Donanemab (Kisunla) is an amyloid-directed antibody treatment for early symptomatic Alzheimer's disease, meaning mild cognitive impairment or mild dementia with confirmed amyloid plaques. Its U.S.
list price is roughly $32,000 for a 12-month course, and Medicare Part B covers it only when the prescriber enrolls the patient in an approved registry. Before you budget, verify registry enrollment, infusion-facility coverage, and who pays for required amyloid PET, ApoE testing, and follow-up MRIs. Those related services can add substantially to the drug price itself.
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.
Table of Contents
- What does Kisunla cost?
- Who qualifies for treatment?
- How does Medicare coverage work?
- Can treatment stop early?
- What safety checks should you plan for?
What does Kisunla cost?
Lilly set the launch list price at about $695.65 per vial, or roughly $32,000 for 13 every-four-week infusions over 12 months, according to Lilly launch reporting via NDA News US Lilly launch report. That figure covers the drug only. It does not include scans, lab tests, or infusion fees.
Lilly's current pricing page lists Kisunla at $731.49 per 350 mg/20 mL vial and notes that actual out-of-pocket cost depends on prescription drug insurance. Ask your plan what deductible, coinsurance, and site-of-care rules apply. A hospital outpatient infusion center often bills differently than a physician office.
Who qualifies for treatment?
The FDA granted traditional approval to Kisunla on July 2, 2024 for early symptomatic Alzheimer's disease with confirmed amyloid pathology, according to the Drugs.com FDA approval history FDA approval history. That group means mild cognitive impairment due to Alzheimer's or mild Alzheimer's dementia.
Coverage follows the same limit. It is restricted to those early-stage patients plus confirmed amyloid-beta pathology, consistent with the population studied in trials. Moderate or severe dementia does not qualify.
How does Medicare coverage work?
Medicare covers FDA-approved amyloid-directed antibodies including Kisunla under Part B only through Coverage with Evidence Development, according to the Eli Lilly Kisunla support page for clinicians Lilly coverage support page. The prescriber must enroll the patient in a CMS-approved registry such as ALZ-NET. Confirm three points in writing before the first infusion:.
- your Part B or Medicare Advantage plan participates and the registry enrollment is complete
- the chosen infusion facility is covered as a Part B site of care
- required amyloid PET, ApoE testing, and serial MRIs are covered and pre-authorized
Can treatment stop early?
The FDA label allows stopping Kisunla once amyloid PET imaging shows plaques reduced to minimal levels. That means treatment may end early rather than continue indefinitely.
Fewer infusions can lower total drug cost for some patients. Stopping still requires medical judgment and follow-up. Ask how often the care team repeats amyloid PET, what threshold they use to stop, and what monitoring continues afterward.
What safety checks should you plan for?
Kisunla carries an FDA boxed warning for amyloid-related imaging abnormalities, brain swelling called ARIA-E and bleeding called ARIA-H. Risk is highest in ApoE ε4 homozygotes.
The label directs ApoE testing, a baseline MRI, and MRIs before later infusions. Build those checks into your cost and schedule plan. Ask who orders the tests, where MRIs must be done, how results change dosing, and what symptoms should prompt urgent care.
