On second thought, NICE backs limits on Xtandi use

The U.K.'s National Institute for Health and Care Excellence (NICE) is known to change its mind. It did so with prostate cancer treatment Zytiga, for one, recommending the drug in 2012 after Johnson & Johnson ($JNJ) offered a new discount. But this time, Britain's cost watchdog has gone somewhat in the other direction, setting limitations on its recommendation for rival prostate cancer pill Xtandi--and maker Astellas is none too happy.

NICE issued a second draft guidance Monday night, recommending Xtandi (enzalutamide) be covered in cases where hormone-relapsed metastatic prostate cancer has progressed during a regimen with chemo drug docetaxel and--the kicker--the patient has not already been treated with Zytiga (abiraterone). That's a revision on prior guidance, which recommended that the National Health Service cover the drug in patients whose disease has progressed during or after one docetaxel-containing chemo regimen.

"Today's announcement from NICE represents a major setback for many prostate cancer patients who would otherwise be eligible for treatment with enzalutamide according to the original draft guidance and licensed indication," Astellas UK Medical Director Dr. Alan McDougall told PMLiVE.

So why the change of heart? According to the cost-effectiveness gatekeeper, it's the dearth of data. Xtandi trial data includes patients whose disease progressed during or after docetaxel treatment, but none of those patients had received Zytiga--a fact NICE felt it should highlight. "The Committee was not able to draw any conclusions about the effectiveness of enzalutamide after previous abiraterone treatment and considered it important to reflect this in its recommendations," it said in a statement.

With $157.8 million in first-half 2013 revenue after launching just the September prior, Xtandi is not exactly short on sales, and some predict it will eventually overtake the J&J drug despite Zytiga's head start in the market. But for Astellas, losing out on the pool of patients who have tried Zytiga means ceding revenues directly to its nemesis, which generated $739 million in the first 6 months of last year.

Things aren't yet set in stone, however. The public, healthcare professionals and Astellas itself will have a chance to say their piece before NICE issues final guidance, and angry nonprofits got a jump-start on the process Monday night.

"NICE is playing fast and loose with men with prostate cancer in the advanced stages of the disease who may become resistant to other treatments," Owen Sharp, chief exec at Prostate Cancer UK, told The Telegraph, noting his charity would fight the decision.

- read the release
- get more from PMLiVE
- see The Telegraph's take

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