Using health outcomes data to inform decision-making: a pharmaceutical industry perspective.

Within the pharmaceutical industry, there is increasing interest in collecting health outcomes data in order to inform decision-making, both internally and externally. The overall aim of generating the health outcomes information is to determine the value of the product, from the perspective of all the stakeholders. In addition to studies carried out during phase II and III of clinical development, pharmaceutical companies have recently begun to collect health outcomes information earlier, with the expected requirements for reimbursement and market access considered during the preclinical and phase I stages. However, there are a number of challenges to the demonstration of product value during drug development, particularly relating to the limitations of clinical trials. One way that pharmaceutical companies are addressing these challenges is through the use of economic modelling, to provide a framework to test assumptions and assess uncertainty, and examine the budget impact of treatments. Although different countries may use the information differently, health outcomes evidence generated by the pharmaceutical industry is generally used to inform decision-making about pricing, reimbursement, treatment guidelines and inclusion of drugs on formularies. A wide variety of health outcomes information is produced by the industry in order to provide data on product value that are appropriate for the different perspectives of the stakeholders in the healthcare system.