After years of regulatory back-and-forth that left families frustrated and patients waiting, Medicare now covers two breakthrough Alzheimer’s drugs that target the disease’s underlying biology rather than just managing symptoms. Leqembi, made by Eisai and Biogen, gained broader Medicare coverage following its full FDA approval in July 2023, and Kisunla, manufactured by Eli Lilly, followed suit after its traditional FDA approval in July 2024. For the roughly 100,000 Americans who could be diagnosed and eligible for Leqembi alone by 2026, this is not a theoretical policy shift — it is a door that has finally opened. The road here was anything but smooth.
When the FDA first granted Leqembi accelerated approval in early 2023, Medicare largely restricted access, limiting coverage to patients enrolled in clinical trials. That changed only after the drug received traditional approval, which triggered a broader coverage pathway under a CMS National Coverage Determination. The same framework now extends to Kisunla and, critically, to any future amyloid-targeting monoclonal antibodies that clear the FDA’s traditional approval process. This article breaks down what these drugs cost, who qualifies, what Medicare actually pays for, and the real limitations families should understand before assuming coverage means affordability.
Table of Contents
- Which New Alzheimer’s Drugs Does Medicare Cover and Why Did It Take So Long?
- What Does Medicare Coverage Actually Look Like — and What It Does Not Include
- Who Qualifies for Coverage — The Eligibility Requirements Most People Miss
- Leqembi vs. Kisunla — How to Think About Choosing Between Them
- The Hidden Costs and Risks That Medicare Coverage Does Not Erase
- What the CMS Policy Means for Future Alzheimer’s Treatments
- What Comes Next for Families Navigating This Decision
- Conclusion
- Frequently Asked Questions
Which New Alzheimer’s Drugs Does Medicare Cover and Why Did It Take So Long?
Medicare covers two anti-amyloid monoclonal antibody treatments: Leqembi (lecanemab) and Kisunla (donanemab). Both work by targeting and clearing beta-amyloid plaques in the brain, a hallmark of Alzheimer’s disease. Leqembi received traditional fda approval on July 6, 2023, and Kisunla followed on July 2, 2024. In both cases, Medicare coverage became available immediately upon full approval — a significant distinction from the earlier period when CMS kept its wallet mostly closed during Leqembi’s accelerated approval phase. The delay was rooted in how CMS evaluates evidence. Under accelerated approval, the agency had only required that Leqembi reduce amyloid plaques, a surrogate marker.
CMS wanted proof that clearing plaques actually slowed cognitive decline before committing to widespread coverage. Traditional approval provided that evidence. CMS then finalized a National Coverage Determination covering FDA-approved monoclonal antibodies directed against amyloid for Alzheimer’s treatment, but with strings attached — coverage falls under a framework called Coverage with Evidence Development, meaning physicians must participate in approved data registries that track real-world outcomes. This is not rubber-stamp coverage. It is coverage with ongoing surveillance. For families who watched this unfold in real time, the bureaucratic distinction between accelerated and traditional approval felt academic while their loved one’s cognition continued to decline. The policy is now settled, but the gap between approval and access cost patients months they did not have.
What Does Medicare Coverage Actually Look Like — and What It Does Not Include
Both Leqembi and Kisunla are covered under Medicare Part B, the medical benefit, not Part D prescription drug plans. This matters because Part B has its own cost-sharing structure. In 2026, patients face a Part B deductible of $283, followed by a standard 20% coinsurance on the Medicare-approved amount. For Leqembi, which runs $26,500 per year, that 20% coinsurance translates to roughly $5,300 out of pocket annually. For Kisunla at $32,000 per year, the coinsurance climbs to about $6,400. Those numbers assume the patient has no supplemental coverage. If you carry a Medigap policy, it may cover part or all of that coinsurance depending on the plan.
Medicare Advantage enrollees should check their specific plan’s cost-sharing rules, which can vary widely. However, if a patient has neither Medigap nor a generous Advantage plan, the out-of-pocket burden is substantial — and this is for a treatment that requires ongoing infusions, not a one-time procedure. There is one notable cost difference between the two drugs. Kisunla is administered every four weeks rather than every two, and patients may be able to stop treatment once brain scans show amyloid plaque has been sufficiently cleared. In clinical trials, the average treatment duration was roughly 18 months. That means total lifetime cost could be significantly lower than Leqembi’s, which currently has no defined stopping point. Families weighing options should have a direct conversation with their neurologist about projected treatment duration and total financial exposure.
