PBAC's latest decision on Pegcetacoplan: Recommended with restriction (2025). Considered for Non-subfoveal geographic atrophy secondary to age-related macular degeneration, with central vision threatened by GA lesion growth and vision impairment in the fellow eye.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
4
first 2022
Submissions
4
2022 → 2025
Eligible population
Adult patients with bilateral geographic atrophy secondary to AMD, with an intact fovea (non-subfoveal lesion ≥1 µm from the foveal centre) in the treated eye, central vision threatened by GA lesion growth (lesions ≤750 µm from foveal centre or beyond 750 µm with imaging-documented progression toward the fovea within the macula), and a compromised fovea (subfoveal GA) in the fellow eye.
Therapy area
Ophthalmology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
DERBY, OAKS, GALE
Comparator
best supportive care
Economic model
CUA
ICER note
The document contains an economic analysis section (paragraph 6.42–6.43) but does not state a numeric ICER value. The ESC raised concerns about model reliability and the quantification of the surrogate functional outcome relationship, but no ICER figure is provided in the public text.
Submission history
Mar 2022: Recommended with restriction · Authority Required
Jul 2022: Recommended with restriction · Authority Required
May 2025: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required