Lecanumab is a monoclonal anti-amyloid antibody that works directly on amyloid, one of the two proteins that builds up in the brain to cause Alzheimer’s disease.
In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and granted Priority Review. On January 6, 2023, the FDA granted accelerated approval for lecanumab based on their phase 2 study which demonstrated reduction of amyloid beta plaque, a biomarker of Alzheimer’s disease. Lecanumab has not been approved by the FDA based on clinical efficacy data.
The Centers for Medicare & Medicaid Services (CMS), who determines whether Medicare will cover lecanumab, had previously announced that any anti-amyloid antibody therapy approved by the FDA via their accelerated approval pathway that relies on a surrogate biomarker (reduction of amyloid beta plaque) will be funded only if participants are enrolled in a randomized, placebo controlled clinical trial. CMS is reviewing the FDA approval and corresponding data but there is no expectation that CMS will deviate from their prior announcement. Thus, if CMS approves, under the current accelerated approval for efficacy based on a surrogate biomarker, lecanumab will only be available for patients enrolled in a clinical trial.
In the Fall of 2022, Biogen and Eisai announced that their Phase 3 Clarity study showed lecanumab treatment in patients with Alzheimer’s disease met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%. All key secondary endpoints were also met with highly statistically significant results compared with placebo (p<0.01).
Biogen and Eisai have submitted their Phase 3, Clarity, study for review by the FDA. The FDA will review the data for evidence of clinical efficacy and may approve lecanumab via their traditional pathway. Once traditionally approved by the FDA, CMS will no longer require enrollment in a clinical trial.
Pending traditional approval by the FDA, we and the BI-Lahey Pharmacy and Therapeutics committee are currently reviewing the data to determine whether we will offer this medicine to our patients; and if we do, who might benefit from this therapy; how to administer it safely (given the potential for significant side effects); how to provide it equitably; and how to properly monitor patients to determine their response.
Patients: If you are interested in learning more about lecanumab, please enroll in our anti-amyloid registry though this link: ANTI-AMLOID REGISTRY
Please leave your name, date of birth, phone, email address. You will be contacted once we are ready to screen and schedule patients for evaluation.
Healthcare providers: If you have patients who are interested in learning more about lecanumab, you can enroll them through our registry as well through this link: ANTI-AMYLOID REGISTRY.
Please provide your name and the patient’s name, date of birth, and email address. If the patient has completed a recent Montreal Cognitive Assessment (MoCA), Mini Mental Status Exam (MMSE), or AD8 Dementia Screening Interview please include those scores as well. Alternatively, you can have your patients self-enroll through the same site.
We plan on updating you regularly by email and through this webpage to keep our community informed as we take these next steps in treating Alzheimer’s disease together. Please stay tuned for additional information.
January 6, 2023
The US Food and Drug Administration has granted accelerated approval for the anti-amyloid monoclonocal antibody medication, lecanumab for Alzheimer’s Disease Treatment based on evidence that it reduces the surrogate biomarker brain beta-amyloid.
Biogen/Eisai submits their Phase 3 Clarity study to the FDA for traditional approval of lecanumab.
What is lecanumab?
Lecanumab is a monoclonal antibody developed by Biogen through partnership with Eisai pharmacuticals that removes a protein called beta-amyloid from the brain. It is infused through a vein every two weeks.
How does lecanumab work?
Patients with Alzheimer’s disease have a build-up of the proteins, beta-amyloid and tau in their brain. The accumulation of these proteins is thought to result in the degeneration of neurons and the associated cognitive decline. With the help of your immune system, lecanumab selectively targets and removes the beta-amyloid from the brain.
How much does lecanumab cost?
Lecanumab will cost $26,500 annually. Additional costs such as, but not limited to, amyloid PET and MRI scans and related blood tests are not included in the cost.
When will lecanumab be available?
We anticipate that it will take up to 6 months for CMS to grant approval of coverage. Once approved, it will be only available for patients enrolled in a clinical trial. We anticipate it may take and additional 1-6 months for the FDA to review the Phase 3 Clarity study and possibly grant approval via the traditional approval pathway. Lecanumab will then be available to patients at the BIDMC. The CNU, BIDMC, and the BI-Lahey system are working together to ensure that the medication can be delivered as safely and effectively as possible to eligible patients when available.
Who is eligible to receive lecanumab?
Lecanumab was shown to be effective in the treatment of mild cognitive impairment or mild dementia stage of disease caused by Alzheimer’s. There is no evidence that it would be effective in the treatment of other types of diseases or in later stages of Alzheimer’s disease. Patients with mild cognitive impairment or mild dementia from Alzheimer’s disease with confirmed amyloid pathology, through either a lumbar puncture or amyloid beta positron emission tomography (PET) scan of the brain, will be eligible.
What are some potential risks of lecanumab?
Patients who receive lecanumab are at risk for developing a kind of brain inflammation called amyloid-related imaging abnormalities (ARIA), which involves brain bleeding, brain swelling, or a combination of the two. A few of these will need to discontinue their treatment due to concerns related to ARIA. Before and after lecanumab is started, patients must receive special monitoring (including brain MRI scans) to screen for ARIA.
There have been 3 reported fatalities from brain bleeds in patients who received lecanumab. It remains unclear whether these deaths were related to the lecanumab infusions.
if I am enrolled in a clinical trial?
We would encourage you to continue participation in ongoing clinical trials. If you have any questions or concerns about how starting aducanumab may impact your continued participation in the clinical trial, please discuss them with the principal investigator of your clinical trial or your physician.
Next steps at BIDMC
The BI-Lahey Pharmacy and Therapeutics Committee is reviewing the Biogen/Eisai data to determine whether we will be offering lecanumab to our patients. Our team will keep this webpage up to date with information about our lecanumab program as it develops, and we will update patients through our Memory A2Z clinic email list (see above for instructions on getting added to this list). We will also include updated educational materials as they become available.
If you or your loved one is worried about new and progressive concerns with memory, language or behavior, the first best step is to consult with a doctor and specifically consider a referral to a neurologist. If you are specifically interested in receiving diagnostic assessment and care at BIDMC, please contact the BIDMC Cognitive Neurology Unit at 617-667-4074.
In June 2021, the FDA approved aducanumab to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.
The CNU and the BI-Lahey Pharmacy and Therapeutics Committee reviewed the aducanumab data and determined that there is insufficient evidence of benefit to warrant offering this medication to our patients. The Centers for Medicare and Medicaid Services have recommended Biogen run an additional clinical trial to verify the clinical benefit of aducanumab. The CNU will be one of the centers involved in this clinical trial.
If you are interested in participating in this or other clinical trials at the BIDMC, please contact: Memory Research Coordinator 617-667-0249 / email@example.com.