Abstract
Macro-level economic evaluations of drugs are expected to provide useful information for making the decision of whether to approve a newly developed drug as a first-line treatment. Leflunomide has been hoped to be an alternative to existing disease-modifying antirheumatic drugs, but has also raised questions about its cost effectiveness due to the high drug cost and high percentage of withdrawals due to adverse events. A method of cost-effective analysis using disability-adjusted life years, which makes it possible to assess the cost effectiveness of a drug at the macro level, is proposed. Using the proposed method, the cost effectiveness of leflunomide in the treatment of rheumatoid arthritis in Japan is determined.