Signals
7NICE's rejection of lecanemab and donanemab is widening the transatlantic access gap
Final NICE guidance declined both anti-amyloid antibodies for routine NHS use on cost-effectiveness grounds. The same products are reimbursed in Germany and approved (with payer fragmentation) in the US. The bifurcation is hardening rather than resolving.
Tau PET reimbursement is the next diagnostic access question
Amyloid PET has settled into routine coverage and availability. Tau PET - which will be the confirmatory pathway for tau-directed therapies - is sited at meaningfully fewer centers and reimbursed unevenly. The access conversation that defined anti-amyloid rollout is about to repeat, one mechanism later.
Commercial payer coverage of anti-amyloid therapy is diverging from Medicare
Commercial payers are setting prior authorization and step-therapy criteria that meaningfully diverge from Medicare's coverage-with-evidence-development frame.
The "clinically meaningful" debate around CDR-SB is not settling
The interpretive argument over whether a sub-half-point CDR-SB delta represents a clinically meaningful slowing of decline continues to shape regulatory, payer, and clinician views.
NICE keeps the UK out of step with US and EU on anti-amyloid coverage
NICE's negative cost-effectiveness opinion on lecanemab and donanemab leaves the UK as a meaningful policy outlier, even after MHRA authorization.
Medicare's coverage-with-evidence-development decision still shapes the rollout
The CMS coverage framework requiring registry participation has had measurable effects on which sites prescribe and where patients get treated.
FDA's accelerated approval pathway under continued post-Aduhelm scrutiny
Aducanumab's voluntary withdrawal in 2024 left lasting institutional caution about surrogate-endpoint approvals in neurodegeneration.
Snapshots
5Anti-amyloid antibody landscape, 2026 mid-year reference
A dated reference snapshot of the anti-amyloid antibody class for Alzheimer's disease as of mid-2026: approved products, withdrawn products, late-stage pipeline, label-defining clinical evidence, and the operational pattern that defines the class.
What we are watching in Alzheimer's, as of Q2 2026
A reference list of the threads PatientSpotlight is actively tracking - clinical readouts, regulatory and reimbursement decisions, real-world evidence accumulation, and operational rollout. Each thread names what to watch and why it matters, without predicting when it will resolve.
Payer coverage for anti-amyloid therapy, as of Q2 2026
A reference view of how anti-amyloid therapy is currently covered across US Medicare, Medicare Advantage, US commercial payers, and select international markets.
Clinical trial endpoints in Alzheimer's disease, as of Q2 2026
A reference view of the cognitive, functional, and biomarker endpoints used in late-stage Alzheimer's trials - what each measures and how to read a readout that uses it.
Alzheimer's regulatory and reimbursement landscape, as of Q2 2026
Two anti-amyloid antibodies have traditional FDA approval; CMS coverage operates under a coverage-with-evidence-development framework; international approvals diverge.
Explained
2What is the FDA accelerated approval pathway, and why does it matter for Alzheimer's?
Accelerated approval is a 1992 FDA regulatory pathway that lets a drug come to market based on a surrogate endpoint reasonably likely to predict clinical benefit, with a confirmatory trial obligated to follow. In Alzheimer's, the pathway is closely associated with the aducanumab episode and a recalibrated bar for what surrogate evidence the agency now considers persuasive.
What is Medicare coverage with evidence development?
Coverage with evidence development (CED) is a Medicare coverage mechanism that pays for a treatment on the condition that clinical data about its use is collected and reported back to CMS. It is how Medicare currently covers anti-amyloid antibodies.