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.
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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 callto 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 Administrationlast week revealed it was evaluating the risk of more serious side effects including hair loss and suicidal ideation.
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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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