Vedolizumab (1) – Entyvio®
Ulcerative colitis, Crohn's disease
Characteristics
| Start date | 15.07.2014 – Marketing authorisation: 22.05.2014 |
|---|---|
| Resolution | 08.01.2015 |
| INN | Vedolizumab |
| Brand name | Entyvio® |
| Pharm. company | Takeda Pharma Vertrieb GmbH & Co. KG |
| G-BA Procedure ID | D-122 |
| ATC code | L04AG05 IMMUNOSUPPRESSANTS (L04A) |
| ICD-10 codes (AIS) | K50.0Crohn´s disease of small intestine, K50.1Crohn´s disease of large intestine, K50.80Crohn´s disease of both small and large intestine without complications, K50.81Crohn´s disease of both small and large intestine with rectal bleeding, K50.82, K50.88, K50.9Crohn´s disease, unspecified |
| Alpha-ID codes (AIS) | I115933Crohn´s disease of the stomach, I115934Crohn´s disease of the esophagus, I18518Crohn´s disease, I5642Crohn´s disease of the small intestine, I5646Crohn´s disease of the large intestine, I87913Crohn´s disease of the small intestine and colon |
| DDD | 5.4 mg P |
| Therapeutic area | Digestive system diseases Crohn's disease, Ulcerative colitis / Pouchitis |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Patients with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy, no longer respond to it, or have an intolerance to appropriate treatment. | A TNF-alpha antagonist (adalimumab or infliximab) |
| b) | Patients with moderate to severe active ulcerative colitis who have had an inadequate response, no longer respond or are intolerant to one of the tumour necrosis factor-alpha (TNFα) antagonists. | One TNF-alpha antagonist (adalimumab or infliximab, taking into account previous therapies). (Note: If therapy with one TNF-α antagonist (adalimumab or infliximab) fails, dose adjustment or switching to the other TNF-α antagonist in each case is possible). |
| c) | Patients with moderate to severe active Crohn's disease who have had an inadequate response to conventional therapy, no longer respond to it, or have an intolerance to appropriate treatment. | A TNF-alpha antagonist (adalimumab or infliximab) |
| d) | Patients with moderate to severe active Crohn's disease who have had an inadequate response, no longer respond or are intolerant to one of the tumour necrosis factor-alpha (TNFα) antagonists. | One TNF-alpha antagonist (adalimumab or infliximab, taking into account previous therapies). (Note: If therapy with one TNF-alpha antagonist (adalimumab or infliximab) fails, dose adjustment or switching to the other TNF-alpha antagonist in each case is possible). |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (GEMINI I) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (Bucher) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Gene/mutation specifics |
- Clinical trials
- The pharmaceutical manufacturer has identified a randomised, double-blind, placebo-controlled trial for vedolizumab (induction and maintenance of remission: GEMINI I [C13006]), in which at least one conventional therapy, including corticosteroids, immunomodulators and/or the TNFα antagonist infliximab, has failed.
- For patient group d), the pharmaceutical manufacturer justifies the additional benefit of vedolizumab over the appropriate comparator therapy on the basis of the results of two randomised, double-blind, placebo-controlled trials (induction and maintenance of remission: GEMINI II [C13007]; induction: GEMINI III [C13011]).
a) Patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant to such treatment.
- For patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant to such treatment, additional benefit is not proven over the appropriate comparator therapy.
- The adjusted indirect comparison submitted by the pharmaceutical manufacturer is not suitable for drawing conclusions regarding additional benefit.
- The study designs of the trials included by the pharmaceutical manufacturer in the adjusted indirect comparison, and the resulting populations, are not sufficiently similar.
- Consequently, there are no suitable data available overall to demonstrate an additional benefit of vedolizumab for patient group a). The additional benefit of vedolizumab compared with the appropriate comparator therapy is therefore not proven.
b) Patients with moderate to severe active ulcerative colitis who have responded inadequately to one of the tumour necrosis factor-alpha (TNFα) antagonists, no longer respond to it, or are intolerant to such treatment.
- For patients with moderate to severe active ulcerative colitis who have responded inadequately to one of the tumour necrosis factor-alpha (TNFα) antagonists, no longer respond to it, or are intolerant to such treatment, an additional benefit is not proven compared with the appropriate comparator therapy.
- The studies identified by the pharmaceutical manufacturer comparing vedolizumab versus placebo and adalimumab versus placebo are not suitable for an adjusted indirect comparison due to their study designs and the resulting differences in the study populations.
- The placebo-controlled study C13006 is not suitable for a comparative assessment of the adverse reaction profiles of adalimumab and vedolizumab.
- Consequently, there are no suitable data available overall to demonstrate an additional benefit of vedolizumab for patient group b). The additional benefit of vedolizumab compared with the appropriate comparator therapy is therefore not proven.
c) Patients with moderate to severe active Crohn’s disease who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant to such treatment.
- For patients with moderate to severe active Crohn’s disease who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant to such treatment, an additional benefit compared with the appropriate comparator therapy is not proven.
- For patient group c), the pharmaceutical manufacturer does not claim that vedolizumab offers any additional benefit over the appropriate comparator therapy.
- Overall, there are no suitable data available to demonstrate an additional benefit of vedolizumab for patient group c). The additional benefit of vedolizumab compared with the appropriate comparator therapy is therefore not proven.
d) Patients with moderate to severe active Crohn’s disease who have responded inadequately to one of the tumour necrosis factor-alpha (TNFα) antagonists, no longer respond to it, or are intolerant to such treatment.
- For patients with moderate to severe active Crohn’s disease who have responded inadequately to one of the tumour necrosis factor-alpha (TNFα) antagonists, no longer respond to it, or are intolerant to such treatment, additional benefit is not proven compared with the appropriate comparator therapy.
- The placebo-controlled studies are not suitable for a comparative assessment of the efficacy and adverse reaction profile of vedolizumab and the TNF-alpha antagonists.
- The effect sizes observed in the placebo-controlled studies with vedolizumab are predominantly minor.
- Nor can reduced efficacy compared with the appropriate comparator therapy be ruled out on the basis of the study data presented.
- Consequently, there are no suitable data available overall to demonstrate any additional benefit of vedolizumab for patient group d). The additional benefit of vedolizumab compared with the appropriate comparator therapy is therefore 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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