Day 25 of the Cochrane-versus-Kisunla evidence arc. NICE confirmed Friday that its reconsultation on donanemab — Eli Lilly's amyloid-clearing antibody marketed as Kisunla — will open a public comment window on June 10. [1] The reconsultation is procedurally a response to the March Cochrane review that found "low-certainty" evidence for clinical benefit. The substantive fight, as the paper argued yesterday, is over carer-economics modelling — not trial design.
Alzheimer's Research UK, John Hardy at UCL, Susanne Kohlhaas at ARUK, and Bart De Strooper at the UK Dementia Research Institute have continued institutional pushback through the week. The line they share — repeated in three open letters since March 25 — is that NICE's cost-effectiveness threshold for Alzheimer's therapies fails to model the unpaid-carer burden the disease imposes on family members, which a slowing-progression therapy would partly defray. [2]
Lilly's submission to NICE, published Friday on the institute's portal, prices Kisunla at £25,000 per year of treatment and models a carer-burden reduction of 4 to 8 hours per week over the first 18 months of therapy. [3] The Cochrane review's authors disputed the carer-burden model in a March response: the underlying CARE-AD trial population was younger and less impaired than the typical UK Kisunla candidate, they wrote, and the hours-per-week reduction does not generalize.
June 10 is the date that turns the methodological dispute into a procurement question.
-- KENJI NAKAMURA, Tokyo