Lilly launches first-in-class type 2 diabetes medicine, while navigating PBAC setback

Pharma News: Eli Lilly Australia took centre stage at the 2023 Australasian Diabetes Congress held in Adelaide, as the company disclosed plans to introduce their first-in-class type 2 diabetes drug to the Australian market.

Mounjaro (tirzepatide) is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, represents the first new class of diabetes medicines introduced in nearly a decade.

Dr Gary Deed, General Practitioner and Adjunct Senior Research Fellow at Monash University, expressed his optimism about the therapeutic landscape.

“Given the high prevalence of diabetes in Australia and its broad impact, it is essential for patients and healthcare professionals to work together towards improved disease management. Unfortunately, many people with type 2 diabetes do not achieve early glycaemic control or weight loss. With early management of the condition, it can reduce the risk of some disease-associated complications,” he said.

Associate Professor Sof Andrikopoulos, CEO of the Australian Diabetes Society (ADS), emphasised the transformative potential of novel medications in reshaping the trajectory of type 2 diabetes management.

“We would like to see a paradigm shift in the treatment of people living with type 2 diabetes to early and stringent HbA1c and weight management. By treating early, with new medicines such as Mounjaro, there is potential to improve patients’ long-term health by reducing hyperglycaemia and addressing excess weight as soon as possible,” said A/Prof Andrikopoulos.

“Mounjaro represents a new class of medicine recognised under the new classification developed by the World Health Organization (WHO). The acknowledgement of the different mechanism of action of GIP and GLP-1 receptor agonists has led to a new anatomical therapeutic classification (ATC) code,” he added.

Mounjaro’s journey to broader accessibility has encountered a hurdle. The Pharmaceutical Benefits Advisory Committee (PBAC), in its July 2023 meeting, did not recommend its inclusion on the Pharmaceutical Benefits Scheme (PBS) for dual therapy with metformin. According to the PBAC, while Mounjaro showed superior efficacy in glycaemic benefits and short-term weight loss compared to Novo Nordisk’s Ozempic (semaglutide) at higher doses, this advantage was not consistent for the 5 mg once weekly dose. Moreover, the high and insufficiently justified cost-effectiveness ratio and uncertain financial impact at the proposed price were key factors in the decision. The PBAC suggested a revised economic model and substantial price reduction for reconsideration.

While the company navigates the PBAC requirements, it will launch launch Mounjaro as a private prescription as a single-dose vial presentation so that it can meet supply chain challenges while supporting “Australian patients with type 2 diabetes to have immediate access to the HbA1c and weight reductions that Mounjaro may offer”.

Tori Brown, Lilly’s General Manager of Australia, affirmed Lilly’s unwavering dedication to bettering the lives of individuals grappling with diabetes.

“For nearly 100 years, Lilly has been advancing care for people living with diabetes. We are thrilled to introduce Mounjaro, which represents the first new class of type 2 diabetes medication introduced in almost a decade and embodies our mission to bring innovative new therapies to the Australian diabetes community,” said Ms Brown.

Mounjaro’s registration follows a robust foundation of evidence, with five global randomised phase 3 studies (SURPASS). Despite many available treatments, most type 2 diabetes patients grapple with unattainable HbA1c =< 7% and recommended body weight goals. Mounjaro’s clinical data indicates sustained, noteworthy reductions in HbA1c and even weight loss, potentially redefining the treatment landscape for type 2 diabetes.

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