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 cure for the mind-damaging disease. 

However the treatment guarantees to provide patients reminiscent of Missie Meeks more time to live their every day lives normally and independently of others.

Meeks, an English professor based in Ellisville, Mississippi, was diagnosed with an early stage of Alzheimer’s last summer ahead of her fiftieth birthday. That eventually made her a great fit for Leqembi, which won regulatory approval within the U.S. in July 2023. 

Meeks received her first infusion of Leqembi in September 2023 after overcoming just a few logistical hurdles, reminiscent of securing an appointment with a neurologist and getting insurance to cover the costly treatment, which it initially denied due to her age. Since then, she has been taking infusions of the drug every two weeks. 

Meeks is not any longer teaching, but she said Leqembi is “extending my time of a standard life.”

“I still have fumbles. I’m not perfect by any means. But I can function day-after-day just about normally. I can drive, I can go to the doctor, I can exit to eat,” Meeks told CNBC. “It’s extending my time of a standard life.”

Leqembi is taken into account a breakthrough for a progressive disease that has proven notoriously hard to treat. Leqembi is a monoclonal antibody that moderately slows the decline in memory and considering in patients within the earliest stages of Alzheimer’s. Only a narrow swath of the nearly 7 million U.S. patients with the disease are in those early phases.

Still, the drug carries risks of brain swelling and bleeding. Some neurologists and other experts also say patients taking the drug have not had it long enough to see a considerable clinical profit, which was observed at 18 months in Biogen and Eisai’s late-stage trial. 

Meeks’ experience also points to the brand new and sophisticated system related to taking Leqembi, which has hampered the drug’s rollout. There are bottlenecks related to reimbursement uncertainties, diagnostic test requirements, the necessity for normal brain scans and difficulties finding neurologists. Some hospitals and clinics simply aren’t equipped to accommodate the brand new flow of patients who could take the drug. 

Some doctors are also reluctant to prescribe Leqembi, citing their concerns about its risks and skepticism around how much it meaningfully advantages patients. 

Some experts say those issues partly reflect the steep learning curve that comes with a latest drug reminiscent of Leqembi, which has ushered in a latest era for the Alzheimer’s treatment space.

“Each time there’s latest technology or medication, it puts a little bit stress on the system, because change is difficult,” said Dr. Julio Rojas, a professor and behavioral neurologist who’s involved with administering Leqembi on the University of California, San Francisco Health. “We’re still determining learn how to use the drug, learn how to monitor it, when to stop it, learn how to determine if it’s working or not.”

Nonetheless, some patients and their caregivers say the danger and grueling process is price it. 

“I do know Leqembi doesn’t cure Alzheimer’s. The main focus is to stop the progression,” said Meeks’ mother, Patricia Waldrup. “She has two children, and he or she’ll have more time to enjoy their lives and her husband’s life. … We’ve got praises for that.” 

Meanwhile, the variety of patients taking Leqembi appears to be increasing.

The treatment raked in nearly $60 million in sales for the primary half of the yr, up from the $10 million the drug brought in during its first yr available on the market in 2023, in accordance with Biogen’s first and second quarter earnings reports. In Biogen’s most up-to-date update, in May, it said roughly 5,000 people were taking the drug on the time. 

Leqembi’s rollout has been gradual partially resulting from the arduous process involved in diagnosing a patient with mild cognitive impairment or mild dementia, the earliest two stages of Alzheimer’s. 

Tracey Collins, a world public relations officer based in Portland, Maine, said it took her roughly 2½ years to receive a diagnosis for early Alzheimer’s after she began experiencing symptoms of cognitive decline, reminiscent of memory loss. 

Collins, 54, said that was partially resulting from her being younger than the typical Alzheimer’s patient and her physician attributing symptoms to other aspects, reminiscent of trauma from recent family-related issues and attention-deficit/hyperactivity disorder.

Collins was also recovering from a benign meningioma — a non-cancerous tumor that forms in tissue covering the brain and spinal cord — which can even cause cognitive dysfunction. But Collins’ physician eventually referred her to a neurologist in Boston who performed a spinal fluid test to diagnose her with early Alzheimer’s in 2022. 

Simply finding a neurologist generally is a difficult task, since there should not enough of them practicing within the U.S., Alex Scott, Eisai’s chief administrative officer, told CNBC. 

“Once you might be told to go see a neurologist, guess what? That puts you within the position of waiting anywhere between 4 and eight months or so to get to see one,” Scott said. 

That was the case for Meeks, who said she waited just a few months to get her first appointment together with her neurologist in South Mississippi.

A 2020 study of Medicare enrollees found that only 24% of patients with a neurologic condition were seen by a neurologist, with notable regional differences. For those with dementia, 38% of individuals in additional rural areas saw a neurologist, compared with 47% in urban areas. 

Patients typically prefer PET scans, that are painless, for detecting amyloid, in accordance with Scott. But, he said, Medicare only decided to broaden coverage of those scans for Alzheimer’s in October, which contributed to Leqembi’s sluggish initial launch.

