Eisai Co. has developed a groundbreaking Alzheimer’s drug that has shown the ability to slow down the progression of the disease. However, the rollout of the drug has been challenging due to logistical issues, uncertainties surrounding insurance coverage, and complex safety testing requirements.
Despite receiving full approval from Medicare on the same day, patients may not have immediate access to Leqembi, which costs $26,500 per year. Top medical centers are still working on coordinating necessary testing, reimbursement processes, and the implementation of a real-world monitoring system for patients’ side effects and cognitive status.
Constantine Lyketsos, director of the Memory and Alzheimer’s Treatment Center at Johns Hopkins Medicine, acknowledges the challenges, stating that they are not fully aware of all the required steps at this moment.
The demand for Alzheimer’s therapy is urgent and widespread, with over 6 million Americans currently affected by the disease. This number is expected to double by 2060 due to the aging population. Leqembi shows promise for a significant portion of patients with mild disease, and Eisai predicts global sales of over $7 billion by fiscal year 2030.
Dr. Anna Nordvig, a neurologist at New York-Presbyterian and Weill Cornell Medicine Alzheimer’s Disease and Memory Disorders Program, describes Leqembi as a “game-changer” that may pave the way for future and improved drugs.
Eisai reports that the launch of Leqembi is progressing well, with coverage from Medicare, Medicaid, and other payers. The company is actively providing healthcare professionals with information about the drug and its use in Alzheimer’s treatment.
Long Wait
Interest in Leqembi is high, as observed by Lawrence Honig, director of the Center of Excellence for Alzheimer’s Disease at Columbia University Medical Center. Honig has already started prescribing the drug, and the Dementia specialists at Columbia University Irving Medical Center receive daily inquiries about it. However, most patients will likely have to wait for weeks or even longer before receiving treatment. John Hopkins plans to introduce Leqembi in September at the earliest, while Mayo Clinic in Rochester, Minnesota, aims to start using the drug more widely in the fall after finalizing administration procedures. Other medical centers intend to conduct pilot programs with a small number of patients before implementing Leqembi on a larger scale, ensuring that it is covered by insurance providers. Analysts estimate that by the end of the year, only 3,000 patients will have access to Leqembi.
Betsy Groves, a 74-year-old retired clinical social worker from Cambridge, Massachusetts, who has early-stage Alzheimer’s, is eager to start treatment with Leqembi after her scheduled neurology appointment in October.
Groves expresses minimal concern about potential side effects, which can include swelling and bleeding in the brain, mostly without symptoms, and rarely, life-threatening. Patients must weigh these risks against the drug’s modest ability to slow down the disease.
Dr. Lyketsos mentions that many eligible patients have chosen not to take Leqembi, as they are not convinced about its benefits and are worried about the associated risks.
To qualify for Leqembi, patients must undergo cognitive and functional tests, as well as a specialized amyloid brain scan that has not been widely covered by insurance until now. Alternatively, patients can undergo a spinal tap, although it is less preferred due to discomfort and limited information provided compared to the scan.
These initial steps are just the beginning. Patients also require a separate scan to establish their brain status before starting treatment. Within the first six months of treatment, patients will need three additional MRI scans to monitor early signs of side effects. The FDA also recommends testing for the APOE4 gene, which indicates a significantly higher risk of brain swelling or bleeding.
Learning Curve
According to neurologist and Alzheimer’s expert Dr. David Knopman from Mayo Clinic, as many as five medical specialists, ranging from genetic counselors to nuclear medicine specialists to neuropsychologists, may need to evaluate a patient before they can receive Leqembi. The facility at Mayo Clinic only treats patients who live close enough to be promptly evaluated if side effects occur. Dr. Paul Schulz, a neurologist at McGovern Medical School at UTHealth in Houston, describes the process of using the drug as similar to a complicated cancer treatment, with a steep learning curve for the average neurologist. Until the insurance situation is clarified, Dr. Schulz plans to use the drug on a limited number of patients to avoid unexpected reimbursement issues.
Once patients overcome these challenges, they will need to undergo infusions, a novel experience for most Alzheimer’s doctors. Hospitals will need to find available slots at busy infusion centers for these biweekly treatments.
A task force of doctors at Northwestern University has been working since January to develop procedures for safe and effective use of Leqembi. Dr. Allison Lapins, a neurologist at Northwestern University Feinberg School of Medicine, anticipates a surge in patients seeking treatment as more individuals diagnosed in the early stages of the disease begin to come in. Northwestern will require gene testing and exclude patients with two APOE4 gene copies, as well as those on blood thinners that may increase the risk of brain bleeding.
Dr. Lapins acknowledges the complexity of using Leqembi, stating that it presents significant challenges. However, she remains optimistic that the medical community will adapt and successfully handle the drug’s demand.
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