EmpagliflozinJardiance

eGFR 20 to <45 in eGFR, eGFR (excluding patients who mL/min/1.73 m2; <10 mL/min/1.73 m2, died without ESKD), time R, DB, PC, or eGFR 45 to <90 EMPA- ESKD, or CV death. to death (for patients 6,609 MC Low mL/min/1.73 m2 KIDNEY Secondary outcomes: without ESKD), and time 12 months with UACR ≥200 mg/g, all-cause mortality, CV from ESKD to death (for treated with standard mortality, ESKD, patients with ESKD) in care of ACEi/ARB unless other renal/CV outcomes …PSD · May 2025

OFFICIAL Public Summary Document – May 2025 PBAC Meeting Abbreviations: ACEi, angiotensin-converting enzyme inhibitors; ARB, angiotensin II receptor blocker; CKD, chronic kidney disease; CV, cardiovascular; DB, double blind; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; MC, multi-centre; PC, placebo controlled; R, randomised; UACR, urine albumin-creatinine ratioPSD · May 2025

The PBAC did not find the economic model informative to support a listing for the incremental population and noted a number of issues, including treatment effects and transition probabilities that were not representative of the incremental population, the inclusion of a large proportion of patients with The resubmission acknowledged PBAC’s concerns with the diabetes (50.5%) and heart failure (12.5%), as well as economic model used in the November 2023 …PSD · May 2025

OFFICIAL Public Summary Document – May 2025 PBAC Meeting Matter of concern How the resubmission addresses it Utilisation and financial impact of listing The PBAC noted DUSC’s advice that the financial estimates Details on the projected size of the incremental population are highly sensitive to the projected size of the incremental sub-populations were not provided in the resubmission. population as it consists of a broad range of sub-populations.PSD · May 2025

compared to placebo plus standard care. Source: Table 1.2, p21 of the resubmission.PSD · May 2025

Abbreviations: ACE, angiotensin converting enzyme; ARB, angiotensin II receptor blocker; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; UACR, urinary albumin to creatinine ratio.PSD · May 2025

6.3 The PBAC noted and welcomed the input from two health care professionals as well as one consumer group and one medical organisation via the Consumer Comments facility on the PBS website. The comments from the health care professionals supported the reimbursement for empagliflozin specifically and SGLT2i medications more generally to delay progression of kidney disease.PSD · May 2025

6.4 The Australian Diabetes Society supported the indication of all SGLT2 inhibitors available in Australia to include CKD, according to the study outcome data — an eGFR down to 20 ml/min/1.73 m2 or an albumin to creatinine ration above 200 mg/g if eGFR is above 45 ml/min/1.73 m2.PSD · May 2025