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UK's NICE rejects J&J's bowel disease drug Stelara in draft guidance

The U.K. National Institute for Health and Care Excellence did not recommend the use of Johnson & Johnson's Stelara for active ulcerative colitis, citing uncertainties on the drug's cost-effectiveness.

Stelara, or ustekinumab, is approved in the U.S. and EU to treat adults with moderately to severely active ulcerative colitis, as well as plaque psoriasis, psoriatic arthritis and Crohn's disease. The drug is being developed by New Brunswick, N.J.-based pharmaceutical giant's Janssen unit.

Ulcerative colitis is a chronic condition characterized by inflammation and ulcers in the bowel and rectum, which could cause bleeding and produce pus.

In its draft guidance, NICE said Stelara cannot be recommended for use in England's National Health Service as a treatment option for adults with moderate to severe active ulcerative colitis when conventional therapy or a biological agent cannot be tolerated. The drug's indication also covers patients whose disease showed inadequate or lost response to treatment.

The initial guidance was based on cost-effectiveness estimates which differ from slightly below to above the range of what the pricing watchdog considers as cost-effective, NICE noted.

Stelara has a list price of £2,147 per 130-milligram vial of concentrate for solution for infusion and £2,147 for each 90-milligram vial of solution for injection. Meanwhile, annual treatment costs are £14,482 in the induction year and £9,304 each year for maintenance treatment for the second year onward.

NICE said its draft guidance is still subject to consultation and will be open for comments and feedback until Feb. 11.