Assessment of biotechnology drugs: what are the issues?

Biotechnology is increasingly regarded as an important reservoir for the de velopment of new and innovative, but generally expensive, pharmaceuticals. At the same time, concerns about cost containment have triggered a keen int erest in evaluating and comparing the values of diverse health care interve ntions. In this paper we studied the process of assessment and diffusion of biotechnology drugs by studying three cases, i.e. nebacumab, colony stimul ating factors and recombinant human growth hormone. These cases are evaluat ed in a standardised format, concerning safety, efficacy, cost-effectivenes s and ethical, legal and social issues. Many factors that determine the fat e of a biotechnology drug seemed to be similar to those of 'classical' drug s. The definition and measurement of clinically relevant outcomes has been identified as a key factor in the assessment process. Another important iss ue is the relatively small population for the primary indications of biotec hnology drugs and the subsequent process of broadening of indications. Para doxically, the current trend towards evidence-based medicine means that we will increasingly have to make decisions based on 'incomplete' knowledge'. (C) 1999 Elsevier Science Ireland Ltd. All rights reserved.