A dated, sourced record of changes in guideline, regulatory, and payer evidence, mapped to rungs 5–7 of the recognition ladder. Changes are recorded after they occur, never predicted — this is a public record, not a forecast.
There are 4 entries so far, and it is worth being straight about what they are: each concerns how the public record itself is published and governed, rather than a change to any particular therapy. Those come as the watchlist resolves. The feed is published now, sparse, so it accumulates somewhere you can see rather than appearing fully formed later.
Each entry maps to the recognition-ladder rung its change occurred at.
Rung 5Guideline actionGuideline committees revise recommendations, grades, or positioning.
Rung 6Regulatory actionAuthorities update labels, indications, or approval status.
Rung 7Payer/coverage actionPayers change access, restrictions, or formulary placement.
Recorded changes
Dated, sourced evidence changes
Entries are recorded after they occur, newest first, each with a source link and a date. Entries recorded in the last quarter are marked recent.
Rung 6 — Regulatory action Recent
FDA grants Breakthrough Therapy Designation for first-line sunvozertinib; sNDA submitted
AstraZeneca announced an exclusive global license from Dizal for sunvozertinib and confirmed that a supplemental NDA for the first-line EGFR exon 20 insertion indication has been submitted to the US FDA, which granted Breakthrough Therapy Designation in this setting.
Recorded as the observation input to registered forecast FF-001 (NCCN guideline listing). Observation only — no probability.
NCCN introduced a free Guidelines Weekly Updates email alongside a paid Flash Updates tier, publishing what changed across its guideline library on a fixed cadence.
A public guideline-change delivery pattern now exists; it documents the change flow modeled as rung 5 transitions.
ICER publishes annual Launch Price and Access Report
ICER released its annual review of launch prices and access conditions — an independent, conflict-disclosed assessment of how new products enter coverage.
Independent assessments of access conditions are the reference standard for coverage-change records.
FDA finalizes guidance on communicating scientific information about unapproved uses
FDA published its final guidance describing how firms may communicate truthful, non-misleading scientific information about unapproved uses, including requirements to keep sources unaltered, complete, and conflict-disclosed.
Sets the source-integrity standard that public evidence records are designed to meet.