Cost effectiveness of replacing diclofenac with a fixed combination of misoprostol and diclofenac in patients with rheumatoid arthritis

OBJECTIVE: To estimate the costs and health consequences of replacing treatment with diclofenac 50 mg with a fixed combination of diclofenac 50 mg and misoprostol 0.2 mg 3 times a day in patients with rheumatoid arthritis (RA). METHODS: A decision tree was developed to simulate 6 months of nonsteroidal antiinflammatory drug (NSAID) treatment for RA. The probabilities of the clinical outcomes were based on a literature review. A survey of Norwegian rheumatologists was undertaken to explore their clinical management of dyspepsia in RA patients taking NSAIDs. Valuation of health states was based on results of the Short Form 36 health survey. RESULTS: In female RA patients without any risk factors associated with serious gastrointestinal (GI) complications, the incremental cost of replacing diclofenac with the fixed misoprostol/diclofenac combination therapy was $72,700 per quality-adjusted life-year gained. For patients with 1 risk factor, the cost was less than $16,000. With 2 or 3 risk factors, the use of misoprostol was cost saving. The cost-effectiveness ratios in males were approximately 20% higher than in females. CONCLUSION: Replacing diclofenac with a fixed diclofenac/misoprostol combination is cost effective when restricted to RA patients at increased risk of serious GI events.