The American journal of managed care
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Coronary heart disease (CHD) has high prevalence in the United States and is associated with significant mortality as well as costs to society. Hyperlipidemia is a major and common modifiable risk factor for CHD. ⋯ Cost-effectiveness data have established that clinical and economic benefits are gained by instituting early and aggressive lipid-lowering therapy. We present new evidence for the clinical benefits and cost effectiveness of aggressive lipid-lowering therapy as primary or secondary prevention of CHD and describe strategies that managed care organizations can take to benefit from a lipid management program.
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Federal law requires the Food and Drug Administration (FDA) to regulate the promotional claims of prescription drugs and certain devices. Standards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at risk. However, equally demanding criteria for claims of cost-effectiveness of marketed technologies seem to be unnecessary because the consequence of error is principally a bad buy rather than patient harm. ⋯ The FDA should moderate its role in regulating cost-effectiveness claims of drugs and devices. This would foster information flow to healthcare providers and insurers and protect the FDA concern regarding false or misleading claims of effectiveness. Although the issues are applicable to both devices and drugs, we draw mainly from the field of pharmacoeconomics because this is where most of the policy has developed.
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Foundation Health Corporation, through its National Pharmacy and Therapeutics Committee, requires all pharmaceutical manufacturers and others who wish products to be considered for formulary listing to meet evidentiary and analytical standards in their submission documentation. This article details the evidentiary and analytical standards required from those making submissions and describes the methodological basis of the guidelines. ⋯ Submissions are required to take what is described as a systems impact perspective. This approach is quite different, in both evidentiary and analytical terms, from standards required by health systems in other countries and standards for the economic evaluation of pharmaceuticals proposed by expert groups in the United States.
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The economic evaluation of a new medicine often must be based on data gathered in multiple countries. Because replication of trials is an expensive and inefficient undertaking, analysts need to determine the validity of transferring cost-effectiveness data from one country to another. ⋯ Because of these differences, a drug can be cost-effective in one country and not cost-effective in another. Adapting a cost-effectiveness study conducted in one country to another country requires careful scrutiny of the relevance of comparators, practice patterns, and relative price weights.
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Comparative Study
Differences in physician compensation for cardiovascular services by age, sex, and race.
The purpose was to determine whether physicians receive substantially less compensation from patient groups (women, older patients, and nonwhite patients) that are reported to have low rates of utilization of cardiovascular services. Over an 18-month period we collected information on payments to physicians by 3,194 consecutive patients who underwent stress testing an 833 consecutive patients who underwent percutaneous coronary angioplasty at the Yale University Cardiology Practice. ⋯ Similar differences were observed for stress testing. These associations were largely explained by differences in insurance status.