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.

On January 6, 2023, the Food and Drug Administration (FDA) approved lecanemab (Leqembi) for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease.  This drug works by clearing amyloid plaques from the brain.  In the clinical trial, people receiving lecanemab declined slightly more slowly over an 18-month period; on an 18-point scale of memory and daily function, people receiving lecanemab declined by 1.21 points, while people on placebo declined by 1.66 points (27% slower decline on drug, equating to about 5-6 months of delayed progression in an 18-month trial).  There is a question of what, if any, real-world impact this medication may would have on the lives of people with Alzheimer's disease.  Furthermore, there is a risk of brain swelling and bleeding with this medication, with 13-17% of people receiving the drug experiencing these serious side effects.  Further studies on lecanemab will be required to ensure safety and longer-term effectiveness.  There is also the question of if clearing amyloid is the best option for treating the symptoms of Alzheimer's disease.  Even with these questions, though, our team is heartened by this progress in the field of Alzheimer's disease research, and we hope it is only the beginning of major changes to come.  

 Insurance, including Medicare, does not currently cover anti-amyloid drugs, including lecanemab and aducanumab, unless the person is participating in a clinical trial.  This may change in the future, but the current list price of lecanemab is $26,500 per year; this does not include the additional costs for monitoring and administration of the drug, which is estimated at $30,000 per year.  The University of Colorado Hospital decided not to carry aducanumab in our pharmacies when it was approved in 2021, primarily based on concerns regarding its efficacy and safety.  There will be a thorough review of the data on lecanemab by our hospital committees over the coming months.  We appreciate your patience while these decisions are made and processes are developed to ensure appropriate and safe treatment.  If you have further questions, please plan to discuss in person with your doctor at your next clinic visit.  

The Food and Drug Administration (FDA) approved a new treatment for Alzheimer's disease, Aduhelm (aducanumab) through their accelerated approval pathway, which the FDA describes as being a pathway "used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments…and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit." This is the first new Alzheimer's disease treatment to be approved since 2003, and the first drug that has been shown to be disease modifying instead of symptom modifying (in research studies, aducanumab has been shown to decrease levels of amyloid plaque in the brains of people with Alzheimer's disease).

Aducanumab has not been shown to improve cognition or halt the disease, but it was shown to slow decline in a limited population of people with Alzheimer’s disease who have  early dementia or mild cognitive impairment (a precursor to dementia). Biogen, the pharmaceutical company that developed the drug and conducted the initial clinical trials, is required to conduct post-approval studies (i.e., phase IV studies) on aducanumab to verify benefit of the drug. If clinical benefit of aducanumab is not verified, it could lead the FDA to remove the drug from the market. The CU Alzheimer's and Cognition Center has been chosen as a site for this clinical trial. 

The Memory Disorders Clinic has also been working to develop processes for including aducanumab as a potential treatment for appropriate patients, and we will provide an update when that information is available. At this time, even though the FDA has approved aducanumab, it is not yet available, because insurance companies, including Medicare, are still determining who will be covered to receive this treatment. We ask that you please be patient while these decisions are made and processes are developed, and if you are interested in seeing if aducanumab is right for you or a family member, please discuss it with your doctor.

The approval of aducanumab is surrounded in some controversy, as the FDA advisory panel did not recommend aducanumab’s approval at their meeting on November 6, 2020. The physicians and scientists at the CUACC will remain up-to-date on the scientific evidence and regulatory issues related to aducanumab. In the meantime, continued research and optimal clinical care for people living with Alzheimer's disease and their families remain our absolute priority.  We are hopeful that aducanumab will be just the first of a new generation of Alzheimer’s disease modifying therapies.

For more information on aducanumab and its approval, please review the press release from Biogen and the press release from the FDA. We also recommend reviewing the University of Michigan Alzheimer's Disease Center's  Frequently Asked Questions page. Please keep in mind some of the answers found on this page may pertain to the processes specific to the University of Michigan. 

9news - Dr. Huntington Potter, director of the CU Alzheimer's and Cognition Center, discusses the Alzheimer's research happening at CU Anschutz, how it is different from the recently FDA approved aducanumab, and what the approval means for future drug development & clinical research.

Denver Channel 7 - Dr. Victoria Pelak discusses the approval of aducanumab and how the CU Alzheimer's and Cognition Center will play a role in the Phase IV clinical trial. 

Newsy/Denver Channel 7 - Dr. Huntington Potter contributes to the discussion around the FDA's approval of aducanumab. 

Links to more information

Biogen press release regarding Aduhelm approval

Eisai press release regarding Leqembi approval

FDA press release for Aduhelm

FDA press release for Leqembi

University of Michigan Frequently Asked Questions

For more information on the advisory panel meeting on November 6, 2021 for aducanumab, check out this New York Times article or this article from Science.

You can find out more about aducanumab here.