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New HTA Decisions in Germany
December 2021
Drug name
XELJANZ® (tofacitinib)
Company
Pfizer Pharma GmbH
Decision date
15/12/2021
Therapeutic area
Musculoskeletal conditions
Therapeutic sub area
Arthritis
G-BA decision date
01/06/2022
Orphan Drug?
No
Decision
No additional benefit
Indication
Patients from 2 years of age with active juvenile idiopathic arthritis (pJIA) who have responded inadequately to previous treatment with classical disease-modifying anti-inflammatory drugs (DMARDs), including methotrexate (MTX). Appropriate comparator therapy: A bDMARD (adalimumab, or etanercept, or golimumab, or tocilizumab) in combination with MTX; possibly as monotherapy, taking into account the case of MTX intolerance or unsuitability.
Decision
No additional benefit
Indication
Patients from 2 years of age with active juvenile idiopathic arthritis (pJIA) who have responded inadequately to previous treatment with one or more biological disease-modifying anti-inflammatory drugs (bDMARDs). Appropriate comparator therapy: A change in bDMARD therapy (abatacept, or adalimumab, or etanercept, or golimumab, or tocilizumab) in combination with MTX; possibly as monotherapy, taking into account the case of MTX intolerance or unsuitability depending on previous therapy.
Decision
No additional benefit
Indication
Patients from 2 years of age with active juvenile psroriatic arthritis (jPsA) who have responded inadequately to previous treatment with disease-modifying anti-inflammatory drugs DMARDs. Appropriate comparator therapy: Therapy as prescribed by a doctor.
Decision Detail
Main drivers of decision: There were no relevant RCTs identified for the benefit assessment of tofacitinib in comparison with the ACT. Therefore, no suitable data was available for the benefit assessment.
Summary
IQWIG concluded that there was no added benefit.