Patients with Alzheimer's disease may receive more time with a new drug, but they must navigate a lengthy path to treatment.

• Patients with early-stage Alzheimer's disease may benefit from Leqembi, a drug developed by Biogen and Eisai, which could increase their ability to live independently and improve their quality of life.
• The new and complicated system associated with taking the drug makes it difficult for patients to access treatment.
• Uncertainties about reimbursement, diagnostic test requirements, the need for regular brain scans, and difficulties in finding neurologists are causing bottlenecks.

The drug Leqembi, developed by Eli Lilly and Company, does not cure Alzheimer's disease.

The treatment aims to provide patients, like Missie Meeks, with more time to live their daily lives independently and normally.

An English professor from Ellisville, Mississippi, was diagnosed with early-stage Alzheimer's last summer, which made her a suitable candidate for Leqembi, which received regulatory approval in the U.S. in July 2023.

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

Leqembi is "extending my time of a normal life," as Meeks is no longer teaching.

"Meeks stated to CNBC that although he still has fumbles and is not perfect, he can function normally on a daily basis. He can drive, visit the doctor, and go out to eat. He believes that this is allowing him to prolong his time of living a normal life."

The monoclonal antibody Leqembi has been hailed as a breakthrough for treating a progressive disease that has proven difficult to treat. Leqembi moderately slows the decline in memory and thinking in patients in the earliest stages of Alzheimer's. However, only a small percentage of the nearly 7 million U.S. patients with the disease are in those early stages.

The drug has risks of brain swelling and bleeding, and some experts say patients haven't seen a substantial clinical benefit yet, which was observed at 18 months in Biogen and Eisai's late-stage trial.

The new and complex system associated with taking Leqembi has hindered its rollout, as evidenced by Meeks' experience. There are issues related to reimbursement uncertainties, diagnostic test requirements, the need for regular brain scans, and difficulties in finding neurologists. Some hospitals and clinics lack the necessary equipment to accommodate the new flow of patients who could take the drug.

Some doctors are hesitant to prescribe Leqembi due to concerns about its risks and doubts about its effectiveness in improving patients' outcomes.

Some experts believe that the challenges faced by patients and caregivers partly stem from the steep learning curve associated with a new drug like Leqembi, which marks a new era in the treatment of Alzheimer's disease.

"Dr. Julio Rojas, a professor and behavioral neurologist at the University of California, San Francisco Health, stated that new technology or medication can put stress on the system because change is difficult. He explained that they are still learning how to use the drug, monitor it, determine when to stop it, and decide if it's effective."

Some patients and their caregivers believe that the risk and arduous procedure are justified.

"Patricia Waldrup, Meeks' mother, stated that she knows Leqembi does not cure Alzheimer's, but the primary goal is to halt its progression. This will give Leqembi more time to enjoy her children's lives and her husband's life. The family has high praise for this."

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

Biogen's drug generated $59.9 million in sales during the first half of 2023, a significant increase from the $10 million it made in its first year on the market in 2023, according to the company's earnings reports. As of May, approximately 5,000 people were using the drug.

A long road to diagnosis

The gradual rollout of Leqembi is due to the challenging process of diagnosing patients with mild cognitive impairment or mild dementia, which are the initial stages of Alzheimer's.

Tracey Collins, a global public relations officer residing in Portland, Maine, stated that it took her approximately 2.5 years to obtain a diagnosis for early Alzheimer's after she began exhibiting symptoms of cognitive decline, including memory loss.

Collins, 54, stated that her being younger than the typical Alzheimer's patient and her physician attributing symptoms to other factors, such as trauma from recent family-related issues and attention-deficit/hyperactivity disorder, contributed to her condition.

In addition to recovering from a benign meningioma, which can cause cognitive dysfunction, Collins was eventually diagnosed with early Alzheimer's in 2022 after a spinal fluid test performed by a neurologist in Boston.

Finding a neurologist in the U.S. can be challenging due to the limited number of them practicing, according to Alex Scott, Eisai's chief administrative officer, who shared this information with CNBC.

If you are instructed to visit a neurologist, you may have to wait anywhere from four to eight months before you can see one, according to Scott.

Meeks waited several months for her first appointment with her neurologist in South Mississippi.

A 2020 study of Medicare enrollees revealed that only 24% of patients with a neurologic condition were seen by a neurologist, with significant regional differences. Notably, 38% of people with dementia in more rural areas saw a neurologist, compared with 47% in urban areas.

Eligibility and insurance bottlenecks

Experts say that even after a diagnosis, patients and neurologists must go through several steps to determine eligibility for Leqembi.

The drug's effectiveness is determined by examining the presence of amyloid plaques in the brain through a PET scan or spinal fluid test, according to its manufacturers.

According to Scott, patients usually prefer PET scans, which are non-painful, for detecting amyloid. However, he noted that Medicare only expanded coverage of those scans for Alzheimer's in October, which slowed down Leqembi's initial launch.

To ensure that patients don't have other brain diseases causing cognitive issues, neurologists perform an MRI scan, as advised by Dr. Ronald Petersen, director of the Mayo Clinic Alzheimer's Disease Research Center. Neurologists use the MRI to evaluate whether patients have microbleeds in their brains, which could make them ineligible for Leqembi due to the risk of its serious side effects, according to experts.

