Relative effectiveness assessment of listed drugs (REAL): a new method for an early comparison of the effectiveness of approved health technologies.
OBJECTIVE
Post-listing assessment of pharmaceuticals depends on national habits. In England, the assessment is based on estimates of cost per quality-adjusted life-year. These are made some considerable time after listing (negative list). In France, effectiveness, and then efficiency, is assessed immediately after listing (positive list). We propose a new formal method--the REAL method--that can help make early comparisons of the effectiveness of medical treatments.


METHODS
Relative efficacies are first obtained from randomized controlled trials (RCTs). Members of the Transparency Committee (French National Authority for Health) are then consulted by questionnaire on the transposability of these results to real life. The RCT results and experts' ratings are entered into an effect model to obtain estimates of relative effectiveness, using unidimensional scaling, and bootstrap procedures.


RESULTS
Application of the REAL method to the example of a new drug to treat Parkinson's disease and three comparators used in the same indication provided graphs of the distributions of their relative efficacy and relative effectiveness. The new drug was found to provide no added value.


CONCLUSIONS
The REAL method is a rational, transparent, and practical procedure for comparing the effectiveness of pharmaceuticals in an immediate post-listing setting.
Falissard
Bruno
B
Department of Public Health, South Paris University, Bicêtre, France. falissard_b@wanadoo.fr
Izard
Valérie
V
Xerri
Bertrand
B
Bouvenot
Gilles
G
Meyer
François
F
Degos
Laurent
L
D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D006801:Humans; D055553:Prescription Drugs / Q000191:economics* / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013673:Technology Assessment, Biomedical / Q000379:methods*
D055553:Prescription Drugs