Source: Healio Interviews
Disclosures: Bedrood reports speaking and consulting for Allergan and Glaukos and consulting for Santen. Buznego reports consulting and speaking for Allergan and being a consultant, speaker and investigator for and shareholder in Glaukos. Herndon reports consulting for AbbVie, Alcon, Genentech, Glaukos, New World Medical, Ocular Therapeutix and Sight Sciences. Radcliffe reports consulting for Alcon, Allergan, ELT Sight, Glaukos, New World Medical, Ivantis, Santen and Sight Sciences. Singh reports having relevant financial disclosures for Allergan, Elios, Glaukos, iStar Medical, Ivantis, New World Medical, Nova Eye, Novartis and Sight Sciences. Van Tassel reports consulting for AbbVie and New World Medical.
October 07, 2021
11 min read
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MIGS: Will reimbursement changes stymie innovation?

Source: Healio Interviews
Disclosures: Bedrood reports speaking and consulting for Allergan and Glaukos and consulting for Santen. Buznego reports consulting and speaking for Allergan and being a consultant, speaker and investigator for and shareholder in Glaukos. Herndon reports consulting for AbbVie, Alcon, Genentech, Glaukos, New World Medical, Ocular Therapeutix and Sight Sciences. Radcliffe reports consulting for Alcon, Allergan, ELT Sight, Glaukos, New World Medical, Ivantis, Santen and Sight Sciences. Singh reports having relevant financial disclosures for Allergan, Elios, Glaukos, iStar Medical, Ivantis, New World Medical, Nova Eye, Novartis and Sight Sciences. Van Tassel reports consulting for AbbVie and New World Medical.
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Minimally invasive glaucoma surgeries offer patients an important midway step between constant drops and significant surgery.

Options such as trabecular meshwork bypass stents and microstents have become key treatments for a disease that can cause a lot of problems for patients.

Carlos Buznego, MD
MIGS can be a “dramatic addition” for glaucoma specialists, comprehensive ophthalmologists and anterior segment surgeons, according to Carlos Buznego, MD.

Source: Carlos Buznego, MD

“Let’s remember that there are still patients going blind from glaucoma every day,” Healio/OSN Board Member Nathan M. Radcliffe, MD, said. “With standard treatments, most patients who have glaucoma still get worse, and it creates a lot of disability.”

While pharmacologic options have been to slow to advance, companies such as Glaukos and Allergan have turned to the MIGS space to provide options for patients and providers.

“MIGS has been a pretty dramatic addition as an option for anterior segment surgeons, glaucoma specialists and even the comprehensive ophthalmologist,” OSN Technology Board Member Carlos Buznego, MD, said. “Traditional filtration surgery was utilized by only relatively few ophthalmologists, but MIGS is a whole new animal.”

Buznego, an anterior segment surgeon, said about 25% of his patients undergo MIGS at the time of cataract surgery, and he has seen significant success.

“About three-quarters of these patients end up being medication-free afterward. That’s just a huge number of patients that are seeing fewer side effects, fewer costs, less hassle,” he said.

Sarah Van Tassel, MD
Sarah Van Tassel

As a younger surgeon, Sarah Van Tassel, MD, has had MIGS available throughout her career, which allows her to offer a unique perspective to patients.

“When I see patients, as a second opinion, who have seen doctors with a strong preference for incisional surgery, I think it’s nice to be able to give an alternate opinion,” she said. “I can reflect on the full scope of MIGS, which I think can be really helpful across many different types and stages of glaucoma.”

MIGS in practice

MIGS procedures have grown in popularity over the last 10 years, Leon W. Herndon, MD, said. These procedures have been valuable for surgeons to treat patients who have high IOP without severe disease.

Leon W. Herndon, MD
Leon W. Herndon

“We’re looking at safer procedures that are associated with quicker visual recovery and procedures that don’t preclude you from doing more involved surgery in the future if you need it,” Herndon said. “You might not want to subject patients without severe disease to traditional surgery because of the potential complications associated with it. It’s been great to have safer alternatives for patients with mild to moderate disease.”

Healio/OSN Board Member I. Paul Singh, MD, said that there has been continued evidence to show that MIGS procedures improve patients’ quality of life and have a greater chance of stabilizing glaucoma progression.

For instance, a recently published study demonstrated patients undergoing the iStent (Glaukos) with cataract surgery had greater quality of life improvement after surgery than those undergoing cataract surgery alone. Patients who received the iStent inject showed particular advantages in general health, ocular pain and driving vision. This is the first time that a MIGS procedure has been shown to positively affect patient quality of life compared with cataract surgery alone, according to Singh.

“You have fewer quality of life issues and fewer compliance issues, which translates to less of a chance for progressing to incisional surgery,” he said. “That has been the big takeaway. It allows us to feel much more comfortable offering MIGS to patients and telling them it will impact their lives for the better.”

