NICE turns down Enhertu in “devastating” move, says charity

AstraZeneca and Daiichi Sankyo’s Enhertu should not be made available via the NHS for HER2-low metastatic or unresectable breast cancer after chemotherapy, according to provisional guidance from NICE.

The cost-effectiveness agency said that, while there is clinical evidence that Enhertu (trastuzumab deruxtecan) increases how long people with this type of cancer live, the cost of the drug means it cannot be covered by the NHS.

Baroness Delyth Morgan, chief executive of the Breast Cancer NOW patient organisation, said the draft guidance from NICE is “devastating” and will “deny patients […] of both more time to live and more time before their disease progresses.”

NICE acknowledges in its guidance that Enhertu represents a “potentially significant development” for people with this type of advanced breast cancer who currently have limited chemotherapy options and no targeted treatments available to them.

The HER2-targeting antibody-drug conjugate is already used by the NHS to treat patients with HER2-positive breast cancer after one or more prior anti-HER2 therapies, although, the cost is picked up by the Cancer Drugs Fund (CDF), which covers therapies with unproven payments on a temporary basis while additional evidence is collected.

NICE’s director of medicines evaluation, Helen Knight, said that in the latest appraisal “there were a number of uncertainties in the company’s economic model [and] this meant that, even when taking into consideration the condition’s severity and its effect on quality and length of life, the cost-effectiveness estimates were too high for it to be recommended for use in the NHS.”

Enhertu is the first drug to be approved by the MHRA for this indication, and around 1,000 patients would be eligible for treatment with it if it gets a NICE recommendation.

The agency said it has identified a number of areas for “clarification” before its next meeting on Enhertu in this type of cancer, scheduled for 7th November, and will work with license holder Daiichi Sankyo to address these.

Baroness Morgan said that the delay means that a “crucial moment to change practice” had been missed.

“We urge NICE and Daiichi Sankyo to work together to explore all possible solutions to ensure this provisional decision is reversed without delay,” she added.

“This should include NICE reviewing any additional flexibilities and the company exploring the further analyses requested, and considering scope to improve the cost-effectiveness of trastuzumab deruxtecan for use on the NHS.”

NICE’s counterpart in Scotland, the SMC, is scheduled to decide on the use of Enhertu in HER2-low breast cancer by 11th December.

Photo by Angiola Harry on Unsplash.