The United Kingdom’s drug pricing watchdog has officially declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu for HER2-low breast cancer in the UK, noting that the companies were “unwilling” to offer a fair price.
Enhertu is the first breast cancer treatment not to win a positive NICE opinion in six years, meaning it won’t be recommended for the UK’s government-funded healthcare system, the National Health Service. The decision follows negative draft guidance issued last year and negotiations with NHS.
“NICE and NHS England offered as much flexibility as possible, but the companies did not put forward a new price, so we have no choice but to publish our final decision which is not to recommend the medicine in this group of patients,” NICE’s director of medicines evaluation Helen Knight announced on Monday alongside the final guidance.
Enhertu is the UK’s first licensed treatment for HER2-low breast cancer, a newly defined subset of patients who were previously classified as HER2-negative. HER2-low patients have some HER2 proteins, but not enough to be classified as HER2-positive. NICE said it accounted for “innovation and uncaptured benefits” in its assessment, and estimated that about 1,000 HER2-low patients in the UK would have been eligible for treatment with Enhertu.
AstraZeneca and Daiichi Sankyo blasted the decision on Monday, noting that 18 other European countries have provided routine access to Enhertu, including Scotland and Romania. Global sales of Enhertu, recorded by Daiichi and AstraZeneca, amounted to $2.6 billion in 2023.
They blamed the decision on NICE’s new process for appraising medicines introduced in 2022. The new formula “misclassifies HER2-low metastatic breast cancer as a ‘medium severity’ disease and this stands in the way of patient access in England, Wales, and Northern Ireland,” the companies told Endpoints News in separate statements.
“At the end of the day, it is not a question of price. The price we have offered is a very competitive price, so much so that we have reimbursement in many countries around the world,” AstraZeneca CEO Pascal Soriot said last Thursday on the company’s second-quarter call with investors. “It is a question of the methodology that NICE is using, in particular the severity scoring.”
AstraZeneca and Daiichi Sankyo both called on NICE to “evolve the way treatments are assessed for patients in England to create a system that appropriately recognises the severity of metastatic cancers.”