Vedolizumab (2) – Entyvio®
Antibiotic-refractory pouchitis, pre-treated patients
Characteristics
| Start date | 01.03.2022 – Marketing authorisation: 31.01.2022 |
|---|---|
| Resolution | 01.09.2022 |
| INN | Vedolizumab |
| Brand name | Entyvio® |
| Pharm. company | Takeda GmbH |
| G-BA Procedure ID | D-802 |
| ATC code | L04AG05 IMMUNOSUPPRESSANTS (L04A) |
| 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 |
| DDD | 5.4 mg P |
| Therapeutic area | Digestive system diseases Ulcerative colitis / Pouchitis |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Entyvio is indicated for the treatment of adult patients with moderate to severe active chronic pouchitis who have undergone proctocolectomy with the creation of an ileoanal pouch for ulcerative colitis (UC) and have had an inadequate response or no response to antibiotic treatment. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with moderate to severe active chronic pouchitis who have undergone proctocolectomy for ulcerative colitis (UC) with the creation of an ileoanal pouch and have had an inadequate response or no response to antibiotic treatment. | Treatment according to physician's choice |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
- Clinical trials
- For the assessment of the additional benefit of vedolizumab in adults with moderate to severe active chronic pouchitis who have undergone a proctocolectomy for ulcerative colitis, during which an ileoanal pouch was created, and who have responded inadequately or not at all to antibiotic treatment, the pharmaceutical manufacturer did not submit any direct comparative studies against the appropriate comparator therapy.
Adults with moderate to severe active chronic pouchitis who have undergone proctocolectomy for ulcerative colitis, during which an ileoanal pouch was created, and who have responded inadequately or not at all to antibiotic treatment
- An additional benefit is not proven.
- Consequently, there are no suitable data available for assessing the additional benefit of vedolizumab compared with the appropriate comparator therapy. This provides no hint of an additional benefit of vedolizumab over treatment as directed by a doctor.
- Overall, for adults with moderate to severe active chronic pouchitis who have undergone a proctocolectomy with creation of an ileoanal pouch due to ulcerative colitis, and who have responded inadequately or not at all to antibiotic treatment, additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Vedolizumab (2) | Entyvio® | Takeda GmbH | Antibiotic-refractory pouchitis, pre-treated patients | 20–40 | 100% additional benefit not proven | |
| Vedolizumab (1) | Entyvio® | Takeda Pharma Vertrieb GmbH & Co. KG | Ulcerative colitis, Crohn's disease | 16,100 | 100% additional benefit not proven |
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