Leqembi and Kisunla Are FDA-Approved. But How Do Patients Actually Get Them?

Leqembi and Kisunla have changed the way we can treat early Alzheimer's disease. Unlike the medications we have had for years, which primarily help manage symptoms, these newer treatments target amyloid—one of the proteins involved in Alzheimer's disease—and can slow the progression of the disease.^1,2

That is exciting progress. But getting one of these medications isn't as simple as getting a prescription and heading to the pharmacy.

If your doctor thinks you or a family member might qualify, here is what that process looks like in practice.

Step 1: Confirming Disease Stage

The first question is whether you are in the right stage of the disease for treatment. These medications were studied in people with Mild Cognitive Impairment (MCI) or mild dementia due to Alzheimer's disease, so treatment is started during these earlier stages.^1,2

Clinicians do not rely on a single test or a rigid score cutoff to make this call. Instead, your care team uses a combination of clinical history, family input, functional status (such as whether you can still manage finances, travel, or medication independently), and formal cognitive testing to determine whether you are within this treatment window.

If the disease has progressed into moderate or severe dementia, these medications are generally no longer an option.^1,2

Step 2: Proving Amyloid Pathology

Because these medications work by removing amyloid plaques from the brain, clinicians must first confirm that amyloid is actually present before prescribing them.^1,2

Historically, this required either an amyloid PET scan—a brain scan that looks for the presence of amyloid plaques—or a lumbar puncture for cerebrospinal fluid (CSF) testing. Today, high-precision blood tests are helping streamline initial diagnostics by detecting amyloid markers directly in blood plasma.^3,4

Exactly how blood testing is used depends on the test and where you are being treated.⁴ In some cases, the blood test may be enough to confirm that amyloid is present. In others, your doctor may still recommend an amyloid PET scan or spinal fluid testing for confirmation.⁴

Step 3: Evaluating Safety & Individual Risks

Once those pieces are in place, the next question is whether treatment can be given safely.

Both Leqembi and Kisunla carry a Boxed Warning for Amyloid-Related Imaging Abnormalities (ARIA).^1,2 ARIA can involve swelling in the brain (ARIA-E) or small areas of bleeding (ARIA-H). Many cases cause no symptoms and resolve on their own, but ARIA can occasionally be serious.^1,2

When ARIA does cause symptoms, they can include headache, confusion, dizziness, vision changes, or nausea, to name a few. More serious cases can cause seizures or other neurological deficits.^1,2 Patients receiving treatment should know exactly what symptoms their care team wants them to report promptly rather than waiting for their next scheduled MRI.

Before treatment begins, your team works through three specific safety checks:

Baseline Brain MRI: Before starting treatment, your doctor will order a brain MRI to look for things like small areas of bleeding or other changes that could make treatment riskier.^1,2 A few minor findings may not prevent you from being treated, but more significant bleeding or other changes on the MRI could.^1,2

APOE Genotyping: APOE ε4 is a gene that increases both the risk of developing Alzheimer's disease and the risk of developing ARIA during treatment.^1,2 Because people who carry two copies of APOE ε4 have a substantially higher risk of ARIA, testing is recommended before treatment begins.^1,2 The test isn't required to receive the medication, but knowing your APOE status can help you and your doctor better understand your individual risk and make a more informed decision.

Medication Audit: Your team will review all your current medications, paying special attention to blood thinners (anticoagulants). Taking blood thinners alongside anti-amyloid therapy may increase the risk of serious brain bleeding, so your care team will weigh this risk carefully.^1,2

Step 4: What Does Treatment Actually Involve?

Once you know you qualify for treatment, the next step is deciding whether it makes sense for you. There is a lot to consider, including the potential benefit, the risks, the time involved, and what treatment may cost.

What the Trials Showed

In clinical trials, both medications slowed cognitive and functional decline compared with placebo.^5,6 The amount of benefit varied between the studies, but both showed that treatment can slow the progression of early Alzheimer's disease.^5,6

It is important to understand what those trial results mean in practice:

• They do not reverse existing memory loss or restore lost cognitive abilities.^5,6
• They do not stop disease progression. On average, both treated and untreated groups continued to decline over time; the treated group simply declined at a slower rate.^5,6

Insurance & Out-of-Pocket Expenses

Medicare covers these medications for eligible patients, but there is an additional step. Your doctor must participate in a Medicare-approved registry that collects information about patients receiving these treatments.⁷

Even when insurance covers the medication, that doesn't necessarily mean there won't be costs for you:

• If you have Original Medicare (Part B), you will typically be responsible for 20% of the Medicare-approved cost after meeting your Part B deductible, although supplemental insurance may cover some or all of that amount.
• Medicare Advantage and commercial insurance plans work differently. Many require prior authorization before treatment can begin, and exactly what is covered—and what you will owe—depends on your individual plan.

It is also important to remember that the medication is not the only potential expense. Treatment includes MRIs for safety monitoring, follow-up appointments, and, if you are receiving IV treatment, visits to an infusion center.⁸ Those costs may be billed separately.

Before starting treatment, I recommend asking your insurance company what your actual out-of-pocket costs will be—not just whether the medication itself is covered.

Step 5: Finding a Treatment Site & Managing Logistics

Even after you qualify for treatment and insurance approves it, there are still some practical things to work out.⁸

Depending on where you live, finding a specialist who offers these treatments may take time.⁸ If you are receiving IV treatment, you will also need access to an infusion center that can accommodate the treatment schedule.⁸

There are MRIs to schedule as well.^1,2,8 These aren't optional—they are an important part of monitoring for ARIA and need to be completed at specific points during treatment.

