HAS to be NICE?
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EDITORIAL
HAS to be NICE? Ge´rard de Pouvourville
Published online: 19 February 2013 Springer-Verlag Berlin Heidelberg 2013
In 2012, two regulatory texts changed the landscape in France quite dramatically with the official introduction of cost-effectiveness analysis (CEA) in the pricing and reimbursement process. The 2012 law for the Financing of Social Security first made a provision requiring HAS to consider cost-effectiveness when assessing new health drugs and medical devices1; this was followed by the publication of a decree in October 20122 describing the modalities of implementation. In October 2011, the official methodological guideline for CEA had already been published by HAS,3 the High Health Authority and French HTA body, and its Committee for Economic and Public Health Evaluation (CEESP). So is HAS turning NICE?
The French P&R process at a glance A brief reminder of the French P&R process is required before proceeding to an analysis of the new regulations. The HAS is mandated to assess all new health care technologies and to provide the Ministry of Health and Social Affairs (MOH) as well as the National Union of Sickness Fund (UNCAM) with recommendations in terms of access to reimbursement on one hand and an assessment of their relative value versus existing interventions on the other. Much like NICE, HAS is a scientific advisory body, but does not make final decisions in terms of reimbursement, coverage level and prices. Setting prices for drugs and medical devices is the responsibility of an inter-ministerial committee, the Economic Committee for Health Products (the CEPS). The pricing principles are themselves subject G. de Pouvourville (&) ESSEC Business School, Cergy Pontoise, France e-mail: [email protected]
to a pluriannual agreement (the so-called ‘‘accords-cadre’’) between the French government, represented by the CEPS, and trade unions (the LEEM for drugs and the SNITEM for medical devices). Tariffs for new medical procedures are under the responsibility of the UNCAM and will require some negotiations with physicians’ unions. Finally, after advice from the HAS on the level of coverage for reimbursement (i.e., the level of copayments for patients), the UNCAM has the final word. Principles for assessing and pricing drugs and medical devices have been progressively harmonized in the past years, so for the purpose of simplicity, only the full P&R process for drugs will be discussed here in relation to CEA; references to medical devices will be made only when significant differences are observed. The main body involved in the assessment of drugs is one the eight commissions of the HAS, the Transparency Commission (CT). The assessment is relative to a combination of a product and indication, which means a different advice is given for the same product for different indications. The published advice includes the following elements: •
A recommendation on reimbursement, based mainly but not only on the benefit/risk ratio of new technologies: the SMR (Service Me´dical Rendu or medical servic
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