Feature, Glaucoma, Report, Therapies

Making a stand for MBGS under Medicare

Advances in glaucoma stent technology far outstripped the Medicare schedule early on, creating a disconnect that had far-reaching consequences. As Australia marks World Glaucoma Week this 7-13 March, Insight traces the turbulent MBGS journey that’s now considered an ophthalmology success story.

A growing list of trans-trabecular stents available for glaucoma patients are revolutionising the way the disease is being treated.

These tiny devices provide the means by which aqueous can bypass areas of outflow limitation with less tissue manipulation and fewer severe complications than traditional trabeculectomy. Due to these perceived benefits, general ophthalmologists and glaucoma subspecialists are increasingly making use of micro-bypass glaucoma surgery (MBGS) techniques for stent implantation.

However, these glaucoma stents, which also fall under the looser umbrella term minimally invasive glaucoma surgery (MIGS), have had a troubled run with the Medicare Benefits Schedule (MBS) since being introduced in Australia seven years ago.

Australian Society of Ophthalmologists (ASO) president Associate Professor Ashish Agar has been instrumental in advocating for MBS inclusion of MBGS from the start. As he puts it: “Securing funding for MBGS under Medicare has been a long, tortuous journey. It has been one of the more challenging episodes in ophthalmology in recent history.”

Generally, he says the introduction of new technology into the operating theatre for eye surgeons has been met with increasing surveillance and a heightened need to justify its use in terms of health economics – and MBGS is no exception.

“From a health economics perspective, technology makes assessment easier, and puts a sharper, stronger focus on evidence- based medicine,” Agar explains.

A/Prof Ashish Agar.

At Agar’s side has been Associate Professor Paul Healey who has also been involved in ophthalmology’s advocacy efforts to recognise MBGS as a safe and effective treatment for glaucoma patients.

A Sydney-based ophthalmic surgeon and academic, Healey is secretary of the Australian and New Zealand Glaucoma Society (ANZGS), and chair of the organisation’s New Devices and Procedures Panel. He also holds a degree in epidemiology and has been a key link in the chain to successfully gain MBS approval for MBGS.

“My strong belief is that all effective health treatments should be funded by both the MBS and the public hospital system. I want to live in a country where your access to medical care is based on your clinical need, not your ability to pay.”

2014 – The arrival of MBGS

MBGS arrived in Australia in 2014, heralding a new era in interventional glaucoma therapies. A MBGS inserted via a small goniotomy (iStent) was approved for use in Australia first, with other types (Hydrus and Cypass) following soon after.

“Australia was the first country outside the US to have early access to MBGS technology,” Agar says. “This is because Australia is, in effect, a testing ground, a proving ground, for such technology because we have a well-regulated medical environment; if Australian ophthalmologists have confidence in a device or technique, that carries weight internationally.”

A market share approach was used to estimate the financial implications of listing MBGS on the MBS in 2014. The expected size of the MBGS market was based on projections of data from MBS goniotomy item 42758 to estimate uptake of MBGS stent implantation when it was used in clinical practice.

A/Prof Paul Healey.

Between 2014 and 2017, surgeons used the item 42758 (goniotomy) when inserting the device, mostly in conjunction with cataract surgery, but occasionally as a stand-alone procedure.

Agar says MBGS initially soared to popularity because it filled a gap in treatment, offering a middle-ground option.

“Ophthalmologists had been using the same trabeculectomy operation for 50 years. For a quarter of a century, we were hanging out for something new,” he says.

“The problem was, there was a gap between first-line treatment – eye drops, or laser therapy – and last-line treatment – trabeculectomy or tube shunt surgery. It is a significant operation, a big leap of faith for patient and surgeon. Surgery has higher morbidity, and longer recovery. It’s a huge psychological barrier.

The iStent inject W is Glaukos’s latest Trabecular Micro-Bypass System.

“We still need to perform trabeculectomy and tube shunt surgery, but it’s not the only option at our disposal now.”

According to Healey, MBGS’s popularity increased exponentially in the three years after its arrival in Australia. In 2013/14, MBS item 42758 (goniotomy) was claimed 138 times; in 2016/17 it was claimed 3,809 times, an increase of 2660%.

“The ANZGS drafted a White Paper in 2017, looking at MBS item 42758’s use, and we concluded that it was appropriate for surgeons to continue to perform MBGS procedures under MBS item 42758,” Healey says.

Professor Graham Lee, Professor of Ophthalmology at University of Queensland and a consultant at City Eye Centre in Brisbane, agrees that MBGS filled a niche for surgeons specialising in glaucoma.

Prof Graham Lee.

“Although MBS item 42758 was established for paediatric glaucoma, the wording of the descriptor did not specifically limit it to only paediatric glaucoma use, as it was for making a goniotomy, ie a hole in the trabecular meshwork. At the time, the Medicare descriptor wording was appropriate, but it wasn’t designed for implanting an MBGS device – it was for congenital-type glaucoma, and seldom used. When MBGS arrived in Australia, that item number use took off,” Lee says.

