Breast cancer drug Enhertu blocked for NHS use after third round of talks

Women in England and Wales with incurable breast cancer have been dealt a blow as they will not gain access to a potentially life-extending drug via the NHS, after the failure of negotiations over pricing for the third time between the health service's spending watchdog and the drug's manufacturer. The National Institute for Health and Care Excellence (Nice) has expressed its "extremely disappointed" stance at being unable to recommend trastuzumab deruxtecan, known by the brand name Enhertu.

It was revealed that Nice was poised to permit patients' access to this treatment within days, should a price agreement be reached. In response to the decision, representatives for AstraZeneca and Daiichi Sankyo, the producers of Enhertu, voiced their disagreement with the recommendation and urged Nice to "evolve" its methods for assessing such treatments.

This development follows the Health Secretary Wes Streeting’s meeting with representatives from Breast Cancer Now about Enhertu-related concerns. On October 24, he shared on X, previously known as Twitter: "An improved offer, brought to the table by the manufacturers, is the fastest way to get this life-extending drug to patients."

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Enhertu represents the first approved therapeutic specifically targeting HER2-low breast cancer that has either spread to other body parts or cannot be surgically removed; known also as metastatic breast cancer.

If Nice had endorsed this medication, around 1,000 patients per annum would have qualified for treatment. .

The National Institute for Health and Care Excellence (Nice) has announced that negotiations with the manufacturer of the breast cancer drug Enhertu have broken down for the third time. Nice had previously expressed concerns about the high price of the treatment and had requested more information from the manufacturer.

Despite a series of talks, an agreement on a fair price could not be reached. The news has been met with disappointment, with Nice's chief executive, Dr Samantha Roberts, stating that the organisation is "extremely disappointed" that a deal could not be reached.

The charity Breast Cancer Now has also expressed its devastation at the outcome, which means that around 1,000 women in England and Wales will not have access to the treatment. Dr Roberts said: "Nice is extremely disappointed that talks to reach a price agreement that would have made advanced breast cancer drug Enhertu available to around 1,000 women in England and Wales have not been successful."

"As we’ve always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is for companies to offer a fair price. We have done all we can to try and achieve that."

Claire Rowney, chief executive of Breast Cancer Now, said the charity is "beyond devastated".

"We welcomed the Secretary of State’s clear support for finding a solution to make Enhertu available on the NHS in England and so, given today’s decision, are requesting his immediate clarification on how this could be achieved," she added. "Having endured over a year of stress, worry and fear, caught in the middle of a stand-off about cost and the system, it’s utterly heartbreaking that women in England, Wales and Northern Ireland who desperately need Enhertu, will now be denied the hope of more time to live their lives – that’s precious time to enjoy another Christmas with families and children, and to create special moments that matter most to them. This is an avoidable tragedy."

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

Ms Rowney said: "With Enhertu available to women in Scotland, and 18 other European countries, a deep injustice is at play here and we’re devastated that the opportunity to put this right has been missed."

"No-one should ever be in a position of considering moving to another country as the only way to access a life-extending treatment."

"The heartbreaking but inescapable reality is, these women don’t have time to wait, and lives will be cut short."

A statement from AstraZeneca and Daiichi Sankyo said: "We are very disappointed by, and disagree with, the decision Nice has made."

The statement read: "Nineteen other European countries, including Scotland and most recently Spain and Romania, have already delivered routine patient access to trastuzumab deruxtecan for HER2-low metastatic breast cancer patients."

"The new Nice severity modifier misclassifies HER2-low metastatic breast cancer as a ‘medium severity’ disease and this stands in the way of patient access in England, Wales, and Northern Ireland."

"Nice has acknowledged that the design of its severity modifier will see patients with metastatic cancer lose out. We are concerned that Nice’s upcoming research into societal preferences is set to take at least another two years to conclude."

"This is too long to wait for patients- especially when there are simple changes that could be made here and now."

"We are calling on Nice to evolve the way treatments are assessed for patients in England and Wales to create a system that enables equitable access for patients in line with other countries."

"We remain committed to finding a way forward for patients – one that appropriately recognises the severity of this disease and the value of the medicines that target it."

An NHSE spokesperson expressed disappointment, stating: "We are deeply disappointed that around 1,000 eligible women with secondary breast cancer will not be able to benefit from Enhertu on the NHS in England – our clinicians desperately want to treat all patients with the latest advances in medicine and today’s outcome denies them this chance."

"Drug companies AstraZeneca and Daiichi Sankyo offering a fair price for the NHS and taxpayers was the only way to enable NICE to approve this drug and their refusal to do so has created a result today that will feel extremely unfair to many."

"Working with the National Institute for Health and Care Excellence, NHS England has done everything possible to secure access for patients and we recognise the distress that this outcome will cause for affected women, their loved ones – but the door remains open to companies to offer a fair price and enter a new NICE evaluation."