Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.
Talks with AZ and Daiichi to negotiate a fair price for Enhertu for treatment of advanced HER2-low breast cancer in the U.K. have “ended without agreement,” the country’s National Institute for Health and Care Excellence (NICE) said in a media statement Tuesday.
As a result, the agency’s decision not to recommend AZ and Daiichi’s cancer-fighting antibody will remain in place. Over the summer, NICE recommended against NHS England reimbursement for the therapy.
NICE’s chief executive, Samantha Roberts, said the organization is “extremely disappointed” by the outcome of the discussions, noting that the decision deprives some 1,000 women in England and Wales of the opportunity to seek treatment with Enhertu.
“As we’ve always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is for companies to offer a fair price,” she said. “We have done all we can to try and achieve that.”
Both AZ and Daiichi said they were disappointed the outcome of the talks and disagreed with NICE's decision.
Nineteen other European countries "have already delivered routine patient access to trastuzumab deruxtecan for HER2-low metastatic breast cancer patients," the companies said in a joint statement.
The partners specifically took issue with NICE's severity modifier for diseases, arguing that the rating scale "stands in the way" of patient access in England, Wales and Northern Ireland.
In its release, NICE argued that it offered “as much flexibility as possible” in trying to come to a consensus.
Nevertheless, “despite the intervention of Secretary of State for Health Wes Streeting, the companies did not put forward a cost-effective price that would have enabled NICE to recommend Enhertu,” the drug cost gatekeeper argued.
Enhertu is the only breast cancer treatment NICE has been unable to recommend in six years, breaking a streak of 21 positive recommendations in the indication, the organization pointed out.
NICE also stood by the merits of its new calculus for determining the cost effectiveness of cancer drugs, noting that the revised policy has yielded more positive recommendations than the former approach.
Partners AZ and Daiichi first locked horns with NICE over Enhertu’s cost in July, when the watchdog issued a release noting its disappointment in the drugmakers’ refusal to offer a fair price.
At the time, NICE argued that Enhertu’s list price of 1,455 pounds sterling per vial before discounts fell “above the upper end of the range NICE considers an acceptable use” of NHS England’s resources.
Naturally, AstraZeneca didn’t agree, with the company’s CEO, Pascal Soriot, taking issue with NICE’s practice of “severity scoring” for diseases during a summer interview with Sky News.
NICE views metastatic breast cancer as a “moderately severe" disease, which makes it harder for new medicines to gain reimbursement, Soriot explained at the time.
“It looks like a technical detail, but it's very important because it drives willingness to pay,” he said.