The National Institute for Health and Care Excellence consultation on donanemab and lecanemab — the two anti-amyloid Alzheimer's antibodies whose UK reimbursement has been disputed since 2024 — closed on Tuesday, April 28. The appraisal committee's fourth meeting is scheduled for June 10. [1] On the same comment-box deadline, the Cochrane Database of Systematic Reviews kept its April 15 publication of a methodology that pooled 17 trials covering 20,342 patients across seven amyloid antibodies — and concluded that effects were "absent or trivial." [2] [3] Eli Lilly and Eisai filed protest comments. So did the Alzheimer's Society UK. The committee will read both stacks.

The paper's Tuesday account of the Cochrane review meeting NICE's Alzheimer's deadline named the collision: a national reimbursement authority closing its consultation in the same week the most-cited evidence-synthesis institution in the world publishes a review whose authors argue the underlying clinical effect is not real. Wednesday's news is procedural. The window has closed. The committee has the dossier. The decision that follows will be a benchmark for amyloid drugs globally — including in the United States, where the FDA has approved both lecanemab and donanemab and where CMS reimburses under conditions, but where there is no parallel deadline forcing the methodological dispute into a single forum.

The arithmetic NICE's committee reviews has been stable since the second-meeting decision in 2025. The treatments delay progression from mild to moderate Alzheimer's by 4-6 months on average in the licensed population. [4] The cost of acquisition plus administration — IV infusions every two or four weeks, ARIA-monitoring MRIs, infusion-suite staffing — pushes cost-effectiveness above the £30,000 per quality-adjusted life year ceiling NICE typically uses. The committee's prior conclusion was that the small benefit did not justify the large NHS resource commitment. [4] The new Cochrane review attacks the size of the benefit itself, by pooling all amyloid-antibody trials — including the ones that failed (gantenerumab, aducanumab) and the ones that were discontinued — into a single estimate that washes out the individual-drug results. The signal disappears.

Eli Lilly and Eisai's objection, restated in coverage on Pulse Today and Pharmaceutical Journal, is that pooling failed and approved drugs together is a methodological choice that prejudges the clinical question. [3] Their argument is that lecanemab and donanemab — the two drugs that crossed FDA and EMA regulatory thresholds — should be assessed individually, against the trial primary endpoints (CDR-SB), in the licensed populations (APOE-E4 non-carriers and heterozygotes for donanemab; the broader Clarity-AD population for lecanemab). The Cochrane authors' counter-argument is that pooling reflects the underlying biology: if the amyloid hypothesis is correct, all anti-amyloid agents should produce roughly proportional effects. The fact that they do not, in their analysis, is itself the methodological signal. [3]

The Alzheimer's Society UK's position, restated this week, is that some patients benefit measurably from these drugs and that NICE's framework should permit access for those patients under managed-access arrangements. [5] The Society argued in 2025 that withholding reimbursement when the EMA and FDA had approved the drugs created a two-tier system — privately funded UK patients can access the drug; NHS patients cannot. The Cochrane review, in their reading, does not change that fact. The committee's reading is what determines whether NHS access opens.

What is at stake beyond the United Kingdom is the methodology. NICE has the authority to reject reimbursement on cost-effectiveness grounds. Cochrane has the authority — informally but persistently — to reject the underlying evidence base on methodology grounds. Today both authorities meet inside the same comment-box. The decision that follows in June will be quoted in CMS reviews, Australian PBS submissions, French HAS appraisals and Canadian CADTH reviews. The number-needed-to-treat figure the committee adopts becomes the global denominator. [3]

The procedural calendar from here is narrow. The June 10 meeting is closed-session. The committee's draft guidance after that meeting goes to a second comment window, typically four to six weeks. Final draft guidance follows. Publication of any positive recommendation — full reimbursement, restricted reimbursement, or managed-access — would land in late summer or early autumn 2026. A negative recommendation would, again, prompt manufacturer appeal and possible commercial-arrangement renegotiation. The two appeal points NICE upheld earlier in this evaluation, and the second consultation that followed, indicate the committee has been receptive to procedural arguments — but not yet to the underlying cost-effectiveness math. [6]

The U.S. parallel is the absence of a deadline. CMS published a National Coverage Determination for lecanemab in 2024 that conditions reimbursement on registry enrollment; donanemab is reimbursed on similar terms. There is no NCD-revisit deadline forcing a confrontation with the Cochrane methodology. The CMS framework treats each drug individually under registry data; the Cochrane methodology treats the class together. The American clinical conversation has not, to date, forced these two frames into the same room. The British clinical conversation is doing it on Tuesdays. [3]

For UK patients with mild cognitive impairment or mild dementia from Alzheimer's disease, the operational fact is simple: NHS access is not available this spring. The June meeting may change that. It may not. The post-meeting draft guidance is the next watch item. Patient-organization comments filed Tuesday are part of the dossier the committee reads. The Cochrane review is the methodology that committee will debate. The clinical effect is the one underlying question. The deadline has closed. The answer is on the schedule for June 10.

-- KENJI NAKAMURA, Tokyo