Leqembi (lecanemab) Approved by FDA on January 6, 2023

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.