Economic and quality of life outcomes in oncology: the regulatory perspective.
The federal government's involvement in cost-effectiveness studies, outcomes measures, and practice guideline development is haphazard, with a number of agencies taking part in the process. The Health Care Financing Administration (responsible for Medicare and Medicaid) and other third-party government payers informally and unscientifically judge the cost-effectiveness of treatments, particularly new technologies, when making coverage decisions. FDA policy restricts pharmaceutical companies from disseminating information on cost-effectiveness by requiring that such data be part of the product labeling. The Agency for Health Care Policy and Research has produced only a small number of practice guidelines and at a much higher cost than the private sector. Medical societies and other private organizations will ultimately find it in their best interest to include cost-effectiveness and outcomes measures in study protocols and to develop treatment guidelines related to their specialties.
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D014487:Centers for Medicare and Medicaid Services, U.S.; D003362:Cost-Benefit Analysis; D006077:Government Agencies; D017048:Health Care Costs; D006291:Health Policy; D006801:Humans; D009369:Neoplasms / Q000191:economics* / Q000523:psychology; D011788:Quality of Life; D014481:United States; D014485:United States Federal Trade Commission; D014486:United States Food and Drug Administration