Etrasimod for treating moderately to severely active ulcerative colitis in people aged 16 and over

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 . 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 .

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 .

Etrasimod (Velsipity, Pfizer) is indicated for 'people 16 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy, or a biological agent'.

The dosage schedule is available in the summary of product characteristics for etrasimod .

The list price of 2 mg etrasimod is £843.84 per pack of 28 tablets (excluding VAT; company submission). The estimated annual cost of treatment is £11,000 (excluding VAT; company submission).

The company has a commercial arrangement . This makes etrasimod available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication. Because etrasimod has been recommended through the cost-comparison process, NHS England and integrated care boards have agreed to provide funding to implement this guidance 30 days after publication.

The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has moderately to severely active ulcerative colitis and the doctor responsible for their care thinks that etrasimod is the right treatment, it should be available for use, in line with NICE's recommendations.

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 . 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 .

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 .

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 . 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 .

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 .