Australian health authorities have approved novel drug Vabysmo for listing on the PBS, as its manufacturer released two-year data confirming the therapy can improve vision with fewer treatments for people with neovascular age-related macular degeneration (nAMD).
The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the Authority Required listing of Roche’s Vabysmo (faricimab) for the treatment of nAMD and diabetic macular oedema (DMO) at its meeting in May 2022.
This month, new two-year data from two studies, known as TENAYA and LUCERNE, reinforced Vabysmo’s long-term efficacy, safety and durability in treating nAMD, according to manufacturer Roche.
Neovascular AMD affects nearly 20 million people globally and can require treatment with eye injections every one to two months. The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on 14 July.
“With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden,” Dr Levi Garraway, chief medical officer and head of global product development at Roche, said.
The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of faricimab would be acceptable if it were cost-minimised to PBS-listed anti-VEGF treatments such as aflibercept and ranibizumab for the same indication.
“The PBAC considered that, based on the clinical evidence provided, the claim of non-inferior comparative effectiveness and safety of faricimab compared to aflibercept was acceptable,” the outcome statement explained.
“The PBAC considered that there should be no extra cost to government given the PBAC’s acceptance of the faricimab administration frequency, based on an analysis of the faricimab administration frequency in the first year of treatment, which was derived from the average doses in the first 48 weeks of treatment in the TENAYA and LUCERNE trials.”
The PBAC provided similar reasoning for its recommendation to list Vabysmo on the PBS for DMO.
In the latest, two-year data from the two trials, Roche reported that more than 60% of people receiving Vabysmo could be treated every four months – which represents an increase from 45% at year one – while achieving comparable vision gains versus aflibercept given every two months.
Nearly 80% of people receiving Vabysmo could be treated every three months or longer.
The company said patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those patients treated with aflibercept, potentially decreasing the number of injections.
Comparable reductions in central subfield thickness (CST) were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months.
No new safety signals were identified and Vabysmo continued to be well tolerated, with a favourable benefit-risk profile.
The primary analyses at one year formed the basis of recent nAMD approvals in the US, Japan, the UK and several other countries around the world. Vabysmo is also approved in these countries for DMO.
Vabysmo is currently under review by the European Medicines Agency for nAMD and DME, and submissions to other regulatory authorities around the world are ongoing.
It is the first bispecific antibody for the eye and the only injectable eye medicine approved in a number of countries for treatments up to four months apart.
According to Roche, the drug is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).
“While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilising blood vessels, which may cause new leaky blood vessels to form and increase inflammation,” the company said.
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