The Scottish Medicines Consortium (SMC) has accepted guselkumab for the treatment of adults with moderately to severely active Crohn’s disease and ulcerative colitis, making the therapy available through NHS Scotland.

The decision follows guidance from the National Institute for Health and Care Excellence (NICE), which recommended the same IL-23 inhibitor for use across England and Wales earlier this year. With both regulatory bodies’ recommendations now in place, eligible patients throughout the UK will have access to the treatment through the NHS.

Guselkumab is the first IL-23 inhibitor recommended in the NHS that offers a fully subcutaneous induction and maintenance regimen for both Crohn’s disease and ulcerative colitis. The therapy can be administered at home or in hospital, depending on clinical suitability, potentially giving patients greater flexibility and convenience.

Over 50,000 people in Scotland live with inflammatory bowel disease (IBD), representing the highest proportion of the population affected anywhere in the UK. In the Edinburgh region of Lothian, prevalence is among the highest worldwide and is projected to increase further over the next few years.

The SMC’s acceptance is based on multiple Phase 3 studies assessing guselkumab’s efficacy and safety in IBD. The GALAXI and GRAVITI trials in Crohn’s disease demonstrated statistically significant higher rates of clinical remission and endoscopic response compared with placebo at week 12. In ulcerative colitis, the QUASAR studies reported significant improvements in remission at both week 12 (induction) and week 44 (maintenance). Safety findings across these studies were consistent with guselkumab’s known profile in other approved indications.

Amanda Cunnington, senior director of patient access at Johnson & Johnson Innovative Medicine UK, said: “The SMC’s acceptance represents an important step forward for people living with Crohn’s disease and ulcerative colitis in Scotland, ensuring that eligible patients in Scotland can benefit from therapies that offer flexibility and have the potential to improve quality of life.”

She added that the company continues to work to ensure equitable access across the UK, supporting patients with chronic inflammatory conditions through advocacy and collaboration with the NHS.

The SMC decision follows marketing authorisation granted earlier this year by the Medicines and Healthcare products Regulatory Agency (MHRA) for guselkumab in moderately to severely active Crohn’s disease and ulcerative colitis, supported by data from several Phase 3 studies including the ASTRO trial in ulcerative colitis.