PBAC's latest decision on Tofacitinib: Recommended with restriction (2024). Considered for Severe active rheumatoid arthritis (initial treatment, first continuing treatment, and subsequent continuing treatment) and severe psoriatic arthritis (initial treatment and continuing treatment).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
8
first 2015
Submissions
8
2015 → 2024
Eligible population
Adults with severe active rheumatoid arthritis or severe psoriatic arthritis, receiving tofacitinib 11 mg modified-release tablet once daily.
Therapy area
Rheumatology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Non-inferiority
Key trials
NCT02281552 (Tanaka et al., 2019), NCT04018001 (Cohen et al., 2021a), NCT04267380, NCT02831855 (Cohen et al., 2021b, ORAL Shift)
Comparator
tofacitinib 5 mg tablets (immediate release)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Submission history
Mar 2015: Recommended with restriction · Authority Required
Nov 2018: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Authority Required
Mar 2020: Deferred
Nov 2020: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required