Remember the groundbreaking HER2-low data for AstraZeneca and Daiichi Sankyo’s Enhertu that garnered a standing ovation at the ASCO meeting last year? England’s cost watchdog now thinks the med’s efficacy doesn’t justify its price.
Enhertu is not recommended for National Health Service coverage for treating HER2-low metastatic or unresectable breast cancer after chemotherapy, the National Institute for Health and Care Excellence (NICE) said in draft guidance (PDF).
NICE’s opinion comes as a surprise given Enhertu’s impressive clinical data, which the agency recognized in its evaluation. But the HER2-targeted drug’s cost-effectiveness isn’t acceptable for the use of NHS resources, a NICE appraisal committee said in the document.
Enhertu bears a list price of £1,455 per vial, and AZ and Daiichi have offered a confidential discount, which already applies to the drug’s use in previously treated HER2-positive breast cancer. Instead of broad coverage in that use, Enhertu is made available through a cumbersome managed access program under the Cancer Drugs Fund.
The decision to not cover Enhertu in HER2-low disease is “disappointing,” a Daiichi spokesman in the U.K. said in a statement to Fierce Pharma. AZ and Daiichi are “committed to working with NICE to provide the further analyses requested during consultation and will continue to focus on working towards a solution to support patient access in this indication,” the spokesman added.
NICE’s recommendation for the HER2-low use isn’t final. The Enhertu docket is now open for comments, and the evaluation committee will meet again on Nov. 7. As the process plays out, AZ and Daiichi might have to offer a steeper discount to change NICE’s mind.
After a groundbreaking trial result, Enhertu opened the HER2-low category, which was previously counted as a subset of HER2-negative cancer. About 1,000 people with this type of cancer would have been eligible for Enhertu had NICE recommended it, according to the agency.
The antibody-drug conjugate represents “a potentially significant development” for patients, Helen Knight, director of medicines evaluation at NICE, said in a statement Tuesday.
In the DESTINY-Breast04 trial, Enhertu reduced the risk of death by about 40%—or the risk of progression or death by 50%—compared with the physician’s choice of chemotherapy. The NICE committee concluded that Enhertu can delay disease progression and improve overall survival in this HER2-low population.
NICE and the drugmakers were divided on Enhertu’s economic model, Knight noted. NICE is challenging AZ and Daiichi on topics such as how much drug in a vial would go to waste, the administration cost and time on treatment.
In his statement, the Daiichi spokesman said the drugmakers are concerned that NICE’s recently adopted methods may underestimate the severity of this disease.
“We urge NICE to consider flexibility when evaluating disease severity in end of life medicines to ensure timely patient access to innovative cancer treatments,” the spokesman said.
The HER2-low indication has been driving Enhertu’s growth since a landmark FDA approval in August 2022. For 2023, Daiichi Sankyo expects Enhertu to more than double its sales year over year to reach 320 billion Japanese yen ($2.34 billion), the company said in July.