Leqembi, an Alzheimer's drug developed by Biogen and Eisai, offers a potential breakthrough for patients in the early stages of the disease, providing them with more time to live independently. While not a cure, Leqembi has shown promise in slowing cognitive decline, but its rollout faces significant logistical and clinical hurdles. These challenges include complex diagnostic requirements, insurance coverage issues, and the need for specialized infusion centers, impacting patient access and treatment pathways.
Clinical Impact and Patient Experience
Missie Meeks, an English professor diagnosed with early-stage Alzheimer's, began Leqembi infusions in September 2023. Although no longer teaching, Meeks reports that Leqembi is "extending my time of a normal life," allowing her to maintain daily functions such as driving and independent living. This sentiment is echoed by other patients and caregivers who view Leqembi as a means to slow disease progression and prolong meaningful engagement in life.
Leqembi, a monoclonal antibody, has demonstrated a moderate slowing of cognitive decline in patients with early Alzheimer's. However, this benefit is available only to a narrow subset of the nearly 7 million Americans with Alzheimer's, specifically those in the earliest stages. The drug's efficacy was observed at 18 months in a late-stage trial by Biogen and Eisai, supporting its regulatory approval.
Diagnostic and Eligibility Challenges
Tracey Collins, a public relations officer, experienced a 2.5-year delay in diagnosis due to her age and initial misattribution of symptoms. Alex Scott, Eisai's chief administrative officer, highlighted the shortage of neurologists, leading to wait times of four to eight months for initial appointments.
Eligibility for Leqembi requires confirmation of amyloid plaques in the brain via PET scans or spinal fluid tests. Dr. Ronald Petersen, director of the Mayo Clinic Alzheimer's Disease Research Center, noted that MRI scans are also necessary to rule out other brain diseases and assess the risk of microbleeds, which could increase the risk of amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding. The Mayo Clinic's Alzheimer's center deems roughly 60% of evaluated patients eligible for Leqembi.
Insurance Coverage and Access Barriers
Despite Medicare coverage for Leqembi, some patients face insurance denials, particularly those not yet eligible for Medicare. Collins, for example, had her coverage denied three times, delaying her treatment. The annual cost of Leqembi is $26,500 before insurance, posing a financial barrier for many.
Infusion Center Availability and Alternative Administration Routes
Access to infusion clinics is another hurdle. An analysis indicated that some states have very few infusion sites, creating logistical challenges for patients. Eisai and Biogen are developing more convenient formulations, including monthly infusions and subcutaneous injections, to reduce the burden on patients. The companies are seeking regulatory approval for a maintenance dose of Leqembi, which would extend infusion intervals to once per month after an initial period of biweekly infusions. Eisai is also pursuing approval for a weekly subcutaneous injection, offering a more convenient administration option.
Monitoring and Side Effects
Patients receiving Leqembi undergo regular MRI scans to monitor for ARIA. Dr. Julio Rojas from UCSF Health noted that while Leqembi has been generally well-tolerated, the risk of ARIA remains a constant concern. Clinics may temporarily halt infusions or use steroids to manage brain inflammation. Dr. Wendell Helveston, Meeks' neurologist, reported a small area of bleeding in her brain that did not necessitate stopping treatment, and her cognitive decline has stabilized.
Long-Term Outlook
While Leqembi reduced cognitive decline by 27% after 18 months in clinical trials, it is still early to assess its long-term benefits in real-world settings. Petersen noted that it is too soon to determine if patients are remaining relatively stable over extended periods. As uptake of Leqembi increases, ongoing evaluation will be crucial to fully understand its impact on Alzheimer's disease progression and patient outcomes.
