Ozanimod (2) (Zeposia®) – Ulcerative colitis (UC), pre-treated patients
Characteristics
| Start date | 15.12.2021 |
|---|---|
| Resolution | 16.06.2022 |
| INN | Ozanimod |
| Brand name | Zeposia® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA procedure ID | 2021-12-15-D-769 |
| Therapeutic area | Digestive system diseases |
| Reason for procedure | New Indication |
| Specialty | ACT change |
| Indication (German) |
|---|
|
Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with moderate to severe active ulcerative colitis (CU) who have had an inadequate response, no longer respond to conventional therapy or have an intolerance or contraindication. | A TNF-α antagonist (Adalimumab or Infliximab or Golimumab) or Vedolizumab or Ustekinumab |
| b) | Adults with moderate to severe active ulcerative colitis (CU) who have had an inadequate response, no longer respond, or are intolerant to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor). | A switch of therapy to vedolizumab or tofacitinib or ustekinumab or a TNF-α antagonist (adalimumab or infliximab or golimumab), in each case taking into account the marketing authorisation and the previous therapy(s). |
9. Associated procedures
| Resolution | INN | Brand name | Indication | Patients | Additional benefit |
|---|---|---|---|---|---|
| 15.07.2020 – 07.01.2021 | Ozanimod | Zeposia® | Relapsing-remitting multiple sclerosis (MS) | 149,500 – 166,000 | |
| 15.12.2021 – 16.06.2022 | Ozanimod (2) | Zeposia® | Ulcerative colitis (UC), pre-treated patients | 5,300 – 25,000 |
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