PBAC's latest decision on Ranibizumab: Recommended with restriction (2025). Considered for Initial and continuing treatment of proliferative diabetic retinopathy (PDR) without diabetic macular oedema (DMO) in adult patients. Treatment via intravitreal injection administered monthly until maximum visual acuity is achieved and/or there are no signs of disease activity.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
12
first 2007
PBS spend
$93M
108,632 scripts · 2024
Eligible population
Adult patients with proliferative diabetic retinopathy without clinically significant diabetic macular oedema, diagnosed by fluorescein angiography, treated by ophthalmologists or accredited ophthalmology registrars.
Therapy area
Ophthalmology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Visual acuity improvement and prevention of clinically significant DMO
Key trials
PRIDE, Protocol S
Comparator
panretinal laser photocoagulation (PRP)
Economic model
CUA
ICER note
ICER not stated in the public text. Document references PBAC's July 2014 consideration of ranibizumab for DMO which accepted ICERs between $15,000 and $45,000/QALY, but no specific ICER for this PDR submission is provided.
ICER (historical)
$15k/QALY–$75k/QALY across 5 submissions (2007–2013) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
PBS expenditure
The Australian government paid $93M in PBS benefits for Ranibizumab in 2024 across 108,632 scripts, at $852 per script.
Submission history
Mar 2007: Recommended with restriction · Authority Required — ICER $45k/QALY
Nov 2012: Recommended with restriction — ICER $45k/QALY
Mar 2013: Not recommended · Authority Required — ICER $45k/QALY
Nov 2013: Not recommended · Authority Required — ICER $45k/QALY
Nov 2013: Not recommended · Authority Required — ICER $75k/QALY
Mar 2014: Deferred · Restricted
Jul 2014: Deferred · Authority Required
Jul 2014: Deferred · Authority Required
Nov 2014: Recommended with restriction · Restricted
Mar 2018: Recommended with restriction · Authority Required
Mar 2018: Recommended with restriction · Authority Required
May 2025: Recommended with restriction · Authority Required