Diclofenac Sodium With Misoprostol
Not recommended RheumatologyAuthority RequiredNot applicable line
Osteoarthritis or rheumatoid arthritis in patients who require prophylaxis against NSAID-induced peptic ulcers.
2
Submissions
2 resub
2009–09
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Nov 2009Not recommended
lack of clinical need, potential for unwanted clinical outcomes, inadequate evidence that Arthrotec is non-inferior to…
- Nov 2009Not recommended
lack of clinical need, potential for unwanted clinical outcomes, cardiovascular toxicity concerns with diclofenac…
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis undertaken; no numeric ICER calculated or presented.
The submission presented a cost-minimisation analysis. PSD · 2009
Decision context
PopulationPatients with osteoarthritis or rheumatoid arthritis who require prophylaxis against NSAID-induced peptic ulcers, including those with risk factors such as age >60 years, history of peptic ulcer disease, smoking, previous NSAID gastrointestinal intolerance, or serious comorbid disease.
Why it was knocked back
- lack of clinical need, potential for unwanted clinical outcomes, cardiovascular toxicity concerns with diclofenac, evidence does not conclusively prove non-inferiority to concomitant diclofenac and misoprostol or combination NSAID and PPI for reduction of NSAID-induced ulcers, insufficient clinical and statistical certainty, suboptimal misoprostol dosing in twice-daily regimen, potential for patient switching from safer NSAIDs
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2009 | Not recommended | diclofenac monotherapy; concomitant diclofenac and misoprostol; NSAID and proton pump inhibitor | — | RCT |
| Nov 2009 | Not recommended | diclofenac monotherapy and concomitant diclofenac and misoprostol | — | Meta-analysis |