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Japanese drugmaker Eisai expects the Food and Drug Administration to fully approve its Alzheimer’s treatment Leqembi this summer, which would expand access to the expensive new antibody under Medicare.

US CEO Ivan Cheung said the FDA, which granted accelerated approval in January, could grant full approval as early as July if the company receives an accelerated “priority review” to show significant improvement in the early treatment of Alzheimer’s.

“We’re literally talking about maybe in five months, so we’re definitely moving urgently with CMS now,” Cheung said in an interview with CNBC on Thursday. The Centers for Medicare & Medicaid Services is the federal agency that will determine the extent to which Leqembi, priced by Eisai at $26,500 per year, is covered for patients with early-stage Alzheimer’s.

The company that helped develop the drug biogenicestimates that 100,000 people will be diagnosed early with Alzheimer’s and be eligible for Leqembi by 2026, although the number of undiagnosed people is almost certainly higher.

The Alzheimer’s Association estimates that more than 2,000 people aged 65 and older progress from mild to moderate dementia due to the disease each day, making them unsuitable for Leqembi.

Early-stage Alzheimer’s typically strikes people over the age of 65 and causes cognitive impairment and other problems. Leqembi has shown promise in slowing the progression of the disease in this population, but it carries the risk of brain swelling and bleeding.

Medicare released guidance in April 2022 limiting coverage for Alzheimer’s drugs like Leqembi, which use antibody treatments to target the plaque that causes the disease. Under Eisai’s current accelerated approval status, Medicare will only pay for people in clinical trials approved by the FDA or the National Institutes of Health.

Eisai has completed its phase 3 study and is no longer accepting patients. This means the drug is currently out of the reach of most but the very wealthy. Cheung said the company is currently not aware of any patients who have managed to get Leqembi insured through Medicare.

Even if it gets full approval under the FDA’s “priority review” process, Medicare could limit coverage to patients participating in research studies approved by CMS, the agency that operates the Medicare and Medicaid state health insurance programs .

Awaiting FDA response on timing

The company submitted all of its phase three data with its submission for full approval in January and was due to hear from the FDA in March on whether the agency will accept its submission. If the agency decides to give Leqembi’s application priority consideration, it could make a final decision within six months.

Medicare beneficiaries who agree to participate in CMS-supported research studies that are broader in scope than clinical trials would receive coverage if Leqembi receives full approval. But it’s possible that CMS could agree to even broader coverage, possibly without restrictions, if the agency determines there is a high level of evidence supporting the treatment, Cheung said.

“With a high level of evidence… the restrictions should be very limited, or maybe even no restrictions at all, and that is Eisai’s position,” Cheung said. “We believe Medicare beneficiaries should have unhindered, broad and easy access to Leqembi because the data meets those criteria,” he said.

If Medicare continues to limit coverage, people in rural communities would be disadvantaged because medical facilities and universities are heavily concentrated in larger cities.

More than 70 members of Congress this month called on Health Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure to relax Leqembi coverage restrictions to allow for better access across America.

“Patients, families and carers living in rural and underserved areas should have an equal opportunity to access treatment,” lawmakers wrote. “It’s a tremendous physical and financial drain on Medicare beneficiaries to spend countless hours traveling to limited research facilities hosting the studies.”

Drugs will take years to market

If all goes according to Eisai’s expectations, the FDA would grant full approval and CMS would give Leqembi full coverage. In this scenario, Eisai estimates that by the drug’s third year on the market, about 100,000 early-diagnosed Alzheimer’s patients will be eligible. Eisai said there is sufficient production capacity at Biogen’s facility in Switzerland.

But Cheung said the biggest challenge in launching Leqembi is that doctors aren’t geared to diagnose early-stage Alzheimer’s because there are so few treatments. CMS must also provide broad reimbursement for diagnostic tests, Cheung said. These include PET scans, which are currently limited to one per life, and CSF testing, which the company says will be reimbursed at a low rate.

“Every time you need to use a new diagnostic method, it just takes time,” Cheung said. “These diagnostic procedures need to be reimbursed, and radiologists and healthcare providers across the country need to start doing them. And it takes a while for people to get used to how to do that,” he said.

