Europe’s payers now decide how much of this label to fund, and the trial gives them grounds to fund less than all of it. Enhertu was first authorised in the EU in 2021, before joint clinical assessments began in January 2025, so this extension goes through national HTA bodies one at a time. Each will compare it with T-DM1, Roche’s Kadcyla.

• HTA bodies: the label is wider than the trial. The EU indication covers any residual invasive disease after neoadjuvant therapy, but DESTINY-Breast05 enrolled only high-risk patients, inoperable before treatment or node-positive after it. Expect assessors to split the population and recognise added benefit only where the trial ran, which leaves lower-risk patients on Kadcyla by default.
• German payers: the price is reopened, not set. Enhertu already carries a negotiated German reimbursement amount from earlier indications, so a G-BA assessment against T-DM1 feeds a renegotiation that covers all of them. Overall survival is a secondary endpoint with no result in the release, so recurrence and the lung-toxicity imbalance will carry the dossier.
• Signposts: the G-BA dossier, the HAS rating and the neoadjuvant filing. Watch how the G-BA frames subgroups, what improvement rating France’s HAS grants against T-DM1, and whether the DESTINY-Breast11 regimen is filed in the EU, which would change who reaches surgery with residual disease.