Glaukos’ iStent trabecular micro-bypass stent, one of the main MIGS devices offering glaucoma patients an alternative to trabeculectomy and reducing their reliance on drops

After more than five years, the debate rages on between Ophthalmology New Zealand (ONZ) and Southern Cross Health Society (SCHS) over funding for minimally invasive glaucoma surgery (MIGS) devices for glaucoma sufferers.

MIGS vs trabeculectomy

Commenting on a recent patient case, ONZ chair Dr Dean Corbett, a senior consultant ophthalmologist with Auckland Eye, said evidence shows four out of every five trabeculectomy operations would be unnecessary if patients were offered MIGS. But, despite several years of discussions, SCHS still only funds trabeculectomy surgery for its members, he said.

Now more than 50 years old, trabeculectomy is still considered the gold-standard for achieving rapid and long-lasting intraocular pressure (IOP) reductions in progressing glaucoma patients. It is an important operation for such patients, said Dr Corbett, but it comes with significant potential for sight-threatening side effects. “(Most patients) don’t need a barbaric, hour-long operation that puts the eye at risk of endophthalmitis for the rest of their life… that requires 10 visits over six months and has its own set of complications, including chronic discomfort.”

MIGS micro-bypass stents, such as AbbVie’s Xen and Glaukos’ iStent, are designed to improve fluid drainage from the eye for patients with mild to moderate glaucoma (there have been few studies on more severe glaucoma patients). The stents are inserted in a quick operation, requiring minimal pre- and post-surgery visits, said Dr Corbett. The patient in his recent case had been advised to have a trabeculectomy but sought a second opinion as she was concerned about the surgery and the amount of travel required for pre- and post-operative checks, he said. “She was elderly, 81, and on her own. She needed her pressure reduced from 21mmHg, so a good target pressure would be 14mmHg. She didn’t need 10mmHg. (Implanting an iStent) is a five-minute procedure that’s incredibly well tolerated under a topical anaesthetic,” said Dr Corbett. “This is a very, very good procedure. It’s very, very safe. It’s predictable, there will be failures, but you do no harm, and patients get an 80% chance of solving their problem with a very simple intervention.” Reporting that his patient is very happy with the outcome of her MIGS operation, he also acknowledged the support provided by Glaukos, which funded the iStent through its compassionate programme.

Dr Corbett’s support for MIGS is echoed by other glaucoma specialists. Professor Helen Danesh-Meyer, a specialist glaucoma and neuro-ophthalmology surgeon and chair of the patient support body Glaucoma New Zealand (GNZ), said iStent is a critical tool in the armamentarium to fight glaucoma. “It is not a substitute for trabeculectomy, which is generally reserved for moderate to advanced glaucoma, but it has an important role in patients with early or mild glaucoma; it provides patients with the opportunity to decrease or even eliminate their need for topical medications.” Many patients have significant side-effects (both local and systemic) from eye drops, she said, and iStent and other MIGS have been shown in multiple, randomised clinical trials to decrease eye-drop dependency.

Southland’s Dr Nic Johnston, who has also tapped Glaukos’ compassionate programme to help patients who needed it, said it would be great if SCHS covered MIGS, especially for elderly patients with joint problems, as it really does give them the chance to live drop-free and improve their vision with one operation. “Most other insurance companies cover it and many of SCHS patients have had policies for a long time,” he said.

The ANZ iStent invasion

MIGS have rapidly gained in popularity, becoming a regular part of the glaucoma specialist’s toolbox in the past five years, as well a standard topic at ophthalmology conferences. The Royal Australian and New Zealand College of Ophthalmologists’ (RANZCO’s) Australia and New Zealand Glaucoma Society (ANZGS) provided advice that led to Australia’s Medical Services Advisory Council (MSAC) approving trabecular micro-bypass stents with cataract surgery in 2017 and as a standalone procedure in 2019. They are also covered by most health insurance companies in the region, including NIB, Sovereign and Partners Life in New Zealand. According to Glaukos, five years ago just 20 ophthalmologists were trained to use its iStent technology in Australasia; today that figure tops 600, with more than one million implantations worldwide. In Aotearoa, before the Health NZ amalgamation, 14 of the 17 district health boards had approved the iStent for use.

RANZCO NZ chair Dr Peter Hadden said multiple requests have been put to SCHS for MIGS and other new technologies in recent years, involving a lot of work by the submitters. “(These) have been turned down for reasons that seem difficult to understand. As a result, there does seem to be a feeling among those who have submitted that it is almost pointless trying to get Southern Cross to look at new technology; thus a certain degree of apathy has crept in.”

A business conundrum

Operating for more than 60 years, the not-for-profit Southern Cross Health Society is by far New Zealand’s largest health insurer. Its 908,000 members account for 62% of Aotearoa’s private health insurance market and it paid out more than 70% of all private health insurance claims last year. Each year, it processes applications for more than 60 new products and procedures, with each applicant aiming to tap the Friendly Society’s net $2 million annual pot of additional cash for ‘new’ things, which are then added to members’ policies.