About 15% of eligible patients are under the age of 65 and mostly privately insured, Cheung said. Private insurers are largely awaiting a CMS coverage decision, although some may choose to make their coverage decisions sooner, he said. Eisai will offer co-payment assistance to people who are privately insured, Cheung said.

“There’s more flexibility and multiple approaches to give these people very good access at a very, very low cost of ownership,” the CEO said. Eisai has a program to provide Leqembi free of charge to uninsured patients who meet eligibility criteria.

Cheung said Leqembi’s annual cost of $26,500 should decrease over time. Currently, treatment is given twice a month, but Eisai is developing a maintenance regimen where patients would receive a single monthly dose after the first 18 months of treatment.

“It’s not approved yet. We expect to file a maintenance dosing application by the end of next fiscal year,” Cheung said. Maintenance dosing would cut Leqembi’s cost by about half, he said.

Medicare under pressure

CMS said in January that it would expand coverage if Eisai provided data answering questions about Leqembi’s usefulness in slowing cognitive decline and potential harm from side effects like cerebral hemorrhage.

“One of the things I want to emphasize is, as you know, in this particular class, [we] We really wanted more information when we learned what these products will do,” CMS Administrator Brooks-LaSure said Tuesday during a call with reporters. “But we remain open to new data from manufacturers and advocates.”

Eisai says the data from its phase 3 study answers these questions with a high level of evidence, Cheung said.

Medicare’s coverage policy is controversial. The Alzheimer’s Association, in a December letter to CMS, requested full and unqualified reporting on Leqembi. Robert Egge, the association’s chief public policy officer, said it was the first time that CMS had made a pre-emptive decision not to provide standard coverage for a future class of drugs.

The Medicare policy stems from controversy surrounding Aduhelm, another Alzheimer’s antibody treatment developed by Eisai and Biogen. The FDA granted fast-track approval for this treatment in 2021, although the agency’s independent consultants said the evidence didn’t show it slowed the disease. Three consultants have resigned because of the FDA’s decision. A congressional investigation in December found that Aduhelm’s admission was “riddled with irregularities.”

Medicare decided last April to limit coverage of all monoclonal antibodies that target brain plaque for the treatment of Alzheimer’s pending more evidence demonstrating benefit for patients.

“It’s not a sensible policy because there’s no reason why they had to do it on a class basis,” Egge said.

The American Academy of Neurology, the world’s largest association of neurologists, told Medicare in a letter earlier this month that their experts agreed that the Phase 3 clinical trial for Leqembi was well designed and the data were clinically and statistically significant be.

The results of the clinical study, published in the New England Journal of Medicine, found that people who received Leqembi had 27% slower cognitive decline than those who did not receive the treatment over 18 months. But there were also safety concerns in some patients who experienced brain swelling and bleeding.

The death of a participant in a Chicago-area clinical trial could also potentially be linked to lecanemab, according to a research letter published in the New England Journal of Medicine in January

The President of AAN, Dr. Orly Avitzur, urged CMS to revise its coverage limitations to allow Leqembi broader access should the treatment receive traditional FDA approval.

CNBC Health & Science

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U.S. senators Friday called for Medicare to offer broad coverage of Alzheimer’s treatments approved by the Food and Drug Administration, warning that the current restrictions are costing patients valuable time as their disease progresses.

“Given the progressive nature of this terminal disease, we encourage you to take action now to ensure patients have immediate access to FDA-approved treatments when the patient and physician decide it is right for the patient,” they said the senators to Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure in a letter.

The group consisted of 18 Republicans and two Democrats, led by Sens. Susan Collins, R-Maine, and Shelley Moore Capito, RW.V.

The 20 senators told CMS that Alzheimer’s disease will cost the nation $1 trillion by 2050 unless the US takes decisive action. The population of seniors, who are most affected by the disease, is expected to increase by more than 50% to 86 million over the next 30 years, according to the Census Bureau.

Public pressure on Medicare has increased since the FDA granted accelerated approval Eisai And biogenic‘s treatment Leqembi, an antibody that targets brain plaques associated with the disease. The product has shown promise in treating early-stage Alzheimer’s disease, slowing cognitive decline by 27% in a late-stage clinical trial. It also carries the risk of brain swelling and bleeding.

