Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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The extent to which patient-based outcomes can be used to evaluate and communicate the effect of new drugs and devices is a subject of much debate. Criteria for evaluating the scientific quality of data to support health-related quality of life (HRQL) and other patient-based labeling and promotional claims in the United States and Europe have been proposed by various scientists and organizations. Since March 2000, a working group composed of members of the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Pharmaceutical Manufacturer's Association Health Outcomes Committee (PhRMA-HOC), and the European Regulatory Issues on Quality of Life Assessment (ERIQA) met to discuss and coordinate the various recommendations by their respective groups and address the need to harmonize outcomes review criteria within and across United States and European regulatory agencies. Over time, the discussion expanded from HRQL outcomes to include any outcome based on data provided by the patient or patient proxy, that is, patient-reported outcomes (PROs). The working group therefore became known as the PRO Harmonization Group. ⋯ The February 16, 2001, meeting represented an important step in harmonizing efforts across various organizations and in opening a dialogue with the FDA around major issues related to methodologic standards for measuring and interpreting PROs in the drug evaluation process.
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The objective of this report is to provide, in detail, the evidentiary requirements contained in Version 2.0 of the Academy of Managed Care Pharmacy's (AMCP's) Format for Formulary Submissions and to elaborate on several key issues regarding the use of the Format that users, potential users, and pharmaceutical manufacturers have raised since AMCP published the first version of the guidelines in October 2000. ⋯ The AMCP and the FMCP believe that the AMCP Format is a tool that will help health systems establish a record of commitment to rational decision making, thus gaining the confidence of patients, clinicians, and members. While providing manufacturers a vehicle for communicating the scientifically based value of their product to a health system, the required evidence to substantiate that value argument allows a pharmacy and therapeutics committee to determine the clinical benefits of a drug, verify any cost savings the drug may generate, and determine the overall cost consequences to their health system. The AMCP Format for Formulary Submissions is an essential tool to evaluate medications, but requires thoughtful consideration as it is used.
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Comparative Study
Economic comparison of home-care-based versus hospital-based treatment of chemotherapy-induced febrile neutropenia in children.
The purpose of this study was to compare health-care resource utilization and outcomes among children treated for low-risk febrile neutropenia (FN) in a hospital-based setting with those treated in a home-care-based setting. ⋯ We found that management of low-risk FN in a home-care-based setting was associated with significantly lower median total charges with no differences in outcome.
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Influenza is a common viral respiratory infection that is associated with significant morbidity. Oseltamivir (Tamiflu) is a neuraminidase inhibitor-a new class of antiviral treatment for influenza where efficacy and safety has been established but cost-effectiveness is unknown. ⋯ Oseltamivir for treatment of patients with ILI is potentially cost-effective if clinical diagnostic specificity for influenza observed in clinical trials is applicable to routine practice. More population-based information on the prevalence of influenza among early (<48 hours) presenters with ILI would be valuable.
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The impact of economic evaluation studies on health-care decision makers has been shown to be rather limited. However, there is an increasing requirement for the cost-effectiveness of health-care interventions to be considered in formulating and implementing guidelines for clinical practice. This paper reports the findings of recent focus group research among UK health authorities, which examined the usefulness of published economic evaluations within the decision-making processes. The findings are presented and discussed in light of other studies that have addressed this issue. ⋯ Decision makers value information on cost-effectiveness as well as effectiveness alone, but methodological improvements are necessary to increase the reliability of economic studies. A quality-scoring system for published studies would be a useful development as a filtering mechanism for decision makers but would raise a number of challenges for health economists.