CMS's coverage-with-evidence-development registry, not IRA negotiation, is the gate on anti-amyloid access, and ICER has priced lecanemab far below its list.
Lecanemab (Leqembi) and donanemab (Kisunla) are administered anti-amyloid biologics and route to Medicare Part B. Since April 2022, CMS's National Coverage Determination (NCD 200.3) covers this drug class only under Coverage with Evidence Development (CED): following traditional FDA approval, Medicare pays for the drug for patients with MCI due to AD or mild AD dementia and confirmed amyloid pathology, but only when the prescribing clinician participates in a CMS-approved nationwide registry that collects real-world cognitive and safety data. This registry requirement, not price, is the defining structural gate on access, and it constrains which sites and physicians can treat. Amyloid confirmation (historically PET, with Medicare coverage long limited to once per lifetime, plus CSF and now blood-based testing) and mandatory serial-MRI ARIA monitoring compound the site-infrastructure barrier.
Unlike the mature specialty classes CMS has begun to negotiate, the anti-amyloid agents are shielded from Inflation Reduction Act price negotiation simply by recency: biologics are exempt for roughly the first 11–13 years after approval, and lecanemab (2023) and donanemab (2024) appear on none of the published CMS selected-drug lists (IPAY 2026, 2027, or 2028). No negotiated-price reset is available to payers in this window. On value, ICER's final evidence report (April 2023) concluded its appraisal committee was not convinced lecanemab's benefits are adequately demonstrated, and found the $26,500 annual list price above cost-effectiveness thresholds — ICER's health-benefit price benchmark was $8,900–$21,500 per year. ICER had reached a harsher verdict on aducanumab in 2021 (benchmark $3,000–$8,400 vs a $56,000 list); Biogen discontinued that agent in 2024. Donanemab's flexible-duration dosing, under which treatment can stop once amyloid is cleared, partially offsets its higher ~$32,000 annual list.
US anti-amyloid agent payer & coverage status — 2025
| Drug (Brand / INN) | Benefit Routing | CMS Coverage Basis | IRA Status | ICER Assessment | Annual WAC |
|---|---|---|---|---|---|
| Leqembi (lecanemab) | Medicare Part B (IV) | NCD 200.3 — Coverage with Evidence Development; registry + amyloid confirmation required | Not selected (IPAY 2026–2028); too newly approved (2023) | Apr 2023: committee unconvinced of net benefit; list above value ($8.9K–$21.5K benchmark) | $26,500 |
| Kisunla (donanemab) | Medicare Part B (IV) | NCD 200.3 — CED registry + amyloid confirmation required | Not selected (IPAY 2026–2028); approved 2024 | Reviewed within ICER's AD assessment; not separately price-benchmarked | ~$32,000 (flexible duration; ~$12,522 per 6-month course) |
| Aduhelm (aducanumab) | Medicare Part B (IV) — historical | NCD 200.3 — CED (originally limited to trials) | n/a — discontinued | 2021: evidence insufficient for net benefit; benchmark $3,000–$8,400 vs $56,000 list | Discontinued by Biogen, 2024 |
Sources: CMS NCD 200.3 (Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease) and CMS Coverage with Evidence Development registry documentation; CMS Medicare Drug Price Negotiation Program selected-drug lists (IPAY 2026–2028); ICER Final Evidence Report on lecanemab (April 2023) and aducanumab (2021); Eisai (Leqembi WAC) and Eli Lilly (Kisunla WAC) list-price announcements; Biogen Aduhelm discontinuation notice (2024).
What this assessment answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- NCD 200.3 CED registry mechanics
- MCI/mild-dementia plus amyloid-confirmation eligibility
- registry data-collection obligations
- amyloid PET coverage limits and ARIA MRI monitoring as site gates
Delivers
- IRA biologic exemption window
- confirmation both agents are absent from CMS selected-drug lists (IPAY 2026–2028)
- implications for price stability and commercial payer leverage
Delivers
- ICER lecanemab April 2023 verdict and $8,900–$21,500 benchmark
- ICER aducanumab 2021 assessment
- Leqembi $26,500 vs Kisunla ~$32,000 WAC and flexible-duration dosing
- Part B reimbursement dynamics
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Commission This AssessmentWhat's inside
- Why lecanemab and donanemab, as administered biologics, route to Medicare Part B rather than Part D
- How the registry requirement under NCD 200.3, not price, is the defining structural gate on access
- The CED mechanism: Medicare pays only when the prescribing clinician participates in a CMS-approved nationwide registry collecting real-world cognitive and safety data
- How mandatory amyloid confirmation and serial-MRI ARIA monitoring compound the site-infrastructure barrier alongside the registry
- Why the roughly 11-13 year biologic exemption window keeps lecanemab (2023) and donanemab (2024) off IRA negotiation lists
- Confirmation that both agents appear on no CMS selected-drug list through IPAY 2026, 2027, or 2028
- ICER's April 2023 verdict that lecanemab's benefits were not adequately demonstrated, with its $26,500 list price above the $8,900-$21,500 value benchmark
- ICER's harsher 2021 finding on aducanumab ($3,000-$8,400 benchmark vs a $56,000 list), ahead of Biogen's 2024 discontinuation
- Leqembi's $26,500 versus Kisunla's ~$32,000 annual list price, and how donanemab's flexible-duration dosing partially offsets its higher cost
- How both agents' Part B routing shapes reimbursement economics differently from a self-administered Part D drug
- Medicare's historical once-per-lifetime limit on amyloid PET coverage as a diagnostic-capacity constraint
- The mandatory serial-MRI ARIA monitoring protocol that adds ongoing site-infrastructure cost to anti-amyloid therapy
Included with every brief
How AXLRx builds this assessment
Prepared by MoatRx analysts.
Alzheimer's payer and HTA analysis is built from CMS coverage documentation, ICER evidence reports, Medicare payment policy, and manufacturer list-price disclosures. Every payer and pricing claim carries a source citation; nothing is modeled or inferred.
Key sources: CMS NCD 200.3 and the CMS Coverage with Evidence Development registry for anti-amyloid monoclonal antibodies; CMS Medicare Drug Price Negotiation Program selected-drug lists (IPAY 2026, 2027, 2028); ICER Final Evidence Report on lecanemab (April 2023) and aducanumab (2021); Eisai and Eli Lilly WAC announcements; Biogen Aduhelm discontinuation (2024).
- CMS Part B coverage-with-evidence-development requirement verified against CMS NCD 200.3 and CMS registry documentation
- Absence of lecanemab and donanemab from IRA negotiation verified against CMS selected-drug lists (IPAY 2026, 2027, 2028)
- ICER lecanemab verdict and $8,900–$21,500 benchmark verified against ICER final evidence report, April 2023
- Leqembi ($26,500) and Kisunla (~$32,000) annual WAC verified against manufacturer list-price announcements
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