UK drug pricing watchdog declines to recommend AstraZeneca's COVID therapy Evusheld
Christopher Furlong

The U.K.'s National Institute for Health and Care Excellence (NICE) said in its draft guidance that it was not recommending AstraZeneca's (NASDAQ:AZN) Evusheld for vulnerable adults who are at high risk of severe COVID-19 as there was not enough evidence of the therapy's effectiveness against current variants and those likely to be circulating in the next six months.
The U.K.'s drug pricing watchdog's decision comes after last monthâs decision by the U.S. FDA to withdraw its emergency use authorization for Evusheld in the U.S. due to lack of efficacy against newly dominant COVID variants.
NICE said that recent studies done in laboratories report that Evusheld (tixagevimab plus cilgavimab) is unlikely to prevent infection with most of the relevant variants in the appropriate time period for this evaluation (January 2023 and the 6 months after).
The agency added that limitations in the clinical evidence mean that it is not possible to make a reliable cost effectiveness estimate and Evusheld is unlikely to be an acceptable use of U.K.' National Health Service's (NHS) resources, thus it is not recommended.
NICE's committee noted that Evusheld did show some effectiveness against some older Omicron variants in the in vitro studies. However, the studies showed that the drug did not work against the current common and fastest growing variants in the U.K.
In addition, NICE said that it is developing a new review process to update recommendations on the cost-effectiveness of COVID-19 treatments so they can be made available more quickly to patients if they show promise against new variants and are found to be cost-effective.
"The rapidly evolving nature of COVID-19 means we need to have a way of establishing the cost effectiveness of existing medicines against current variants in an agile way. That is why we are developing a process to monitor real world data and re-evaluate the medicines as needed against that data in a faster way than we currently do for other drugs. The ambition is that we will be able to produce updated recommendations in as little as 6 to 8 weeks from receiving a positive signal of effectiveness," said Helen Knight, director of medicines evaluation at NICE.
NICE said that the draft guidance is open for public consultation until March 9 and the committee will consider any comments received at a meeting, which will take place on April 4.
COVID therapy Evusheld had generated sales of $734M in Q4.
AZN -0.72% to $69.19 premarket Feb. 16