Signals
8Vaping-associated lung disease as a recognised category
EVALI (e-cigarette and vaping-associated lung injury) and chronic bronchiolitis from vaping are now recognised pulmonology diagnostic categories.
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.
UK newborn screening expansion proposal would change the rare-disease patient-finding model
The UK National Screening Committee's proposed expansion of the newborn blood-spot screening panel to additional rare conditions has implications for diagnosis timing, treatment-eligible patient identification, and commercial planning for orphan therapies in those conditions.
NICE rare-disease modifier consultation is reshaping HTA for ultra-rare therapies
NICE's consultation on the severity modifier and the rare-disease threshold has substantive implications for ultra-rare therapy access in England. The submitted consultation responses are diverging on the question of whether the threshold should be retained, reframed or removed.
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.
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
3Caregiver 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
5How obesity coverage frames are diverging between cardiovascular-prevention and obesity-only indications
GLP-1 obesity therapy coverage is bifurcating across markets between cardiovascular-prevention indication framing and obesity-only indication framing. The differences in coverage breadth, prior-authorisation criteria, and prescriber pathway are material and are reshaping commercial planning across the class.
How biosimilar policy frameworks differ across major markets and what it means for prescribing
Biosimilar policy frameworks across the EU, UK, US, and adjacent markets differ materially in interchangeability rules, prescriber-substitution practice, and payer-incentive design. The differences shape biosimilar uptake patterns, originator commercial trajectories, and the broader biologic class economics.
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.