Some healthcare facilities mandate genetic testing for two copies of the APOE4 gene variant, which increases the risk of brain swelling and bleeding, as per experts and Eisai. These side effects are referred to as amyloid-related imaging abnormalities, or ARIA.

At the Mayo Clinic's Alzheimer's center, a panel of 20 to 30 neurologists, radiologists, psychiatrists, and other experts vote on whether a patient qualifies for treatment with Leqembi after completing certain tests, as stated by Petersen.

According to Petersen, the Mayo Clinic's panel evaluated approximately 60% of people and found them eligible for treatment. Most of these patients agreed to take the drug. The Mayo Clinic's center, which started screening patients for Leqembi in October, currently has 50 to 60 patients taking the drug.

At the start of each week, Petersen's team evaluates three to five new patient referrals and determines their eligibility for Leqembi by Thursday.

Mayo Clinic patients may face months of hurdles, including insurance issues, before receiving Leqembi, according to Petersen.

Although Medicare covers Leqembi, some patients who are not yet eligible for the federal program may face challenges in obtaining coverage. Some commercial health plans do not cover the drug, which has an annual cost of $26,500 before insurance.

In January 2023, Collins, a patient from Portland, began taking Leqembi after her insurance denied her request for coverage three times, delaying her ability to start the drug.

If patients are going to health centers that aren't fully equipped to perform MRI scans or other requirements, it can take longer for them to receive the necessary care.

Michael Irizarry, Eisai's senior vice president of clinical research, acknowledged the lengthy process that patients have to undergo to receive Leqembi. However, he noted that "all those steps are completely new, essentially since the approval of [Leqembi], and really is a transformation in the care of these patients."

Infusion clinics can be hard to find

Patients who receive coverage for Leqembi can receive biweekly intravenous infusions of the drug, but some neurologists don't have infusion clinics in their office, so they have to send patients to another health center that does.

The nearest infusion clinic may be far away, posing a significant challenge for patients and caregivers without reliable transportation or time to travel to another location.

A recent analysis by Being Patient, a leading online news source for Alzheimer's disease, revealed that over 850 infusion sites in the U.S. offer Leqembi. However, the study discovered that 11 states have only five or fewer infusion clinics providing the drug.

Eisai does not have a specific number of Leqembi infusion clinics in the U.S., but they have a tool that helps patients find clinics near them.

Eisai and Biogen are developing more user-friendly versions of Leqembi to ease the strain on patients and their caregivers, and increase its adoption.

The companies are seeking regulatory approval for a "maintenance dose" of Leqembi, which would increase infusion intervals from biweekly to monthly after an initial period of treatment.

Scott, Eisai's representative, stated that the company aims to obtain regulatory approval for a weekly subcutaneous version of Leqembi that can be administered at home or in a medical facility. This would enable patients to utilize this form of the drug as a maintenance dose of Leqembi.

Collins receives Leqembi infusions at her primary care doctor in South Portland, which she describes as a "spa day" despite having an IV in her arm for almost an hour.

""I enjoy reading on reclining chairs while savoring coffee and snacks. My kids often join me, making it a fun event. The setting is not a hospital, which makes it less intimidating," she stated."

Meeks stated that her infusions are like "therapy sessions" because she gets to converse with other patients and their caregivers at her clinic regarding their experiences with the disease.

"Hearing other people's stories while sitting in there is comforting, Meeks stated, adding that the 40-minute infusion goes by quickly."

Irizarry states that patients may experience flu-like symptoms during their first two infusion sessions.

Eisai states that neurologists regularly monitor patients for ARIA, or brain swelling and bleeding side effects, through MRI scans.

Side effects

Rojas stated that although Leqembi has been well-tolerated by patients, the risk of ARIA is always present and a concern.

Patients at UCSF's clinic will be advised to skip Leqembi infusions until ARIA subsides or use steroids to reduce brain inflammation.

According to Petersen, the Mayo Clinic's Alzheimer's center stops dosing patients if ARIA appears on an MRI. The center has observed a few cases of side effects, but they were not severe or fatal.

"Our experience thus far has generally been positive," Petersen said.

Dr. Wendell Helveston, Meeks' neurologist, reported that a follow-up MRI detected a small area of bleeding in her brain that did not cause any symptoms.

Leqembi dosing was not stopped due to Meeks' bleeding, which was below the threshold level, according to Helveston, who practices at the Hattiesburg Clinic in Mississippi.

The patient's rate of cognitive decline has stabilized after several months of treatment, which is what we want to see in patients taking the drug.

The promise of Leqembi

Although the use of the drug is increasing, it is still uncertain how much patients are benefiting from it, according to Petersen.

In July, Eisai released new data indicating that the progression of the disease in patients taking Leqembi slowed after three years, suggesting the need for long-term treatment. This data supported the treatment's approval in 2023, as shown in Biogen and Eisai's pivotal late-stage trial, which reduced cognitive decline by 27% after 18 months.

Although it has only been approximately 14 months since Leqembi was approved, some patients have been taking the drug for an even shorter duration.

"Petersen stated that it is too early to determine if individuals are remaining stable as we have not yet gone far enough. Although it appears to be the case subjectively, this is a weak criterion at present. As a result, we will continue and assess our experience at the end of the 18 months."

Patients, including Collins, are relying on Leqembi to prolong their independence and enable them to carry out their routine tasks.

"What keeps me going for the next week is having something that enables me to perform my job, stay in my environment, and take care of teenagers," she stated.