Pharmacoeconomics is the area of health care research that evaluates and compares the costs and outcomes associated with drug therapy.1 Corresponding to Principles of · Discounting Costs · Pharmacoeconomical Study. The Principles of Pharmacoeconomics and Valuation of Health States course is offered at 17, AP. Pharmacoeconomics: Principles, Methods and Economic Evaluation of Drug Therapies. Pharmacoeconomics identifies, measures, and compares the costs and consequences of drug therapy to healthcare systems and society.
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This is the reason why we have to spend public resources only on the most cost-effective health care technologies, and we have to sacrifice those treatments that are effective, but too expensive.
Principles of pharmacoeconomics would be complicated and time consuming to rank all available health care technologies according to their cost-effectiveness Mauskopf et al.
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Classification of pharmacoeconomic evaluations according to the method of data collection There are several different approaches to assess the cost-effectiveness of pharmaceuticals. Pharmacoeconomic evaluations can be classified based upon their method of data collection see Principles of pharmacoeconomics 1.
In these studies, the incremental cost of pharmacoeconomic data collection is principles of pharmacoeconomics than if it is done separately in stand-alone health economic trials Hlatky et al. Prospective follow-up of patients in randomized trials reduces diversity of patient groups.
Therefore, perceived differences in pharmacoeconomic parameters are not attributable to differences between patient groups, and so the internal validity of cost-effectiveness conclusions is strong.
Economic analyses are mostly carried out alongside the pivotal clinical principles of pharmacoeconomics for registration purposes.
Thus, pharmacoeconomic results are available before the submission of full documentation for reimbursement purposes. The piggy-back approach, however, has several caveats Ramsey et al.
In prospective clinical trials, the time horizon of data collection is limited. As the inclusion criteria for selecting principles of pharmacoeconomics population are strict, it is difficult to generalize health economic results for ordinary patients.
The lack of external validity can be illustrated with the example on how we value the cost-effectiveness of statins over the age of 80, as patients over the age of 70 are principles of pharmacoeconomics excluded from clinical trials.
It is difficult to prove in economic analyses alongside pivotal clinical trials that a new medicine reduces the number of outpatient visits or diagnostics, as the clinical trial protocol requires strictly scheduled meetings with the investigator or diagnostic procedures to record efficacy end points.
Regular protocol-driven consultations with physicians or diagnostic tests reduce the chance of unexpected outpatient visits and the need for symptom-driven diagnostic procedures. Furthermore, much greater attention is paid for the monitoring of efficacy and safety variables than for the validity of health economic data; therefore, the quality of economic data collection may not always meet the expectations.
In pivotal clinical trials, the calculation of principles of pharmacoeconomics power is based on primary efficacy end points.
As usual, a larger sample size is needed to achieve confirmatory evidence for economic end points than for efficacy parameters; economic analyses alongside pivotal clinical trials often show no difference or only trends, but rarely statistically significant differences.
The final methodological reason principles of pharmacoeconomics inconclusive piggy-back analyses stems from the problem of study drug discontinuation. When principles of pharmacoeconomics reach major clinical study end points e.
Principles of pharmacoeconomics study drug discontinuation, the thorough data collection is stopped, and further data collection is restricted only to fatal events, malignancies and pregnancies. Strange but true, the real health economic story starts only after the detailed data collection ends.
Patients are relatively problem-free before they reach major clinical end points, the majority of non-scheduled resource utilization occurs only after these events.
This problem is especially valid in the principles of pharmacoeconomics of prevention and chronic maintenance therapies, consequently economic analyses alongside pivotal clinical trials are rarely decisive for these therapies.
In naturalistic health economic analyses, health gain and resource utilization of patients are measured in routine care settings; there are no protocol-driven outpatient visits or diagnostic procedures. Health economic results represent real-world benefits and costs in non-selected patient population Garrison et al.
This approach improves the generalizability, in other words the external validity of health economic conclusions, but the implementation of such trial is very difficult.
Appointments with the investigators cannot be planned in advance, principles of pharmacoeconomics of collected data is complicated unless the medical history and the resource utilization of patients are recorded in a validated database.
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Feasibility of naturalistic trials is easier in managed care settings or in health care systems with unique patient ID that can link resource utilization events of patients. Naturalistic pharmacoeconomic studies are mostly non-interventional. As opposed to interventional clinical trials information on patient compliance can be collected in observational studies.
However, the selection bias may significantly reduce the confirmatory evidence from non-interventional trials, as there is no classical randomization of patients, therefore selection principles of pharmacoeconomics treatment principles of pharmacoeconomics can be influenced by the clinical and socioeconomic status of patients.
Statistical techniques, such as multivariate regression analysis, can help to reduce the impact of selection bias.
Time horizon of naturalistic studies is also limited, similarly to economic analyses alongside clinical trials.