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Over a quarter of a million people back charity petition calling for urgent solution on life-extending breast cancer treatment, as charity and campaigners say the time for action is now

A petition calling for life-extending treatment Enhertu (trastuzumab deruxtecan) to be made available on the NHS in England for women with HER2-low incurable secondary (metastatic) breast cancer, has received staggering public support from over a quarter of a million signatories.

Breast Cancer Now’s #EnhertuEmergency petition - backed by patient advocacy group METUPUK, and campaigners - is the charity’s largest ever petition – calling on NICE, NHS England, Daiichi Sankyo and AstraZeneca to urgently reach a solution to make Enhertu available on the NHS in England, for thousands of women living with secondary breast cancer, as this drug can bring them precious hope of more time to live.  

This follows on from Enhertu - the first licensed targeted treatment for HER2-low secondary breast cancer - devastatingly being rejected for use on the NHS in England in March, despite it offering women the chance of over six months longer to live.[1] NICE’s decision is likely to determine access for people in Wales and Northern Ireland too, creating an insufferable postcode lottery of access whereby the treatment is only available for use on the NHS in Scotland.[2]

Deep concern around Enhertu’s rejection prompted an urgent Health and Social Care Committee session (8 May). This meeting examined the wider impact of a change to NICE methods for evaluating health technologies – the introduction of the severity modifier – and its impact on new drugs being available on the NHS, including access for people with incurable secondary breast cancer to Enhertu.[3] 

On the same day, NICE, NHS England, Daiichi Sankyo and AstraZeneca came together with women living with HER2-low secondary breast cancer, at an All Party Parliamentary Group on Breast Cancer (APPGBC) meeting, to discuss possible solutions to make Enhertu available. Following this meeting, NICE delayed publication of its final guidance on Enhertu (previously due 15 May), allowing crucial extra time for action. 

Breast Cancer Now is urgently calling on all parties to seize the opportunity presented by the delay to NICE’s final guidance being published, by getting back around the table and finding a solution that sees Enhertu made available on the NHS in England. 

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

“Over a quarter of a million people have signed our Enhertu Emergency petition, rallying behind us and keeping up pressure and momentum in calling on NICE, NHS England, Daiichi Sankyo and AstraZeneca to get back around the table to reach a solution to ensure Enhertu is made available on the NHS in England for women who desperately need it. This must happen urgently, or women’s lives will tragically be cut short.  

“NICE’s delay to the publication of its final guidance on Enhertu creates a crucial ‘window of opportunity’ for this heartbreaking situation to be fixed now, and women with HER2-low secondary breast cancer to be granted precious hope of more time to live and to create special moments that matter.

“Beyond doing the right thing for women who need NHS access to Enhertu right now, an urgent review by NICE of the impact of its new methods for evaluating drugs is critical to ensuring we guard against access to a drug being blocked when it could have been approved on NHS.”

Jo Taylor, Founder of METUPUK, a metastatic breast cancer patient advocacy group, said:

“There is a huge public outcry with the petition and after a quarter of a million signatures, this shows that there is concern that patients are not getting the treatments that they need to live. Tragically, these women - who deserve the hope of more time to live - are not being supported. There has been a pause in the publication of the guidelines, and we must urge NHS England and pharma to come back around the table and make sure that there is a viable solution to make Enhertu available for patients in England, Wales and Northern Ireland and stop the inequalities.”

“METUPUK with our Metastatic May campaign will still focus on the severity modifier as we know that this is having a detrimental effect on drug approvals, and we do believe that the change in the NICE system from End Of Life criteria to severity modifier has created a system that is not fit for purpose and we must challenge this and get the best for our patient community.” 

Tracy Pratt, 52, from Tydd St Mary, Lincolnshire, has worked as a nurse for the NHS for over 30 years, and was diagnosed with HER2-low secondary breast cancer in November 2022 after experiencing upper back pain. She is one of the thousands of women who have been denied access to the life-extending drug, Enhertu.[4] Talking about the urgent need for Enhertu, Tracy said:

“When I heard the news that it had been rejected for use on the NHS, I was in shock. I quickly went through a wide range of emotions – disbelief, sadness, anger, disappointment. I cried, I felt completely let down and lost, sad for me, sad for my family and sad for everyone else in the secondary breast cancer community, that this decision affects.

“Enhertu would give me more quality time to enjoy my life with my family and friends. More time to live with secondary breast cancer. It would give me more time to travel and continue to work as a nurse. Ultimately it would give me hope.

“This decision does not just affect us living with secondary breast cancer now but also those that will develop it in the future. The reality is that the decision is likely to affect you or someone you love in the future. This decision must be reversed.”

Mandie Stevenson, 34, from Falkirk, has accessed Enhertu in Scotland. Talking about the importance of Enhertu being made available for all women who need it, Mandie said:

“I have had the most amazing year whilst receiving Enhertu, being able to focus on enjoying life again, which for me is simply the joy of living well.

“Prior to receiving this game changing treatment I was very poorly; my body was giving up on me and I feared the worst. Thankfully my body responded well to Enhertu and instantly it enabled me to grab life with both hands and make a lot of special memories with family and friends. These precious extra months and with such a high quality of life is something a price cannot be put on.

“I felt extremely disappointed and saddened at the awful inequality when I read the remainder of the UK are being denied this vital lifeline. I am really passionate about being able to show I am living proof of how excellent Enhertu is. Breast Cancer Now is really driving the Enhertu Emergency campaign forward and I am delighted to play a small part in this. Everyone in the UK deserves access to this fantastic treatment and hopefully the right decision will be made.”

To join our call on NICE, NHS England and the drug companies Daiichi Sankyo and AstraZeneca, to do everything possible to find a solution that makes Enhertu available on the NHS, please sign and share our petition: https://action.breastcancernow.org/enhertu-emergency-sign-petition

ENDS

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. https://breastcancernow.org/about-us/media/press-releases/dark-day-as-life-extending-drug-blocked-from-nhs-use-in-england/

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).

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

[3] 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.

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

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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