BrolucizumabBeovu
Treatment of subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD) in patients with persistent macular exudation despite at least 6 months of treatment with VEGF inhibitors (aflibercept or ranibizumab).
Decisions on record
- Meeting Mar 2021 Recommended Wet AMD; second/subsequent-line neovascular AMD
- Meeting Jul 2020 Not recommended Brolucizumab is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
- Meeting Mar 2020 Not recommended Brolucizumab is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
- Meeting Nov 2019 Not recommended Subfoveal choroidal neovascularisation (CNV)
Access path
- TGA registered · Beovu
TGA label narrower than the PBS population
- Nov 2019Not recommended
vs aflibercept and ranibizumab
- Mar 2020Not recommended
Comparator changed: aflibercept and ranibizumab → ranibizumab
- Jul 2020Not recommended
Comparator changed: ranibizumab → aflibercept (main) and ranibizumab (secondary)
- ↻ resubmittedMar 2021Recommended
Comparator changed: aflibercept (main) and ranibizumab (secondary) → aflibercept (main…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required listing of brolucizumab for the treatment of subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD) in patients who have persistent disease despite prior anti-VEGF treatment.PSD · Mar 2021
7.2 The PBAC acknowledged that a second- or subsequent-line treatment option of brolucizumab in CNV due to AMD would be useful for some patients who have ongoing exudation/fluid despite prior anti-VEGF treatment.PSD · Mar 2021
6.25 The resubmission presented a cost-minimisation analysis of brolucizumab compared with aflibercept primarily based on the direct randomised trials of HAWK and HARRIER that were conducted in treatment naïve patients, using an assumed effective price for aflibercept ($'''''''''''''').PSD · Mar 2021
6.26 The equi-effective doses are estimated as 1:1 for brolucizumab 6 mg and aflibercept 2 mg (or ranibizumab 1.65 mg). This was in line with previous advice from the ESC and the PBAC (Brolucizumab PSD November 2019, paragraph 7.7). The ESC considered that a 1:1 ratio for the equi-effective doses was appropriate in the absence of evidence to demonstrate that dosing would be different in second-line compared to first-line use.PSD · Mar 2021
6.20 A claim of “superiority in terms of efficacy is made based on anatomical benefits of brolucizumab compared with aflibercept or ranibizumab within a subgroup of patients with subfoveal choroidal neovascularisation due to age-related macular degeneration that are non-responsive to existing anti-VEGF agents” was not supported by the resubmission.PSD · Mar 2021
While statistically significant results were observed for both change in CSFT and DA, no detail of the translation of the comparative treatment effects of these surrogate measures to target clinical outcomes were included in the resubmission.PSD · Mar 2021
5.2 The PBAC noted and welcomed the input from health care professionals (9) via the Consumer Comments facility on the PBS website. The comments described a range of 6PSD · Jul 2020
6.34 No risk sharing arrangement (RSA) was detailed in the resubmission. The Sponsor did not acknowledge the RSA in place for ranibizumab and aflibercept in CNV due to AMD, or propose inclusion of brolucizumab in this RSA.PSD · Mar 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER reported. Prices are commercially sensitive/redacted in the document.
The PBAC considered that the CMA was not adequately supported as non-inferior safety of brolucizumab had not been established. PBAC · 2020
Decision context
PopulationPatients with subfoveal CNV due to AMD who are non-responsive (persistent macular exudation) despite at least 6 months of treatment with VEGF inhibitors (aflibercept or ranibizumab).
Risk sharing5% price reduction for brolucizumab acknowledged that there may be uncertain costs in managing brolucizumab-specific safety events in clinical practice, particularly retinal vasculitis (RV) and retinal vascular occlusion (RVO).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2021 | Recommended | aflibercept (main comparator); ranibizumab (secondary comparator) | — | RCT · Other |
| Jul 2020 | Not recommended | aflibercept (main) and ranibizumab (secondary) | — | RCT |
| Mar 2020 | Not recommended | ranibizumab | — | RCT · Other |
| Nov 2019 | Not recommended | aflibercept and ranibizumab | — | RCT · Change in best corrected visual acuity (BCVA) from baseline |
Clinical evidence
Consumer voice
A healthcare professional commented that brolucizumab is effective as a rescue treatment for patients failing on other agents, requires fewer injections, and suggested restriction to specialist ophthalmologists to manage occlusive vasculitis complications.
brolucizumab is successful as a rescue treatment for patients who fail on aflibercept or ranibizumab, and that it allows for fewer injections compared to those agents Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to subfoveal CNV with persistent exudation after ≥6 months of prior VEGF inhibitor therapy; TGA label covers all neovascular AMD.