Medico-economic Evaluation of Healthcare Products. Methodology for Defining a Significant Impact on French Health Insurance Costs and Selection of Benchmarks for Interpreting Results

¹ Délégation à la recherche clinique et à l’innovation, CHRU, Lille, France
² Laboratoire Lilly, Neuilly sur Seine, France
³ Comité économique des produits de santé, Paris, France
⁴ Direction de la sécurité sociale, Paris, France
⁵ AMGEN, Neuilly sur Seine, France
⁶ Laboratoire Janssen Cilag, Issy les Moulineaux, France
⁷ Medtronic, Boulogne Billancourt, France
⁸ CEMKA-EVAL, Bourg la Reine, France
⁹ Boston Scientific, Saint Quentin en Yvelines, France
¹⁰ LEEM, Paris, France
¹¹ ANAP, Paris, France
¹² Direction générale de la santé, Paris, France
¹³ GlaxoSmithKline, Marly le Roy, France
¹⁴ CNAMTS, Paris, France
¹⁵ MSD-Chibret, Courbevoie, France
¹⁶ Association française des hémophiles, Paris, France
¹⁷ Laboratoire Roche, Boulogne Billancourt, France
¹⁸ Institut Pasteur, Paris, France

Correspondence and offprints: Benoit Dervaux, Délégation à la recherche clinique et à l’innovation, CHRU Lille, 1 avenue Oscar Lambret, 59037 Lille Cedex, France. E-mail: benoit.dervaux@chru-lille.fr

Received: 9 June 2014
Accepted: 11 June 2014

Abstract

Decree No. 2012-1116 of 2 October 2012 on medico-economic assignments of the French National Authority for Health (Haute autorité de santé, HAS) significantly alters the conditions for accessing the health products market in France. This paper presents a theoretical framework for interpreting the results of the economic evaluation of health technologies and summarises the facts available in France for developing benchmarks that will be used to interpret incremental cost-effectiveness ratios. This literature review shows that it is difficult to determine a threshold value but it is also difficult to interpret then incremental cost effectiveness ratio (ICER) results without a threshold value. In this context, round table participants favour a pragmatic approach based on “benchmarks” as opposed to a threshold value, based on an interpretative and normative perspective, i.e. benchmarks that can change over time based on feedback.