Leqembi (lecanemab) Approved by FDA on January 6, 2023
LECANEMAB FULL FDA APPROVAL AND CMS COVERAGE STATEMENT (July 10, 2023)
This statement is current from our Memory Disorders Clinic as of July 10th,2023 but may be changed at any time as our team evaluates the new approval and clinic processes to do what is best for our patients. Please continue checking our website for the most up to date version.
On July 6, 2023, the Food and Drug Administration (FDA) fully approved lecanemab (brand name: Leqembi) for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease. See more information from the FDA here. Quickly following the FDA announcement, the Center for Medicare & Medicaid Services (CMS) announced that it would cover the lecanemab medication. See more information from CMS here.
Of note, the current list price of lecanemab is $26,500 per year and Medicare Part B requires a 20% co-pay, therefore there are still out-of-pocket costs for the medication. In addition, the CMS coverage does not clearly include the additional costs for intravenous (IV) administration or monitoring including regularly scheduled MRI brain, which is estimated to be around $30,000 per year. Additionally, other private insurance companies may still need to determine their coverage policies and individual plans will differ, so it is best to confirm with individual plans whether lecanemab and the associated additional costs will be covered.
Lecanemab is a monoclonal antibody that works by clearing amyloid plaques from the brain through a twice monthly IV infusion. In the clinical trial, individuals receiving lecanemab had slightly slower decline over an 18-month period. More specifically, individuals on lecanemab declined by 1.21 points on an 18-point scale of memory and daily function, while people on placebo (not on lecanemab) declined by 1.66 points. Therefore, individuals on lecanemab were reported to have 27% slower decline, which equates to about 5-6 months of delayed progression over the 18-month trial. Per the trial, there is a 13-17% risk of brain swelling and bleeding (referred to as amyloid-related imaging abnormalities or ARIA) with lecanemab. Further post-FDA approval studies on lecanemab are required to ensure safety and longer-term effectiveness, therefore CMS has stipulated that any patient that is given lecanemab clinically must receive it from a professional that submits safety data to a CMS-facilitated registry. There are still questions as to whether the reported clinical benefit from the clinical trial translates to real-life benefit for individuals living with Alzheimer's disease. There are also ongoing debates about whether clearing amyloid is the best option for treating the symptoms of Alzheimer's disease.
In order to be considered a candidate for lecanemab, an individual first has to meet clinical criteria for mild cognitive impairment or mild dementia due to underlying Alzheimer's disease. Lecanemab is not approved for moderate or severe stages of dementia. Additionally, biomarker confirmation of Alzheimer's disease is required for lecanemab administration, which can be done clinically with lumbar puncture (spinal tap) that is considered the "gold standard" or some blood tests. The full FDA approval for lecanemab also requires genetic testing for the apolipoprotein E (APOE) gene, as individuals that are homozygous for APOE4 have an increased risk of ARIA therefore need to be counseled about this increased risk. We are working with our Neurology Genetic Counselors to help coordinate this testing. Additionally, individuals on anticoagulation (blood thinners) are at an increased risk for brain bleeding, but can still be considered as lecanemab candidates. Lastly, all individuals being considered for lecanemab need a recent (<12 months) MRI brain interpreted by an American Society of Neuroradiology ARIA-Educated Practitioners to determine ARIA risk.
As outlined above, there will be a very detailed process for being prescribed lecanemab through the University of Colorado Behavioral Neurology and Memory Disorders Clinic. Although the FDA has approved and CMS has announced medication coverage for lecanemab, this medication is not going to be immediately available. There may be local centers advertising availability of lecanemab, but our first goal for new use of lecanemab is to "do no harm" and provide the safest possible care. As such, we will follow certain protocols before prescribing lecanemab at any location. Additionally, our pharmacy and administrative teams are actively meeting to determine whether lecanemab will be offered at UCHealth locations.
Lastly, not every provider at the University of Colorado Behavioral Neurology and Memory Disorders Clinic will be prescribing this medication. If your provider is one that is not going to be prescribing lecanemab, we will help facilitate being connected with one that will.