Neurologists also perform an MRI scan to make sure that patients haven’t got other brain diseases which may be causing cognitive issues, Dr. Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Disease Research Center, told CNBC. Neurologists use the MRI to judge whether patients have microbleeds of their brains, which could make them ineligible for Leqembi since it puts them at a better risk of its serious uncomfortable side effects, in accordance with experts.

Some hospitals and clinics also require genetic testing for 2 copies of the so-called APOE4 gene variant, which can be related to an increased risk of brain swelling and bleeding, in accordance with experts and Eisai. Those uncomfortable side effects are also often known as amyloid-related imaging abnormalities, or ARIA. 

Once those tests are complete, a panel of 20 to 30 neurologists, radiologists, psychiatrists and other experts vote on whether or not they think a patient qualifies for treatment with Leqembi, Petersen said, referring to the method on the Mayo Clinic’s Alzheimer’s center.

He said roughly 60% of individuals evaluated by the Mayo Clinic’s panel find yourself being eligible for the treatment and that the majority of those patients conform to take it. The Mayo Clinic’s center, which began screening patients for Leqembi in October, has 50 to 60 patients currently taking the drug, in accordance with Petersen.

Petersen said the middle evaluates three to 5 latest patient referrals initially of every week and his team determines whether or not they are eligible for Leqembi by Thursday.

Still, Petersen said it could take months for a patient on the Mayo Clinic to receive Leqembi resulting from other hurdles, reminiscent of insurance issues. 

While Medicare covers Leqembi, some patients who aren’t sufficiently old to enroll within the federal program may struggle to get coverage. Some business health plans simply don’t cover the drug, experts say, which has a $26,500 annual price tag before insurance. 

Collins, the patient from Portland, said her insurance denied her request for Leqembi coverage 3 times, delaying her ability to begin taking the drug. She was referred to a neurologist in April 2023 and received her first infusion in January. 

It may take other patients even longer, particularly if they’ll health centers that are not fully equipped to perform MRI scans or other requirements. 

Michael Irizarry, Eisai’s senior vice chairman of clinical research, acknowledged the lengthy process that patients must undergo to receive Leqembi. But he noted that “all those steps are completely latest, essentially because the approval of [Leqembi], and really is a metamorphosis within the care of those patients.”

An evaluation published in April by Being Patient, a web-based news source dedicated to Alzheimer’s disease, estimated that there are greater than 850 infusion sites within the U.S. offering Leqembi. However the evaluation found that 11 states had five or fewer infusion clinics administering the drug. 

A spokesperson for Eisai didn’t provide a particular variety of Leqembi infusion clinics within the U.S. but noted that the corporate has a tool that helps patients locate sites within the U.S. near them.

But Eisai and Biogen said they’re working on more convenient types of Leqembi that might reduce the burden on patients and their caregivers and potentially expand uptake.

The businesses are hoping to win regulatory approval for a so-called “maintenance dose” of Leqembi, which might stretch infusion intervals to once per thirty days after an initial period of receiving biweekly infusions.

Eisai’s Scott added that the corporate is hoping to win regulatory approval for a version of Leqembi that’s injected weekly under the skin at home or in a medical facility. The approval would allow patients to eventually switch to that subcutaneous type of the drug as a maintenance dose of Leqembi.

Collins drives 20 minutes to her primary care doctor in South Portland to receive Leqembi infusions, which she said looks like “a spa day” despite having an IV in her arm for nearly an hour. 

“They provide me coffee, snacks, and I sit and browse on reclining chairs. I sort of make it a fun event,” she said. “My kids have sometimes come to hang around with me. It’s not likely in a hospital setting so it doesn’t feel scary.” 

Meeks said her infusions feel like “therapy sessions” because she gets to refer to other patients and their caregivers at her clinic about their experiences with the disease. 

“It’s just comforting to listen to other people’s stories as you sit in there,” Meeks said, adding that the roughly 40-minute infusion is “done before you realize it.”

Patients may experience infusion-related reactions during their first two sessions, reminiscent of flu-like symptoms, in accordance with Irizarry.

Neurologists also conduct regular MRI scans on patients to observe for ARIA, or brain swelling and bleeding, uncomfortable side effects, in accordance with Eisai.

Meeks’ neurologist, Dr. Wendell Helveston, said a follow-up MRI picked up one small area of bleeding in her brain that did not cause any symptoms. 

Helveston, who practices on the Hattiesburg Clinic in Mississippi, said Meeks’ bleeding was “well below the extent where we would want to stop dosing” Leqembi.

He also said Meeks’ rate of cognitive decline has stabilized after several months of treatment, which is “exactly what we would really like to see” from patients taking the drug. 

But at the same time as uptake of the drug ramps up, Petersen said it should be too early to say how much patients are benefiting from the drug. 

Leqembi reduced cognitive decline by 27% after 18 months in Biogen and Eisai’s pivotal late-stage trial – data that supported the treatment’s approval in 2023. Eisai in July also released latest data showing that the progression of the disease in patients on Leqembi continued to slow after three years, suggesting the necessity for them to take the treatment long-term.