Who Qualifies for Coverage — The Eligibility Requirements Most People Miss
Not every Alzheimer’s patient qualifies. Medicare’s coverage requirements are specific, and missing even one can result in a denied claim. The patient must be enrolled in Medicare and must have a diagnosis of either mild cognitive impairment or mild-stage Alzheimer’s disease dementia. Moderate or advanced Alzheimer’s patients are not eligible under the current coverage determination. Additionally, there must be documented evidence of beta-amyloid plaque on the brain, typically confirmed through a PET scan or cerebrospinal fluid test.
The prescribing physician must also participate in a CMS-approved qualifying registry and have an appropriate clinical team in place for follow-up care. This registry requirement is part of the Coverage with Evidence Development framework, and it means not every doctor’s office or memory clinic is set up to prescribe these drugs. A patient in a rural area, for example, may find that the nearest participating provider is hours away, adding travel burden and infusion logistics to an already difficult situation. This is the gap between coverage on paper and access in practice. A patient can meet every clinical criterion and still face barriers if their local healthcare infrastructure has not caught up with the policy. Before pursuing treatment, confirm that your provider participates in an approved registry and can coordinate the required monitoring, including regular MRIs to watch for side effects like brain swelling or microbleeds, known as ARIA.
Leqembi vs. Kisunla — How to Think About Choosing Between Them
Both drugs target amyloid plaques, but they differ in ways that matter for daily life and long-term planning. Leqembi requires an IV infusion every two weeks, indefinitely under current guidelines. Kisunla requires an IV infusion every four weeks, and treatment may end once imaging confirms sufficient plaque clearance. For a caregiver coordinating appointments, transportation, and the patient’s energy, the difference between biweekly and monthly infusions is not trivial. On cost, Leqembi’s $26,500 annual price tag looks lower than Kisunla’s $32,000, but that comparison is misleading without factoring in duration. If a Kisunla patient completes treatment in 18 months, the total cost could land around $48,000.
A Leqembi patient continuing for three years would spend $79,500. These are rough figures, and individual cases vary, but the point is that annual cost alone does not tell the full story. Clinical trial data showed both drugs modestly slowed cognitive decline in early-stage patients. Neither reverses damage already done. The decision between them should involve a neurologist who understands the patient’s specific disease stage, amyloid burden, cardiovascular risk factors, and tolerance for infusion frequency. There is no universally better option — only the better option for a particular patient.
The Hidden Costs and Risks That Medicare Coverage Does Not Erase
Medicare covering these drugs does not mean treatment is without financial or medical risk. The 20% coinsurance alone can exceed $5,000 annually, and that does not include the cost of required monitoring — regular MRIs, PET scans, and clinical assessments that may carry their own copays. For patients on fixed incomes, this adds up quickly, and pharmaceutical patient assistance programs do not always fill the gap for Medicare beneficiaries due to federal anti-kickback rules. There are also serious medical risks. Both drugs carry a risk of amyloid-related imaging abnormalities, or ARIA, which can manifest as brain swelling or small brain bleeds. In Leqembi’s clinical trials, about 13% of participants experienced ARIA, and while most cases were mild or asymptomatic, some were serious.
Patients taking blood thinners face elevated risk. The required MRI monitoring exists precisely because these side effects need to be caught early, but monitoring itself adds cost, time, and anxiety. Families should also understand that “slowing decline” is not the same as improvement. These drugs may buy time — measured in months of preserved function — but they do not stop or reverse Alzheimer’s. Setting realistic expectations is essential. A drug that slows progression by 27% over 18 months, as Leqembi’s trial showed, is meaningful, but it is not a cure, and the day-to-day experience of caregiving may not feel dramatically different.
What the CMS Policy Means for Future Alzheimer’s Treatments
The CMS National Coverage Determination was written with the future in mind. It does not just cover Leqembi and Kisunla — it covers any amyloid-targeting monoclonal antibody that receives traditional FDA approval. This forward-looking structure means that if a third or fourth drug clears the FDA, Medicare coverage could follow without a new yearslong policy debate.
