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Making sure that Enhertu is approved for NHS use in England

Enhertu (also known as trastuzumab deruxtecan) is an exciting new drug for certain people with HER2-low, secondary breast cancer. It’s the first and currently only licensed treatment for this type of breast cancer, and it’s estimated that around 1,000 people each year could be eligible in England. 

Enhertu can slow the spread of the cancer and increase survival compared to chemotherapy. It offers people the life-changing hope of more time to live and do the things that matter most to them. 

It has already been made available in Scotland. But women in England are still waiting to find out if they’ll be able to access it on the NHS.

What’s happened?

Disappointingly, in September 2023, the National Institute for Health and Care Excellence (NICE) provisionally rejected Enhertu for use on the NHS in England. In response, we did everything in our power to make sure that NICE and the drug company Daiichi Sankyo heard our message. We asked them to do everything they can to make Enhertu available on the NHS.

We responded directly to the consultation, setting out why the decision should be reversed. Our response included comments from women living with HER2-low secondary breast cancer, who shared what access to the drug would mean to them. We also encouraged women who could benefit from Enhertu to respond directly to NICE.

As well as responding to the consultation and taking part in the multiple NICE committee meetings, we've been in direct contact with NICE and Daiichi Sankyo. Our Chief Executive, Delyth Morgan, has spoken to both parties, urging them to work together to ensure that Enhertu could be made available to people who desperately need it.

A pause in the process

In December 2023, NICE announced they were pausing the process to enable NHS England and Daiichi Sankyo to try to negotiate a deal that would allow them to make Enhertu available on the NHS.

Since NICE announced the pause, we’ve held meetings with NHSE and Daiichi Sankyo to stress the importance of quickly reaching a deal. We’ve continued to make sure that the people making the decisions about this drug hear from the women who so desperately need it. We supported over 30 women to send an open letter to NHSE and Daiichi Sankyo. Their message:

Knowing this treatment exists but is out of reach is so cruel. So please, do everything you can to make a deal. And do it as soon as possible. Give us hope for the future.

Problems with the NICE process

However, there’s a wider issue at play. 2 years ago, NICE made changes to the methods it uses to assess treatments end-life-modifier being replaced with a new severity modifier.

A modifier is something that can affect NICE's decision-making on whether or not they are able to recommend a treatment for use on the NHS.

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. While the end-of-life modifier was largely applied to cancer treatments, the severity modifier is much broader and applies to more diseases.

At the time, we raised concerns about the impact this change could have on cancer drugs, especially on drugs for secondary breast cancer. We’re concerned about the impact this change is having on the NICE appraisal of Enhertu. We’ve raised these concerns again with NICE, asking them to consider Enhertu as a case study when looking at the impact of this change.

Our concerns have been reiterated by the All-Party Parliamentary Group on Breast Cancer and the Health and Social Care Committee. Both have written to NHSE, NICE and Daiichi Sankyo.  They raised the issue about whether the introduction of a severity modifier was affecting the appraisal processes for some secondary breast cancer drugs.  

We’ll continue to call for NICE to publish an assessment of the impact of this change.

What’s next?

We’re still waiting to hear whether a deal has been reached by NHSE and the drug company which would enable NICE to recommend this treatment for use on the NHS in England. Wales and Northern Ireland normally follow NICE decisions.

We’ve had an amazing response so far to our work on Enhertu. Thank you to everyone who has raised awareness, responded to our call outs to share their story, and responded directly to NICE during the consultation process.

We’ll continue doing everything we can to make sure that this potentially life-extending treatment reaches those who need it, as quickly as possible. We will keep everyone updated as soon as we know more.

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