CMS has severely limited coverage of Alzheimer’s treatments like Leqembi, which are receiving accelerated approval. Medicare covers the drug, which Eisai estimates at $26,500 a year, only for people who are in clinical trials approved by the FDA and the National Institutes of Health.

But Eisai has already completed its late-stage study and is no longer accepting participants. As a result, Medicare coverage for the expensive drug is essentially non-existent.

Ivan Cheung, Eisai’s US CEO, told CNBC Thursday that the company is not aware of any seniors who have the drug covered by Medicare.

The senators said delays in treatment can cause massive harm to patients as Alzheimer’s disease progresses.

“Processes that can delay coverage decisions by several months can cause significant delays in access, resulting in irreversible disease progression and additional burdens on caregivers and families,” the senators told CMS.

The senators’ letter comes after more than 70 House lawmakers issued a similar call this month. Representatives said the current restrictions put people living in rural communities at a disadvantage, as trials often take place in larger cities.

“Patients, families and caregivers who live in rural and underserved areas should have equal opportunities to access treatment,” House lawmakers told Becerra and Brooks-LaSure. “It’s a tremendous physical and financial drain on Medicare beneficiaries to spend countless hours traveling to limited research facilities hosting the studies.”

The Alzheimer’s Association wrote to CMS in December, urging the agency to provide Leqembi with unlimited Medicare coverage. The association’s letter was signed by more than 200 Alzheimer’s researchers and experts.

The American Academy of Neurology, the world’s largest association of neurologists, told Medicare in a letter earlier this month that its experts concluded that Eisai’s clinical trial for late-stage Leqembi was well designed and the data were clinically and statistically significant be. The President of AAN, Dr. Orly Avitzur, asked Medicare to give Leqembi broader access.

Eisai expects to receive full FDA approval for Leqembi as early as this summer. Under CMS policy, Medicare would then provide broader coverage for people participating in agency-sponsored research studies.

“One of the things I want to emphasize is, as you know, in this particular class, [we] We really wanted more information when we learned what these products will do,” Medicare Administrator Brooks-LaSure said Tuesday while speaking with reporters. “But we remain open to new data from manufacturers and advocates.”

Cheung said it’s possible Medicare could offer coverage without restrictions if the agency determines there is significant evidence supporting the benefits of the treatment.

“With a high level of evidence… the restrictions should be very limited, or maybe even no restrictions at all, and that is Eisai’s position,” Cheung said. “We believe that Medicare beneficiaries should have unhindered, broad and easy access to Leqembi because the data meets these criteria.”

Medicare’s restrictive policy stems from controversies involving Aduhelm, another antibody developed by Biogen and Eisai. The FDA granted Aduhelm accelerated approval, although its independent advisors said the data showed no benefit to patients. Three consultants have resigned due to Aduhelm’s FDA approval.

Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, with his BCI.

Source: Synchronous

In a Brooklyn lab crammed with 3D printers and a makeshift pickleball rig, employees at a brain-interface startup called Synchron are working on technology that promises to transform the daily lives of people living with paralysis.

The Synchron Switch is implanted through the blood vessels so that people with no or very limited physical mobility can use their minds to operate technologies such as cursors and smart home devices. So far, the nascent technology has been used on three patients in the US and four in Australia.

“I’ve seen moments between patient and partner or patient and spouse where it’s incredibly joyous and empowering to have regained the ability to be a little bit more independent than before,” Synchron CEO Tom Oxley said in an interview with CNBC. “It helps them get involved in ways we take for granted.”

Founded in 2012, Synchron is part of the burgeoning Brain Computer Interface or BCI industry. A BCI is a system that decodes brain signals and translates them into commands for external technologies. Perhaps the most well-known name in the industry is Neuralink, thanks to the high profile of founder Elon Musk, who is also the CEO of TeslaSpaceX and Twitter.

But Musk isn’t the only tech billionaire betting on BCI’s potential transition from a radical scientific experiment to a thriving medical business. In December, Synchron announced a $75 million funding round that included funding from its investment firms Microsoft Co-founder Bill Gates and Amazon Founder Jeff Bezos.

