AVACINCAPTAD PEGOL

The PBAC recommended PBS listing of avacincaptad pegol (ACP) for the treatment of geographic atrophy (GA) or dry AMD secondary to age related macular degeneration. The PBAC welcomed input from consumers, health care professionals and Macular Disease Foundation Australia. The PBAC noted mixed support from health care professionals. Some suggested delayed progression of GA would help patients retain their sight for longer. Others suggested the evidence showed only small delays in progression of GA which may not lead to meaningful benefits for patients. The PBAC noted the differing opinions, and acknowledged that there was a high clinical need for treatments for GA, which is a leading cause of irreversible vision loss in older Australians.
 
The PBAC noted that the clinical trials showed ACP reduced GA lesion growth when compared with placebo. The PBAC considered that, although the clinical trials did not demonstrate clear improvements in vision related activities, it was reasonable to assume that protecting the structure of the eye by slowing GA lesion growth would result in slower loss of functional vision than current care. Despite uncertainty about how large this benefit may be on preserving vision, the PBAC was satisfied that for some patients, ACP would provide a worthwhile improvement in efficacy over existing treatment options. The PBAC also noted an increase in ocular adverse events, especially chorionic neovascularisation (CNV or “wet” AMD), in patients treated with ACP for GA and recommended that treatment be restricted to patients with monocular vision who stood the most to benefit from ACP.
 
The PBAC considered there was some uncertainty about the extent to which benefits claimed by the sponsor in support of its proposed price would be realised in practice. The PBAC considered the benefits claimed by the Sponsor may be overestimated and, in particular, the extent to which delayed eye damage may translate to less vision loss. The PBAC therefore considered ACP would provide acceptable value for money if the proposed price was reduced. In addition, the PBAC considered a financial agreement with Astellas Pharma Australia would be required to manage uncertainty about how many patients would use ACP and to ensure PBS reimbursement was for treatment in one eye only. 
 
The PBAC noted it had already recommended similar treatment, pegcetacoplan, for the same disease at its November 2025 meeting. Although listing arrangements for pegcetacoplan were yet to be finalised at the time of the PBAC’s consideration of ACP, the PBAC considered that it both medicines show similar benefits in delaying disease progression with neither medicine being more effective than the other. Therefore, should pegcetacoplan proceed to PBS listing, the PBAC advised that ACP should be price matched with pegcetacoplan.

The PBAC noted the flow on changes to the pegcetacoplan listing, should pegcetacoplan be listed for this indication, with amendments to the restriction wording for the listings outlined in Section 8 of the pegcetacoplan Public Summary Document (November 2025 PBAC meeting) in order to remove the numerical values associated with confirmation of lesion growth and location.