Meeting the Information Needs of a National Drug Payer: Aspirations of the Guidelines from Australia

The information needs of drug payers at the provincial or national level are reasonably similar across the world. Until recently, the evidence generated to meet these needs has been largely intended to meet the information needs of regulatory agencies responsible for determining whether marketing approval should be authorized. This has meant that evidence for one purpose (determining whether a drug should be approved for marketing) usually has to be translated to meet another purpose (determining whether the drug should be paid for in a reimbursement or subsidy). As the context in each jurisdiction might be different, there is also a need to translate evidence developed for a global audience to address different local contexts. A common set of methods to translate evidence can help address both needs, from a common starting point of randomized trials as the most scientifically rigorous evidence available for estimating the extent of intended treatment effects. Experience with these methods to increase confidence in the translated evidence has proved helpful, as meeting the information needs of drug payers has recently become more influential in determining what evidence is generated during the pre-marketing research and development phase in the life cycle of a new drug. Drug Dev Res 71:463-469, 2010. (C) 2010 Wiley-Liss, Inc.