EVALUATION OF BIOTECHNOLOGY PRODUCTS

Biotechnology products have had a substantial impact on the health car e system, including cost and patient care. In some hospitals, agents p roduced by biotechnology account for 10% or more of the pharmacy budge t. 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 comp ounds are different molecules, often with very different types of prop erties from synthetic chemicals. They are relatively expensive compare d with traditionally manufactured synthetic drugs. The increasing avai lability, individual characteristics, and relative expense of these pr oducts mandate a systematic method of evaluating them for use in vario us health care systems. Thirteen essential points must be considered w hen evaluating them for clinical use: availability of alternative agen ts; indications (both labeled and unlabeled); glycosylation; adverse e vents; administration and pharmacokinetics; monitoring needs; shipping , handling, and storage; stability; pharmaco-economic studies; concomi tant drug costs; special pharmacy procedures; reimbursement; and manuf acturer's support.