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.