Real medical benefit assessed by indirect comparison.
Frequently, in data packages submitted for Marketing Approval to the CHMP, there is a lack of relevant head-to-head comparisons of medicinal products that could enable national authorities responsible for the approval of reimbursement to assess the Added Therapeutic Value (ASMR) of new clinical entities or line extensions of existing therapies.Indirect or mixed treatment comparisons (MTC) are methods stemming from the field of meta-analysis that have been designed to tackle this problem. Adjusted indirect comparisons, meta-regressions, mixed models, Bayesian network analyses pool results of randomised controlled trials (RCTs), enabling a quantitative synthesis.The REAL procedure, recently developed by the HAS (French National Authority for Health), is a mixture of an MTC and effect model based on expert opinions. It is intended to translate the efficacy observed in the trials into effectiveness expected in day-to-day clinical practice in France.
Falissard
Bruno
B
INSERM, U669, Paris, France - Université Paris-Sud et Université Paris Descartes, UMR-S0669, Paris, France - AP-HP, Hôpital Paul Brousse, Département de Santé Publique, Villejuif, France. falissard_b@wanadoo.fr
Zylberman
Myriam
M
Cucherat
Michel
M
Izard
Valérie
V
Meyer
François
F
D003362:Cost-Benefit Analysis / Q000379:methods*; D003627:Data Interpretation, Statistical; D004358:Drug Therapy / Q000191:economics* / Q000592:standards*; D005602:France; D006077:Government Agencies; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000592:standards