No PBS listing for Mounjaro® (tirzepatide) in type 2 diabetes

Key Facts:

·        A positive PBS funding recommendation came with unviable and unsustainable conditions¹ that Lilly cannot accept

·        Mounjaro is designated by the WHO as an Essential Medicine for type 2 diabetes² and is already reimbursed for type 2 diabetes in 11 countries – including the UK and countries with larger populations and lower GDP per capita than Australia, such as China³

·        Without wholesale changes to the PBS, Australia will further entrench a two‑tier system where medicines access depends on a person’s ability to pay

Friday 24 April: Eli Lilly Australia (Lilly) regretfully advises that Mounjaro will not become available through the Pharmaceutical Benefits Scheme (PBS) for Australians living with type 2 diabetes, following four unsuccessful attempts to secure a viable funding recommendation.

 

While the Pharmaceutical Benefits Advisory Committee (PBAC) has finally recommended that Mounjaro be made available through the PBS and acknowledged the clinical value of the medicine,¹ Lilly cannot proceed with the listing under the proposed conditions.

 

“We do not make this decision lightly. After four reimbursement submissions and extensive departmental engagement over three years, we were left with no other option,” said Manny Simons, General Manager of Lilly Australia and New Zealand.

 

“We understand how disappointing this will be for up to 450,000 Australians living with type 2 diabetes who should have access to Mounjaro through the PBS.”³

 

The World Health Organization lists Mounjaro as an Essential Medicine for type 2 diabetes based on clinical evidence and unmet medical need.²

 

Australia continues to undervalue medical innovation by comparing modern medicines with older, low-cost therapies and insisting on rigid expenditure caps. The result is that while Australia was one of the first countries where Mounjaro was launched, 11 other countries now fund the therapy and Australians miss out.³

 

Why the PBS listing of Mounjaro for type 2 diabetes will not proceed1,2 The price that the Australian Government is willing to pay for Mounjaro is significantly lower than any other reimbursed price globally – including comparable healthcare systems like the UK and countries with lower GDP per capita, such as China. The recommendation included strict funding caps that would have assigned disproportionate financial risk to Lilly. The PBAC rejected proposed safeguards to restrict prescribing only to eligible patients, meaning Lilly would have to pay for the treatment of other patients. The value of Mounjaro was ultimately price benchmarked against a medicine that is 20 years old, is no longer available in Australia and involves 14 times as many injections. Under existing policies, a significant share of the proposed expenditure on Mounjaro would flow to wholesalers and pharmacies rather than to Lilly, making long‑term supply through the PBS unsustainable.

 

Diabetes experts concerned by chronic undervaluing of medical innovation

Associate Professor Sof Andrikopoulos, CEO of the Australian Diabetes Society, said, "Australians living with type 2 diabetes are being penalised by the chronic undervaluing of medical innovation."
 
"Type 2 diabetes is the single greatest challenge facing Australia’s health system. In spite of significant advancements in treatment, over 850,000 Australians living with this condition have inadequately managed blood glucose levels.^4,5

 

^“The Australian Diabetes Society supports individualised care for people with diabetes and choice for health professionals, but bureaucratic inflexibility is now impeding access to therapies which effectively manage their condition and reduce the risk of diabetes-related complications."

 

Lilly notes that approximately 100 positive PBAC recommendations have not progressed to PBS listings over the past five years.⁶

 

Mr Simons said, “Our decision was driven by the simple reality that the price conditions proposed by the Australian Government are unrealistic and unviable, independent of global pricing dynamics influenced by the US Administration's Most-Favoured-Nation policy.”

 

“Health stakeholders know that Australia’s medicines access system is in a state of disrepair. They also know that a fix is within reach if the Federal Government fully implements the recommendations of the Health Technology Assessment review and matches these reforms with a substantial increase in budget allocated to innovative medicines.”

 

“While the door to a PBS listing for type 2 diabetes is now shut, we remain focused on finding new ways to make Mounjaro more accessible for Australians with chronic cardiometabolic conditions – including working with the Government on potential solutions outside of the PBS.”

 

What does this mean for people living with obesity?

While Lilly’s decision is specific to type 2 diabetes, systematic barriers to equitable medicines access in Australia are likely to impede future reimbursement submissions for other Mounjaro indications – including the treatment of obesity.

 

“Based on today’s outcome, it is difficult to see how a PBS listing for Mounjaro could be secured for Australians living with obesity or obesity-related disease,” Mr Simons said.

 

“Lilly would like to thank the diabetes community for their vocal support of equitable access to Mounjaro in Australia.”

 

#ENDS#

Media contacts

Max Weber – 0452 213 513 or [email protected]

John Morton – 0416 184 044 or [email protected]

Issued by Ethical Strategies on behalf of Eli Lilly Australia.

 

About Mounjaro (tirzepatide)

Mounjaro is available on private prescription, not through the Pharmaceutical Benefits Scheme (PBS), for the treatment of:⁷

Type 2 Diabetes Mellitus: Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

• as monotherapy when metformin is not tolerated or contraindicated.
• in addition to other medicinal products for the treatment of type 2 diabetes.

Chronic Weight Management: Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management, including weight loss and weight maintenance, in adults with an initial body mass index (BMI) of:

• ≥30 kg/m2 (obesity) or
• ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes mellitus).

Obstructive Sleep Apnoea (OSA): Mounjaro is indicated for the treatment of moderate to severe obstructive sleep apnoea in adults with obesity.

As with all medicines, Mounjaro may be associated with some side effects. The most commonly occurring side effects can be gastrointestinal, injection site-related, and low blood sugar.⁷

Mounjaro should not be used for the treatment of diabetic ketoacidosis, or by people with type 1 diabetes, children or adolescents under 18 years of age, pregnant women, or those who are allergic to any of the medicine’s ingredients.⁷

For further information, please review the Mounjaro KwikPen^® Consumer Medicine Information.

 

References

1. Australian Department of Health, Disability and Ageing. Pharmaceutical Benefits Advisory Committee (PBAC) March 2026 meeting outcomes. Published 24 April 2026
2. World Health Organization. The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list. 5 September 2025
3. Lilly Australia. Data on file
4. Australian Institute of Health and Welfare. Diabetes: Australian facts. 12 December 2024
5. Szwarcbard et al. The association of weight status with glycemic control, diabetes related complications and anti-hyperglycemic medication use in patients with type 2 diabetes mellitus: The results of the Australian National Diabetes Audit (AND) 2015-2022. Diabetes Research and Clinical Practice, 2025
6. Amgen Patient Access Gap Tracker (Edition 9). April 2026
7. Lilly Australia. Mounjaro Product Information. February 2026.

 

Eli Lilly Australia Pty Limited. Level 9, 60 Margaret Street, Sydney, NSW 2000, Australia. ABN 39 000 233 922. Prepared April 2026. CMAT-26322

 

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About Lilly 

Lilly is a medicine company making life better for people around the world. We've turned science into pioneering new discoveries for nearly 150 years, and today our medicines support more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: treating obesity, redefining diabetes and obesity care; advancing the fight against Alzheimer's disease; providing some of the most debilitating immune system disorders; and targeting the most difficult-to-treat cancers. With each step towards a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com.au or follow us on LinkedIn.  

Contact details:

Max Weber – 0452 213 513 [email protected]

 

John Morton – 0416 184 044 or [email protected]