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TABLE 2
PharmacoeconomicsInterest Groups
Pharmaceutical company
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Want an early assessment of project opportunity/viability; fearful of exclusion of drugs from formularies and HMOs, recognize need to invest in pharmacoeconomic studies but unsure of their impact on decision makers
Pharmacists
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Play an important role in deciding which drugs are used in a hospital; this includes formulary decisions and treatment strategy; they help in monitoring patient compliance
Patients
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Becoming much better informed and organized in pressure groups increasingly prepared to pressure clinicians and lobby governments; Internet will increase coherence of such groups globally resulting in better attention being given to their needs
Office physicians
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Increasingly cost-conscious; generally concerned with long term patient outcome; efficacy focused, they are keen to see time saving benefits (reduced return visits)
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Managed case organizations/health insurance companies
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Want substantive real-world outcome data to select most cost effective drugs; may not have infrastructure to provide this data; not easily impressed with small scale PE studies
Reimbursement agency
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Responsible for setting a reimbursement level/copayment for the drug; concerned with the impact of new medicine on health care expenditures; will set pricing which reflects the perceived cost effectiveness of the new medicine

intervention with a new drug. Therefore, this type of study should be conducted early in development so that its findings are available to shape the pivotal phase 3a study strategy.
Phase 3a clinical studies provide an important opportunity to collect a variety of types of data that can help document cost effectiveness. The limited scale of such trials, the homogenous nature of patients studied, and the protocol limitations do not make such studies typical of subsequent product use. The collection of data for pharmaco-economic purposes in such trials

 
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