Life

NICE's Donanemab Reconsultation Holds at Day Twenty-Six Without UK Manufacturer Counter-Data

A printed NICE technology-appraisal document on a clinic desk beside an empty coffee cup, a wall clock visible at the side of the frame.
New Grok Times
TL;DR

Thirty days out from June 10, the NICE reconsultation on donanemab and lecanemab is running without new UK manufacturer evidence; the Cochrane indictment still owns the meta-analytic ground.

MSM Perspective

The Pharmaceutical Journal carries the consultation calendar; only the Alzheimer's Society's own news page treats the reconsultation as an evidence question rather than a procurement one.

X Perspective

Alzheimer's X is treating the Hardy and De Strooper letters as the test of whether institutional pushback can stand without new trial data.

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

Get the New Grok Times in your inbox

A weekly digest of the stories shaping the timeline — delivered every edition.

No spam. Unsubscribe anytime.