If you or a loved one suffers from mild cognitive impairment or have been diagnosed with early Alzheimer’s Disease, you’ve likely followed the news over the last few months about a new treatment awaiting FDA approval. Well, that FDA approval has arrived: Leqembi, a medication that targets the amyloid plaques thought to contribute to Alzheimer’s, has now been approved by the FDA for those who have been diagnosed with mild cognitive impairment or early Alzheimer’s. With this approval comes the decision by Medicare to cover costs for Leqembi under Medicare Part B, as long as patients meet the eligibility criteria and providers agree to submit data to patient registries to track results and side effects experienced by those taking the medication. A recent poll of Americans shows overwhelming support for Medicare coverage of this new drug, though the costs to individuals taking the drug and to the larger healthcare system are only beginning to emerge. One recent study estimated that Leqembi could cost Medicare up to $5 Billion per year, possibly requiring a raise in premiums for all Medicare beneficiaries, regardless of whether they take the drug. The Medicare coverage decision for this drug will apply to both traditional plans as well as private Medicare Advantage plans. Commercial insurers who handle private Medicare accounts are now working on their own coverage decisions.

During the clinical trials which yielded FDA approval, patients taking Leqembi experienced a slower cognitive decline than patients on a placebo. Data suggests the Leqembi recipients had a 27% slower cognitive decline over an 18-month period than those not taking the drug (though there is some dispute as to whether men and women experienced the same levels of cognitive slowing). To be clear, Leqembi does not stop the decline, reverse it or in any way fix the damage that’s already been done by Alzheimer’s. What it appears to do is slow the speed of decline by 5-6 months. While that additional time may be precious to patients and loved ones, it does come with some risks: Brain swelling and brain bleeds are risks of Leqembi, and while many cases are asymptomatic and will resolve, some patients experience more significant side effects. During the clinical trials, 3 patients died as a result of their brain bleeds. Those patients who have 2 copies of the gene associated with a higher risk of Alzheimer’s are at higher risk of brain bleeds, as are patients who take blood thinners. Because of these risks, the FDA issued a “Black Box” warning for Leqembi, and taking the medication should involve both genetic testing to ascertain heightened risk along with regular scans to monitor for brain swelling or bleeding. Medicare has stated it will pay for this testing and monitoring. Patients taking Leqembi will receive a transfusion of the medication every 2 weeks, for 30-60 minutes at a time.

Thus, for every patient who meets the eligibility criteria, there will need to be an individualized decision about what benefit is worth what risk- and what cost. For example, some may think, as one patient did, “I know it’s not a cure but if it can give me another six months of time with my family and friends, it’s worth it for me to take the risk.”  For others, that calculation may go the other way, especially given the expert opinion that the benefit of Leqembi may not be “visible” to a patient – but the costs might be considerable. Even though Medicare Part B will pay the proposed $26,5000 for the medication each year, there will still be co-pays of 20%, along with other tests that may not be covered by Medicare, plus the burdens of getting back and forth for scheduled infusions. Especially for patients of lower socioeconomic means or in rural areas, these burdens may raise the possibility that the benefits of Leqembi are not worth it or are not really accessible. With co-pays and other expenses, even those covered by Medicare will still have to spend many thousands of dollars to receive Leqembi, though those who are dual-eligible for Medicare and Medicaid may have all costs covered. Of the 6 million people currently diagnosed with Alzheimer’s in the United States, estimates are that only 10,000 will be able to receive Leqembi within the next 9 months.

In addition to the medication’s risks, the costs, and the challenges of gaining access, there is real concern that our healthcare system lacks the infrastructure to deliver Leqembi to currently eligible patients in any reasonable time period. We have a shortage of neurologists and other trained specialists who can help diagnose eligible patients, and we lack a sufficient number of facilities to administer the twice-monthly infusions, along with the necessary monitoring of side effects such as brain bleeds. Diagnosing and monitoring take time, and finally getting a patient into the system to get Leqembi may result in patients being too far along to be eligible to be enrolled. In essence, while we now have an exciting new treatment option for some patients with Alzheimer’s, our system of diagnosis and biomarkers to determine who has Alzheimer’s needs to catch up, as does our infrastructure to care for patients who start Leqembi or any other novel Alzheimer’s drug that comes down the pike in the future. So while the FDA approval and Medicare decision coverage are very positive developments for people with early Alzheimer’s and their families, we still have a long way to go to find and support treatments for the vast number of individuals with Alzheimer’s for whom Leqembi will not be an option.