Avacincaptad Pegol

7.1 The PBAC recommended the listing of avacincaptad pegol (ACP), on the basis that it should be available as a General Schedule listing for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Committee acknowledged the high clinical need for treatments for GA, which is a leading cause of irreversible vision loss in older Australians.PSD · Mar 2026

OFFICIAL Public Summary Document – March 2026 PBAC Meeting of $45,000 to < $55,000 per QALY gained would be acceptable. A price reduction would be required to achieve cost-effectiveness based on the revised model. In addition, the PBAC considered a risk sharing arrangement (RSA) was needed to address any residual uncertainty regarding estimated patient numbers and to ensure PBS reimbursement was for treatment in one eye only.PSD · Mar 2026

6.52 The submission presented a modelled economic evaluation based on the direct randomised trials, GATHER1 and GATHER2. The economic model assessed ACP compared to BSC in patients with GA secondary to AMD for patients who have an intact fovea and central vision threatened by GA growth.PSD · Mar 2026

6.53 Table 10 summarises the key components of the economic evaluation.PSD · Mar 2026

ACP is non-inferior to pegcetacoplan in terms of clinical effectiveness and safety. Source: Table 1.1-1, p25 of the submission.PSD · Mar 2026

6.44 The submission described ACP 2 mg IVT injection monthly as superior in terms of effectiveness compared to BSC/sham. The evaluation considered this claim was adequately supported but the magnitude of the benefit was uncertain.PSD · Mar 2026

6.81 The ESC noted that the submission did not propose a risk sharing arrangement. The ESC considered that such an arrangement may be required to address any residual uncertainty around the patient numbers and the proportion of patients likely to receive EM or EOM dosing of ACP.PSD · Mar 2026

6.82 In its recommendation for pegcetacoplan, the PBAC considered that a risk sharing arrangement was required, including to address any residual uncertainty regarding estimated patient numbers and ensure PBS reimbursement was for treatment in one eye only (paragraph 7.17, pegcetacoplan PSD, November 2025 PBAC meeting). For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2026