Payer coverage for anti-amyloid therapy, as of Q2 2026

Scope

This snapshot summarizes the current coverage and reimbursement position for the two FDA-approved anti-amyloid antibodies - lecanemab (Leqembi) and donanemab (Kisunla) - across the major payer categories. It is descriptive: it does not evaluate whether any individual coverage decision is appropriate.

US Medicare (traditional)

Both drugs are covered under the National Coverage Determination for monoclonal antibodies directed against amyloid, structured as coverage with evidence development - see our explainer on CED for the plain-language overview. Coverage is conditional on:

• Patient enrollment in a CMS-approved registry that captures defined clinical and outcomes data.
• Use under a qualified prescriber and at a participating site.
• Patient meeting the labeled population - early symptomatic Alzheimer's disease with confirmed amyloid pathology.

The CED framework is the de facto national policy frame for the older eligible population. The operational friction of the registry requirement is a persistent topic in published health-system rollout reports.

Medicare Advantage

Medicare Advantage plans generally follow the NCD floor for Medicare-covered services. In practice this means coverage exists, but plan-specific prior authorization timelines, network restrictions, and site-of-care policies vary. Patients on Medicare Advantage may face different operational hurdles than patients in traditional Medicare with the same clinical profile.

US commercial payers

Major commercial payers cover both drugs under medical-benefit policies that include FDA-label-aligned criteria - confirmed amyloid pathology, APOE genotyping, baseline MRI, defined treatment-monitoring schedule. Beyond the label-aligned criteria, plans differ on:

• Step-therapy or sequencing requirements.
• Site-of-care restrictions (preferred infusion settings).
• Reauthorization frequency and criteria.
• Coverage of plasma-biomarker testing as a triage step before PET.
• Treatment of CMS registry participation as a coverage condition.

The result is meaningful variation between commercial plans for a clinically identical patient. Discussed in our coverage of commercial payer divergence.

United Kingdom

MHRA authorized both drugs. NICE issued negative cost-effectiveness guidance for routine NHS funding of both products. Routine NHS-funded access is therefore meaningfully constrained. Discussed in our coverage of NICE's cost-effectiveness divergence.

Continental Europe

EMA authorization is in place. National reimbursement decisions vary by country, and several major markets have implemented managed-entry agreements or restricted-population reimbursement frames. The picture is fragmented at the country level and continues to evolve.

Other major markets

Coverage decisions in Japan, Canada, Australia, and other major markets are at varying stages of regulatory and reimbursement review. The general pattern continues: regulatory authorization and reimbursement coverage are increasingly distinct decisions.

What this implies

The aggregate effect is that two patients with effectively identical clinical profiles can have meaningfully different access to anti-amyloid therapy depending on the payer in front of them. This is the central operational fact of the current access landscape, and it is the subject of our Insight on payer fragmentation.

This snapshot is updated when material changes occur in the major payer policy landscape.