1 Recommendations

1.1 Trastuzumab deruxtecan is recommended with managed access as an option for treating HER2‑positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments in adults. It is only recommended if the conditions in the managed access agreement for trastuzumab deruxtecan are followed.

1.2 This recommendation is not intended to affect treatment with trastuzumab deruxtecan that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Standard treatment for HER2‑positive unresectable or metastatic breast cancer includes anti-HER2 treatments. After first-line treatment with trastuzumab and a taxane, standard treatment is trastuzumab emtansine. Trastuzumab deruxtecan would be an alternative anti-HER2 treatment after trastuzumab and a taxane.

Clinical trial evidence shows that trastuzumab deruxtecan increases how long people have before their cancer gets worse compared with trastuzumab emtansine.

There is not enough evidence yet to show if people live longer with trastuzumab deruxtecan compared with trastuzumab emtansine because the clinical trial is still ongoing. This means the cost-effectiveness estimates are highly uncertain and trastuzumab deruxtecan cannot be recommended for routine use in the NHS.

Trastuzumab deruxtecan could be cost effective if further evidence shows that people live longer with treatment. Evidence from the trial and from NHS practice could help address the uncertainty about how long people live. So, trastuzumab deruxtecan is recommended for use with managed access.

  • National Institute for Health and Care Excellence (NICE)