The Therapeutic Goods Administration (TGA) in Australia has approved tirzepatide, marketed as Mounjaro, for the treatment of overweight and obesity in adults with comorbidities. This decision expands the drug's indication beyond its current use as an adjunct to diet and exercise for adults with insufficiently controlled type 2 diabetes.
The approval allows GPs to prescribe tirzepatide to eligible patients with a body mass index (BMI) of ≥30 kg/m2, or ≥27 kg/m2 in the presence of at least one weight-related comorbidity such as hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, pre-diabetes, or type 2 diabetes. The treatment is intended to be used in conjunction with a reduced-calorie diet and increased physical activity for chronic weight management, including weight loss and weight maintenance.
Supply and Availability
While the TGA has approved the expanded use of tirzepatide, supply challenges persist. The tirzepatide solution for injection vial remains in shortage and is expected to remain so until August of the following year. Eli Lilly Australia has announced a transition period in which Mounjaro single-use vials will be replaced with Mounjaro multi-use KwikPens to mitigate supply issues. The company has stated its commitment to ongoing replenishment of all doses of the Mounjaro KwikPen presentation.
Eli Lilly Australia general manager Tori Brown stated, 'Consistent supply of essential medicines to patients is our company’s highest priority.' The company also confirmed that it is on track to meet increased global production targets for its incretin medicines, including Mounjaro, with production in the second half of 2024 expected to increase by at least 150% compared to the second half of 2023.
Expert Commentary
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, welcomed the expanded indication but emphasized the importance of a multidisciplinary approach. 'It won’t suit everyone, and that’s where a really good GP provides the key anchoring point for patients to open the conversation of managing weight, but also giving them support to see what’s appropriate,' he said. He further noted the potential need for psychologists, dietitians, and exercise physiologists in a comprehensive weight management plan.
Broader Context
The approval of Mounjaro for weight management comes amid growing demand for weight loss medications and concerns about shortages of drugs like Ozempic. In response to these concerns, compounding pharmacies have been banned from producing replicas of Ozempic and Mounjaro. Wegovy, another semaglutide-based medication specifically for weight loss, was recently launched in Australia.
Mounjaro is currently only available via private prescription, with a recommended price starting at $395 per month for the initiation dose. Mounjaro is set to be reconsidered for Pharmaceutical Benefits Scheme (PBS) reimbursement for the treatment of type 2 diabetes in November this year.
