Clinicians welcome reimbursement of Roche’s new therapy for vision loss

Pharma News: From 1 January 2023, a new therapy has become available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of neovascular or wet age-related macular degeneration (nAMD) and diabetic macular oedema (DMO), both leading causes of vision loss.

Anti-vascular endothelial growth factor (VEGF) therapies have been regarded as a turning point for patients with nAMD and associated macular diseases since Novartis’ Lucentis (ranibizumab) was listed on the PBS in 2007. This followed the listing of Bayer’s Eylea (aflibercept) in 2012, with Australia being the second country in the world to introduce the therapy at the time.

Real-world data indicates that nAMD patients receive fewer anti-VEGF injections than the desired number (approximately seven) and experience worse visual outcomes compared with patients receiving fixed, frequent therapy in randomised controlled trials. Therefore, longer-acting therapies will overcome the treatment burden often associated with patient drop out, as well as other issues like macular scarring or fibrosis.

Roche’s Vabysmo (faricimab) is the first bispecific antibody TGA approved and now reimbursed for nAMD and DMO in Australia. The treatment works by specifically recognising and blocking the activity of proteins known as angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF). Vabysmo is administered by four initial 4-weekly eye injections. Thereafter, the frequency of the ongoing injections may be extended up to every four months, as determined by the ophthalmologist.

“The availability of Vabysmo on the PBS is welcome news for Australians with nAMD and DMO,” said Professor Robyn Guymer AM, Deputy Director, Centre for Eye Research Australia and Professor of Ophthalmology, University of Melbourne.

“With Vabysmo, patients may have the opportunity to only require ongoing treatment at four-monthly intervals, depending on individual response, which will reduce the burden of treatment on them and their carers, who often bring them to appointments.”

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In the Phase 3 TENAYA and LUCERNE trials, Vabysmo patients were treated every eight, 12 or 16 weeks and compared to Eylea every 8 weeks. Non-inferior vision gains were demonstrated in all Vabysmo groups. However, the studies did not extend the Eylea control arms beyond 8 weeks, so potentially it did not present a true head-to-head comparison.

The subsequent two-year data from the Susvimo Archway study showed that even though vision was declining in both groups, a large proportion of Vabysmo patients can be kept on 12 weekly treatment (14.7%) and 16 weekly treatment (63.1%), resulting in the published 77.8% combined data. 

Another therapy seeking to overcome the treatment burden barrier is a refillable port delivery system (PDS) implanted in the eye that slowly releases Lucentis – branded Susvimo PDS. While it has been granted approval in the US, it is still under review in other jurisdictions including Australia.

“Macular diseases can have devastating and long-lasting physical, emotional and social consequences for those affected and their families if not identified and treated early,” said Professor Guymer.

“Regular eye screening for people over 50 and those with diabetes is therefore critical. Untreated macular disease can lead to rapid and severe vision loss. People may become increasingly reliant on their loved ones for everyday activities; they may be more susceptible to falls and fractures and they may see their professional and social lives severely impacted as their ability to live independently declines,” Professor Guymer added.

Stuart Knight, General Manager, Roche Products Australia said “We thank the Australian Government for recognising the value Vabysmo will bring to Australians living with nAMD and DMO and for their investment in this important treatment via the PBS.

“The reimbursement of Vabysmo illustrates our commitment to doing now what people living with retinal conditions need next and we extend our gratitude to the Australian ophthalmology and macular disease communities for their collaboration in bringing this therapy to Australians in need.”

Between 128,000 – 192,000 Australians are estimated to be living with nAMD, whilst DMO affects approximately 40,000 Australians, many of whom are working-age adults.

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