Mounjaro manufacturer rejects PBS recommendation

Tirzepatide (sold as Mounjaro) will not be listed on the Pharmaceutical Benefits Scheme (PBS) for type 2 diabetes, despite a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC).
 
The decision comes after Mounjaro’s manufacturer Eli Lilly rejected the recommendation, saying the ‘price conditions proposed by the Australian Government are unrealistic and unviable’.
 
In its March meeting, PBAC recommended the listing for the treatment of adults with inadequately controlled type 2 diabetes to ‘improve equity of access, particularly for patients for whom cost may be a barrier’.
 
It was Eli Lilly’s fourth attempt to have the drug added to the PBS.
 
However, Eli Lily Australia and New Zealand general manager Manny Simons said the price proposed was ‘significantly lower than any other reimbursed price globally’.
 
‘We do not make this decision lightly,’ he said.
 
‘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.’
 
Mounjaro is approved by the Therapeutic Goods Administration as an adjunct treatment for insufficiently controlled type 2 diabetes and chronic weight management.
 
The recommended weekly dose of the drug costs Australians up to $645 a month.
 
RACGP Specific Interests Diabetes Chair Dr Gary Deed said there are still effective medications available on the PBS ‘at both reasonable cost to people living with type 2 diabetes and the Government’, in semaglutide (sold as Ozempic) and dulaglutide (sold as Trulicity).
 
‘Unless the cost is suitable for the PBS then we as doctors need to make best use of what we have,’ he told newsGP.
 
Dr Deed said while some people living with diabetes ‘may benefit from tirzepatide when other therapies have failed or are not tolerated’, optimising current therapies may also help.
 
‘It makes GPs be vigilant about management options and current therapies, and use the RACGP handbook to look at optimal use of what is currently available on the PBS,’ he said.
 
Dr Deed is aware of a rise in ‘unsustainable prescribing’ of injectable weight-loss medications outside of PBS guidelines.
 
He said the Federal Government is therefore trying to preserve its funding pool to ensure ‘all people with diabetes [have] sustainable access to current medications, let alone new or novel therapies’.
 
‘That has been in everyone’s minds if tirzepatide was allocated PBS access – how much would be used outside of PBS guidelines and how could that cost be contained?,’ Dr Deed said.
 
‘So, this is a real economic issue.’
 
Federal Health and Ageing Minister Mark Butler said ‘robust price negotiations’ are common between Government officials and multi-national drug companies.
 
‘That tension and that price negotiation is a very big reason why we have such a successful and sustainable Pharmaceutical Benefits Scheme,’ he said.
 
Eli Lilly said the result of its fourth attempt to have Mounjaro PBS-listed is likely to ‘impede’ future submissions for the drug’s other indications.
 
‘Based on [the] 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.
 
‘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.’
 
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