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) |
| DDD | 10 mg O |
| Therapeutic area | Digestive system diseases |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
Studies and Results
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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