Using health outcomes data to inform decision-making - Government agency perspective

In the developed world, the demand for healthcare is rising faster than sup ply, so that governments are faced with the need to allocate limited resour ces for maximum benefit. Many governments are responding to these pressures by developing health technology assessment agencies, which evaluate the co st effectiveness of new pharmaceutical and medical products relative to exi sting interventions. In England and Wales, the agency concerned with health technology assessment is the National Institute for Clinical Excellence (N ICE). NICE brings together evidence of clinical and cost effectiveness to j udge the value of the treatment relative to alternative uses of National He alth Service (NHS) resources and makes recommendations on use of the treatm ent by the NHS in England and Wales. NICE evaluates technologies where they may result in significant impact on NHS resources or key healthcare policy . The health technology assessment includes a review of the clinical effect iveness, cost effectiveness and service impact of the technology under cons ideration. This health technology assessment report, together with submissi ons from the technology manufacturer, and patient and healthcare profession als groups, is then considered by an appraisal committee that formulates gu idance to the NHS and is ultimately published by NICE. A number of countries have formal guidelines on the use of outcome measures and economic evaluations in the submissions required for health technology assessment prior to market access. These guidelines vary in both the detai l and level of mandatory requirement to be followed by technology manufactu rers. NICE has recently updated its guidance to technology manufacturers on their submissions. These guidelines, developed in consultation with the he althcare industry, provide detailed specification of the requirements of NI CE for health outcomes data and economic evaluation. These details are desc ribed in more detail in this paper.