I. Paul Singh, MD
I. Paul Singh

Singh said the most difficult part of implanting MIGS into practice has been convincing his colleagues that the standard of care was shifting.

“Patients don’t come in and say, ‘I want the drops because that’s standard of care,’” he said. “What patients are telling me is that they want protection from losing vision from glaucoma without it affecting their quality of life. With MIGS, I can tell them I have multiple ways of doing that. We can try X, Y and Z first, but we have multiple other technologies that we can do if we need to in the future.”

Herndon said the success of MIGS often depends on patient selection and knowing baseline and target IOPs. For most procedures, Herndon said he looks for patients with open-angle glaucoma and those who have mild or moderate severity. This is because IOP does not get lower than 11 mm Hg or 12 mm Hg due to episcleral venous pressure issues.

“However, for mild or moderate disease, it can be done with cataract surgery or as a stand-alone procedure,” he said. “And most glaucoma in the United States is mild to moderate, and probably even more on the mild side.”

Sahar Bedrood, MD, PhD, said MIGS can make a significant difference in a patient’s life. Even a slight reduction in medication burden can have an impact.

“If you go from two drops to one, you’ve really changed that person’s daily routine,” she said. “There’s a higher likelihood that they’re actually using their drops if they have less of them.”

Singh has continued to get good feedback from patients. Generally, he said they like to know there are more options to get their glaucoma under control. He said it comes down to managing expectations, and MIGS provides surgeons with options to match patients with the right treatment.

“We have multiple options, so we’re not going to exhaust them all at one time,” he said. “I can tell them that we will try a couple of things first, and then, we can apply other technologies as needed. Patients need to realize glaucoma is a progressive disease, and we are trying halt the progression in the safest way possible at any given time.”

Emerging data

In recent years, there have been a number of studies showing the benefits of MIGS in patients with glaucoma. Specifically, studies such as HORIZON have shown that less invasive procedures may spare patients from progressing to incisional surgery.

HORIZON was a multicenter, randomized study that assessed IOP, need for medical therapy, reoperation rates and other outcomes in 556 patients with cataract and primary open-angle glaucoma. It included patients with one or more glaucoma medication and a washout diurnal IOP of 22 mm Hg to 34 mm Hg.

After phacoemulsification, patients received either a Hydrus microstent (Ivantis) or no stent.

At 4 years of follow-up, researchers found that 65% of eyes in the microstent group were medication-free compared with 41% of eyes in the cataract surgery-only control group (P < .001). The treatment group also had a higher proportion of eyes with an IOP of 18 mm Hg or less without medication compared with the control group (56.2% vs. 34.6%; P < .001).

At 5-year follow-up, the investigators determined that the microstent group had a lower cumulative probability of needing incisional glaucoma surgery (2.5% vs. 6.4%; P = .02).

“The bottom line is that we’re seeing less chance of progression or needing those more invasive incisional surgeries, which is really something that we knew right away, but it’s good to see the data to back it up,” Singh said.

Trabecular microbypass stents were the subject of several studies presented at the American Society of Cataract and Refractive Surgery meeting in July.

One evaluated the long-term safety and efficacy of the iStent combined with cataract surgery in patients with primary open-angle glaucoma. The retrospective cases series looked at cases from September 2012 to December 2014 and comprised 411 eyes. Researchers collected data from preop to up to 8 years postop. Mean IOP decreased from 18.8 mm Hg at baseline to 14.7 mm Hg at 8 years, with no intraoperative or postoperative complications.

Another study explored the long-term safety and efficacy of the iStent combined with cataract surgery in patients with pseudoexfoliation glaucoma.

Among the 117 eyes included in the study, the mean IOP decreased from 20.5 mm Hg at baseline to 15 mm Hg at 7 years (P < .001). Ninety-four percent of eyes with a baseline IOP of 18 mm Hg or greater achieved a reduction in IOP. After surgery, 5% of eyes experienced an IOP increase of 15 mm Hg or greater above their baseline IOP, and five eyes underwent additional surgery.

Buznego said the data highlighting the safety and efficacy of combined cataract surgery and MIGS should be reassuring, with the percentage of patients who consent to MIGS procedures at the time of cataract surgery close to 100%.

“I tell my patients at the time of cataract surgery that we have a good chance of killing two birds with one stone. It only adds a few minutes to the procedure, you don’t feel it, and we can probably get you off of medications about three-quarters of the time,” he said.

“I offer it to everyone who is having cataract surgery, and there is a high level of acceptance from patients,” Buznego said. “If there is any chance of avoiding drops every day for the rest of their lives, it’s a real motivating factor.”

Van Tassel said there is still a need for more data, particularly for studies comparing different procedures.

“That additional data would not only help us and help our patients in terms of informing surgical decisions,” she said. “We could hone some of our efforts for innovation if we really had a better sense of which surgery is best for which type of patient or which type of glaucoma.”