So far, there have been three applications for MIGS technology – the first in 2016, before the advent of SCHS’s $2m new-tech fund, and the next two between 2017 and 2019. In 2018, SCHS approved Xen for funding, but the pricing provided and approved for the surgery turned out to be significantly less (up to half as much) as ophthalmologists were actually charging or were willing to be paid, said Dr Stephen Child, SCHS’s chief medical officer. So Xen funding was dropped.

SCHS's Dr Stephen Child

Appointed to SCHS in November 2017, Dr Stephen Child is a consultant in medicine and respiratory diseases with Te Whatu Ora Auckland, chair of the NZ Medical Association’s Auckland division and a member of the NZ Telehealth Leadership Forum and the NZ Medical Council. Meeting with NZ Optics to discuss the MIGS issue, a clearly frustrated Dr Child said, “I 100% agree MIGS is an outstanding procedure for the right patient and hugely benefits our members when it is done. But this is not a clinical decision, it’s a business decision. I don’t need a glaucoma specialist or anyone else to tell me how great it is clinically; we know how great it is clinically, that’s not the decision we’re making.”

He took umbrage at at accusations SCHS hadn't spoken to ophthalmologists on the matter and said he’d spoken at length to ONZ, GNZ and individual glaucoma specialists in New Zealand. International ophthalmologists were also involved in the 2019 assessment of MIGS commissioned by SCHS from Best Doctors, an international insurance company-affiliated organisation with a range of international medical consultants. Clinical efficacy is not the issue, stressed Dr Child; the issue is that his team has not been given the patient and financial data required to get the submission through SCHS’s two assessment boards (the first chaired by the head of marketing and sales, the second by the head of finance), he said.

Talking to all parties involved, there is some dispute about the type of data requested, when and what was actually given over the years, but suffice to say, SCHS’s Dr Stephen Child said the Society currently has no or inadequate data on:

• Which patients actually require, say, an iStent, ie. what are the patient indications for an iStent vs trabeculectomy vs drops?
• How many patients, or what percentage of a glaucoma specialist’s patients, is that likely to equate to?
• How much does it cost, including the iStent itself, the operation and the pre- and post-surgery visits and tests required at these visits?
• What is the likelihood of a patient who has an iStent implanted then needing a trabeculectomy later in their life?

As a not-for-profit Friendly Society, SCHS works differently to other health insurance companies and operates under different rules. It does not have the option to allow individual members to pay additional amounts to access new technologies as ‘add ons’ to policies, for example, explained Dr Child. All products approved are made available to all, with premium payments age-matched across members according to the level of care they have chosen. Given the number one thing members complain about is premium costs, SCHS does everything in its power to keep those premiums steady by favouring new technologies that are financially equivalent or cost less than the product they are replacing, or add the greatest bang for their buck, said Dr Child.

Illustrating his point, he reeled off several new technologies that would be life-changing for some members – brilliant developments clinically, but not necessarily the best financially for all members to pay for, especially if they can already be accessed in the public sector, he said. “It isn’t a case of we will only pay for things that work; we will pay for things that give the best value-add to our members for a net $2m per year! So if we fund something cheaper than the comparator, we then save money for the Society that we can then invest in some other application.”

For example, though it’s great an iStent can help patients become drop-free, unless SCHS funds those drops, there’s actually no financial benefit for SCHS, so that has to be taken into consideration, he explained.

As an interesting aside, Dr Child said SCHS might well consider funding preservative-free drops for glaucoma (currently very limited and unfunded in Aotearoa, despite repeated requests to Pharmac from ophthalmologists). This could provide a point of difference for attracting new SCHS members unable to access such drops under the public system, he said. “That’s the kind of thing SCHS thinks about.”

Though Dr Child’s involvement in a new product or procedure ends with a simple ‘yes’ or ‘no’ about its clinical efficacy, he often tries to advocate on behalf of patients and the medical profession as the new product is debated through SCHS’s two committees, he said. “Which is part of the reason why I get so upset, when I get personal attacks on this issue.”

No other new product or procedure has undergone the scrutiny and assessment of MIGS at SCHS, said Dr Child, admitting the Xen debacle was an unfortunate setback for all involved. That said, as most MIGS are good products and SCHS’s recent new product approvals have actually saved the Society some money, he’d welcome a new application from Aotearoa’s glaucoma specialists on the matter, he said. “Essentially, for Southern Cross, the decision our committees make is, ‘Do we want to increase the premiums of our members by X% to help Y number of members get Z benefit?’. So, absolutely, we’d love to look at it again, but what I want is for (the submitter) to take the time to clearly understand our processes, to understand what we’re looking for to get this across the line.”

For more about what is currently approved by SCHS, and the sorts of products MIGS is up against, see: www.southerncross.co.nz/society/for-members/making-a-claim/unapproved-healthcare-services

For more about MIGS vs trabeculectomy, see: https://www.reviewofophthalmology.com/article/migs-and-the-arc-of-glaucoma-care