For the Alzheimer’s research pipeline, this is a significant signal that CMS is prepared to cover treatments in this class. Several anti-amyloid therapies are in late-stage trials, and the pharmaceutical industry is also exploring treatments that target tau protein, neuroinflammation, and other pathways. Whether CMS extends similar coverage frameworks to non-amyloid approaches remains an open question, but the precedent set by this NCD suggests the agency is willing to cover Alzheimer’s treatments that meet a high evidence bar — provided physicians participate in outcomes tracking.
What Comes Next for Families Navigating This Decision
The practical reality for most families in 2026 is this: coverage exists, but access requires navigation. Start with a neurologist who can confirm the diagnosis, order the appropriate biomarker testing, and participate in a CMS-approved registry. Ask about both drugs, their side effect profiles, and what the expected treatment timeline looks like. Get a clear picture of out-of-pocket costs by calling your Medicare plan and asking specifically about Part B coinsurance for physician-administered drugs.
This is not the end of the Alzheimer’s drug story. It is the beginning of a new chapter in which treatments that modify the disease’s biology are available to ordinary Medicare beneficiaries, not just clinical trial participants. The drugs are imperfect, the costs are real, and the eligibility criteria exclude many patients. But for those who qualify, the option exists in a way it simply did not three years ago.
Conclusion
Medicare now covers two FDA-approved Alzheimer’s drugs — Leqembi and Kisunla — that target amyloid plaques in the brain, marking a genuine shift in how the healthcare system treats early-stage Alzheimer’s disease. Coverage falls under Part B with standard cost-sharing, requires documented amyloid pathology and a participating physician, and applies only to patients with mild cognitive impairment or mild Alzheimer’s dementia. The CMS framework also paves the way for coverage of future amyloid-targeting therapies without starting the policy process from scratch.
For families weighing whether to pursue treatment, the key steps are confirming eligibility through biomarker testing, finding a provider enrolled in an approved registry, understanding the full financial picture including coinsurance and monitoring costs, and having an honest conversation with the care team about realistic outcomes. These drugs slow decline — they do not stop it. But for the right patient at the right stage, slowing decline by even a few months can mean more time with clearer thinking, more independence, and more of the person their family knows.
Frequently Asked Questions
Does Medicare cover Leqembi and Kisunla for all stages of Alzheimer’s?
No. Coverage is limited to patients with mild cognitive impairment or mild Alzheimer’s disease dementia who have documented evidence of beta-amyloid plaque on the brain. Patients with moderate or advanced Alzheimer’s are not eligible under the current CMS policy.
How much will I pay out of pocket for these drugs with Medicare?
After the 2026 Part B deductible of $283, you pay 20% coinsurance on the Medicare-approved amount. That works out to roughly $5,300 per year for Leqembi ($26,500/year) or about $6,400 per year for Kisunla ($32,000/year). Medigap or Medicare Advantage plans may reduce these costs further.
Can my regular doctor prescribe Leqembi or Kisunla?
Not necessarily. The prescribing physician must participate in a CMS-approved qualifying registry and have a clinical team in place for required follow-up care, including regular MRI monitoring. You may need to seek out a neurologist or memory clinic that meets these requirements.
Is Kisunla cheaper than Leqembi overall even though its annual cost is higher?
It can be. Kisunla’s annual cost is $32,000 compared to Leqembi’s $26,500, but Kisunla patients may stop treatment after about 18 months once amyloid clearance is confirmed on brain scans. Leqembi currently has no defined stopping point, so total lifetime treatment cost may actually be higher.
Are these drugs covered under Medicare Part D?
No. Both Leqembi and Kisunla are covered under Medicare Part B as physician-administered infusion treatments, not under Part D prescription drug plans. This affects how cost-sharing is calculated.
Will Medicare cover future Alzheimer’s drugs automatically?
The CMS National Coverage Determination covers any amyloid-targeting monoclonal antibody that receives traditional FDA approval. So future drugs in this class would be covered under the same framework without requiring a new coverage determination, though physicians must still participate in approved registries.
