An independent expert panel has recommended Novartis’ treatment Beovu be subsidised through the Pharmaceutical Benefits Scheme (PBS) for neovascular age-related macular degeneration (nAMD) patients as a second-line anti-VEGF treatment.
Beovu (brolucizumab) obtained Australian registration in January 2020, however efforts to have the drug listed on the government-subsidised medicines program have been denied on three occasions since November 2019.
In the latest decision from its March 2021 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended Beovu’s listing for the treatment of subfoveal choroidal neovascularisation (CNV) due to AMD in patients who are non-responsive despite first-line anti-VEGF treatment.
“The PBAC considered that a second- or subsequent-line treatment option of brolucizumab in CNV due to AMD would be useful for patients who have ongoing exudation/fluid despite first-line anti-VEGF treatment,” the PBAC noted.
“The PBAC considered the cost-effectiveness of brolucizumab would be acceptable in the later-line setting as it is likely to be equi-effective to currently listed anti-VEGF agents (aflibercept and ranibizumab). The PBAC advised that brolucizumab would be required to join the risk sharing arrangement currently in place for ranibizumab and aflibercept in this indication.”
A Novartis spokesperson told Insight the company welcomed the decision to recommend its drug for PBS listing in patients with subfoveal CNV due to AMD who “have persistent disease despite prior anti-VEGF treatment”.
“Novartis will work closely with the Department of Health to allow Beovu to be accessible in a timely manner by eligible Australians,” the spokesperson said.
In Australia, Beovu presents as the third major option for nAMD patients, joining the Novartis-distributed ranibizumab (Lucentis) and Bayer-supplied aflibercept (Eylea).
The March 2021 meeting was the fourth time Novartis’ application for PBS-listing of Beovu was considered, after the PBAC initially chose not to recommend it for listing in November 2019, followed by subsequent decisions in March and July 2020.
In the July outcome, the independent panel said that while Novartis’ claim of Beovu’s non-inferior effectiveness compared with aflibercept was reasonable, it did not accept that the evidence supported less frequent dosing.
It also considered [Beovu] is likely inferior to aflibercept in terms of comparative safety, based on the clinical trial evidence of a significant difference in serious adverse events between brolucizumab and aflibercept, and changes made to the approved Product Information to reflect an emerging safety signal of retinal vasculitis and/or retinal vascular occlusion.
Novartis disagreed with the July decision, stating its therapy represented an important treatment option for nAMD, with an overall favourable benefit-risk profile.
From July 2019 to June 2020, the Australian government spent more than $610 million on anti-VEGF treatments, with Eylea leapfrogging a hepatitis C drug to become the costliest PBS drug for the first time.