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

Author:

Kahoul Riad12,Gueyffier François23,Amsallem Emmanuel4,Haugh Margaret1,Marchant Ivanny5,Boissel François-Henri1,Boissel Jean-Pierre123

Affiliation:

1. Novadiscovery SAS, 60 Avenue Rockefeller, 69008 Lyon, France

2. 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

3. Service de Pharmacologie Clinique et Essais Thérapeutiques, Hospices Civils de Lyon, Faculté de Médecine Laennec, Rue Guillaume Paradin, BP8071, 69376 Lyon cedex 08, France

4. CETAF, 67 Avenue Rochetaillée, 42100 Saint-Etienne, France

5. Departamento de Pre-clínicas, Escuela de Medicina, Universidad de Valparaíso, Errázuriz 1834, Valparaíso, Quinta Región de Valparaíso, Chile

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.

Publisher

The Royal Society

Subject

Biomedical Engineering,Biochemistry,Biomaterials,Bioengineering,Biophysics,Biotechnology

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