NICE shuts out AstraZeneca's Tagrisso—and dings J&J's Stelara, too

AstraZeneca's Tagrisso took a hit at NICE, with England's cost watchdogs shutting the drug out in final guidance. (AstraZeneca)

It’s final: England won’t be covering AstraZeneca’s quick-selling Tagrisso in previously untreated non-small cell lung cancer patients with EGFR mutations.

The treatment has won global approvals on the back of data showing it could stall cancer growth for 18.9 months, compared with 10.2 months for rival meds Tarceva from Roche and Iressa from AZ. But there’s no direct evidence that it works better than Gilotrif, a med the National Institute for Health and Care Excellence (NICE) already backs.

Of course, it’s not just a matter of evidence; NICE also isn’t crazy about Tagrisso’s price. The med—which costs £5,770 for a pack of 30 tablets—doesn’t meet the gatekeeper’s criteria as an end-of-life treatment, and therefore, even with a confidential discount, NICE deemed it too expensive in its final guidance (PDF).

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RELATED: NICE shuts down AZ's Tagrisso—and backs Pfizer rival Vizimpro instead

AstraZeneca, unsurprisingly, is “very disappointed with this decision,” it said in a statement, further lamenting that “NHS patients in England and Wales will not have access to a treatment that is becoming the standard of care.”

In particular, the British drugmaker took issue with the idea that Tagrisso was excluded from end-of-life consideration. “AstraZeneca remains firm in its belief that it should have been eligible, on the basis of real-world Public Health England data showing that overall survival for patients who would be eligible for osimertinib in this setting is estimated to be less than 17 months,” it said.

AstraZeneca isn’t the only Big Pharma player to run into trouble with NICE this week. Monday, the body released draft guidance rejecting Johnson & Johnson’s Stelara in ulcerative colitis, an indication the company is leaning on for sales as psoriasis competition intensifies.

RELATED: J&J's Stelara clinches ulcerative colitis nod to back up declining Remicade

The reason for the cold shoulder? “The cost-effectiveness estimates vary from slightly below to above the range normally considered to be a cost-effective use of NHS resources,” NICE’s guidance (PDF) reads. In other words, it’s seeking a discount.

But J&J still has a chance to right the ship. NICE now has a comment period open until February 11, after which it’ll reconsider the evidence and draw up its final verdict.

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