Raymond J Townsend and Jane T Osterhaus 2J Gregory Boyer

1 Wasatch Health Outcomes, Park city, Utah, USA and 2Pharmacia Corporation,

Stokie, Illionrs, USA

For most of the past 25 years, the development of most pharmaceutical products has followed a predictable path from discovery to preclinical and clinical development, approval and marketing. With the onset of increased competition, decision makers want to hold down healthcare costs while maintaining or increasing quality. This has dictated changes in the traditional drug development path. To maximize the commercialization and clinical use of a product, successful drug development today must now also focus on measuring other outcomes of a pharmaceutical intervention.

Decisions, both large and small, relating to healthcare are now made based on information gathered from economic and humanistic outcome evaluations. The information gained from valid outcome measures can be used on a national level to allocate expenditures for treating various sectors of the population (e.g. the elderly, neonates, etc.) or to determine which programs will receive financial resources (e.g. vaccine programs vs. acute influenza treatments). Outcome information can be used to help make decisions regarding the inclusion or exclusion of drugs on formularies. Complete information about the economic, humanistic and clinical impacts that medications have on specific patients can help healthcare providers make better prescribing decisions.

Decision makers, including prescribers, providers, payers and patients, all want to maximize the clinical value received for the money spent. Value to a prescriber might mean achieving a desired clinical impact for the cost of drug; value to a payer could mean spending more for a drug that reduces the number of days in a hospital, thus reducing the total economic impact of a condition. Value to a patient or employer might also be making sure that the drug prescribed maintains quality of life or worker productivity. To be successful, the pharmaceutical developer must address the needs of all these decision makers. To do this, it is imperative that drug development programs today include quantitative measures of economic, clinical and humanistic value of the drugs they develop. It is never too early to begin to think about how the value of a product will be demonstrated.

The intent of this chapter is to help pharmaceutical developers and researchers understand how to document the value of pharmaceuticals through appropriate pharmacoeconomic development programs.

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