Leqembi could give Alzheimer’s patients more time, but road to treatment is long

Leqembi, an Alzheimer’s drug from Biogen and Eisai, is not a remedy for the mind-damaging illness. 

However the treatment guarantees to present sufferers equivalent to Missie Meeks extra time to stay their every day lives usually and independently of others.

Meeks, an English professor primarily based in Ellisville, Mississippi, was recognized with an early stage of Alzheimer’s final summer season forward of her fiftieth birthday. That ultimately made her a very good match for Leqembi, which won regulatory approval within the U.S. in July 2023. 

Meeks obtained her first infusion of Leqembi in September 2023 after overcoming a number of logistical hurdles, equivalent to securing an appointment with a neurologist and getting insurance coverage to cowl the pricey therapy, which it initially denied due to her age. Since then, she has been taking infusions of the drug each two weeks. 

Meeks is now not instructing, however she mentioned Leqembi is “extending my time of a traditional life.”

“I nonetheless have fumbles. I am not excellent by any means. However I can perform day-after-day just about usually. I can drive, I can go to the physician, I can exit to eat,” Meeks advised CNBC. “It is extending my time of a traditional life.”

Leqembi is taken into account a breakthrough for a progressive illness that has confirmed notoriously exhausting to deal with. Leqembi is a monoclonal antibody that moderately slows the decline in reminiscence and pondering in sufferers within the earliest levels of Alzheimer’s. Solely a slim swath of the nearly 7 million U.S. sufferers with the illness are in these early phases.

Nonetheless, the drug carries dangers of brain swelling and bleeding. Some neurologists and different specialists additionally say sufferers taking the drug have not had it lengthy sufficient to see a considerable medical profit, which was observed at 18 months in Biogen and Eisai’s late-stage trial. 

Meeks’ expertise additionally factors to the brand new and sophisticated system related to taking Leqembi, which has hampered the drug’s rollout. There are bottlenecks associated to reimbursement uncertainties, diagnostic check necessities, the necessity for normal mind scans and difficulties discovering neurologists. Some hospitals and clinics merely aren’t geared up to accommodate the brand new stream of sufferers who might take the drug. 

Some medical doctors are additionally reluctant to prescribe Leqembi, citing their issues about its dangers and skepticism round how a lot it meaningfully advantages sufferers. 

Some specialists say these points partly mirror the steep studying curve that comes with a brand new drug equivalent to Leqembi, which has ushered in a brand new period for the Alzheimer’s therapy house.

“Each time there’s new know-how or treatment, it places a bit of stress on the system, as a result of change is difficult,” mentioned Dr. Julio Rojas, a professor and behavioral neurologist who’s concerned with administering Leqembi on the College of California, San Francisco Well being. “We’re nonetheless determining methods to use the drug, methods to monitor it, when to cease it, methods to resolve if it is working or not.”

Nonetheless, some sufferers and their caregivers say the danger and grueling course of is value it. 

“I do know Leqembi doesn’t remedy Alzheimer’s. The main target is to cease the development,” mentioned Meeks’ mom, Patricia Waldrup. “She has two kids, and he or she’ll have extra time to get pleasure from their lives and her husband’s life. … Now we have praises for that.” 

In the meantime, the variety of sufferers taking Leqembi seems to be rising.

The therapy raked in practically $60 million in gross sales for the primary half of the 12 months, up from the $10 million the drug introduced in throughout its first 12 months available on the market in 2023, in response to Biogen’s first and second quarter earnings stories. In Biogen’s most up-to-date replace, in Could, it mentioned roughly 5,000 folks have been taking the drug on the time. 

Leqembi’s rollout has been gradual partly as a result of arduous course of concerned in diagnosing a affected person with delicate cognitive impairment or delicate dementia, the earliest two stages of Alzheimer’s. 

Tracey Collins, a world public relations officer primarily based in Portland, Maine, mentioned it took her roughly 2½ years to obtain a analysis for early Alzheimer’s after she began experiencing signs of cognitive decline, equivalent to reminiscence loss. 

Collins, 54, mentioned that was partly attributable to her being youthful than the typical Alzheimer’s patient and her doctor attributing signs to different elements, equivalent to trauma from latest family-related points and attention-deficit/hyperactivity dysfunction.