‘More Scalable’

In August 2020, the Food and Drug Administration granted Synchron breakthrough device designation, which applies to medical devices that have the potential to provide improved treatment for debilitating or life-threatening conditions. The following year, Synchron became the first company to receive an investigational product exemption from the FDA to conduct trials of a permanently implantable BCI in human patients.

Synchron is enrolling patients in an early proof of concept study designed to show the technology can be safely used in humans. Six patients will be implanted with Synchron’s BCI during the study, and Chief Commercial Officer Kurt Haggstrom said the company is currently about halfway through the study.

The company has no revenue yet, and a spokesman said Synchron is not commenting on how much the process will ultimately cost.

While many competitors have to implant their BCIs through open-brain surgery, Synchron is taking a less invasive approach that builds on decades of existing endovascular techniques, the company said.

The Stentrode™ Endovascular Electrode Array.

Source: Synchronous

Synchron’s BCI is introduced through blood vessels that Oxley calls the “natural highways” into the brain. Synchron’s stent, called a Stentrode, is fitted with tiny sensors and is inserted into the large vein, which is adjacent to the motor cortex. The stentrode is connected to an antenna that sits under the skin in the chest and collects raw brain data, which it sends from the body to external devices.

Peter Yoo, senior director of neuroscience at Synchron, said because the device isn’t inserted directly into brain tissue, the quality of the brain signal isn’t perfect. But the brain doesn’t like being touched by foreign objects, Yoo said, and the less invasive nature of the procedure makes it more accessible.

“There are about 2,000 interventionalists who can do these procedures,” Yoo told CNBC. “It’s a bit more scalable than, say, open-brain surgery or drill holes, which only neurosurgeons can do.”

Philip O’Keefe, one of Synchron’s patients in the SWITCH clinical trial, was the first person in the world to tweet with a BCI device.

Source: Synchronous

For patients with severe paralysis or degenerative diseases such as amyotrophic lateral sclerosis or ALS, Synchron’s technology can help them regain their ability to communicate with friends, family and the outside world, whether that’s through typing, texting or even accessing social media.

Patients can use Synchron’s BCI to shop online and manage their health and finances, but Oxley said what she often gets most excited about is text messaging.

“Losing the ability to text is incredibly isolating,” Oxley said. “Restoring the ability to text loved ones is a very emotional restoration of power.”

In December 2021, Oxley donated his Twitter account to a patient named Philip O’Keefe, who has ALS and has trouble moving his hands. About 20 months earlier, O’Keefe was implanted with Synchron’s BCI.

“Hello World! Short tweet. Monumental progress,” O’Keefe tweeted on Oxley’s page using the BCI.

Synchron’s technology has caught the attention of its competitors. Musk reached out to the company last year to discuss a potential investment, according to a Reuters report. Synchron declined to comment on the report. Neuralink did not respond to a request for comment.

Neuralink is developing a BCI designed to be inserted directly into brain tissue, and while the company isn’t testing its device in humans just yet, Musk hopes to do so later this year.

Haggstrom said his company’s funding will help accelerate Synchron’s product development and advance it toward a pivotal clinical trial that would bring the company closer to commercialization.

Khosla Ventures partner Alex Morgan, who led a previous funding round, said that while Synchron’s device might seem like something straight out of science fiction, it’s based on “real science” and is already making significant changes to patients’ lives.

“Synchron is already helping people today,” he said in an interview. “It’s really extraordinary for me.”

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Synchron’s brain-computer interface, the Stentrode™ endovascular electrode array, and the implantable receiver-transmitter unit.

Source: Synchronous

In January, the medical journal JAMA Neurology published the peer-reviewed long-term safety results of a study of Synchron’s BCI system in Australia. The study found that the technology remained safe over a 12-month period, with no degradation in signal quality or performance.

“This was a huge release for us,” Haggstrom said.

Haggstrom said commercialization is key for all industry players.

“I always like to be competitive, so being first to market is crucial for me,” Haggstrom said. “We meet future patients to talk to them about their needs and things and when you see that and talk to these families and the caregivers, you want to start racing as soon as possible to help them in their daily lives.”

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