A breast cancer charity has said it was “beyond devastated” that talks to make a life-extending drug available on the NHS to women with a terminal diagnosis have collapsed.
The National Institute for Health and Care Excellence (Nice) said it had not been able to reach agreement with the makers of Enhertu so that it could approve its use in England and Wales.
It is the third time that talks to try to agree a price for the drug have failed, which means that women with incurable breast cancer will not be able to obtain it. Enhertu has been available in Scotland since last December and is also provided in 18 other European countries.
Wes Streeting, the health secretary, had personally intervened to attempt to ensure that negotiations between Nice and the manufacturers, AstraZeneca and Daiichi Sankyo, succeeded.
Streeting said: “We know how disappointing it will be for many families that we have not been able to reach an agreement to offer this on the NHS. I understand that both Nice and NHS England have offered unprecedented flexibilities in negotiations.
“Enhertu is the first breast cancer treatment that Nice has been unable to recommend in over six years, a period in which it approved 21 other treatments for the disease. Our door remains open to support the development of medicines at a cost-effective price which can bring benefits to patients across our country.”
Claire Rowney, the chief executive of Breast Cancer Now, said that she was “beyond devastated” that, despite Streeting’s involvement and relentless campaigning by women who could benefit from the drug, it would still remain out of reach for patients in England and Wales.
If a deal had been struck, thousands of women with incurable HER2-low secondary breast cancer would have benefited from access to it, Rowney said. “Having endured over a year of stress, worry and fear, caught in the middle of a standoff 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,” she said.
“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.”
Nice would have made the drug available almost immediately if a price had been agreed. Dr Samantha Roberts, Nice’s chief executive, said: “Nice is extremely disappointed that talks to reach a price agreement that would have made advanced breast cancer drug Enhertu available to about 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 to achieve that.”
She thanked breast cancer campaigners for their efforts to help strike a deal, adding: “I am sorry the outcome was not what we, nor they and the patients they represent, expected.”
A spokesperson for AstraZeneca and Daiichi Sankyo said they disagreed with Nice’s decision not to recommend it and urged the regulator to “evolve” the way it assessed treatments. In their joint statement the two drug companies hit out at Nice, saying: “We are very disappointed by, and disagree with, the decision Nice has made.
“Nineteen other European countries, including Scotland and most recently Spain and Romania, have already delivered routine patient access to trastuzumab deruxtecan [Enhertu] 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.”