(Bloomberg) -- England’s drug-price regulator won’t recommend AstraZeneca Plc and Daiichi Sankyo Co.’s breast cancer medicine for about 1,000 extra patients, on the grounds that it isn’t cost effective.

The drug, Enhertu, is already used in the National Health Service to treat patients with high levels of a protein called HER2 in breast tumors. However, the National Institute for Health and Care Excellence said Tuesday that it did not recommend it for advanced HER2-low breast cancer — an advanced, late-stage form of the disease — in England and Wales. 

Scotland approved the drug in December and it’s available in 13 other European countries.

NICE, as the regulator is known, published its final draft guidance after commercial negotiations ended between NHS England and Daiichi Sankyo, which holds the marketing rights in the UK.

“The cost the NHS was being asked to pay was too high in relation to the benefits it provides for it to be recommended for routine use in the NHS,” said Helen Knight, director of medicines evaluation at NICE. 

She said the decision was disappointing as the drug was a significant development, yet added there was uncertainty over cost-effectiveness and how much longer people on Enhertu live. The drug is still available for patients in England who have HER2-high breast cancer.

Read More: UK Regulators Withhold Support for Astra Breast-Cancer Drug

A US study in 2022 showed that the drug can extend the lifetime of patients with HER2-low breast cancer by about six months.

‘Devastating decision’

“This is a dark day for people affected by incurable secondary breast cancer,” said Delyth Morgan, chief executive officer at the charity Breast Cancer Now, which said it would appeal the decision. 

NICE’s verdict follows a change to how it appraises the cost-effectiveness of cancer medicines, which removed the flexibility of an extra value weighting for some treatments that extended the life of terminal patients. Now NICE uses a severity of illness measure that drug companies think is flawed.

A spokesperson for Daiichi Sankyo said it was “extremely disappointed” with the decision.

The “rigid application of a flawed methodology has here been prioritized ahead of doing what’s right for breast cancer patients in England and Wales,” said Tom Keith-Roach, Astra’s UK president. “This is a devastating decision.”

©2024 Bloomberg L.P.