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‘Dark day’ as life-extending drug blocked from NHS use in England

A vital treatment offering precious hope of more time to live for people with incurable secondary breast cancer, has been rejected for use on the NHS in England.

The devastating decision will deny thousands of women access to Enhertu (trastuzumab deruxtecan), the first licensed targeted treatment for HER2-low secondary breast cancer.[1] Crucially, the drug could offer people both more time to live and more time before their disease progresses, compared to chemotherapy.[2]

It comes after the provisional rejection of the drug in September left women enduring months of deep anxiety and uncertainty about whether they’d get the treatment they so desperately need.

Today’s decision in England now leaves a heartbreaking postcode lottery of access, following the approval, in December, of Enhertu for use on the NHS in Scotland. Of grave concern, is, this decision could also determine whether people in Wales and Northern Ireland will be able to access this vital treatment.[3]

Breast Cancer Now warns that lives will be cut short unless NICE, NHS England, Daiichi Sankyo and AstraZeneca get back round the table and find a solution. This rejection could also be a troubling sign of things to come without an urgent review of the impact of a recent change to a critical element of the NICE methods for evaluating health technologies - the severity modifier.[4]

The charity is looking to appeal today’s decision, and is making another plea to NICE, NHS England, Daiichi Sankyo and AstraZeneca to do everything possible to make this treatment available on the NHS.

Baroness Delyth Morgan, chief executive at Breast Cancer Now said:

“This is a dark day for people affected by incurable secondary breast cancer. NHS England, NICE, Daiichi Sankyo and AstraZeneca have failed people living with the disease. They’ve blocked a vital treatment that offers hope of more time to live for thousands of people with a certain type of secondary breast cancer.

“This means that thousands of mums, daughters, sisters, wives, colleagues, and friends who want to be there and create special memories, now face the unbearable reality of knowing a treatment that could have been a lifeline for them exists, but remains out of reach, while women in Scotland have been granted access.

“Neither we, nor people affected by secondary breast cancer will walk away. NICE, NHS England, Daiichi Sankyo and AstraZeneca must not either - they must come back to the table, and a solution found that puts women with secondary breast cancer first. NHS England must do all they can to be flexible and help deliver their continued commitment to getting the latest cutting-edge drugs to patients. Daiichi Sankyo and AstraZeneca must ensure they are doing everything possible to price the drug at a cost that is fair to the NHS.

"Underlying this all is the fact that, without an urgent review by NICE of the impact of its new methods for evaluating health technologies, we risk being left with a broken system which denies secondary breast cancer patients access to potentially life-extending medicines that may have previously been approved on the NHS.

“Join us and call for this life-extending drug to be made available on the NHS before it’s too late, it’s an #EnhertuEmergency.”

Sign Breast Cancer Now’s #EnhertuEmergency petition to NICE, NHS England, Daiichi Sankyo and AstraZeneca now


Notes to editors

[1] Trastuzumab deruxtecan (Enhertu) has been rejected for use on the NHS in England for treating HER2-low secondary (metastatic) or unresectable (cannot be removed by surgery) breast cancer after chemotherapy. It is the first treatment licensed for HER2-low breast cancer. 

It is estimated that around 1,000 people would be eligible for treatment with trastuzumab deruxtecan in England each year.

[2] Clinical trial DESTINY-Breast 04 found that Enhertu offered an additional 4.8 months of progression free survival than chemotherapy (median 9.9 months for trastuzumab deruxtecan compared to 5.1 months for chemotherapy) and an additional 6.4 months of overall survival (median 23.9 months for trastuzumab deruxtecan versus 17.5 months for chemotherapy).

[3] This decision will also impact people in Wales and Northern Ireland as they normally follow NICE decisions. 

[4] In 2022 NICE, published its new methods and process manual which sets out how medicines and health technologies will be evaluated. As part of this, a severity modifier was introduced replacing the end-of-life modifier which had been part of NICE’s methods since 2009. A ‘modifier’ can be taken into account during decision-making and can apply extra weight for severe diseases. Breast Cancer Now is concerned about the impact this change may have had on the appraisal of Enhertu.

About HER2-low

HER2-low is a newly classified subgroup of breast cancer previously considered HER2-negative. People with HER2-low secondary or unresectable breast cancer have cancer cells with low amounts of HER2.

All invasive breast cancers are tested for HER2 (human epidermal growth factor receptor 2) levels. Some breast cancer cells have a higher than normal level of HER2 on their surface, which stimulates them to grow.

There are various tests to measure HER2 levels. IHC (immunohistochemistry) is usually done first. It’s reported as a score of 0-3*.

Historically, patients usually find out whether their breast cancer is HER2 positive or HER2-negative. HER2 positive breast cancers can be treated with HER2-targeted therapies such as pertuzumab (Perjeta), trastuzumab deruxtecan  (Enhertu), trastuzumab emtansine (Kadcyla).

Around one in five invasive breast cancers are HER2 positive. Those whose breast cancer has lower levels of HER2 have always been considered HER2 negative and are not eligible for HER2 targeted treatments. Instead they would be treated according to their hormone receptor status or whether they are triple negative.

But now, within the HER2 population, there are breast cancers which have low levels of HER2 expression which are now being termed HER2-low rather than HER2-negative.

*Historically, a score of 0 or 1+ means the breast cancer is HER2 negative. A score of 2+ is borderline and a score of 3+ means the breast cancer is HER2 positive. Breast cancers with borderline results should be retested using more specialised techniques. This is called an in situ hybridization (ISH) test.

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