While MBGS uptake offered great hope for glaucoma surgeons and patients in Australia, its meteoric rise in use alarmed the government.

Subsequently, publicly funded access to some glaucoma stents was virtually eliminated overnight following the health department’s decision to place limitations on MBS item 42758.

2017 – MBS exclusion 

To the dismay of ophthalmologists, in 2017 Medicare altered the item descriptor for item 42758 (goniotomy) to explicitly exclude any such prostheses and to exclude its use for anything other than primary congenital glaucoma.

Thousands of patients about to receive the iStent platform (Glaukos) or Hydrus (Ivantis) stent for glaucoma – who could previously access subsidised treatment under an MBS item for goniotomy – lost access.

“Overnight, the government pulled the rug out from under us and our patients, when all MBGS lost funding,” Agar says.

But, he adds, the government was merely doing its job and reacting to the information at hand. The problem was that information didn’t paint the full picture.

Featuring a wide flange at its base, the iStent inject W optimises stent visualisation and placement, enhances procedural predictability and increase confidence for the surgeon.

“The government saw a large increase in MBS item 42758 (goniotomy), from a few dozen cases to a few thousand cases, which rang alarm bells so it pulled the plug on funding,” Agar says.

That sudden change lit a fuse among Australia’s foremost glaucoma surgeons.

The ASO led the advocacy effort and made a submission to the Medicare Services Advisory Committee (MSAC) with support from industry and organisations including the Australian and New Zealand Glaucoma Society (ANZGS), RANZCO and Glaucoma Australia.

According to Healey: “MSAC threw the challenge back to clinicians to justify our use of MBS item 42758 for glaucoma stent procedures. They set the bar high and the subsequent internal review was detailed and time-consuming.”

2018 – A reprieve 

After extensive lobbying, there was some respite in 2018 when the government announced the permanent listing of MBS item 42705 for MBGS in conjunction with cataract surgery, to take effect from 1 November.

This also included the listing of a new MBS item for the removal and replacement of trans-trabecular drainage devices due to device related complications (item 42505).

“When the unique MBGS Hydrus (Ivantis) device was introduced to Australia in 2014, every case was audited and data analysed,” Agar recalls. “And as part of that initial process, surgeons who implanted Hydrus had to record each case on the Spectrum Registry. This built up a strong evidence-base and developed more confidence and certainty in its efficacy over three years.”

The ASO drew on this data as part of its 2017 submission to MSAC to show the technology is safe and effective.

“We worked through the MSAC system, and we got a good hearing without needing to make a political or public campaign. Our case was based on scientific, clinical evidence, and supported by ANZGS, RANZCO, Glaucoma Australia, and individual ophthalmologists,” Agar says.

In hindsight, he notes the introduction of MBGS in Australia in 2014 was not closely guarded in a clinical sense.

An image demonstrating the size of the Glaukos iStent inject W.

“The use of MBGS devices initially was not well-supported clinically. It was pushed out to general ophthalmologists and marketed as an optional extra for cataract surgery – and this muddied the water,” he says.

“We paid the price for unregulated and unscientific use. And when funding was pulled, it became a social justice issue. Patients were effectively left ‘high and dry’. If you had money, you could still buy it, but private health funds wouldn’t cover it. It became the province of the rich for 18 months,” Agar says.

Healey agrees this was one of the issues with the government’s decision to pull funding for MBGS procedures.

“One of the unintended consequences of restricting MBGS on the MBS was it also halted private health fund rebates. If the MBS completely pulls out of funding an item number, not only do private health funds also stop paying on that item, they also all stop paying the very high ancillary and hospital costs associated with the procedure,” Healey says.

“The decision to stop public funding for MBGS suddenly made the surgery unaffordable for almost all privately insured Australians as well.”

2020 – Standalone approved 

Although it was a step in the right direction, ophthalmologists believed the 2018 permanent listing of MBS item 42705 for MBGS didn’t go far enough because it was only available to those simultaneously undergoing cataract surgery.

There was a belief this would create two classes of glaucoma patients, because those not needing cataract surgery – or who had already had the operation – weren’t eligible.

This prompted the ASO to lodge another MSAC submission in 2019 for standalone use of MBGS.

Originally, MSAC assessed the application but advised the Minister of Health against it because, as Healey explains: “MSAC considered that patient population and eligibility criteria were poorly defined with uncertain comparative safety, clinical effectiveness and cost-effectiveness.”

When MSAC reviewed the data, he says they formed a view that the evidence was strong for a combined MBS item number for MBGS in conjunction with cataract surgery but funding a standalone item wasn’t justified.

“The ANZGS felt strongly that the safety profile of MBGS was much better than the alternative of trabeculectomy. The reported outcomes for standalone stents actually appeared better than combined stent with cataract surgery. We felt strongly there was a place for this technology,” he says.

“We argued to MSAC that if standalone surgery reduces complications, even if it works only in a small percentage of patients, then it will be worthwhile. In a narrow group of patients, standalone MBGS surgery would be appropriate.”

In 2019, the chair of MSAC convened a stakeholder meeting about the submission, which Agar and Healey attended.

