In the past few years a number of anti-amyloid monoclonal antibodies have been developed for the treatment of Alzheimer’s disease. Many of these have not been shown to be effective in slowing cognitive decline, but several of the newer medications have been able to slow cognitive and functional decline by about 30% over the course of 18 months.
If you are interested in anti-amyloid therapy for the treatment of Alzheimer’s disease, please join our registry
We will only be offering anti-amyloid therapy to patients on our registry.
Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
On April 7, 2022, the Center for Medicare and Medicaid Services (CMS) announced their coverage policy for all anti-amyloid monoclonal antibody therapies for treatment of Alzheimer’s disease.
The CMS announced that for drugs that FDA has received an accelerated FDA approval, Medicare will cover in the case of FDA or NIH approved trials. In other words, patients will need to be enrolled in a randomized clinical trial.
For monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease that receive traditional approval from the FDA under coverage with evidence development (CED). CMS, as a part of this decision, will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a data collection through routine clinical practice or registries. In other words, patient will need to be in a study that collects clinical information into a clinical database. They will not need to be enrolled in a clinical trial.
Anti-Amyloid Monoclonal Antibody Therapy at the BIDMC
The CNU and the BI-Lahey Pharmacy and Therapeutics committee have reviewed the data and will be offering the monoclonal antibody, lecanemab, to eligible patients, if the FDA grants traditional approval. We are meeting to decide 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.
These medications are only available to patient with CSF or amyloid-PET confirmation of amyloid. The medications require intravenous infusions (done through the BIDMC infusion clinic) every 2-4 weeks for up to 18 months and there is a small risk for brain swelling and brain bleeding while on the medication.
Patients: If you are interested in learning more about anti-amyloid monoclonal antibody therapy, 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 lecanemab, 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.
On January 6, 2023, The FDA granted Accelerated Approval for the anti-amyloid monoclonocal antibody medication, lecanemab (trade name Leqembi) for Alzheimer’s Disease Treatment
Lecanemab 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. Lecanemab has not been approved by the FDA based on clinical efficacy data.
In the Fall of 2022, Biogen and Eisai announced that their Phase 3 Clarity study showed lecanemab 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).
On Jan 6, 2023, Biogen and Eisai submitted their Phase 3, Clarity, study to the FDA to request approval of lecanemab via the FDA traditional pathway. The FDA has accepted Eisai’s application for traditional approval through their priority review with action date of July 6, 2023. If the FDA grants traditional approval to lecanemab, CMS will no longer require enrollment in a clinical trial.
Updates
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 lecanemab.
March 5, 2023
The FDA grants priority review for traditional approval of lecanemab for the treatment of Alzheimer’s disease with prescription drug user fee act action date of July 6, 2023.
DONANEMAB
On May 3, 2023, Eli Lilly and Company announced positive results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. The Phase 3 trial met primary endpoint and all secondary endpoints measuring cognitive and functional decline. Nearly half (47%) of the participants on donanemab (compared to 29% on placebo) had no clinical progression at 1 year (defined as no decline in CDR-SB). Donanemab treatment slowed clinical decline by 35% compared to placebo, and resulted in 40% less decline on the ability to perform activities of daily living. Full results of the TRAILBLAZER-ALZ 2 Phase 3 study will be presented at the Alzheimer’s Association International Conference in July and submitted for publication in a peer-reviewed clinical journal.
Donanemab will require monthly IV infusions for possibly between 12-18 months. It was effective in more advanced patients than lecanemab, but 24% of patients had the side effect of brain swelling and bleeding.
The FDA has not granted donenamab approval, having rejected Eli Lilly’s accelerated approval request in January 2023 due to the limited number of patients who had seen at least 12 months of drug exposure in a clinical study. Eli Lilly has announced that they will work with the FDA and other global regulators to achieve the fastest path to traditional approvals.
ADUCANEMAB
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 / alz@bidmc.harvard.edu.
