A breast cancer charity has said it is “extremely devastated” that talks to make a life-extending drug available through the NHS to women with a terminal diagnosis have failed.
The National Institute for Health and Care Excellence (Nice) said it had failed to reach an agreement with the makers of Enhertu so it could approve its use in England and Wales.
It is the third time that talks to agree on a price for the drug have failed, meaning women with incurable breast cancer will not be able to get the drug. Enhertu has been available in Scotland since December last year and is also offered in 18 other European countries.
Wes Streeting, the health minister, had personally intervened to try to ensure that negotiations between Nice and the manufacturers, AstraZeneca and Daiichi Sankyo, would succeed.
Claire Rowney, the chief executive of Breast Cancer Now, said she was “extremely devastated” that despite Streeting’s involvement and the relentless campaign from women who could benefit from the drug, it would still remain out of reach for patients in England and Wales.
Had a deal been struck, thousands of women with incurable HER2-low secondary breast cancer would have benefited from access to it, Rowney said. “After enduring more than a year of stress, worry and anxiety, in the midst of a cost and system impasse, it is deeply heartbreaking that women in England, Wales and Northern Ireland who urgently need Enhertu are now hoping will be denied more. time to live their lives,” she said.
“That is precious time to enjoy Christmas once again 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, CEO of Nice, said: “Nice is extremely disappointed that talks to reach a pricing deal that would have made the advanced breast cancer drug Enhertu available to around 1,000 women in England and Wales have not been successful.
“As we have always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is by offering companies a fair price. We have done everything we can to achieve that.”
She thanked breast cancer activists for their efforts to reach a deal, adding: “I am sorry that 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 treatments are assessed. In their joint statement, the two pharmaceutical companies told Nice: “We are very disappointed and do not agree with the decision that Nice has taken.
“Nineteen other European countries, including Scotland and most recently Spain and Romania, have already provided routine patient access to trastuzumab deruxtecan (Enhertu) for patients with HER2-low metastatic breast cancer.
“The new Nice severity modifier incorrectly classifies HER2-low metastatic breast cancer as a ‘moderate severity’ disease and this is preventing access to patients in England, Wales and Northern Ireland.
“Nice has recognized that the design of the severity modifier will ensure that patients with metastatic cancer suffer the consequences. We are concerned that the upcoming Nice survey on social preferences will take at least another two years.
“This is too long to wait for patients, especially when there are simple changes that can be made here and now.”