1 Recommendations

1.1

Etrasimod is recommended, within its marketing authorisation, as an option for moderately to severely active ulcerative colitis in people aged 16 years and over when:

  • conventional or biological treatments cannot be tolerated or

  • the condition has not responded well enough, or lost response to treatment.

    Etrasimod is only recommended if the company provides it according to the commercial arrangement.

1.2

If people with the condition and their clinicians consider etrasimod to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements.

Why these recommendations were made

Usually, after conventional treatment, people with moderately to severely active ulcerative colitis have advanced treatment, such as a biological medicine or JAK inhibitor. Etrasimod is a sphingosine-1-phosphate receptor agonist, another kind of advanced treatment, which would be offered to the same population.

Clinical trial evidence shows that etrasimod is more effective than placebo for treating moderately to severely active ulcerative colitis. Etrasimod has not been directly compared in a clinical trial with usual treatments. Indirect comparisons suggest that it is likely to work better than adalimumab (a biological treatment) and may be similarly effective to other usual treatments for moderately to severely active ulcerative colitis which has not been previously treated with advanced treatment. For moderately to severely active ulcerative colitis which has previously been treated with advanced treatment, indirect comparisons are highly uncertain and the possibility that treatments differ in terms of their effectiveness for this population could not be ruled out. Based on experience with other treatments used for this population with the same mechanism of action, it was considered likely that etrasimod would also be effective for moderate to severely active ulcerative colitis which has previously been treated with advanced treatment. On balance etrasimod appeared an effective treatment that would be a welcome additional option for people with moderately to severely active ulcerative colitis.

A cost comparison suggests etrasimod has lower or similar costs to adalimumab and other advanced treatments. So, etrasimod is recommended.

For all evidence see the committee papers.