NICE recommends Janssen's first-of-its-kind Crohn's drug Stelara

Janssen has announced that it has secured recommendation from NICE for Stelara (ustekinumab) in the indication of moderately to severely active Crohn’s disease in adults who have proved unresponsive to conventional therapy or a TNFα inhibitor.

Stelara presents a new mechanism of action to previous therapies in the indication, as the first human monoclonal antibody for Crohn’s disease to target the interleukin (IL)-12 and IL-23 cytokines. While the drug is now set to be used on the NHS in England and Wales, NICE’s recommendation specifies that Stelara should be offered as a one option among a range of potential treatments.

“The choice of treatment between ustekinumab or another biological therapy should be made on an individual basis after discussion between the patient and their clinician about the advantages and disadvantages of the treatments available,” the recommendation reads. “If more than one treatment is suitable, the least expensive should be chosen (taking into account administration costs, dosage and price per dose).”

Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK, commented on the news of the drug’s recommendation: “We are delighted with today’s recommendation from NICE. We know that people living with Crohn’s disease are in real need of additional treatment choices where other traditional treatments have failed. Therapies with a unique mode of action can be life-transforming for people living with this debilitating condition who have had problems with other treatments or are facing surgery. The clear guidance set out by NICE means that physicians can make informed decisions with their patients.”

Matt Fellows