The National Institute for Health and Care Excellence (NICE) has now issued a positive Final Appraisal Document (FAD) recommending Janssen's Stelara (ustekinumab) as an option for treating ulcerative colitis, having initially rejected the drug earlier this year.
Specifically, NHS funding is being approved for the drug's use to treat moderately to severely active ulcerative colitis (UC) in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if: a tumour necrosis factor (TNF)-alpha inhibitor has failed, cannot be tolerated, or is unsuitable.
Stelara is the first biologic therapy for UC that targets interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses, offering a new mechanism of action for treating the condition.
The drug is already recommended by NICE as a clinical and cost-effective option for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.
Around 146,000 people in the UK have UC. It is a chronic immune-mediated inflammatory disease affecting the rectum and large intestine, for which there is currently no cure.
“We are delighted that NICE revisited its decision and will now recommend ustekinumab for use in ulcerative colitis, as it is in Crohn’s disease. The impact of uncontrolled symptoms of ulcerative colitis can be devastating and debilitating. Current treatments simply do not work for everyone, so having as many treatment options as possible available, and allowing doctors and other clinicians to personalise their approach, is critical,” commented Sarah Berry, health service project manager, Crohn’s & Colitis UK.
“The decision from NICE reflects the true patient and clinical need for new treatment options for patients living with moderately to severely active ulcerative colitis,” added Jennifer Lee, EMEA Therapy Area Market Access Lead for Immunology, Janssen-Cilag Limited.
Stelara was accepted for use by NHS Scotland back in April.