FaricimabVabysmo
Recommended OphthalmologyAuthority RequiredFirst-line line 💬 consumer voice
Treatment of macular oedema secondary to retinal vein occlusion (RVO), including both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).
4
Submissions
1 resub
2022–25
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2025 Recommended Macular oedema secondary to retinal vein occlusion (RVO)
- Meeting Jul 2024 Recommended Retinal vein occlusion macular oedema
- Meeting May 2022 Recommended Diabetic macular oedema (DMO)
- Meeting May 2022 Recommended Neovascular (wet) age-related macular degeneration (nAMD)
Access path
- TGA registered · Vabysmo
TGA label narrower than the PBS population
- May 2022Recommended · restricted
vs aflibercept
- May 2022Recommended · restricted
- Jul 2024Recommended
Comparator changed: aflibercept → aflibercept 2 mg
- Mar 2025Recommended
Comparator changed: aflibercept 2 mg → lowest cost PBS-listed anti-VEGF treatment…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended listing faricimab 21 mg in 0.175 mL (120 mg per mL) pre- filled syringe (PFS) intravitreal injection under the same circumstances as the current PBS listings for faricimab 28.8 mg in 0.24 mL (120 mg per mL) vial for the treatment of macular oedema secondary to retinal vein occlusion (RVO).PSD · Mar 2025
6.2 The PBAC advised that the new PFS form of faricimab should be cost-minimised to the lowest cost alternative anti-VEGF therapy listed on the PBS for RVO (i.e., faricimab vial, aflibercept and ranibizumab), based on a 1:1 dose relativity for RVO, consistent with its May 2022 and July 2024 recommendations (paragraph 7.1, DMO and nAMD PSD, May 2022 PBAC meeting; paragraph 7.1, RVO PSD, July 2024 PBAC meeting).PSD · Mar 2025
Economic analysis
5.4 The submission requested that the published dispensed price for maximum quantity (DPMQ) and published ex-manufacturer price (AEMP) of the PFS form be the same as for the currently PBS-listed vial form, noting the effective AEMP of the vial form for the RVO indication was under negotiation at the time of submission lodgement, but was expected to be consistent with the agreed effective price per injection of the vial presentation in RVO.PSD · Mar 2025
Clinical claim
The submission described faricimab as non-inferior in terms of effectiveness and safety compared with aflibercept. While the evaluation and ESC considered that this claim may be adequately supported by the evidence presented in the submission, they noted the lack of comparative data beyond Week 24 in the T&E maintenance phase.PSD · Jul 2024
Notwithstanding the uncertainty around the lack of comparative data beyond Week 24, the evaluation noted that BCVA gains achieved at Week 24 were maintained through Week 72 in both the BALATON and COMINO trials during the period where all patients received faricimab using a T&E approach.PSD · Jul 2024
Consumer comments
Macular Disease Foundation Australia noted that patients with DMO are often of working age and experience a range of issues including a high health care burden, high out of pocket costs and access issues, and that persistence with the current PBS-listed treatment options drops to less than 50% by year 3. Diabetes Australia provided general support for the submission.PSD · May 2022
The PBAC noted and welcomed the input from Macular Disease Foundation Australia and The Royal Australian and New Zealand College of Ophthalmologists via the Consumer Comments facility on the PBS website.PSD · May 2022
Financial management – risk sharing
6.65 No risk-sharing arrangements were proposed. For more detail on PBAC’s view, see section 7 PBAC outcomePSD · May 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as this is a formulation change (pre-filled syringe vs vial) of an already-listed drug.
The PBAC recommended the listing of faricimab on a cost-minimisation basis with aflibercept. PBAC · 2024
Economic model disputedPrice cut / RSA neededCost-effectiveness accepted ×2
Decision context
PopulationAdults with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) with best corrected visual acuity between 73 and 20 letters, or central retinal vein occlusion (CRVO) with best corrected visual acuity between 73 and 24 letters, diagnosed by optical coherence tomography or fluorescein angiography.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended | lowest cost PBS-listed anti-VEGF treatment (faricimab vial, aflibercept, or ranibizumab) | — | Cost-minimisation · Cost-minimisation |
| Jul 2024 | Recommended | aflibercept 2 mg | — | RCT · BCVA |
| May 2022 | Recommended · restricted | aflibercept | — | RCT · BCVA |
| May 2022 | Recommended · restricted | aflibercept | — | RCT · BCVA |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| RHINE | Ph 3 | 951 | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and … | completed |
| BALATON (GR41984) | Ph 3 | 553 | Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at We… | completed |
| COMINO (GR41986) | Ph 3 | 729 | Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at We… | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to RVO only with specific visual acuity thresholds; TGA label includes nAMD, DMO, and RVO without acuity limits.