Britain’s NICE Recommends Janssen’s Stelara as New Treatment for Crohn’s Disease

Britain’s NICE Recommends Janssen’s Stelara as New Treatment for Crohn’s Disease

The United Kingdom’s National Health Service (NHS) is about to grant access to Stelara (ustekinumab) as a new treatment for Crohn’s disease, after a positive National Institute for Health and Care Excellence (NICE) recommendation is finalized.

Stelara, developed and sold by Belgian pharmaceutical giant Janssen, will soon become available as a routine treatment option for adult Crohn’s patients who cannot tolerate or have little or no response to existing therapies.

NICE has already recommended Stelara to treat psoriasis and psoriatic arthritis, due to its mechanism of action. The drug binds to specific cell proteins, known as IL-21 and IL-23, which stop production of cytokines responsible for inflammatory response in the body.

“We are delighted to be able to recommend ustekinumab for routine NHS use. Crohn’s disease can have a debilitating impact on a person’s quality of life, from self-esteem to experiencing regular relapses,” Carole Longson, director of NICE’s Health Technology Evaluation Centre, said in a press release.  “Ustekinumab provides a convenient and viable option for patients with Crohn’s. It is a new way of treating the disease compared to conventional treatment, and can be used where other options have already been tried and stopped working.”

A final draft of the recommendation is now under review and can be appealed until June 30. Once NICE recommends a treatment as a viable option in final guidance, the NHS must ensure that the treatment is available within three months of its publication date, unless otherwise specified.

Some 132,000 people in England and Wales have Crohn’s, according to NICE estimates, and just under 28,000 of them are eligible for this treatment.

Sarah Berry, health policy and public affairs officer at Crohn’s and Colitis UK, said her organization welcomes NICE’s recommentation and praised the agency for listening to and valuing the evidence submitted by patients.

“The impact of uncontrolled symptoms of Crohn’s disease can be profoundly debilitating and current treatment options simply do not work for everyone,” Berry said. “This ruling gives access to a desperately needed additional treatment to those who may otherwise have been condemned to living with unmanageable disease progression with devastating impact on their quality of life.”