Empagliflozin is also PBS listed for HFrEF, independent of diabetes status, but is not currently TGA approved for CKD
According to the FDA's approval, the eligibility criteria are as follows: For Adults: A Body Mass Index (BMI) of 30 kg/m or greater (defined as obesity), OR a BMI of 27 kg/m or greater (defined as overweight) with at least one weight-related comorbidity, such as high blood pressure, type 2 diabetes, or high cholesterol
13 1 1057 8YW3 2024 Jul 17 Structural insights into the triple agonism at GLP-1R, GIPR and GCGR manifested by retatrutide
and Demonstrate a substantial clinical improvement, that is, substantially improve the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body part compared to the benefits of a device or devices in a previously established category or other available treatment, or, for devices for which pass-through payment status will begin on or after January 1, 2020, as an alternative pathway to demonstrating substantial clinical improvement, a device is part of the FDA's Breakthrough Devices Program and has received marketing authorization for the indication covered by the Breakthrough Device designation
