NICE approves breast cancer drug after initial refusal

A breast cancer drug, Enhertu, also known as trastuzumab deruxtecan, has been recommended by NICE for NHS use in England, following an initial rejection due to cost.

U-turn for NICE

The therapy, manufactured by AstraZeneca and Daiichi Sankyo, was reconsidered by the UK medicines body after changes were made to NICE’s cost-effectiveness methodology this year.

As part of the UK-US pharmaceutical agreement, NICE has raised its cost-effectiveness threshold for new drugs, alongside introducing a new method for assessing quality of life.

This, alongside the manufacturers agreeing to a new commercial arrangement, has allowed the drug to now be recommended for NHS use. The drug is available from today in England.

Unmet needs

Around 1,000 women with HER2-low metastatic breast cancer could benefit from the treatment.

In clinical trials, Enhertu was shown to help patients live longer, while increasing the time before their cancer gets worse compared with standard chemotherapy.

Enhertu is already available in Scotland, having been approved in 2023, as well as 26 other European countries. It also received approval in Japan yesterday.

Too expensive

The news has been welcomed by charities like Breast Cancer Now, which, alongside patients living with the disease, has spent more than two years campaigning for access to Enhertu.

“This is a momentous day for thousands of people who will now have access to a drug that could give them precious extra time with loved ones,” said Claire Rowney, CEO, Breast Cancer Now.

However, she added that the delayed recommendation was a sign of a “broken system”, with women forced to “spend precious months and years campaigning for treatments that could give them more time”.

When NICE first rejected the drug in 2024, Enhertu had a list price of £1,455 per 100mg vial. At the time, NICE said this was above the upper end of the range it considered an acceptable use of NHS resources, despite a confidential discount already in place.

The agreed price has not yet been publicly disclosed.

NICE responds to campaigners

In a statement, Helen Knight, Director of Medicines Evaluation, NICE, said: “I’m pleased that a commercial solution has meant this treatment can now be provided on the NHS.

“However, we know this decision comes too late for many families and our thoughts are with them today.”

Around 59,400 people are diagnosed with breast cancer in the UK each year, with around half of cases estimated to have low levels of HER2.