Johnson & Johnson-owned Janssen Pharmaceutica today expressed its disappointment in the National Institute of Health and Care Excellence (NICE) draft guidance not recommending its ulcerative colitis drug STELARA (ustekinumab).
The company added that it is committed to continue collaborating closely with NICE throughout the subsequent stages of the appraisal.
In a draft guidance, published Tuesday, NICE has decided not to recommend ustekinumab, within its marketing authorisation, for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment.
The committee found considerable uncertainties in the cost-effectiveness estimates but said the recommendation is not intended to affect the treatments that were started in the NHS before the publication of the latest guidance.
However, NICE made it clear that there is an unmet need for new treatment options for adults with ulcerative colitis.
Ustekinumab is already recommended by NICE as a clinically and cost-effective option for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.
“We firmly believe patients living with ulcerative colitis have the right to treatment choices that improve their lives and address their ongoing needs. This initial guidance reinforces the need for reform of existing NICE technology appraisal processes through the NICE Methods Review,” said Jennifer Lee, Director of Health Economics, Market Access & Reimbursement (HEMAR) and Advocacy, Janssen-Cilag Limited.
“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.”
The draft guidance is currently open for consultation until February 11. A second committee meeting is scheduled for February 25, and final guidance is expected to be published in May 2020.