The National Institute for Health and Care Excellence (NICE) has released a draft guidance not recommending Janssen’s Stelara (ustekinumab) for moderately to severely active ulcerative colitis in adults.
Despite there being an unmet need for new, non-surgical treatment options because many people have an inadequate response to current therapies or they stop working, the organisation said there is considerable uncertainty about the cost-effectiveness estimates for the drug.
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.
If approved, Stelara would be used when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment.
The annual treatment costs are £14,482 in the induction year, and £9,304 per year for maintenance treatment, but the company has agreed a confidential pricing arrangement for the drug with the Commercial Medicines Unit.
However, NICE 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.
Janssen has responded to the decision, welcoming NICE’s recognition of unmet need, but also stating: “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.”
Jennifer Lee, director of health economics, market access & reimbursement (HEMAR) and advocacy continued to say, “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. 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.”
In December last year, The European Medicines Agency (EMA)’s human medicines committee (CHMP) suggested an extension for Stelara, after it garnered positive results in moderately to severe ulcerative colitis back in October.
Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the bowel and rectum, with around 146,000 people in the UK living with the condition.
