Filgotinib (2) – Jyseleca®
Ulcerative colitis (UC), pretreated patients
Characteristics
| Start date | 01.12.2021 – Marketing authorisation: 12.11.2021 |
|---|---|
| Resolution | 19.05.2022 |
| INN | Filgotinib |
| Brand name | Jyseleca® |
| Pharm. company |
Dossier: Galapagos Biopharma Germany GmbH
New distributor: Alfasigma GmbH |
| G-BA Procedure ID | D-743 |
| ATC code | L04AF04 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 | 0.2 g O |
| Therapeutic area | Digestive system diseases Ulcerative colitis / Pouchitis |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with moderate to severe active ulcerative colitis (UC) who have had an inadequate response, no longer respond to conventional therapy, or have an intolerance or contraindication to therapy | A TNF-α antagonist (adalimumab or infliximab or golimumab) or vedolizumab or ustekinumab |
| b) | Adults with moderate to severe active ulcerative colitis (UC) 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). |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (SELECTION) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
- Clinical trials
- Instead, the pU presents the results of the SELECTION trial, which is a randomised, double-blind trial comparing filgotinib with placebo.
a) Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or have an intolerance or contraindication.
- An additional benefit is not proven.
- To assess the additional benefit of filgotinib compared with the appropriate comparator therapy in adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy or to a biologic, no longer respond to such treatment, or who are intolerant to such treatment, there are no suitable data available for comparing filgotinib with the appropriate comparator therapy (ZVT) specified by the G-BA.
- Instead, the pharmaceutical company presents the results of the SELECTION study, which is a randomised, double-blind trial comparing filgotinib with placebo.
- In line with the pharmaceutical manufacturer’s assessment, the SELECTION study is therefore not suitable for evaluating the additional benefit of filgotinib compared with the appropriate comparator therapy.
- Overall assessment
- Consequently, for both patient populations, there is no hint of additional benefit from filgotinib compared with the appropriate comparator therapy; additional benefit is therefore not proven in either case.
b) Adults with moderate to severe active ulcerative colitis who have had an inadequate response to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it, or are intolerant to such treatment.
- 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 to such treatment, additional benefit for filgotinib compared with the appropriate comparator therapy is not proven.
- There are no suitable data available to assess the additional benefit of filgotinib compared with the appropriate comparator therapy in adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy or to a biologic, no longer respond to such treatment or are intolerant of it, there are no suitable data available for comparing filgotinib with the appropriate comparator therapy (ZVT) as determined by the G-BA.
- Instead, the pharmaceutical company presents the results of the SELECTION study, which is a randomised, double-blind trial comparing filgotinib with placebo.
- In line with the pharmaceutical manufacturer’s assessment, the SELECTION study is therefore not suitable for evaluating the additional benefit of filgotinib compared with the appropriate comparator therapy.
- Overall assessment
- Consequently, for both patient populations, there is no hint of additional benefit from filgotinib compared with the appropriate comparator therapy; additional benefit is therefore not proven in either case.
Courtesy translation only, please refer to the German original.
Associated procedures
| Filgotinib (2) | Jyseleca® | Galapagos Biopharma Germany GmbH | Ulcerative colitis (UC), pretreated patients | 5,300–25,000 | 100% additional benefit not proven | |
| Filgotinib (1) | Jyseleca® | Gilead Sciences GmbH | Rheumatoid arthritis (RA) | 89,710–193,750 | 33% Hint for minor additional benefit |
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