In 2008, the French established a Finance Act which introduced health economic (HE) evaluation into the French market access process, through the creation of the Commission for Economic Evaluation and Public Health (CEESP).1 The act supports recommendations from the French Health Authority or Haute Authorité de Santé (HAS) and was part of an effort to tackle the increasing deficit of Social Health Insurance (SHI). The act’s goal was to ensure optimization of healthcare resources and thereby support fiscal recovery in France.2
The Transparency Commission (CT) and the Pricing Committee (CEPS) assess new medicines in France. The Ministry of Health (MOH) utilizes conclusions from these assessments to determine the settings in which the new medicine will be used, the reimbursement rate and the price.
Health economics is playing a greater role in decisions in France
The Social Security Finance Act in 2012 further defined the role of CEESP, requiring them to assess health economics (HE) data supplied by the manufacturer to determine whether their new medicine fulfills the following criteria:
1. The manufacturer has applied for a major, important or moderate medical benefit (ASMR I to III).
2. The medicine is expected to have a significant impact on the SHI budget. (HAS later defined what a “significant” impact on the budget was by setting an annual revenue threshold of €20 million.)3,4
CEESP reviews the health economics of new medicines, specifically cost per quality-adjusted life-year (QALY), submitted by the manufacturer
HAS issued guidelines in 2011 on the choice of the economic assessment to be utilized. 5 It is the responsibility of the manufacturer to produce the economic evidence supporting their product, as CEESP will not conduct any HE studies.
Review by CEESP is, however, not the same as a formal health technology assessment (HTA), such as that conducted by the National Institute for Health and Care Excellence (NICE) in the UK. In France, these CEESP reviews are intended to serve as a basis for price negotiations and renegotiations with the CEPS and are separate from the clinical assessments conducted by the CT.
Figure 1: Role of CT, CEESP and CEPS
|Evidence reviewed:||clinical||economic||clinical and economic|
More is still expected from CEESP which currently relies solely on evidence submitted by the manufacturer
Under the current framework, CEESP is expected to inform CEPS on the compliance of the manufacturer’s HE evaluations to HAS guidelines, but not to inform them on whether the intervention is cost-effective.6 Therefore, for the moment CEESP’s role seems to be limited to a consultative one (e.g.,. assisting CEPS with their pricing decisions). This explains the delay observed between the availability of the decisions and their publication (only seven reports were published between December 2014 and June 2015),7 as CEESP’s decision can only be published once prices have been published in the official public record, Journal Officiel de la République Française.
In addition, CEESP’s opinions rely only on the evidence submitted by the manufacturer. Unlike NICE, which actively gathers clinical and economic data from different sources in order to conduct health technology assessments, CEESP does not produce any evidence.8 Currently, CEESP appears to be more of a consultative committee, with little power to challenge manufacturers.
As the clinical and economic reviews are separated, there is also a risk of missing something that falls between the two reviews.
The current process is most likely a transition step toward a wider use of health economic evidence in France
While a transition to a wider use of health economics is likely, a merger between CEESP and CT is not. France has always favored clinical evidence over economic arguments. However, recent budget constraints mean that they are forced to consider health economic evaluation in order to optimize resource allocation.
Manufacturers will need to understand that health economics are likely to play an increasing role in the future. Moving forward, having a medicine with important clinical benefits will not be sufficient to provide manufacturers with a favorable price and reimbursement decision in France. Cost-effectiveness will also have to be demonstrated.
 Loi n° 2007-1786 du 19 Décembre 2007 de financement de la sécurité sociale pour 2008 [French]. Available at: http://www.legifrance.gouv.fr/affichTexteArticle.do;jsessionid=A51124210A870B450651619B3FE0765E.tpdjo17v_2?idArticle=JORFARTI000017726750&cidTexte=JORFTEXT000017726554&dateTexte=29990101&categorieLien=id. Accessed July 2015.
 Inspection Générale des Affaires Sociales. Evaluation medico-economique en santé. Rapport (décembre 2014).
 Haute Autorité de Santé. Production of economic opinion on drugs and medical devices in France: Challenges and issues. HTAi 2014
 Décret n° 2012-1116 du 2 Octobre 2012 relatif aux missions médico-économiques de la Haute Autorité de santé [French] Available at : http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000026453514&categorieLien=id
 Haute Autorité de Santé. Choix méthodologiques pour l’évaluation économique à la HAS. Octobre 2011.
 Haute Autorité de Santé [online]. Available at : http://www.has-sante.fr/portail/jcms/c_419565/fr/commission-evaluation-economique-et-de-sante-publique. Accessed June 2015.
 Haute Autorité de Santé [online]. Available at: http://www.has-sante.fr/portail/jcms/c_6056/fr/recherche-avancee?expression=exact&expression=exact&text=Saisir+vos+mots+cl%C3%A9s&text=Saisir+vos+mots+cl%C3%A9s&liaison_word=and&searchOn=fullText&catMode=or&dateMiseEnLigne=indexDateFrom&dateDebut=&dateFin=&typesf=opinions%2Fgenerated.AVISMedicament&typesf=opinions%2Fgenerated.AVISProduitsEtPrestations&search_antidot=&portlet=c_39085&FACET_CATEGORY_ADMIN=Accueil%2FPiliers%2F%C3%89valuation+%26+Recommandation%2F%C3%89valuation+M%C3%A9dico-%C3%A9conomique&sort=pdate Accessed June 2015.
 NICE. Guide to the multiple technology appraisal process (2009) Available at: www.nice.org.uk