Early modelling for assessing health and economic outcomes of drug therapy.

Models for assessing health and economic outcomes of new drugs have an increasing role in the early phases of drug development. Their input into go/no go and priority setting decisions can reveal that further development of a drug is unattractive from an economic viewpoint, or that developing a certain indication is more attractive than another. They may also influence the later choice of indication, positioning, comparators, length of follow-up, and other elements in the further development of drugs. Their specific nature, characterized by limited budget, timelines and data availability should not necessarily lead to compromises in design and conduct. It is argued that high quality early models form the breeding ground for later solid evidence on value for money, and are consequently both worthwhile to the pharmaceutical industry and to health care decision-makers and payers.