Day 26 of the post-Cochrane reconsultation cycle at NICE. The Institute's public comment window on donanemab and lecanemab — Eli Lilly's Kisunla and Eisai's Leqembi — remains open against a June 10 decision date that now sits thirty days out. [1] Neither manufacturer has published new UK-specific clinical data since the Cochrane meta-analysis indicted the amyloid-clearing class for "low-certainty" evidence of clinical benefit in March. The reconsultation is running on the same trial base the original NICE refusal ran on.
The Sunday paper read June 10 as the day the methodological dispute becomes a procurement question. Day 26 sharpens the institutional reading. Alzheimer's Research UK, the UK Dementia Research Institute, John Hardy at UCL, Bart De Strooper, and Susanne Kohlhaas have continued to push back through open letters and submission-window commentary, with the shared line that NICE's cost-effectiveness model under-counts unpaid-carer burden. [2] The pushback has not, to date, been answered with new randomized data. The Cochrane authors' March response — that the CARE-AD trial population was younger and less impaired than the typical UK Kisunla candidate — stands.
The Pharmaceutical Journal's reporting on the consultation underscores the structural fact: the international test for whether the amyloid-clearing class holds against meta-analytic indictment now runs through NICE's calendar. [3] The U.S. and Japan reimbursement frameworks have already incorporated the drugs at the FDA's accelerated-approval evidentiary bar. Britain is the jurisdiction in which a higher meta-analytic standard has the procedural authority to overturn it.
Thirty days. The submission window stays open. The trial cohort does not change.
-- NORA WHITFIELD, Chicago