Reimbursement

Radcliffe said the innovations driven by industry investment in recent years could be in jeopardy as a result of a CMS proposal to reduce reimbursement for trabecular stent procedures.

Nathan M. Radcliffe, MD
Nathan M. Radcliffe

“All of this investment depends on doctors being able to use those products to keep their economics healthy,” Radcliffe said.

The proposed change — set to go into effect on Jan. 1, 2022, if implemented — includes a reduction to just $34 for trabecular stent placement. Radcliffe said that figure is not only below current reimbursement, which he said is in the range of $250 to $350, but also well short of what was initially expected.

“When CMS sees a cost like stent placement rising, they seem not to consider whether patients are benefiting and whether the treatment is a good thing or saves pharmaceutical costs,” Radcliffe said. “If they simply see a surgical number going up and then cut reimbursement to make it go back down again, it is hard to argue that that’s the best way to take care of patients or run a health care system. It’s simply a political mechanism for CMS to maintain budget neutrality independent from rationality, quality care and evidence-based medicine.”

Reimbursement is part of the process, but Buznego said the proposed change does not make sense.

“Technology is a complex road that industry has to travel to get a product to market and into the hands of surgeons,” Buznego said. “Unfortunately, the final brick in the wall is reimbursement. This draconian, arbitrary cutdown is just unfathomable for doctors. You’re basically telling me that a person doing my job placing a stent and someone doing a manicure should be getting the same amount for our procedures.”

Radcliffe said the process for determining the new value may have had flaws. Surgeons may have underestimated their surgical times and time spent dealing with common intraoperative complications such as bleeding. He also said that limiting stent usage may limit patients from accessing glaucoma care because cataract surgeons are more available and deliver this important glaucoma surgical treatment.

“I understand that codes are growing very quickly, and they want to control that growth,” Radcliffe said. “But it’s impossible to imagine how a procedure that basically took me 9 years to learn should get paid $34. That just seems disproportionately aggressive.”

Herndon said the proposed change would make the technology unaffordable and ultimately limit advancements in the field of MIGS.

“My concern is that, over time, all of the advances and all of the improvements we’ve seen in the space for the past 6 or 7 years will be stymied because nobody is doing the procedures anymore,” he said. “That’s when innovation suffers.”

In a press release issued after the announcement of the proposed change, Glaukos president and CEO Thomas Burns said the company was “extremely disappointed.”

“While this is unwelcomed and unexpected news that we believe is unjustified, we are eager to engage with our key ophthalmic societies and are committed to exploring every option during the public comment period in hopes that medical providers across our network are paid appropriately for conducting these types of procedures,” he said in the release. “We remain steadfastly dedicated to transform the treatment of chronic eye diseases for the benefit of patients worldwide.”

Singh said it was disheartening that the decision looked at only limited factors of placing a stent and not everything that goes into preparing patients for the procedure, such as consulting them through the process, making sure they have proper head placement and getting a good view into the eye.

“When you look at how they came up with that number, it wasn’t really fair. When they did their polling, they came out and said it took less time to do a combination cataract and stent than to do a cataract alone. That is physically impossible, but that is the kind of arbitrary numbers they used to pick this value,” Singh said.

“These are skill sets that take a lot of time and a lot of training. There is no value in that time and skill just because it ‘looks easy.’ It’s not easy. It only looks easy because of the time and training we put into building that skill set,” he said.

Van Tassel agreed, saying that the process is much more involved than just placing the stent.

“Glaucoma patients typically end up being seen a bit more frequently during the postop care because of concerns about pressure spikes from their steroid therapy and needs for titrating their glaucoma medication,” she said. “It just tremendously undervalues the amount of time that is spent caring for our patients and undervalues our expertise.”

Looking beyond the impact on innovation and business, Buznego said the clear losers of the proposed change would be patients, particularly those who might be dependent on others to keep up with therapy.

“Patients and patients’ families are the ones who have benefited the most from MIGS,” he said. “A family member might have to race over after work or leave early in the morning to make sure they get their drops in. Doing successful cataract surgery with MIGS means that we can get that patient down to one drop per day or less. It’s such a valuable tool, and having to throw it all away because no one is going to pay you to do it is just really sad.”

While she is holding out hope for a reversal, Bedrood said many surgeons will have to make some tough decision on what to do moving forward.

“Some people are going to stop, some people are going to modify, and there’s going to be some portion of people who are still going to do it because those particular devices are good for those patients,” she said. “At the end of the day, we always have to think about the patient, but we have to be realistic about how we move forward with providing proper care and also ensuring our practices survive.”

While some surgeons might consider dropping the iStent because of the reimbursement decrease, Singh said the benefits are too great to give up.

“That’s my biggest fear, that people stop doing it for financial reasons,” he said. “I’m going to keep doing these stents even at $34 because I think it still has value for patients, and I believe in it.”

Click here to read the Point/Counter to this Cover Story.