This tracker pulls together the dates, costs, and eligibility windows that matter most for families managing early Alzheimer's care in 2026. The short answer: two amyloid-clearing drugs (Leqembi and Kisunla) are FDA-approved and Medicare-covered, but only for early-stage disease, and enrollment periods plus diagnostic timing decide whether you can actually use them. Below you will find the approval and coverage dates, real list prices, caregiver benefit rules, and the narrow "windows" — both medical and administrative — that can open or close access. Confirm every detail with your clinician and plan, since waitlists and personal eligibility vary.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Official resources:
- Medicare Coverage & Enrollment official page — Use this page to review requirements and register directly.
- Read the official notice from FDA — Use this primary source to verify the official announcement.
Table of Contents
- Approval and coverage dates that matter
- What these treatments cost
- The eligibility window that gates access
- Safety monitoring and its schedule
- Enrollment deadlines and caregiver benefits
- Frequently Asked Questions
Approval and coverage dates that matter
Two drugs now treat early Alzheimer's by clearing amyloid, a sticky brain protein linked to the disease. Leqembi (lecanemab) earned FDA accelerated approval on January 6, 2023, and full traditional approval on July 6, 2023, according to the FDA approval notice. Kisunla (donanemab) received traditional approval on July 2, 2024, per Eli Lilly's announcement. medicare coverage is tied to those dates.
For each drug, coverage began the day of traditional approval under a National Coverage Determination that requires enrolling in a patient registry, a rule CMS calls Coverage with Evidence Development. See the CMS coverage update for details. A newer option changes the routine, not the eligibility. The FDA approved Leqembi Iqlik, a weekly at-home subcutaneous injection for maintenance dosing, on August 29, 2025, after 18 months of IV therapy.
What these treatments cost
List prices are high, and they come before any insurance adjustment. Kisunla lists at $695.65 per vial, which works out to roughly $32,000 a year and about $48,700 for its full 18-month course. Leqembi lists near $26,500 a year before insurance, according to reporting on Lilly's approval and pricing.
These figures are the drug's list price only. Your out-of-pocket cost depends on Medicare Part B, any supplemental coverage, and the required registry participation. Infusion visits, mri scans, and diagnostic testing add separate charges, so ask your care team for a full estimate before starting.
The eligibility window that gates access
Both drugs are approved only for early-stage disease — mild cognitive impairment or mild dementia — with amyloid confirmed by biomarker testing. The Alzheimer's Association notes that moderate or advanced dementia does not qualify.
That creates a real diagnostic window: treatment must begin while the disease is still early. This makes timing a medical deadline of its own. If symptoms progress past the mild stage before diagnosis and biomarker confirmation, the window can close.
- Symptoms fit MCI or mild dementia, not moderate or advanced stages
- Amyloid is confirmed through PET scan or spinal fluid testing
- You can commit to ongoing MRI monitoring during treatment
- You are willing to enroll in the required Medicare registry
Safety monitoring and its schedule
Both drugs carry a risk of ARIA — amyloid-related imaging abnormalities, meaning brain swelling or small bleeds. Because of this, the FDA issued a drug safety communication recommending additional, earlier MRI monitoring for Leqembi patients.
Practically, this means MRI scans are scheduled around your dosing, not just once. Missing these checks is a safety risk, so treat the monitoring calendar as part of the treatment itself.
Enrollment deadlines and caregiver benefits
Medicare enrollment periods set hard administrative deadlines. Medicare Open Enrollment for 2026 coverage ran October 15 to December 7, 2025, and the Medicare Advantage Open Enrollment Period runs January 1 to March 31 each year, per CMS enrollment resources. To review or change a plan, start at the official Medicare plan-joining page. Caregivers may qualify for separate support.
Some state Medicaid HCBS waivers pay family caregivers through self-directed care, but the rules are strict. According to Medicaid Planning Assistance, in 2026 most states cap individual assets at $2,000 and income near $2,982 a month. These waivers are not entitlements. That means qualifying does not guarantee a spot — many states keep waitlists, so apply early rather than waiting for a crisis.
Frequently Asked Questions
Can someone with advanced dementia start Leqembi or Kisunla?
No. Both are approved only for early-stage disease with confirmed amyloid, so moderate or advanced dementia does not qualify.
Does Medicare pay for these drugs automatically?
Coverage exists but requires enrolling in a patient registry under CMS's Coverage with Evidence Development rule; your out-of-pocket share depends on your plan.
What happens if I miss Medicare Open Enrollment?
You generally wait for the next period. Medicare Advantage members get a second window from January 1 to March 31 to make one change.