It is also important to consider whether MRI is an option for you. Some people have difficulty tolerating an MRI because of claustrophobia, while others may not be able to have one because of certain implanted devices. There is currently no substitute for MRI when it comes to detecting and monitoring ARIA, so this is something that needs to be considered before treatment begins.

And then there is the time involved.⁸ Between treatment, MRIs, and follow-up appointments, there can be quite a few trips back and forth. If you live several hours from your treatment center or rely on a family member to take you to appointments, that can become a very real part of the decision.⁸

Leqembi Can Now Be Started at Home

In July 2026, another option became available. Leqembi can now be started as a once-weekly injection at home instead of requiring IV infusions every two weeks.¹ For some patients and families, that may make treatment much easier—especially if getting to an infusion center means a long drive or taking time away from work.^1,8

You will still need regular MRIs and follow-up with your treatment team, but the treatment itself can now be given at home.¹

Step 6: Starting Treatment & Monitoring Safety

What treatment looks like will depend on which medication you receive:

Lecanemab (Leqembi)

• Administration: Started either as an IV infusion (10 mg/kg) every two weeks or as a 500-mg weekly subcutaneous injection using the Leqembi IQLIK autoinjector.¹ Subcutaneous doses can be administered at home by a trained patient or caregiver.¹
• Safety Monitoring: A baseline MRI is required prior to starting.¹ For IV therapy, follow-up monitoring MRIs are obtained prior to the 5th, 7th, and 14th infusions (or at equivalent week 9, 13, and 27 milestones for weekly subcutaneous therapy).¹
• Maintenance Options: After 18 months of initiation, patients can continue their schedule or transition to maintenance dosing (such as monthly IV infusions or a 360-mg weekly subcutaneous dose).¹

Donanemab (Kisunla)

• Administration: Administered as an IV infusion every four weeks.²
• Safety Monitoring: Requires a baseline MRI, followed by monitoring MRIs prior to the 2nd, 3rd, 4th, and 7th infusions.²
• Treatment Duration: Unlike Leqembi, Kisunla allows for treatment completion once plaque clearance is achieved.^2,6 Your doctor may pause or stop dosing based on follow-up amyloid PET imaging.^2,6

Step 7: If Insurance Denies Coverage

If insurance denies treatment at first, it doesn't necessarily mean you aren't eligible. Sometimes the insurance company needs additional records or information from your doctor before they will approve it.

Depending on the plan, your clinician may be able to take specific steps to resolve a denial:

• Review the Denial Notice: Check whether the rejection was caused by missing records, such as an omitted functional assessment score, PET scan documentation, or APOE test results.
• Peer-to-Peer Review: Your prescribing clinician may be able to request a formal discussion with the health plan's medical director to clarify clinical details directly.
• Verify Registry Submission: Confirm that your treating clinical team has enrolled you and submitted the baseline data required under CMS Coverage with Evidence Development guidelines.⁷
• Submit a Formal Appeal: If necessary, your care team can submit supplemental medical notes and clinical evidence within your insurance plan's required appeal window.

Key Questions to Ask Your Insurance Plan

• Is [Leqembi / Kisunla] covered under my medical benefit (Part B / outpatient medical) or pharmacy benefit?
• Does this medication require prior authorization, and what exact diagnostic proof must my doctor submit?
• Do the required monitoring MRIs need separate prior authorizations from the medication itself?
• Which infusion centers, imaging centers, and specialty pharmacies are in-network for my plan?
• What is my estimated out-of-pocket cost per dose, including facility fees and radiology visits?

What Happens When Treatment Stops?

One question patients frequently ask is what happens after treatment stops. The answer is that researchers are still figuring that out.

Removing amyloid plaques does not necessarily mean they will never accumulate again. Ongoing research is looking at what happens to amyloid levels after treatment is stopped, how quickly plaques may return, and whether some patients might eventually benefit from additional treatment.^2,6 For now, long-term answers about whether retreatment will be necessary, when it should happen, or whether it will provide the same benefit remain active areas of study.^2,6

References

1. U.S. Food and Drug Administration. LEQEMBI (lecanemab-irmb) injection, for intravenous or subcutaneous use: prescribing information. Revised July 2026. Accessed August 11, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761269s013lbl.pdf
2. Eli Lilly and Company. KISUNLA (donanemab-azbt) prescribing guide. Accessed August 11, 2026. https://kisunla.lilly.com/es/assets/pdf/prescribersguide.pdf
3. U.S. Food and Drug Administration. 510(k) Premarket Notification: Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio (K242706). May 2025. Accessed August 11, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242706
4. Palmqvist S, Whitson HE, Allen LA, et al. Alzheimer's Association Clinical Practice Guideline on the use of blood-based biomarkers in the diagnostic workup of suspected Alzheimer's disease within specialized care settings. Alzheimers Dement. 2025;21(7):e70535. doi:10.1002/alz.7053
5. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer's disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948
6. Sims JR, Zimmer JA, Evans C, et al. Donanemab in early symptomatic Alzheimer disease: The TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239
7. Centers for Medicare & Medicaid Services. Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (NCD 200.3). Accessed August 11, 2026. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=375
8. Snider BJ, Biffi A, Bozeat S, et al. System readiness and the patient care pathway for Alzheimer's disease diagnosis and treatment. Alzheimer's Dement (N Y). 2025;11(2):e70094. doi:10.1002/trc2.70094