Enhertu emergency

Frequently asked questions

• What is trastuzumab deruxtecan (Enhertu)?

  Trastuzumab deruxtecan is a targeted (biological) therapy. Targeted therapies interfere with processes in cells that help cancer grow.

  Trastuzumab deruxtecan combines 2 drugs: 

  • A targeted therapy drug that’s very similar to trastuzumab (Herceptin) and works in the same way
  • A chemotherapy drug called deruxtecan or DXd 

  The drug is developed and commercialised by Daiichi Sankyo and AstraZenca.

• What is HER2-low?

  HER2-low is a newly-classified subgroup of breast cancer previously considered HER2-negative.

  People with HER2-low secondary breast cancer have low levels of HER2-expression.

• Who is eligible for Enhertu?

  Enhertu was assessed by NICE for treating HER2-low secondary or unresectable (cannot be removed by surgery) breast cancer in adults following:

  • Chemotherapy for secondary breast cancer
  • Or after a recurrence during chemotherapy for primary breast cancer or within 6 months after finishing chemotherapy

• Why was Enhertu rejected for use on the NHS in England?

  In September 2023, Enhertu was provisionally rejected by the National Institute for Health and Care Excellence (NICE) for use on the NHS. There was a period of consultation about this decision which we responded to.

  In December, the NICE process was paused to enable the drug companies Daiichi Sankyo and AstraZeneca, and NHS England, to enter negotiations which we hoped would result in a deal that would make the treatment available on the NHS.

  Since September, we’ve met NICE, NHS England and the drug companies on numerous occasions, urging them all to work together to ensure this life-extending treatment could be made available on the NHS.

  But now we’ve received the devastating news that no deal has been made and NICE has not recommended this treatment for use on the NHS.

  NICE has said that the most likely cost-effectiveness estimates are above what NICE considers an acceptable use of NHS resources.

  Underlying all of this is another issue which we believe has played a part in this appraisal. 2 years ago, NICE made changes to the methods it uses to assess treatments and the end-life-modifier being replaced with a new severity modifier.

  A modifier is something that can affect NICE's decision-making.

  Broadly speaking, the end-of-life modifier gave additional weight to treatments that extended the lives of those living with an incurable disease, such as secondary breast cancer. The severity modifier gives additional weight to the most severe conditions.

  At the time, we raised concerns about the impact this change could have on some cancer drugs for people living with incurable cancer. We’re concerned about the impact this change has had on the NICE appraisal of Enhertu.

  Our concerns have been reiterated by the All-Party Parliamentary Group on Breast Cancer and the Health and Social Care Committee. Both wrote to NHS England, NICE and Daiichi Sankyo.

• Is Enhertu available in Scotland, Wales or Northern Ireland?

  Wales and Northern Ireland usually follow drug decisions made in England.

  So the decision to not recommend Enhertu means people in Wales and Northern Ireland will likely miss out too.

  Enhertu was approved by the Scottish Medicines Consortium (SMC) for use on the NHS in Scotland in December 2023.