TA925 · STA

Mirikizumab for treating moderately to severely active ulcerative colitis

Recommended with restrictions

Only if a TNF-alpha inhibitor has not worked or cannot be tolerated/is not suitable, and the company provides it according to the commercial arrangement. When mirikizumab is 1 of a range of suitable treatments (including vedolizumab and ustekinumab), use the least expensive.

Source documents

Final Appraisal Document Committee Papers Scope

Intervention

mirikizumab (Omvoh)

IL-23 inhibitor · IL-23 inhibitor · intravenous infusion and subcutaneous injection

Condition

moderately to severely active ulcerative colitisgastroenterology · chronic

Comparators

Name	Type	Established	Committee preferred
vedolizumab	active drug	Yes	—
ustekinumab	active drug	Yes	—
tnf-alpha inhibitors	active drug	Yes	—

Methodological decisions (1)

equivalence assumption

Committee accepted cost comparison method based on indirect comparison suggesting similar effectiveness between mirikizumab, vedolizumab, and ustekinumab

Committee: Mirikizumab only needs to cost less than 1 relevant comparator to be recommended as a treatment option

ICER impact: negligible

Evidence gaps

no direct comparison—No clinical trials directly comparing mirikizumab with vedolizumab or ustekinumab; indirect comparison suggests similar effectiveness

Commercial arrangement

simple discount pas · confidential

Special considerations

Cross-references

comparator guidance — vedolizumab and ustekinumab guidance for committee discussion