title: Comparison of an effect-model-law-based method versus traditional clinical practice guidelines for optimal treatment decision-making: application to statin treatment in the French population.
abstract: Healthcare authorities make difficult decisions about how to spend limited budgets for interventions that guarantee the best cost-efficacy ratio. We propose a novel approach for treatment decision-making, OMES-in French: Objectif thérapeutique Modèle Effet Seuil (in English: Therapeutic Objective-Threshold-Effect Model; TOTEM). This approach takes into consideration results from clinical trials, adjusted for the patients' characteristics in treatment decision-making. We compared OMES with the French clinical practice guidelines (CPGs) for the management of dyslipidemia with statin in a computer-generated realistic virtual population, representing the adult French population, in terms of the number of all-cause deaths avoided (number of avoided events: NAEs) under treatment and the individual absolute benefit. The total budget was fixed at the annual amount reimbursed by the French social security for statins. With the CPGs, the NAEs was 292 for an annual cost of 122.54 M€ compared with 443 with OMES. For a fixed NAEs, OMES reduced costs by 50% (60.53 M€ yr(-1)). The results demonstrate that OMES is at least as good as, and even better than, the standard CPGs when applied to the same population. Hence the OMES approach is a practical, useful alternative which will help to overcome the limitations of treatment decision-making based uniquely on CPGs.
authors.affiliation: Novadiscovery SAS, 60 Avenue Rockefeller, 69008 Lyon, France UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, CNRS, UCB Lyon 1 - Bât. Grégor Mendel, 43 bd du 11 novembre 1918, 69622 Villeurbanne cedex, France riad.kahoul@novadiscovery.com.
authors.forename: Riad
authors.initials: R
authors.lastname: Kahoul
authors.affiliation: UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, CNRS, UCB Lyon 1 - Bât. Grégor Mendel, 43 bd du 11 novembre 1918, 69622 Villeurbanne cedex, France Service de Pharmacologie Clinique et Essais Thérapeutiques, Hospices Civils de Lyon, Faculté de Médecine Laennec, Rue Guillaume Paradin, BP8071, 69376 Lyon cedex 08, France.
authors.forename: François
authors.initials: F
authors.lastname: Gueyffier
authors.affiliation: CETAF, 67 Avenue Rochetaillée, 42100 Saint-Etienne, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Amsallem
authors.affiliation: Novadiscovery SAS, 60 Avenue Rockefeller, 69008 Lyon, France.
authors.forename: Margaret
authors.initials: M
authors.lastname: Haugh
authors.affiliation: Departamento de Pre-clínicas, Escuela de Medicina, Universidad de Valparaíso, Errázuriz 1834, Valparaíso, Quinta Región de Valparaíso, Chile.
authors.forename: Ivanny
authors.initials: I
authors.lastname: Marchant
authors.affiliation: Novadiscovery SAS, 60 Avenue Rockefeller, 69008 Lyon, France.
authors.forename: François-Henri
authors.initials: FH
authors.lastname: Boissel
authors.affiliation: Novadiscovery SAS, 60 Avenue Rockefeller, 69008 Lyon, France UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, CNRS, UCB Lyon 1 - Bât. Grégor Mendel, 43 bd du 11 novembre 1918, 69622 Villeurbanne cedex, France Service de Pharmacologie Clinique et Essais Thérapeutiques, Hospices Civils de Lyon, Faculté de Médecine Laennec, Rue Guillaume Paradin, BP8071, 69376 Lyon cedex 08, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Boissel
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D003198:Computer Simulation; D003365:Costs and Cost Analysis; D050171:Dyslipidemias / Q000175:diagnosis / Q000188:drug therapy / Q000191:economics; D005260:Female; D005602:France; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D008297:Male; D008954:Models, Biological; D017059:Models, Econometric; D017410:Practice Guidelines as Topic
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
keywords: cardiovascular diseases; clinical practice guidelines; effect model; personalized medicine; treatment decision-making