NICE's rejection of lecanemab and donanemab is widening the transatlantic access gap

Signal

NICE's final draft guidance on lecanemab (August 2024) and on donanemab (October 2024) both declined the products for routine NHS commissioning, citing inadequate cost-effectiveness against the modest absolute benefit measured in the pivotal trials (CLARITY AD for lecanemab, TRAILBLAZER-ALZ 2 for donanemab). Patients in the UK can access either product privately, with lecanemab quoted at approximately £60,000 per year at the major private centres and donanemab at a similar order of magnitude.

The contrast with other major European markets is sharp. Germany's G-BA has accepted lecanemab into reimbursed care under specific clinical criteria. France has signalled willingness to assess in 2026. Japan's PMDA approved both products and the national health insurance system reimburses, with a notably lower per-patient list price than the US. The US payer landscape is fragmented but predominantly covers, with the patient-access friction concentrated at the prior-authorisation step and the diagnostic infrastructure step rather than at the coverage step.

Why it matters

For commercial teams, the UK is now functionally a private-pay market for both products. Eisai's published commentary in early 2025 acknowledged the reality and reframed the UK market as a private-care segment rather than a primary commercial target. Lilly's positioning has been similar.

For health systems internationally, NICE's reasoning - that the modest cognitive benefit at the price point did not clear the cost-effectiveness threshold - is being read closely by other HTA bodies. CDA in Canada, HAS in France, and the Australian PBAC have all engaged with NICE's analysis. A NICE-style rejection elsewhere would compound the bifurcation.

For Eisai's broader strategic position, the UK rejection is an important data point in the long-running argument that anti-amyloid pricing should be more responsive to single-payer systems' willingness-to-pay. The expectation is that price negotiation in markets with NICE-style HTA scrutiny will tighten over the next 24 months as longer-term real-world data accumulates.

What we are watching

• Whether NICE re-engages with revised data submissions from either company in 2026-27. Both have signalled willingness to come back with updated evidence.
• Outcome of the AHEAD 3-45 readout on asymptomatic AD - if positive, the addressable population expands but so does the budget impact, potentially deepening the cost-effectiveness problem rather than resolving it.
• Comparative HTA decisions in Canada, France, Australia, and the Netherlands through 2026.
• Whether any major UK private healthcare provider (Bupa, AXA Health) builds a covered programme around anti-amyloid treatment, which would partially de-bifurcate the UK access situation.