NHS watchdog blocks breast cancer drug in England

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Patients with terminal breast cancer in England will be denied access to a new treatment that has already been approved in Scotland, after a public health body said the drug did not provide value for money.

The National Institute for Health and Care Excellence announced on Tuesday that it would not approve the medication Enhertu, developed by pharmaceutical companies Daiichi Sankyo and AstraZeneca, to treat a form of advanced breast cancer that affects about half of late-stage cases.

“This is a dark day for people affected by incurable secondary breast cancer. NHS England, Nice, Daiichi Sankyo and AstraZeneca have failed people living with the disease,” said Baroness Delyth Morgan, chief executive of charity Breast Cancer Now.

About 1,000 people in England would have been eligible for the treatment, according to estimates by the watchdog and companies.

Scotland approved the drug for advanced cancer treatment in December, creating a “heartbreaking postcode lottery of access”, the charity said. The medication is also available in 13 other European countries.

Nice said it did not approve Enhertu for metastatic breast cancer with low levels of HER2, a protein that promotes growth of cancer cells, after chemotherapy. Nice provides guidance for the NHS on the value for money of treatments.

The cost-effectiveness is “above the upper end of the range Nice considers an acceptable use of NHS resources”, the body said. The drug has a list price of £1,455 per vial but is available to the NHS at an undisclosed discount.

The body recommended the drug for “HER2 positive” patients in guidance in 2021 and 2023. The latest decision follows new guidance that gives weight to drugs used for the most severe medical cases rather than a previous focus on end-of-life treatment. In Scotland, the new criteria do not apply.

“Sadly, the rigid application of a flawed methodology has here been prioritised ahead of doing what’s right for breast cancer patient,” said AstraZeneca’s UK president Tom Keith-Roach.

Daiichi Sankyo, which developed the drug with AstraZeneca and leads on marketing of the product in the UK, said it was “extremely disappointed by the decision”.

“As we have demonstrated in Scotland, it is possible to provide access to this medicine cost-effectively within the UK,” said Haran Maheson, Daiichi Sankyo UK’s head of oncology.

Enhertu is one of a new generation of cancer drugs known as antibody drug conjugates that are more targeted than traditional chemotherapy drugs.

Clinical trial data has shown the drug could double the time that a patient can live without their cancer progressing compared with traditional chemotherapy for breast cancer patients who have low levels of HER2. But Nice said the effect on patient life expectancy was not clear.

“NHS England expected drug companies AstraZeneca and Daiichi Sankyo to offer this treatment at a price that would enable Nice to recommend its use,” NHS England said.