Évaluation du coût médicamenteux évité lié à la gratuité du médicament pour essai clinique

Abstract

Excluding all other costs or benefits of participation in clinical trials, the objective of this study was to evaluate and analyse the cost avoidance represented by the free supply of the investigational drug in place of paying for a marketed drug. The cost avoided was defined as money that would most likely have been spent, but not because of inclusion of the patient in the clinical study. Only studies for which a marketed alternative drug was available with a standard dosage have been analysed. The numbers of delivered doses or the treatment durations were tabulated from pharmacy dispensing records for each study, and were used to calculate the medication cost avoided. No marketed alternative drug was available for 10 of 56 clinical studies. In total, in 2000, the cost avoidance was estimated between €585 492 and €603 674, with a wide variability between studies or between patients (CV: 120–520%). The two disease categories associated with the largest cost avoidance were multiple sclerosis and growth hormone deficiency. The cost avoidance was essentially of benefit to the medical insurance or the patient (98%) and was lower than €10 000 for the hospital, because 91% of patients are not hospitalised. So, why are clinical studies involving ambulatory patients performed in hospital? Of the 56 studies analysed, 46 could be shown to be non-innovative, because a marketed alternative drug was available. Few studies appeared to permit free access to treatment with non-reimbursable marketed drugs.