Signals
15Tardive dyskinesia therapy access patterns
Approved VMAT2 inhibitor therapy for tardive dyskinesia continues to expand but underdiagnosis remains the primary gap.
NICE'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.
Donanemab's limited-duration treatment paradigm is reshaping the lifetime cost calculation against lecanemab
Donanemab's protocol stops dosing once amyloid clearance is achieved, typically 12-18 months. Lecanemab is continuous indefinitely. Over a 10-year treatment horizon, the implied lifetime cost difference is substantial.
Plasma biomarker testing is displacing amyloid PET as the screening modality for anti-amyloid eligibility
Three FDA-cleared blood tests for amyloid pathology are now in routine use at major Alzheimer's centres, materially reducing the amyloid-PET demand that constrained early lecanemab uptake.
ARIA monitoring infrastructure is the rate-limit on anti-amyloid uptake
Centres prescribing lecanemab and donanemab consistently report that MRI surveillance capacity, not patient demand or insurance approval, is the bottleneck on how many patients they can treat in 2026.
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.
Real-world ARIA rates from registries are landing close to trial estimates
Early registry data on lecanemab and donanemab in routine clinical use is producing ARIA incidence numbers that broadly track the pivotal trials, with APOE4 homozygotes consistently the highest-risk group.
Plasma-biomarker rollout is concentrated at academic centers
Adoption of plasma p-tau217 testing remains concentrated at academic medical centers and large specialty practices, with community uptake meaningfully behind.
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.
Caregiver support is becoming part of the Alzheimer's policy frame
CMS's GUIDE Model and adjacent caregiver-support policy are reshaping how dementia care is paid for outside the medication and diagnostic frame.
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.
Lecanemab uptake constrained by infusion infrastructure, not demand
Real-world rollout of lecanemab is gated by infusion-chair capacity and MRI monitoring schedules - not by patient interest or prescriber willingness.
ARIA surveillance is becoming the rate-limiting step in anti-amyloid care
Amyloid-related imaging abnormalities require protocol-defined MRI at multiple intervals, and managing positive findings demands neurologist judgment that is in short supply.
Subcutaneous anti-amyloid formulations move toward filing
Subcutaneous lecanemab data has been submitted to regulators; subcutaneous donanemab is in late development. Both reframe the access question.
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.
Snapshots
5Migraine prevention therapy class reference (2026)
Reference snapshot of approved migraine prevention options including CGRP class, traditional preventives, and emerging mechanisms.
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.
Caregiver support landscape for Alzheimer's disease, as of Q2 2026
A reference view of the federal, state, employer, and direct-support programs that currently exist for unpaid family caregivers of people with Alzheimer's disease in the US, with notes on the UK and EU.
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.
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
5What is a subcutaneous anti-amyloid antibody, and why does it matter for access?
Subcutaneous formulations of the anti-amyloid antibodies are reformulations that allow the same active drug to be given as a small under-the-skin injection rather than an intravenous infusion. The biology is the same. The delivery is dramatically simpler. The access implications are real but partial - subcutaneous administration removes the infusion-chair constraint, but does not change the MRI surveillance requirement.
What is tau PET, and how is it different from amyloid PET?
Tau PET is a brain scan that shows the build-up of tau, the second protein associated with Alzheimer's disease. The image is closer to the clinical picture than amyloid is - tau accumulation tracks more directly with where and how a person is currently impaired. The trade-off is that tau PET is harder to access than amyloid PET, and the access gap is now a rate-limiter on multiple fronts.
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.
What is the CMS GUIDE Model, and who is it for?
The Guiding an Improved Dementia Experience (GUIDE) Model is a Medicare payment pathway for comprehensive dementia care - including direct support for family caregivers. It pays participating practices to deliver a coordinated care package that standard Medicare doesn't.
What is ALZ-NET, and what does it do with patient data?
ALZ-NET is the Alzheimer's Network for Treatment and Diagnostics - the main patient registry collecting real-world data on people receiving anti-amyloid therapy in the US. It is the registry that Medicare's coverage-with-evidence-development framework routes patients through.