Health Economics

In the past, clinical efficacy and safety data were sufficient to successfully market a compound. Now, clinical effectiveness, long-term safety and pharmacoeconomics data are increasingly being requested by third-party payors and governments, in order to make informed choices about covering a growing number of available pharmaceutical and biotechnology products and devices. To help facilitate the design and meaningful reporting of health outcomes research, the Academy of Managed Care Pharmacy (AMCP) have developed and provided guidelines for collecting and presenting this information to decision-makers.

PPD provides comprehensive services in the design and implementation of pharmacoeconomic research:

• Preparation of pharmacoeconomic component for the AMCP formulary kits, including conducting extensive literature searches for pharmacoeconomic data on a given drug and class of drug and compiling data collected by the client and pharmacoeconomic modeling (if required)
• Burden of illness studies
• Data capture forms for Phase II-IV trials with economic endpoints, including quality of life questionnaires (which can translate to cost-utilities), work loss questions and medical resource utilization
• Analysis of medical resource utilization in clinical and observational studies compared with standard of care, placebo or a competitor, resulting in a general statement about the cost of therapy within a clinical or real world setting
• Retrospective costing of events using existing databases, primarily mapping events observed in clinical trials or in databases to external costing databases
• Cost-effectiveness analyses including cost-minimization, cost-benefit, cost-effectiveness and cost-utility – rolled into a single equation that describes the relative costs and benefits of competing therapies
• Budgetary impact modeling, including Markov models and decision trees, in which costs and consequences of interventions are estimated given certain assumptions that may be changed by the user, particularly useful for establishing price bands