Tofacitinib (4) – Xeljanz®
Ulcerative colitis
Characteristics
| Start date | 01.09.2018 – Marketing authorisation: 31.07.2018 |
|---|---|
| Resolution | 21.02.2019 |
| INN | Tofacitinib |
| Brand name | Xeljanz® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-374 |
| ATC code | L04AF01 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 | 10 mg O |
| Therapeutic area | Digestive system diseases Ulcerative colitis / Pouchitis |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Tofacitinib 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) | Adult patients with moderate to severe active ulcerative colitis who have had an inadequate response or no longer respond to conventional therapy, or who have an intolerance or contraindication to conventional therapy | TNF-α antagonist (adalimumab or infliximab or golimumab) |
| b) | Adult patients with moderate-to-severe active ulcerative colitis who have had an inadequate response, no longer respond, or are intolerant to a biologic, such as a TNF-α antagonist or integrin inhibitor | TNF-α antagonist (adalimumab or infliximab or golimumab) or integrin inhibitor (vedolizumab) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (OCTAVE SUSTAIN) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
a) Adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or in whom there is intolerance or a contraindication.
- For adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or in whom there is intolerance or a contraindication, the additional benefit is not proven.
- For this patient group, the pharmaceutical manufacturer has not provided any comparative studies of tofacitinib against the appropriate comparator therapy.
- On balance, therefore, an additional benefit is not proven.
- Overall assessment
- Consequently, there are no suitable data available for assessing the additional benefit of tofacitinib in the treatment of adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or who have an intolerance or contraindication.
b) Adult patients with moderate to severe active ulcerative colitis who have responded inadequately to a biologic, such as a TNF-α antagonist or integrin inhibitor, no longer respond to it, or who are intolerant to such treatment.
- For adult patients with moderate to severe active ulcerative colitis who have had an inadequate response to a biologic, such as a TNF-α antagonist or integrin inhibitor, have responded inadequately to a biologic such as a TNF-α antagonist or integrin inhibitor, no longer respond to it, or are intolerant to such treatment, the additional benefit is not proven.
- For this patient group, the pharmaceutical manufacturer has not submitted any comparative studies of tofacitinib against the appropriate comparator therapy.
- On balance, therefore, additional benefit is not proven.
- Overall assessment
- Consequently, there are no suitable data available for the assessment of the additional benefit of tofacitinib in the treatment of adult patients with moderate to severe active ulcerative colitis who have responded inadequately to a biologic, no longer respond to it, or who are intolerant to such treatment.
Courtesy translation only, please refer to the German original.
Associated procedures
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