Healthcare System Changes in France

By Xcenda |

Before being assessed by the Haute Autorité de Santé (HAS) committees, all medicinal products have to receive regulatory approval from the European Medicines Agency (EMA) or the local regulatory agency (Agence Nationale de Sécurité du Médicament et des produits de santé—ANSM). We examine the changes coming for the reimbursement and price of medicinal products in France.

HTA QUARTERLY | SUMMER 2019

Healthcare System Changes in France

By Clémence Arvin-Berod, PharmD

Date last updated: August 8, 2019

Introduction

France has a public healthcare system, within which 75% of total health expenditures are covered by the public health insurance system, 12.5% are covered by out-of-pocket payments, and the remaining 12.5% are paid by private health insurance companies (supplementary taken by individuals). 
 
Before being assessed by the Haute Autorité de Santé (HAS) committees, all medicinal products have to receive regulatory approval from the European Medicines Agency (EMA) or the local regulatory agency (Agence Nationale de Sécurité du Médicament et des produits de santé—ANSM).
 
The level of reimbursement and price of medicinal products are determined by 2 different agencies in France: the Transparency Committee (TC) belongs to the HAS, while the Comité Économique des Produits de Santé (CEPS) belongs to the French health ministry. The process is summarized in Figure 1.
 
Figure 1. Overview of the Access Pathway for Medicinal Products in France

Figure 1. Overview of the Access Pathway for Medicinal Products in France

The TC evaluates the medical evidence, while the Commission d’Évaluation Économique et de Santé Publique (CEESP) might perform the economic evaluation when required. Following the TC recommendation, the medicinal products may be included on the positive list for reimbursement. Prices are determined by CEPS within the French health ministry.

Since the human immunodeficiency virus (HIV) outbreak in 1994, temporary use authorization (ATU) has been delivered by ANSM in France for products that do not have marketing authorization but are developed for conditions with high unmet needs and meet the following criteria:

  • Products for diagnosis, prevention, or treatment of severe or rare conditions
  • Currently no other treatment available
  • Efficacy and safety known to date justify the use in patients

There are 2 types of ATU, detailed in Table 1.

Table 1. Summary of ATU Types

Table 1. Summary of ATU Types

The ATU path has the advantage for accelerating the access to innovative health products in France to 210 days before marketing authorization, as the usual time between marketing authorization and reimbursement is 500 days on average. In contrast, the timing between marketing authorization and reimbursement is only 100 days in Germany and, at most, 180 days as required by the European commission.

What Changes Are Expected?

In September 2018, new legislation—the Plan de loi sur le financement de la sécurité sociale (PLFSS) 2019—was introduced by the French government. This ambitious law is projected to restructure some segments of the healthcare system to decrease healthcare spending and reduce the 300 million euros deficit of health insurance.

The law’s scope concerns various aspects of the healthcare system, such as reimbursement of glasses, dental prostheses, and hearing aids, funding of maternity leaves for self-employed women, and relieving the congestion in hospitals’ emergency rooms. 

Others are expected to directly impact access to medicines and the environment for manufacturers, such as:

  • Increased incentives to prescribe and dispense generics and biosimilars
  • Flat rate financing for chronic diseases (diabetes and end-stage renal disease as priorities)
  • Shortened time to set up clinical trials
  • Increased flexibility to set up clinical trials for rare diseases or in oncology
  • Simplified program to set up ATU
  • Extended ATU system to therapeutic indications for certain medicinal products looking to expand to another indication, even before their marketing authorization for the current indication
  • Mandatory data collection for innovative therapies 

While the time frame for implementation may vary, the changes have the potential to impact access and the level of opportunity for reimbursement, as well as the level of local support given to innovative products.

Conclusions

Manufacturers will have to remain on the lookout for the discussion and implementation of the changes engendered by the PLFSS 2019 regulation. There will likely be opportunities to influence and shape the changes, but also to understand the exact impact of these on the overall pathway to access in France.



 

The article should be referenced as follows: 

Arvin-Berod C. Healthcare System Changes in France. HTA Quarterly. Summer 2019. August 27, 2019.


 
Sources
  • Agence Nationale du Sécurité du Médicament et des produits de santé. https://www.ansm.sante.fr/Activites/Autorisations-temporaires-d-utilisation-ATU/Demandes-d-ATU-nominatives-du-mercredi-14-aout-18h00-au-lundi-19-aout-2019-9h00-Systeme-d-astreinte-et-recommandations/(offset)/0.
  • Assemblée Nationale. PLFSS 2019. http://www.assemblee-nationale.fr/15/projets/pl1297-ei.asp.
  • The French Health Care System: A Brief Overview. https://www.irdes.fr/english/documentation/documents/the-french-health-care-system.pdf.
  • Haute Autorité de Santé. Pricing and reimbursement of drugs and HTA policies in France. 2014.
  • Les entreprises du médicaments. https://www.leem.org/chantier-3-levaluation-et-lefficacite-administrative-pour-un-acces-linnovation-plus-rapide.
  • Michel Haering. French early access compassionate use program ATU: still an eternal flame? 2019.