After a prior skirmish over tax policy in England, AstraZeneca is now butting heads with officials in the country over innovative drug access.
In a decision released Monday, England’s National Institute for Health and Care Excellence (NICE) said it’s “disappointed” that AstraZeneca and its antibody-drug conjugate partner Daiichi Sankyo won’t “offer a fair price” on Enhertu to treat advanced HER2-low breast cancer.
At a list price of 1,455 pounds sterling per vial before any discounts, NICE’s cost-effectiveness estimate found that Enhertu falls “above the upper end of the range NICE considers an acceptable use" of NHS England’s resources, according to the agency's guidance document (PDF).
The determination means that about 1,000 patients in England and Wales won’t be able to access Enhertu, while others in places such as the U.S. and European nations can benefit from the drug.
“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, said in a statement.
AstraZeneca naturally sees things differently. Speaking with Sky News, CEO Pascal Soriot took issue with NICE’s practice of “severity scoring” for diseases. As he explained to the news outlet, NICE views metastatic breast cancer as a “moderately severe disease,” which raises the bar for new medicines to gain reimbursement.
“It looks like a technical detail, but it's very important because it drives willingness to pay,” Soriot told Sky News.
For its part, NICE noted that Enhertu is the first breast cancer therapy it has been unable to approve in 6 years. The rejection breaks a streak of 21 consecutive breast cancer recommendations, according to the agency.
Despite the current standstill, NICE said it will review the drug again under a “rapid review” process if the companies opt to reduce the price.
The Monday decision follows draft guidance recommending against Enhertu's reimbursement in this use in September.
Meanwhile, this isn't the first time AstraZeneca has publicly clashed with U.K. on policy grounds. Notably, Soriot last year said the country's "discouraging" tax rate drove AstraZeneca's decision to build a manufacturing plant in nearby Ireland. But then in a sign that tensions had eased, AstraZeneca this year pledged £650 million in investments in its home country.
At the time of AZ's investment announcement, Chancellor Jeremy Hunt touted the decision as a "vote of confidence in the attractiveness of U.K. as a life sciences superpower."