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Tofacitinib (new scientific evidence (§ 13): rheumatoid arthritis, pretreated patients, monotherapy or in combination with methotrexate)
Subject:
- Active Substance: Tofacitinib
- Name: Xeljanz®
- Therapeutic area: Rheumatoid arthritis
- Pharmaceutical company: Pfizer Pharma GmbH
Time table:
- Start: 01.09.2021
- Final decision by G-BA: 17.02.2022
Final decision:
- a1) Patients who do not have unfavorable prognostic factors and for whom previous treatment with disease-modifying antirheumatic drugs (DMARDs) proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib as monotherapy is indicated:
- No additional benefit proved - a2) Patients who do not have unfavorable prognostic factors and for whom previous treatment with DMARDs proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib in combination with MTX is indicated:
- No additional benefit proved - b1) Patients for whom a therapy with biotechnologically manufactured DMARDs (bDMARDs) or target-oriented synthetic DMARDs (tsDMARDs) is indicated for the first time and for whom and treatment with tofacitinib as monotherapy is indicated:
- No additional benefit proved - b2) Patients for whom a therapy with bDMARDs or tsDMARDs is indicated for the first time and for whom treatment with tofacitinib in combination with MTX is indicated:
- No additional benefit proved - c1) Patients for whom previous treatment with one or more bDMARDs and/or tsDMARDs proved inadequate or was not tolerated and treatment with tofacitinib as monotherapy is indicated:
- No additional benefit proved - c2) Patients for whom previous treatment with one or more bDMARDs and/or tsDMARDs proved inadequate or was not tolerated and treatment with tofacitinib in combination with MTX is indicated:
- No additional benefit proved