Abstract

The increasing costs of health-care and the need for cost containment have resulted in a 'fourth hurdle' in the establishment of drug approval and reimbursement policies. This hurdle is the demonstration of a drug's cost-effectiveness through the process of economic evaluation. The role of models in the economic evaluation of pharmaceuticals is becoming increasingly accepted with the recent trend towards developing models with greater transparency and clinical relevance. However, health-care decisions do not, and should not, rely solely on the cost-effectiveness of a drug or intervention. Factors such as disease severity, availability of alternative treatment strategies, cost of drugs to patients, compliance with therapy and patients' satisfaction with overall treatment effectiveness should also be considered, and in some cases can be incorporated into economic evaluation. The Arthritis Cost Consequences Evaluation System (ACCES) is provided as an example of the attributes and limitations that should be considered in determining the usefulness of a model for economic evaluations with the purpose of determining reimbursement policy decisions.

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