摘要：In response to requests for the funding of new drugs, reimbursement agencies are re-evaluating some of the methods used in assessing these products. Many trials submit- ted for the regulatory review of new drugs do not provide adequate data for subsidy deci- sions. We argue that all involved in bringing medicines to market need to be explicit about the additional information required, decide how these data should be collected and assessed and the methods that should be used to set a fair price for a new drug. In Australia, a formal appraisal of the cost–effectiveness and budget impact of a new medicine precedes any subsidy deci- sion at national level. 1 If a new product is subsidized, the government pays an agreed price to the manufacturer, sometimes with requirements for financial contracts to manage expenditure.
