Janssen’s ulcerative colitis medicine not recommended by NICE for use in adults
pharmafile | January 21, 2020 | News story | Manufacturing and Production | IBS, Irrated Bowels, NHS, NICE, bowel, ulcerative colitis
NICE has published draft guidance which does not recommend Stelara (ustekinumab) for treating moderately to severely active ulcerative colitis in adults, due to concerns about cost-effectiveness.
Stelara would have been given when conventional therapy or a biological agent could nnot be tolerated or the disease responded inadequately or lost response to treatment.
Jennifer Lee, Director of Health Economics, Market Access & Reimbursement (HEMAR) and Advocacy at Janssen, said: “If NICE’s decision is upheld, approximately 15,000 people in the UK living with moderately to severely active UC who may be eligible for treatment with ustekinumab, would potentially not have access to an important new treatment option.
“This initial guidance reinforces the need for reform of existing NICE technology appraisal processes through the NICE Methods Review. We will continue to collaborate closely with NICE throughout the subsequent stages of this appraisal as we believe ustekinumab should become routinely available as an alternative treatment option.”
Clinical trials showed that Stelara is more effective than a placebo in treating the disease. Indirect comparisons suggest it may be more effective than current treatments for some people, but this was not conclusive.
But ultimately Stelara could not be recommended because of considerable uncertainty about the cost-effectiveness estimates, which vary from slightly below to above the range normally considered to be a cost-effective use of NHS resources. The annual treatment costs are £14,482 in the induction year, and £9,304 per year for maintenance treatment.
NICE already recommends several treatment options for when conventional therapy or a biological agent cannot be tolerated.
However, NICE’s technology appraisal committee were told there is still an unmet need for new, non-surgical treatment options because many people have an inadequate response to current therapies.
Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the bowel and rectum which can bleed and produce pus. It affects about 1.6 million people in the US.
Conor Kavanagh
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