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New HTA Decisions in Germany
December 2021
Drug name
XELJANZ® (tofacitinib)
Company
Pfizer Pharma GmbH
Decision date
01/12/2021
Therapeutic area
Musculoskeletal conditions
Therapeutic sub area
Arthritis
G-BA decision date
15/02/2022
Orphan Drug?
No
Decision
No additional benefit
Indication
In combination with methotrexate (MTX), or as monotherapy if MTX is not tolerated or is unsuitable, in adults with moderate to severely active rheumatoid arthritis that have received one previous treatment with a disease-modifying antirheumatic (csDMARDs) and have not responded. Appropriate comparator therapy: Alternative csDMARDS, or if suitable; MTX, leflunomide or sulfasalazine as mono- or combination therapy.
Decision
No additional benefit
Indication
Adults with moderate to severely active rheumatoid arthritis that are receiving first-time therapy with bDMARDs or tsDMARDS. Appropriate comparator therapy: bDMARDs or tsDMARDs (abatacept, or adalimumab, or baricitinib, or certolzumab-pegol, or etanercept, or golimumab, or infliximab, or sarilumab, or tocilizumab, or upadacitinib) in combination with MTX, or as monotherapy, depending on tolerance or suitability to MTX.
Decision
No additional benefit
Indication
Adults with moderate to severely active rheumatoid arthritis who have received previous treatment with one or more bDMARDs and/or tsDMARDs, and have not responded or tolerated. Appropriate comparator therapy: Change of bDMARD or tsDMARD therapy (abatacept, or adalimumab, or baricitinib, or certolizumab-pegol, or etanercept, or golimumab, or infliximab, or sarilumab, or tocilizumab, or upadacitinib in combination with MTX, or as monotherapy, depending on tolerance or suitability to MTX; or in patients with severe rheumatoid arthritis taking rituximab) in dependence of previous therapy.
Decision Detail
Main studies: ORAL STANDARD, ORAL STRATEGY and ORAL SURVEILLANCE. Main driver of decision: For indication 2, the ORAL SURVEILLANCE study was not relevant. There was no suitable data available from the ORAL STANDARD and ORAL STRATEGY trials. No data was presented for indications 1 and 3.
Summary
IQWIG concluded that was no added benefit for indications 1, 2 and 3.