Nova Eye Medical is seeking a modification to the existing minimally invasive glaucoma surgery (MIGS) Medicare item number that only came into effect in May, stating the current wording has the unintended consequence of excluding microcatheter technology.
The details were included in the Adelaide company’s now publicly available application to the Medicare Services Advisory Committee (MSAC). It also comes as it reported strong sales growth for its iTrack and Molteno3 glaucoma devices in markets outside of Australia.
Nova Eye’s MSAC submission centres on its iTrack Surgical System, which it believes is the only known microcatheter system in use in Australia.
It is currently excluded from reimbursement via the Medicare Benefits Schedule (MBS) because item number 42504 – a standalone MIGS item introduced eight months ago – only mentions implantation of a micro-bypass surgery stent system.
It is seeking modification to the existing wording to encompass the use of a microcatheter to decrease outflow resistance in the trabecular meshwork, Schlemm’s canal and distal outflow system.
Assuming a population growth of 1.6% a year since 2016, the company estimated item number 42504 would be utilised up to 4,056 times in 2020/2021.
“[Nova Eye] believes that the wording of the current item number has the unintended consequence of excluding currently used technology (microcatheters),” the MSAC application stated.
“Incorporating the use of microcatheters in the wording of MBS item 42504 will not change the utilisation of the item number but will only offer an alternative choice of device used during the procedure. Use of a microcatheter is non-inferior to the use of micro stents in terms of clinical effectiveness and safety.”
The MSAC application is the latest twist in the MIGS journey, which has trod a turbulent path since arriving in Australia six years ago.
When surgeons started using MIGS in 2014 they performed the procedure under MBS item 42758 (goniotomy). Its popularity soared from 138 claims in 2013/14 to 3,809 in 2016/17, which promoted the government to step in and change the descriptor and effectively halt its use in a large proportion of glaucoma patients.
Following extensive advocacy from the sector, the issue was partially addressed in October 2018 when the government approved a new item number but limited its availability to those simultaneously undergoing cataract surgery.
Ophthalmologists believed the measure didn’t go far enough because glaucoma patients not needing cataract surgery, or who had already had the operation, weren’t eligible.
This led to the current item number 42504, introduced this year, which allows for standalone MIGS. Australia subsequently became the world’s first universal healthcare system to allow this.
Meanwhile, Nova Eye provided an update on the sales performance of its glaucoma surgical device business for the four-month period ending 31 October 2020.
Comprising its iTrack and Molteno3 technologies, worldwide glaucoma surgical device unit sales were $4.4 million for the period. This compares with $2.6m for the four months ending 30 June 2020, which comprised the initial first wave of COVID-19 lockdowns in the US and Europe.
Mr Tom Spurling, director Nova Eye Medical Limited, said: “The 63% growth in global sales over the first wave COVID-19 period and 13% growth on the same time last year is testament to the quality of our suite of products as accepted standards of care across the spectrum of glaucoma disease.”
In July, Nova Eye acquired the Molteno3 platform from privately-owned New Zealand company Molteno Ophthalmic for $921,000.
Molteno3 is available in Australia and has an MBS reimbursement item.