PegcetacoplanEmpaveli

7.1 The PBAC did not recommend listing pegcetacoplan for treatment of complement 3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The PBAC considered that there is a high clinical need for treatments for C3G or IC-MPGN, which are conditions that impact relatively young patients and cause decline in kidney function.PSD · Mar 2026

7.2 The PBAC considered that the primary reason for this outcome was the economic evaluation.PSD · Mar 2026

6.68 The submission presented an economic evaluation of pegcetacoplan compared to standard of care for the treatment of patients aged 12 years or older with C3G or primary IC-MPGN with native kidneys or disease recurrence following a kidney transplant. The economic evaluation was based on the VALIANT trial with additional modelled data. The economic evaluation was presented as a cost-effectiveness/cost- utility analysis.PSD · Mar 2026

6.69 Key components of the economic evaluation are summarised in Table 10.PSD · Mar 2026

Pegcetacoplan is likely to be superior in terms of efficacy compared to iptacopan. No clinical claim was made regarding comparative safety Source: Table 1-1, p15 of the submission Abbreviations: ACEI/ARB, angiotensin converting enzyme inhibitor or angiotensin receptor blocker; C3G, complement 3 glomerulopathy; eGFR, estimated glomerular filtration rate; IC-MPGN, immune-complex membranoproliferative glomerulonephritis; RAAS, renin- …PSD · Mar 2026

6.60 The submission described pegcetacoplan as superior in terms of efficacy compared to standard of care. The evaluation considered this claim was reasonable in terms of short-term reductions in proteinuria but was inadequately supported in terms of changes in eGFR decline and longer-term reductions in the risk of progression to end- stage kidney disease.PSD · Mar 2026

6.2 The PBAC noted and welcomed the input from health care professionals (6), health -care related organisations (3), consumer groups (1) and individuals (69) via the Office of Health Technology Assessment Consultation Hub.PSD · Nov 2025

6.3 The PBAC noted feedback from prospective consumers who would like to access the medicine to treat their own health condition which described the significant cost barriers associated with access to pegcetacoplan especially for those at advanced age.PSD · Nov 2025