AstraZeneca's Enhertu Becomes First Breast Cancer Drug in Six Years Denied Approval in England

The UK's renowned MNC AstraZeneca is once again at odds with the British government.

Previously, AstraZeneca had a minor conflict in the UK regarding tax policies. Now, AstraZeneca is again at odds with British officials over the issue of access to innovative drugs.

In a decision announced on Monday, the UK's National Institute for Health and Care Excellence (NICE) said it was "disappointed" that AstraZeneca and its antibody-drug conjugate partner Daiichi Sankyo did not offer a "fair price" for Enhertu to treat advanced low HER2 breast cancer.The guidance from NICE shows that the list price of Enhertu is £1,455 per vial (without any discount), and its cost-effectiveness analysis found that Enhertu "exceeds the upper limit of what NICE considers an acceptable use range."At the same time,In September last year, NICE stated in the draft guidelines that Enhertu is not recommended for the treatment of metastatic or unresectable breast cancer with low HER2 expression after chemotherapy., although the HER2 low-expression indication has been driving the growth of Enhertu since HER2 received the FDA's landmark approval in August 2022.

Of course, the main issue is the price. The two owners of the drug have indicated they can offer a confidential price discount, but this also doesn't seem to move NICE.The UK's cost watchdog now believes that the efficacy of the drug does not justify its price.

NICE pointed out that Enhertu is the first breast cancer treatment drug that has failed to gain approval in six years.According to the agency, this rejection breaks a streak of 21 consecutive recommendations for breast cancer. This means that in the Western world, currently only about 1,000 patients in England and Wales are unable to access this drug.

"NICE and the NHS have offered as much flexibility as possible, but with no new price offers from the companies we had no choice but to publish our final decision not to recommend the drug in this group of patients," Helen Knight, NICE's director of medicines evaluation, said in a statement.

Although currently stalled, NICE said that if these companies choose to cut prices, it would review the drug again under a "rapid review" process.

And now, NICE has chosen to follow the previous document, and they have refused to give the green light to Enhertu.

AstraZeneca naturally has a different perspective. During an interview with Sky News, CEO Pascal Soriot questioned NICE's practice of assigning a "severity score" to diseases. As he explained to the press, NICE considers metastatic breast cancer to be a "moderately severe condition," which raises the bar for new drugs to receive reimbursement.

Notably, this is not the first time AstraZeneca has publicly clashed with the UK over policy issues. Soriot stated last year that the UK's "disappointing" tax rates prompted AstraZeneca to decide to build a manufacturing plant in neighboring Ireland.But tensions between the pharmaceutical company and the government have eased after AstraZeneca pledged to invest £650 million in the UK this year.

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