A life-extending drug for incurable breast cancer will not be made available on the health service in England after its manufacturers and the NHS spending watchdog failed to reach an agreement on price.
The National Institute for Health and Care Excellence (Nice) said it is “deeply disappointed” it was unable to recommend trastuzumab deruxtecan – sold under the brand name Enhertu – due to company pricing.
However, the companies behind the drug said they “disagree with” the decision by the NHS spending watchdog and called for it to “evolve” the way treatments are assessed for patients in England.
The charity Breast Cancer Now said it is “devastated and angry” that patients have been “caught in the middle of a stand-off about cost and the system which is denying them precious hope of more time to live”.
Enhertu is the first licensed targeted treatment for patients with HER2-low breast cancer that cannot be removed surgically or that has spread to other parts of the body, also known as metastatic breast cancer.
It then paused its appraisal in December while commercial talks with pharmaceutical companies Daiichi Sankyo and AstraZeneca were ongoing.
In March, it was announced that the talks concluded without a price agreement in place and the treatment was blocked for widespread NHS use.
However, in May, Nice issued an exceptional pause to the publication of its final guidance, which it said would aim “to allow all parties to reach a rapid commercial solution that enables patient access to this treatment”.
Helen Knight, director of medicines evaluation at Nice, said: “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 are deeply disappointed that we are unable to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer, which breaks a sequence of 21 positive breast cancer recommendations over the last six years.
“Nice and NHS England offered as much flexibility as possible, but the companies did not put forward a new price, so we have no choice but to publish our final decision which is not to recommend the medicine in this group of patients.
“I would like to thank the breast cancer community for their hard work on this issue and I am sorry we do not have better news.”
Had Nice recommended the treatment, about 1,000 patients a year would have been eligible.
A Daiichi Sankyo and AstraZeneca statement said: “We are very disappointed by, and disagree with, the decision Nice has made.
“Nice 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.
“Eighteen other European countries, including Scotland and most recently Romania, have already delivered routine patient access to trastuzumab deruxtecan for HER2-low breast cancer patients.
“We are calling on Nice to evolve the way treatments are assessed for patients in England to create a system that appropriately recognises the severity of metastatic cancers and enables equitable access for patients in line with other countries.
“We remain committed to working with Nice to find a way forward for these patients – one that appropriately recognises the severity of this disease and the value of the medicines that target it.”
The charity’s interim chief executive Rachael Franklin added: “We are both devastated and angry that women’s lives will be shortened as a direct result of Nice, NHS England, Daiichi Sankyo and AstraZeneca failing to agree a solution that would make Enhertu available on the NHS in England for thousands of people with HER2-low secondary breast cancer.
“This was an avoidable tragedy. Patients have found themselves caught in the middle of a stand-off about cost and the system, which is denying them precious hope of more time to live – that’s time with their families and children and doing what matters most to them.
“With Enhertu available to women in so many other countries, including Scotland, it is unacceptable this promising treatment will be out of reach for women in England, Wales and Northern Ireland.”
Enhertu was approved for use on the NHS in Scotland by the Scottish Medicines Consortium (SMC) in December.
Ms Franklin said: “A deep injustice is at play here and we will continue to do all in our power to see this decision reversed.
“We have raised this situation with the new government and will continue to work with patient advocates and the hundreds of thousands of people who have backed our Enhertu Emergency campaign to press all parties to see a solution found.
“However, the heartbreaking but inescapable reality is, that these women don’t have time to wait.”
