Novartis is working to ensure its newly-approved drug Beovu is accessible via the Pharmaceutical Benefits Scheme (PBS) at the earliest opportunity after expressing disappointment over an initial decision not to recommend it for the government-subsidised medicines program.
In Sydney on 28 January, the multi-national pharmaceutical company announced the Therapeutic Goods Administration (TGA) had registered its new intravitreal injection therapy, Beovu (brolucizumab), for nAMD.
The Australian approval follows in the footsteps of the US, which was the first market to clear the therapy in October. The therapy was later approved in Europe on 17 February.
A key feature of Beovu has been its potential for extended dosing intervals, which some members of Australia’s ophthalmic community believe could be a key factor in helping reduce non-adherence rates. It is now said to be the first approved anti-VEGF in Australia that can maintain eligible patients on a three-month dosing interval directly after three initial monthly loading doses.
The TGA approved Beovu followed the findings of the Hawk and Harrier clinical trials, in which Beovu was reported to demonstrate non-inferior best-corrected visual acuity change from baseline at year one compared with competing therapy Eylea, which is sold and marketed by Bayer in Australia.
Novartis is now keen on creating a pathway for Australian patients to access Beovu via the PBS and has lodged a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) for the treatment of subfoveal choroidal neovascularization (CNV) due to AMD.
However, at a meeting in November, the independent advisory panel decided not to recommend the therapy.
According to the public outcome statement: “The PBAC noted the higher incidence of ocular serious adverse events reported for brolucizumab (Beovu) compared with aflibercept (Eylea) in the clinical studies and considered the claim of non-inferior safety was uncertain.”
In its response, Novartis stated it was “disappointed” with the PBAC decision. “But [the company] will work collaboratively with the PBAC and the Department of Health to ensure that Australians with CNV due to age-related macular degeneration receive access to Beovu (brolucizumab) through the PBS at the earliest opportunity.”
A Department of Health spokesperson stressed a decision not to recommend a medicine does not represent the PBAC’s final view.
“It remains open to the pharmaceutical company sponsor of the medicine to make a further application to the PBAC addressing the concerns identified by the PBAC,” he said.
“The sponsor of Beovu, Novartis Pharmaceuticals Australia Pty Limited, has made a resubmission to the PBAC for consideration at its March 2020 meeting.”
That meeting is scheduled to take place today. The outcome will be published to the PBS website on 24 April. It is Australian Government policy to list all medicines on the PBS following a positive PBAC recommendation.
Applications to the TGA and PBAC come under parallel processing arrangements, which means both processes can be undertaken at the same time in order to expedite the availability of PBS medicines.
Beovu is now the newest player in an expanding anti-VEGF market and advocates hope this will translate into improved patient outcomes.
The recommended dose for Beovu is monthly injections for the first three doses, according to the TGA. Thereafter, the physician may individualise treatment to every two months for patients with disease activity, and every three months for those without disease activity.
“The trials have shown this new therapy [Beovu] may extend the duration between treatments for some patients with neovascular age-related macular degeneration,” Macular Disease Foundation Australia CEO Ms Dee Hopkins told Insight.
“As the peak body representing the macular disease community, we hope that real world outcomes will result in reduced treatment burden on patients. Hopefully, this may further improve persistence rates for sight-saving treatment.
“It’s important patients have a choice of treatments, but it’s also important that treatment is accessible and affordable. Currently in Australia, there is a 20-25% non-adherence rate for [intravitreal injection] treatment in the first 12 months. I’m hopeful our sector can work collectively to reduce that number moving forward.”
For the treatment of nAMD, Beovu joins Lucentis (ranibizumab), the pioneering anti-VEGF treatment that was listed on the PBS in 2007, which is also marketed by Novartis in Australia.
Ophthalmologists will also be keen to see how Beovu measures up against Eylea (aflibercept), which itself is recommended for a treat-and-extend regimen of up to three months or more in some cases.
In a press release, Novartis said it was committed to ensuring patient access to Beovu and will work closely with all stakeholders to help improve the lives of Australians living with eye diseases.
Commenting on the TGA approval, Mr Richard Tew, general manager of Novartis Pharmaceuticals Australia and New Zealand, said: “Beovu is a testament to our commitment here at Novartis to reimagine medicine for patients living with wet age-related macular degeneration. We are delighted that Beovu is now registered in Australia.”