LeflunomideAPO-LEFLUNOMIDE
Treatment of active psoriatic arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate and/or ineffective.
Decisions on record
- Meeting Sep 2022 Recommended Severe active psoriatic arthritis and severe active rheumatoid arthritis no PSD
- Meeting Mar 2007 Recommended Psoriatic arthritis and rheumatoid arthritis
Access path
- TGA registered · APO-LEFLUNOMIDE
TGA label narrower than the PBS population
- Mar 2007Recommended · restricted
Listing: Authority required → Authority Required
- Mar 2007Recommended · restricted
Listing: Authority required → Authority Required
- PBS listing · Authority Required
Cost-effectiveness
ICER stated as < $15,000 per QALY; only upper bound clearly specified in public text
The base case modelled incremental discounted cost per extra discounted Quality Adjusted Life Year (QALY) gained over 5 years was estimated to be < $15,000. PSD · 2007
Decision context
PopulationPatients with active psoriatic arthritis for whom other disease modifying anti-rheumatic drugs (including methotrexate) are ineffective and/or inappropriate.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2007 | Recommended · restricted | placebo | $0k–15k | RCT · Other |
| Mar 2007 | Recommended · restricted | placebo | $15k | RCT · PsARC |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe psoriatic arthritis only, requiring prior DMARD failure/inappropriateness; TGA label includes both rheumatoid and psoriatic arthritis without severity or prior therapy requirements.