NICE Reversed on Enhertu Because the Threshold Moved, Not the Evidence
The clinical evidence did not change. NICE’s cost-effectiveness threshold did, as a term of a bilateral trade agreement.
The Brief
GENEROUS Lets Manufacturers Cut Medicaid Prices Without Touching Best Price or 340B
Seven of 19 applicant states have signed. CMS itself tells them to check whether its international price beats the rebates they already have.
Korea’s Reimbursement Delay Is a Staffing Problem, and the Ministry Said So
An industry association found the public agrees with industry. The news came later, from a division director naming headcount as the bottleneck.
The First Approval for Denecimig Came From Riyadh, Not Washington
One of the four Phase 3 studies is a safety-only switch from emicizumab. The commercial target was the incumbent, not the untreated.
Axon Targeting’s Switch Lives in the Cell Body Observed Here, Not Operated
Regeneration programmes can make axons grow. If targeting is transcriptional, growth was always the achievable half of a two-part problem.
NICE Withdrew Four Appraisals Because the Medicine Went Off Patent.
Going off patent now costs a medicine its named appraisal. And the withdrawal is a routing decision carrying no right of appeal.
CMS Added Five Tracks to ACCESS. The Payer Pledge Covers 165 Million People Who Cannot Join It.
The expansion is the announcement. Payers covering 165 million pledged to align with a model none of their members can join.
The UK Commission Wants L-Plates for AI and an End to One-Time Approval
Coverage is calling these new AI rules. What they propose is replacing the single approval decision with supervised entry and permanent monitoring.
Lilly Confirmed the Calculations Were Wrong. A Jury Is Deciding What That Cost Nektar.
Most partnership disputes turn on what data meant. Both sides here accept the published numbers were wrong, and every correction favours the drug.
Years After NCCN Recommended It, FET-PET Finally Has an FDA-Approved Drug
The clinical case was settled before the regulatory one. Clinicians held an NCCN recommendation with no lawful product to act on it.