EtoricoxibArcoxia
Symptomatic treatment of osteoarthritis.
Decisions on record
- Meeting Jul 2008 Not recommended Symptomatic treatment of the signs and symptoms of osteoarthritis (OA); treatment of acute gouty arthritis; and treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures.
- Meeting Jul 2007 Not recommended Symptomatic treatment of the signs and symptoms of osteoarthritis (OA). Treatment of acute gouty arthritis. Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures. Currently, the 30 mg strength is not registered.
Access path
- TGA registered · Arcoxia
TGA label narrower than the PBS population
- Jul 2007Recommended
Evidence: RCT, indirect safety meta-analysis → RCT
- Jul 2007Recommended
Evidence: RCT, indirect safety meta-analysis → RCT
- Jul 2008Not recommended
Lack of demonstrated clinical need, inferior safety profile with increased hypertension-related adverse events compared…
- Jul 2008Not recommended
Uncertain safety profile regarding hypertension; increased risk of hypertension-related adverse events compared to…
From the public summary
The results of trial 007, in which the efficacy of etoricoxib 30 mg or 60 mg was compared with placebo, demonstrated a statistically significant and a clinically important reduction in the primary outcome of pain compared to placebo.PSD · Jul 2007
Reduction in pain, in patients treated with 60 mg etoricoxib, was significantly greater, although not to a clinically important extent, compared to patients treated with 30 mg etoricoxib Based on the results of trial P076/077, which compared the efficacy of etoricoxib 30 mg with celecoxib 200 mg, the PBAC agreed that treatment with etoricoxib 30 mg appeared to be no worse than treatment with celecoxib 200 mg in terms of reducing pain, improving function …PSD · Jul 2007
Cost-effectiveness
Cost-minimisation analysis submitted; no ICER calculated.
The PBAC agreed that the cost-minimisation approach taken in the re-submission was not adequately justified. PBAC · 2008
Decision context
PopulationAdults with symptomatic osteoarthritis, non-hypertensive or with adequately controlled hypertension at baseline.
Why it was knocked back
- Uncertain safety profile regarding hypertension; increased risk of hypertension-related adverse events compared to celecoxib; non-inferiority in safety not established; lack of demonstrated clinical need in context of inferior safety profile
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2008 | Not recommended | celecoxib 200 mg | — | RCT, cost-minimisation · Pain reduction, improvement in function, patient global assessment of disease status |
| Jul 2008 | Not recommended | celecoxib 200 mg | — | RCT · pain_VAS |
| Jul 2007 | Recommended | celecoxib | — | RCT, indirect safety meta-analysis · null |
| Jul 2007 | Recommended | celecoxib | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to osteoarthritis only; excluded acute gouty arthritis, acute pain, dysmenorrhea, and dental pain covered by TGA label.