BACKGROUND INFORMATION
Pharmacoeconomics, Real World Data and Health Outcomes Program (Health Outcomes Research) spans a broad spectrum of issues related to health-care delivery, from studies evaluating effectiveness of a pharmaceutical intervention, to the impact of reimbursement policies on outcomes of care. It also ranges from the development and use of patient-level real-world data and tools to perform patient-based assessments to analyses of ways in which results of Health Outcomes Research are disseminated to providers or consumers to encourage behavior change.
Health Outcomes Research incorporates a variety of methods, data, and tools from different disciplines. The application of Health Outcomes Research principles in evaluating the design, delivery, safe use and effectiveness of pharmaceuticals includes but isn’t limited to the following general areas:
Pharmacoeconomics evaluates behavior of individuals, organizations, and markets concerning use of pharmaceutical products, services, and programs. The discipline frequently focuses on costs (inputs) and consequences (outcomes) of pharmaceutical use.
Clinical Outcomes Assessment (COA) includes Patient Reported Outcomes, Clinician-Reported Outcomes, Performance Outcomes and Observer-Reported Outcomes. COA focuses on the value assigned to duration of life as modified by the impairment of physical, social, and psychological functional states, symptoms, satisfaction, perceptions, and opportunities influenced by disease, injury, treatment, or policy.
Patient-level Real-World Data and Analytic Tools: Health Outcomes Research depends on the evolving and increasing use, and evaluation of technologies, analyses and patient-level prospective databases (e.g. electronic medical records, health insurance claims data, registries, patient health-networks, patient health status monitoring) to assist in better understanding diseases and interventions.
Analyses and terminology under the umbrella of health outcomes include:
Biomarkers and Genetic Epidemiology Cost-Utility Analysis
Burden of Disease Health Services Research
Clinical Outcomes Assessment Health Technology Assessment
Comparative Effectiveness Research Patient Engagement in Research
Compliance/Adherence Pharmacoepidemiology
Cost-Benefit Analysis Real-World Data and Evidence
Cost-Effectiveness Analysis Value Assessment