Mirikizumab (1) – Omvoh®
Ulcerative colitis, pre-treated
Characteristics
| Start date | 15.07.2023 – Marketing authorisation: 26.05.2023 |
|---|---|
| Resolution | 18.01.2024 |
| INN | Mirikizumab |
| Brand name | Omvoh® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-950 |
| ATC code | L04AC24 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | K51.0Backwash ileitis, K51.2Ulcerative (chronic) proctitis, K51.3Ulcerative (chronic) rectosigmoiditis, K51.4Inflammatory polyps of colon, K51.5Left hemicolitis, K51.8Other ulcerative colitis, K51.9Ulcerative colitis, unspecified |
| Alpha-ID codes (AIS) | I115712Chronic ulcerative pancolitis, I115938Left-sided colitis, I26042Ulcerative colitis, I5661Chronic ulcerative proctitis, I5664Chronic rectosigmoiditis ulcerosa, I74949Colitis polyposa |
| Therapeutic area | Digestive system diseases Ulcerative colitis / Pouchitis |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Omvoh is indicated for the treatment of adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy or biologic treatment, who no longer respond to it or were intolerant. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, are no longer responding to it or are intolerant to it | A TNF-α antagonist (adalimumab or infliximab or golimumab) or vedolizumab or ustekinumab or ozanimod |
| b) | Adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor), are no longer responding to it or are intolerant to it | Vedolizumab or tofacitinib or ustekinumab or filgotinib or ozanimod or a TNF-α antagonist (adalimumab or infliximab or golimumab) |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (LUCENT 1, LUCENT 2) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
| ACT change | 25.07.2023 – Neuer Therapiestandard |
- Clinical trials
- In the dossier, the pharmaceutical manufacturer presents data from the randomised, sequential studies LUCENT 1 and LUCENT 2 comparing mirikizumab with placebo.
a) Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant of it
- For adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, they no longer respond to it, or are intolerant of it, the additional benefit is not proven.
b) Adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it, or are intolerant to it
- For adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, the additional benefit is not proven.
- Overall, therefore, for b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, additional benefit is not proven for mirikizumab compared with the appropriate comparator therapy.
- Overall assessment
- In summary, therefore, for b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, additional benefit is not proven for mirikizumab compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Mirikizumab (2) | Omvoh® | Lilly Deutschland GmbH | Crohn's disease, pre-treated | 12,600–78,300 | 100% additional benefit not proven | |
| Mirikizumab (1) | Omvoh® | Lilly Deutschland GmbH | Ulcerative colitis, pre-treated | 5,300–25,000 | 100% additional benefit not proven |
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