AstraZeneca's chief exec publicly criticized the U.K.'s tax policies last month, but that didn't stop officials there from backing the company's key asthma launch.
England's National Institute for Health and Care Excellence (NICE) has issued final draft guidance in support of AstraZeneca and Amgen's Tezspire as a maintenance treatment for people 12 and older with severe asthma. Pending a final signoff, the drug looks set to be available to tens of thousands of severe asthma sufferers in England.
NICE said it supports usage of the drug in cases where patients aren't getting adequate relief from high-dose inhaled corticosteroids and another asthma maintenance therapy. Tezspire is recommended only for people who have had three or more exacerbations in the last year or for those who are on maintenance oral corticosteroids.
The guidance comes amid a review process that started in the spring of 2021, according to NICE's website. Tezspire won approvals in the U.K. and Europe in September 2022. The asthma biologic won an FDA endorsement in late 2021.
AstraZeneca and Amgen updated their global collaboration around the drug back in 2020. Under their deal, AstraZeneca is leading development, while Amgen is leading manufacturing. Both companies jointly market the drug in North America. Outside of the U.S., AZ is recording sales while Amgen is recording its share of profit under its "collaboration revenue" category on its financial reports.
NICE reviewers found that the drug "reduces exacerbations and the dose of oral corticosteroids" that patients require compared with placebo. Tezspire looks similarly effective to other biologics, the agency said, though it acknowledged some uncertainty on that point.
On cost effectiveness, the reviewers found that the drug provides value when used as an add-on maintenance therapy. AstraZeneca offered a confidential discount on the med's 1,265 pounds sterling ($1,560) per vial list price to secure the coverage. The company estimates that around 60,000 people will be eligible for treatment, according to NICE.
With its launches on both sides of the Atlantic, Tezspire is challenging other biologics including Sanofi and Regeneron's Dupixent, which snagged a NICE recommendation in severe asthma in the fall of 2021. In the U.S., Dupixent won an FDA label expansion in asthma in 2018.
At the time of Tezspire's FDA approval in December 2021, analysts pegged the drug to become a blockbuster later this decade.
For AstraZeneca, the NICE endorsement marks a bit of good news after CEO Pascal Soriot criticized the country's "discouraging" tax rate last month. Speaking to reporters on a conference call, Soriot said the company chose to build a factory in Ireland because of the U.K.'s punitive tax code.