Collins was additionally recovering from a benign meningioma — a non-cancerous tumor that varieties in tissue masking the mind and spinal wire — which might additionally trigger cognitive dysfunction. However Collins’ doctor ultimately referred her to a neurologist in Boston who carried out a spinal fluid check to diagnose her with early Alzheimer’s in 2022. 

Merely discovering a neurologist could be a tough job, since there are usually not sufficient of them training within the U.S., Alex Scott, Eisai’s chief administrative officer, advised CNBC. 

“As soon as you’re advised to go see a neurologist, guess what? That places you within the place of ready anyplace between 4 and eight months or so to get to see one,” Scott mentioned. 

That was the case for Meeks, who mentioned she waited a number of months to get her first appointment along with her neurologist in South Mississippi.

A 2020 study of Medicare enrollees discovered that solely 24% of sufferers with a neurologic situation have been seen by a neurologist, with notable regional variations. For these with dementia, 38% of individuals in additional rural areas noticed a neurologist, in contrast with 47% in city areas. 

Even after a analysis, sufferers and neurologists should leap by way of a number of hoops to find out eligibility for Leqembi, specialists say.

The drug works partly by clearing poisonous plaques within the mind referred to as amyloid, an indicator of Alzheimer’s, in response to its producers. Meaning sufferers should endure a PET scan or a spinal fluid check to find out if amyloid has collected of their brains.

Sufferers usually want PET scans, that are painless, for detecting amyloid, in response to Scott. However, he mentioned, Medicare solely determined to broaden coverage of these scans for Alzheimer’s in October, which contributed to Leqembi’s sluggish preliminary launch.

Neurologists additionally carry out an MRI scan to make sure that sufferers do not produce other mind ailments that could be inflicting cognitive points, Dr. Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Illness Analysis Middle, advised CNBC. Neurologists use the MRI to guage whether or not sufferers have microbleeds of their brains, which might make them ineligible for Leqembi as a result of it places them at a better threat of its severe unwanted effects, in response to specialists.

Some hospitals and clinics additionally require genetic testing for 2 copies of the so-called APOE4 gene variant, which can also be related to an elevated threat of mind swelling and bleeding, in response to specialists and Eisai. These unwanted effects are often known as amyloid-related imaging abnormalities, or ARIA. 

As soon as these checks are full, a panel of 20 to 30 neurologists, radiologists, psychiatrists and different specialists vote on whether or not they assume a affected person qualifies for therapy with Leqembi, Petersen mentioned, referring to the method on the Mayo Clinic’s Alzheimer’s heart.

He mentioned roughly 60% of individuals evaluated by the Mayo Clinic’s panel find yourself being eligible for the therapy and that almost all of these sufferers comply with take it. The Mayo Clinic’s heart, which started screening sufferers for Leqembi in October, has 50 to 60 sufferers presently taking the drug, in response to Petersen.

Petersen mentioned the middle evaluates three to 5 new affected person referrals at first of every week and his group determines whether or not they’re eligible for Leqembi by Thursday.

Nonetheless, Petersen mentioned it could take months for a affected person on the Mayo Clinic to obtain Leqembi attributable to different hurdles, equivalent to insurance coverage points. 

Whereas Medicare covers Leqembi, some sufferers who aren’t sufficiently old to enroll within the federal program might battle to get protection. Some industrial well being plans merely do not cowl the drug, specialists say, which has a $26,500 annual price ticket earlier than insurance coverage. 

Collins, the affected person from Portland, mentioned her insurance coverage denied her request for Leqembi protection thrice, delaying her capability to start out taking the drug. She was referred to a neurologist in April 2023 and obtained her first infusion in January. 

It could actually take different sufferers even longer, significantly if they’re going to well being facilities that are not totally geared up to carry out MRI scans or different necessities. 

Michael Irizarry, Eisai’s senior vp of medical analysis, acknowledged the prolonged course of that sufferers need to endure to obtain Leqembi. However he famous that “all these steps are utterly new, primarily because the approval of [Leqembi], and actually is a change within the care of those sufferers.”

As soon as a affected person will get protection for Leqembi, they will begin biweekly intravenous infusions of the drug. However some neurologists haven’t got infusion clinics of their workplace, in order that they need to ship sufferers to a different well being heart that does. 

In some circumstances, the closest infusion clinic could also be dozens of miles away, which could be a large impediment for sufferers and caregivers who haven’t got dependable entry to transportation or time to drive to a different location. 

