What are the costs, insurance coverage, and access issues for newly approved Alzheimer’s therapies in 2025?
Executive summary
New disease‑modifying monoclonal antibodies for early Alzheimer’s—lecanemab (Leqembi) and donanemab (Kisunla)—are expensive at scale (Leqembi cited at $26,500/year; Kisunla initial pricing described as “eye‑popping”) and have driven major payer policy changes including Medicare registry requirements for coverage of anti‑amyloid mAbs (Leqembi pricing cited; CMS coverage rules cited) [1] [2]. Access is limited by diagnostic requirements (amyloid confirmation by PET or blood tests), specialist and infusion infrastructure, and payer utilization controls; long‑term cost‑effectiveness and broader coverage remain contested in the literature [3] [4] [2].
1. Price tags that reshape markets
The new anti‑amyloid antibodies carry steep annual costs that reshape expectations for Alzheimer’s care: Leqembi has been publicized at about $26,500 per year and Aduhelm’s earlier list price was far higher, signaling a new era of costly biologic therapies for early AD [1]. Market analysts expect these expensive DMTs to expand the Alzheimer’s drug market and exert pressure on budgets and pricing negotiations globally [5] [1].
2. Medicare’s conditional pathway for coverage
Medicare will cover traditionally FDA‑approved anti‑amyloid monoclonal antibodies for patients with mild cognitive impairment or mild dementia—but only when providers participate in registries and meet diagnostic and follow‑up criteria intended to collect real‑world evidence [2]. CMS links coverage to participation in a data submission effort and to care being delivered in "appropriate settings," effectively gating access through provider readiness and reporting obligations [2].
3. Diagnostic gates: PET, plasma tests and specialist bottlenecks
Both the treatments and payer policies require amyloid confirmation—historically by PET scans and increasingly by emerging plasma biomarkers—so diagnosis becomes a rate‑limiting step [3] [6]. Specialists who can interpret biomarkers and manage infusion and MRI monitoring are unevenly distributed; many patients live far from qualified centers, creating geographic access disparities [4].
4. Infusion logistics, MRI monitoring and safety monitoring costs
These antibodies are delivered via IV infusion (monthly for some regimens) and require MRI surveillance for amyloid‑related imaging abnormalities, adding facility, staffing and imaging costs beyond the drug’s list price—expenses that insurers and families must absorb or negotiate [1] [4]. Real‑world programs like ALZ‑NET are being promoted to track outcomes and equity, but they also underscore the work and cost of building delivery systems [7] [4].
5. Insurance mix: what pays, what doesn’t
Medicare (Parts A/B/C and supplemental plans) is the primary payer for older adults and will cover medical services tied to diagnosis and administration if coverage conditions are met; Part D covers self‑administered drugs but these infused mAbs are routed through Part B in many cases, shaping out‑of‑pocket exposure [8] [9]. Private, marketplace and Medicaid plans vary by state and plan; the Alzheimer’s Association is actively pushing for insurance coverage of diagnostic testing to speed access [10] [11]. Sources note a $2,000 cap on Part D out‑of‑pocket spending in 2025, a change that alters medication affordability dynamics for some beneficiaries [12] [13].
6. Cost‑effectiveness and long‑term budget questions remain unsettled
Economic models suggest that a disease‑modifying therapy priced much lower (e.g., hypothetical $5,000/year) could be cost‑effective by delaying progression, but whether current high prices will yield net system savings is unresolved [14]. Research groups and projection models emphasize that overall dementia costs are already vast—estimates for U.S. dementia costs range into the hundreds of billions annually—so the fiscal impact of broad DMT uptake is material to future budgets [15] [16].
7. Equity, rural access and implicit agendas
Experts warn that the “final gate” to benefit is access: rural counties and underserved populations may lack nearby specialists, infusion centers, or reimbursable diagnostic services, producing unequal uptake [4]. Advocacy groups (e.g., Alzheimer’s Association) press insurers and lawmakers to mandate coverage of testing and support infrastructure expansion—an agenda that amplifies patient access arguments but also shifts fiscal burdens to payers and taxpayers [10].
8. What reporting and follow‑up will mean for patients and clinicians
CMS’s registry requirement and calls for real‑world data collection (ALZ‑NET) make post‑market surveillance central to continued coverage and to answering effectiveness and safety questions in typical clinical populations; clinicians will shoulder documentation and reporting responsibilities as a condition of treatment provision [2] [7].
Limitations: available sources do not provide exhaustive, up‑to‑the‑minute national price lists for every newly approved therapy or firm national uptake numbers in 2025; I rely on cited reporting on Leqembi/Kisunla pricing, CMS policy, and peer‑reviewed pipeline and policy analyses [1] [2] [3]. For individual coverage decisions, consult a patient’s insurer and treating clinician; for policy trends, follow CMS and Alzheimer’s Association updates [2] [10].