“After much discussion we forged a path that we thought could lead to a successful re-submission,” Healey says.

He anticipated this would be “ethically, politically and epidemiologically challenging but essential if we are to have publicly funded access to those who really need it”.

Then, in the 2019-20 Mid-Year Economic and Fiscal Outlook, the Federal Government announced it would support an MSAC recommendation to list a new item for the insertion of micro-bypass glaucoma stent as a standalone procedure.

New MBS item 42504 commenced on 1 May 2020 and is available to patients with open angle glaucoma for whom conservative treatment has failed or is contraindicated.

Lee, the education chair of the ANZGS alongside Healey, was involved in the advocacy push.

“Paul [Healey] and I wrote updates for RANZCO members as we wanted to avoid confusion before MBS item 42504 for standalone MBGS became active, with the aim of appropriate usage of the number,” Lee says.

The device landscape 

Agar says the green-light for standalone MBGS has been encouraging, with some devices cementing their popularity while others are still finding
their place.

“The iStent platform (Glaukos) is the most widely used MBGS device; Hydrus (Ivantis) is the second most widely used. Both are TGA-approved and MBS-funded in Australia,” he says.

“iTrack (Nova Eye Medical) is a different technology altogether. It is currently undergoing the approval process for funding under the MBS. It has to go through a new process, with limited use in Australia, and most of the clinical evidence is from the USA – iTrack is still finding its feet.”

Nova Eye Medical’s iTrack Surgical System is the only known microcatheter system in use in Australia.

Further to this, Insight reported in December that Nova Eye had lodged an application with MSAC to modify the existing item number 42504, stating the current wording has the unintended consequence of excluding its microcatheter technology (iTrack). At present, the descriptor only mentions implantation of a micro-bypass surgery stent system.

Assuming population growth of 1.6% a year since 2016, the company estimates item number 42504 would be utilised up to 4,056 times in 2020/2021. Incorporating the use of microcatheters in the wording, it states, will not change utilisation of the item number but will only offer an alternative choice of device.

With the rapid development of glaucoma implants, Lee believes technology is outpacing the Medicare process.

“The MBS doesn’t always keep pace with technological developments. MBGS is a niche area, performed by a small group of surgeons, whereas the MBS covers a lot of ground, it’s wide-ranging. In an ideal world, MBS descriptors and item numbers would keep pace with changing technology,” Lee says.

For Agar, the motivation to advocate for the MBS listing was never personal.

“It was never about what I earned for the operation. Surgery is only a small fee; the biggest cost is the facility fee – accessing hospital infrastructure, nurses, an anaesthetist, and getting in an operating theatre. Without an MBS item code, hospitals can’t raise a charge, they can’t pay staff.”

When it approved the item number last year, MSAC compared MBGS alongside trabeculectomy and concluded that although MBGS was less effective, it was safer and may allow some patients to delay or avoid trabeculectomy.

Other analysis shows MBGS generally costs less than trabeculectomy and is projected to save the MBS approximately $500,000 per annum by the fourth year of listing. This saving is driven by fewer initial and revision trabeculectomy services, however the true financial impact will depend on the efficacy of MBGS in reducing trabeculectomies, which is uncertain.

“MSAC will review the use of standalone MBGS after two years to see what effect it has on the number of trabeculectomies being done and make sure it is still cost-effective,” the committee stated.

Throughout the advocacy process, Agar says he and his colleagues presented their case grounded on the importance of evidence-based medicine.

“We continue to encourage surgeons to collect and collate data from MBGS procedures and add them to the Fight Glaucoma Blindness! Registry, which is a free service and not specific to any MBGS device,” Agar says.

This will help ensure history doesn’t repeat and when MSAC reviews the use of MBGS in two years, the ASO will have ready-made data to present.

2021 – Access

With new devices in the pipeline for approval, Agar says he only wants devices included under the MBS if they work.

“Some devices come and go. It’s like the iPhone effect – we don’t want updates just for the sake of it,” he says.

“What we hope is that the patient should have access to the technology available. Access should not be dictated by their ability to pay.”

Agar, who also practises at Prince of Wales public hospital, wants to see MBGS available in the public system and in private setting.

Aside from the financial gap, he says MBS funding for MBGS is also invaluable in closing another gap; the tyranny of distance.

“I travel to Broken Hill and Bourke and remote towns as part of the Prince of Wales outback eye service. Because of the geography and accessibility, I have to plan surgeries meticulously, or schedule a patient for an operation in Adelaide or Sydney,” he says.

“Access to affordable MBGS has made a huge difference to these patients in particular; it’s safe and requires less follow-up. The accessibility gap is huge and MBGS is the only treatment that allows us to fill this gap.”

Healey says government funding for glaucoma stent procedures is in everyone’s interest if the procedures and associated devices have a useful role. “In the history of glaucoma surgery, there’s been some interesting ideas that haven’t panned out. The government is interested in health-economic benefits and a reduction in health costs overall,” he says.

“All the studies of MBGS show a reduction in medicine use. If MBGS is more cost-effective than using drops it may actually be cheaper in the long run.”