval for a new semaglutide product known as Wegovy, specifically for chronic weight management, including weight loss and weight maintenance in adults with an initial body mass index of ?30kg/m2 (obesity) or ?27kg/m2 to <30kg/m2 (overweight) in the presence of at least one weight-related comorbidity.

“Novo Nordisk is working hard to make Wegovy (semaglutide 2.4mg) available for patients living with obesity as soon as possible,” the spokesman told TMR.

“The timing of its availability in Australia is not yet confirmed.”