Evaluation of biotechnology products.

Biotechnology products have had a substantial impact on the health care system, including cost and patient care. In some hospitals, agents produced by biotechnology account for 10% or more of the pharmacy budget. As of May 1996, 29 biological products had been approved for use in the United States, including, in many instances, agents for diseases or conditions for which no drugs were previously available. These compounds are different molecules, often with very different types of properties from synthetic chemicals. They are relatively expensive compared with traditionally manufactured synthetic drugs. The increasing availability, individual characteristics, and relative expense of these products mandate a systematic method of evaluating them for use in various health care systems. Thirteen essential points must be considered when evaluating them for clinical use: availability of alternative agents; indications (both labeled and unlabeled); glycosylation; adverse events; administration and pharmacokinetics; monitoring needs; shipping, handling, and storage; stability; pharmaco-economic studies; concomitant drug costs; special pharmacy procedures; reimbursement; and manufacturer's support.