Methodological issues in economic assessments of new therapies. The case of colony-stimulating factors.

Pharmacoeconomic evaluations estimate the value of medical interventions by comparing their clinical consequences and costs. Economic analyses, based on resource use data collected during 3 clinical trials of lenograstim, were performed as part of a lenograstim economic evaluation programme. Undertaking economic evaluations alongside clinical trials presents a number of methodological challenges, since the trials may be performed in atypical settings, have inappropriate follow-up, or use end-points that are not useful for economic evaluation. This paper reports on how these challenges were met in the lenograstim economic evaluation programme. In particular, it was decided that the evaluations would be based on an intent-to-treat perspective, with the same period of follow-up (for costs) for both lenograstim and vehicle groups.