Tofacitinib (7) – Xeljanz®
Ankylosing spondylitis (AS)
Characteristics
| Start date | 15.12.2021 – Marketing authorisation: 15.11.2021 |
|---|---|
| Resolution | 16.06.2022 |
| INN | Tofacitinib |
| Brand name | Xeljanz® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-764 |
| ATC code | L04AF01 IMMUNOSUPPRESSANTS (L04A) |
| ICD-10 codes (AIS) | M45.00, M45.01, M45.02, M45.03, M45.04, M45.05, M45.06, M45.07, M45.08, M45.09 |
| Alpha-ID codes (AIS) | I28627Ankylosing spondylitis, I80914Spondylitis in chronic polyarthritis |
| DDD | 10 mg O |
| Therapeutic area | Musculoskeletal system diseases Axial spondyloarthritis / Ankylosing spondylitis (Bechterews disease) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a1) | Adults with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy and who are eligible for treatment with tofacitinib. | A TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or an IL17 inhibitor (secukinumab). |
| a2) | Adults with active ankylosing spondylitis (AS)who have responded inadequately to previous therapy with biological with biologic antirheumatic drugs (bDMARDs) or who are intolerant to these drugs and who are or who are intolerant to them and who are eligible for treatment with tofacitinib. | Switching to another biological disease-modifying antirheumatic drug: TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or IL17 inhibitor (secukinumab). |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
- Clinical trials
- Furthermore, no indirect comparisons were presented to address the questions raised in the benefit assessment.
a1) Adults with active ankylosing spondylitis who have responded inadequately to conventional therapy and who are eligible for treatment with tofacitinib
- The additional benefit is not proven.
- In its dossier for the assessment of the additional benefit of tofacitinib, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
- Furthermore, no indirect comparisons were submitted to address the issues raised in the benefit assessment.
- On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.
- Overall assessment
- On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.
a2) Adults with active ankylosing spondylitis who have responded inadequately to prior treatment with biological anti-rheumatic drugs (bDMARDs) or who are intolerant to such treatment and who are eligible for treatment with tofacitinib
- An additional benefit is not proven.
- In its dossier for the assessment of the additional benefit of tofacitinib, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
- Furthermore, no indirect comparisons were submitted to address the issues raised in the benefit assessment.
- On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.
- Overall assessment
- On balance, the additional benefit of tofacitinib over the appropriate comparator therapy is not proven for this patient group.
Courtesy translation only, please refer to the German original.
Associated procedures
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