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.