An analysis printed in April by Being Affected person, a web-based information supply devoted to Alzheimer’s illness, estimated that there are greater than 850 infusion websites within the U.S. providing Leqembi. However the evaluation discovered that 11 states had 5 or fewer infusion clinics administering the drug. 

A spokesperson for Eisai didn’t present a selected variety of Leqembi infusion clinics within the U.S. however famous that the corporate has a tool that helps sufferers find websites within the U.S. close to them.

However Eisai and Biogen mentioned they’re engaged on extra handy types of Leqembi that might cut back the burden on sufferers and their caregivers and doubtlessly increase uptake.

The businesses are hoping to win regulatory approval for a so-called “upkeep dose” of Leqembi, which might stretch infusion intervals to once per month after an preliminary interval of receiving biweekly infusions.

Eisai’s Scott added that the corporate is hoping to win regulatory approval for a model of Leqembi that’s injected weekly under the skin at dwelling or in a medical facility. The approval would enable sufferers to ultimately swap to that subcutaneous form of the drug as a upkeep dose of Leqembi.

Collins drives 20 minutes to her major care physician in South Portland to obtain Leqembi infusions, which she mentioned appears like “a spa day” regardless of having an IV in her arm for nearly an hour. 

“They provide me espresso, snacks, and I sit and browse on reclining chairs. I type of make it a enjoyable occasion,” she mentioned. “My children have generally come to hang around with me. It is not likely in a hospital setting so it does not really feel scary.” 

Meeks mentioned her infusions really feel like “remedy classes” as a result of she will get to speak to different sufferers and their caregivers at her clinic about their experiences with the illness. 

“It is simply comforting to listen to different folks’s tales as you sit in there,” Meeks mentioned, including that the roughly 40-minute infusion is “finished earlier than you realize it.”

Sufferers might expertise infusion-related reactions throughout their first two classes, equivalent to flu-like signs, in response to Irizarry.

Neurologists additionally conduct common MRI scans on sufferers to observe for ARIA, or mind swelling and bleeding, unwanted effects, in response to Eisai.

Leqembi has to this point been well-tolerated by sufferers, in response to Rojas. However he mentioned the danger of ARIA is “at all times behind our head always.” 

UCSF’s clinic may have sufferers skip infusions of Leqembi till ARIA goes away, or use steroids to lower mind irritation. 

The Mayo Clinic’s Alzheimer’s heart equally stops dosing sufferers if ARIA seems on an MRI, in response to Petersen. The middle has seen a number of circumstances of these unwanted effects, however “nothing too dramatic, nothing deadly,” he mentioned.

“Our expertise to date has typically been optimistic,” Petersen mentioned. 

Meeks’ neurologist, Dr. Wendell Helveston, mentioned a follow-up MRI picked up one small space of bleeding in her mind that did not trigger any signs. 

Helveston, who practices on the Hattiesburg Clinic in Mississippi, mentioned Meeks’ bleeding was “effectively beneath the extent the place we would wish to cease dosing” Leqembi.

He additionally mentioned Meeks’ fee of cognitive decline has stabilized after a number of months of therapy, which is “precisely what we wish to see” from sufferers taking the drug. 

However whilst uptake of the drug ramps up, Petersen mentioned it could nonetheless be too early to say how a lot sufferers are benefiting from the drug. 

Leqembi decreased cognitive decline by 27% after 18 months in Biogen and Eisai’s pivotal late-stage trial – information that supported the therapy’s approval in 2023. Eisai in July additionally launched new data exhibiting that the development of the illness in sufferers on Leqembi continued to gradual after three years, suggesting the necessity for them to take the therapy long-term. 

However it’s solely been roughly 14 months since Leqembi was permitted, and a few sufferers have been taking the drug for an excellent shorter time period.

“We’re not out that far but to actually see if individuals are remaining comparatively secure,” Petersen mentioned. “Subjectively, it appears to be like prefer it, however that is actually a mushy criterion right now. So we’re simply going to proceed on and consider our expertise on the finish of the 18 months.” 

In the meantime, sufferers equivalent to Collins are pinning their hopes on Leqembi to present them additional time to stay independently and carry out their standard every day actions.

“Having one thing that may hold me dwelling in my atmosphere, doing my job and having the ability to care for youngsters — it is what will get me by way of the subsequent week,” she mentioned.