Based on the published clinical trials, an effect of rHuEpo therapy can be shown for selected indications outside the setting of uremia in a variable portion of patients. Cost-effectiveness cannot be demonstrated for the majority of these indications, at least using death and dollars as primary endpoints. Physicians can prescribe rHuEpo for nonapproved indications, but they should do so only for patients who are likely to benefit from its administration. Ideally, rHuEpo should be indicated for treatment of defective endogenous Epo production. We favor a patient-oriented approach in which the physician carefully evaluates the individual patient's symptoms, life style, and potential for response.
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