Two days after the National Institute for Health and Care Excellence closed its consultation on lecanemab and donanemab with the Cochrane Database review of seventeen anti-amyloid trials in the dossier, neither Eli Lilly nor Eisai has issued a public statement on the methodology fight. The FDA has not commented. CMS has not commented. [1] Wednesday's paper argued that the closed comment-box converted NICE and Cochrane into a single forum settling the global pricing benchmark for amyloid drugs whether the United States answered or not. Thursday adds forty-eight hours of manufacturer silence to that frame.

What both manufacturers filed in the consultation comment-box is procedural protest, not public statement. Eli Lilly's and Eisai's argument — that the Cochrane review's pooling of failed and approved drugs prejudges the clinical question, and that lecanemab and donanemab should be assessed individually against trial primary endpoints in licensed populations — sits inside the committee dossier the appraisal committee will review on June 10. [2] What does not sit in the public record, two days after the close, is a press release, an investor-call comment, an X-account post, or a statement to the BMJ or Pharmaceutical Journal addressing the methodology question outside the committee's reading frame.

The silence is the strategy. A manufacturer that argues outside the dossier risks creating a parallel public record the committee is not obliged to weigh; a manufacturer that argues inside the dossier preserves the procedural shape of its appeal. What the strategy concedes is the public framing. Cochrane's number-needed-to-treat figure, in the absence of an Eisai or Lilly counter-statement, is the freshest evidence on the table for clinicians, payers, and journalists referencing the consultation. The Alzheimer's Society UK's managed-access argument, also unanswered by manufacturers in the public record, is the freshest patient-advocacy frame.

CMS, in particular, is the parallel watch. The U.S. agency reimburses both lecanemab and donanemab under conditions, and a NICE rejection on the basis of a methodology that pools amyloid trials would create reimbursement-rationale pressure on Medicare's existing coverage criteria. Neither CMS nor the FDA has commented. The June 10 NICE meeting is now forty-one days out.

-- NORA WHITFIELD, Chicago