Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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The industry perspective on drug costs should be framed by the need for decision-makers to use actual and relevant costs, and to inform real-world decisions regarding medication selection and use. The objective of this report is to provide guidance and recommendations on how manufacturers should approach the use of drug costs. ⋯ Understanding and accounting for all costs and consequences of the use of a medical treatment is in the best interests of all parties involved in the prescribing, consuming, reimbursement, selling, and manufacturing of bio/pharmaceuticals. Transparency, consistency, and clear communication of costs and value are essential for appropriate decision-making and should be important goals for all parties.
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The assignment of prices or costs to pharmaceuticals can be crucial to results and conclusions that are derived from pharmacoeconomic cost effectiveness analyses (CEAs). Although numerous pharmacoeconomic practice guidelines are available in the literature and have been promulgated in many countries, these guidelines are either vague or silent about how drug costs should be established or measured. This is particularly problematic in pharmacoeconomic studies performed from the "societal" perspective, because typically the measured cost of a brand name pharmaceutical is not a true economic cost but also includes transfer payments from some members of society (patients and third party payers) to other members of society (pharmaceutical manufacturer stockholders) in large part as a reward for biomedical innovation. Moreover, there are numerous and complex institutional factors that influence how drug costs should be measured from other CEA perspectives, both internationally and within the domestic US context. The objective of this report is to provide guidance and recommendations on how drug costs should be measured for CEAs performed from a number of key analytic perspectives. ⋯ Drug transaction prices not only ration current use of medication but also ration future biomedical research and development. CEA researchers should tailor the appropriate measure of drug costs to the analytic perspective, maintain clarity and transparency on drug cost measurement, and report the sensitivity of CEA results to reasonable drug cost measurement alternatives.
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Comparative Study
Mapping the cancer-specific EORTC QLQ-C30 to the preference-based EQ-5D, SF-6D, and 15D instruments.
To estimate models, via ordinary least squares regression, for predicting Euro Qol 5D (EQ-5D), Short Form 6D (SF-6D), and 15D utilities from scale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). ⋯ Evidence on the ability of QLQ-C30 scale scores to validly predict 15D and SF-6D utilities, and to a lesser extent, EQ-5D, has been provided. The modeling equations must be tried in future studies with larger and more diverse samples to confirm their appropriateness for estimating quality-adjusted life-year in cancer-patient trials including only the QLQ-C30.
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This study aimed to evaluate the length of stay (LOS), costs, and treatment consistency among patients hospitalized with community-acquired pneumonia (CAP) initially treated with intravenous (IV) moxifloxacin 400 mg or IV levofloxacin 750 mg. ⋯ In-hospital treatment of CAP with IV moxifloxacin 400 mg or IV levofloxacin 750 mg was associated with similar hospital LOS and costs in propensity-matched cohorts.
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Patient-reported outcome (PRO) instruments are used to evaluate the effect of medical products on how patients feel or function. This article presents the results of an ISPOR task force convened to address good clinical research practices for the use of existing or modified PRO instruments to support medical product labeling claims. The focus of the article is on content validity, with specific reference to existing or modified PRO instruments, because of the importance of content validity in selecting or modifying an existing PRO instrument and the lack of consensus in the research community regarding best practices for establishing and documenting this measurement property. ⋯ Published evidence of the content validity of a PRO instrument for an intended application is often limited. Such evidence is, however, important to evaluating the adequacy of a PRO instrument for the intended application. This article provides an overview of key issues involved in assessing and documenting content validity as it relates to using existing instruments in the drug approval process.