NICE does not recommend Stelara to treat Ulcerative Colitis.- Janssen

The National Institute for Health and Care Excellence (NICE) has released a draft guidance not recommending Janssen’s Stelara (ustekinumab) for moderately to severely active ulcerative colitis in adults. Although there is an unmet need for new, non-surgical treatment options because many people have an inadequate response to current therapies or they stop working, NICE stated there is considerable uncertainty about the cost-effectiveness estimates for the drug.

The NICE decision was due to uncertainty about Stelara’s clinical and cost-effectiveness. The appraisal consultation document (ACD) states that although clinical evidence suggested that Janssen’s drug is more effective than placebo for treating moderate to severe UC, its superiority to existing therapeutics options were very uncertain beyond eight weeks of treatment.

NICE said that it already recommends several treatment options for when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment.