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Global Health Technology Assessment Road Maps

France - Medical Devices


Updated/posted: October 2011
Validated by: Dr François Meyer, Dr Catherine Denis –Haute Haute Autorité de Santé (the French National Authority for Health)
  

France Map

BACKGROUND

France has a population of 63.9 millions, out of which 1.8 million live in the overseas departments (DOM) (INSEE, 2008).

The health care system is primarily managed by the government and the Parliament, at national level. Since 1996, regional level has been reinforced and since 2010,  22 regional health agencies (Agences régionales de Santé) in mainland and 3 in overseas departments, head  of which are nominated by the Prime Minister,  are in charge of regulating hospital and ambulatory care and medico-social care, in coordination with regional and local sickfunds.
The overall health care expenditure amounted in 2008 to 215  billions €, including collective expenditures, allowances to elderly and sick employees, ie  11 % of GDP. Health care consumption was 173 billions € mainly due to hospital care (44%), outpatient care (27%), drugs (20%) and other medical goods (6%) and to 8,7 % of GDP.(1)
The mandatory health insurance (HI) system (Assurance Maladie Obligatoire - AMO) covers the entire population. Expenditure target is fixed annually by the parliament which votes the Social Security Funding Law (loi de financement de la sécurité sociale). The HI schemes contract with the Ministry for Health, Youth and Sport (Ministère de la Santé, de la Jeunesse et des Sports) for implementation of the health and financial policies. There are three principal health insurance schemes, as well as a number of special schemes for civil servants, miners, railway employees and other workers. The general scheme (régime general) is the largest, covering salaried workers and their families (some 80% of the population in 2007), and is administered by the Caisse Nationale d’Assurance Maladie des Travailleurs Salariés (CNAMTS). Two other major ones are the Mutualité Sociale Agricole (MSA) for farmers and the Régime Social des Indépendants (RSI) for self-employed.  People not qualifying for any of the health insurance schemes by virtue of their profession or personal situation (eg unemployed people,) benefit from universal sickness coverage (Couverture Maladie Universelle, CMU), with free access for annual income up to 8 774 €.

Healthcare is primarily funded  through the mandatory health insurance system (75,5% in 2008). The AMO is funded through contributions from employers and employees (48% in 2008) and taxations (Contribution Sociale Généralisée 37% et Impôts et Taxes Affectés : 10%). Most of the remaining costs are covered by complementary health insurers (AMC) (13.7%), patient co-payments (9,4%) and the CMU (1,3%). CMU is principally funded thanks to taxation over complementary health insurance premiums (5.9%) eventually abounded by the government.
Over 90% of the population takes out complementary health insurance provided by a network of mutuelles (not-for-profit providers, provident institutions), private-for-profit providers. The government provides free complementary cover, known as “Couverture Maladie Universelle Complémentaire” (CMU-C), to anyone with an annual income below a fixed threshold, as well as financial assistance for contracting complementary cover (aide à l’acquisition d’une complémentaire santé) for low-income families and individuals who do not qualify for the CMU-C.
Primary care: in theory, patients are free to consult any healthcare provider, including specialists, without a referral. However, a gatekeeper system (médecin traitant) was introduced in 2004 and has been widely adopted. While it remains voluntary, patients not registered with a gatekeeper practitioner  – normally a general practitioner (GP) – or who consult a specialist without a referral are reimbursed for the consultation fee at a lower rate. Office-based doctors are paid on a fee-for-service basis, which is fixed through an agreement with the UNCAM and approved by the government. There were 61 294 office-based general practitioners in 2007, and 54 315 office based specialists, out of a total of 208 000 physicians in France.

Hospital care: there were 2 877 hospitals in France in 2006, amongst which 31 academic hospitals and 20 cancer centers.  Around 55% of hospitals work in the public sector (public establishments, plus private-not-for-profit contracted establishments). But the public sector amounts to 77% of the overall hospital expenditure. Since 2004 funding through DRGs (Tarification à l’activité) is implemented and now applied to both sectors, although tariffs still differ. Hospital care has been growing on average 3.6% per annum between 2006 and 2008, versus 5,1 % in the previous 5 years (2000-2005).

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DECISION-MAKERS AND INFLUENCERS

1. NATIONAL LEVEL

   HEALTH TECHNOLOGY ASSESSMENT ORGANIZATIONS

  • Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS): The law of 1st July 1998 created the French Health Products Safety Agency within a global context of reinforcing health monitoring and control of all products for human use. Therefore, the AFSSAPS is the competent authority for all safety decisions taken concerning health products from their manufacturing to their marketing. The AFSSAPS carries out three core missions: scientific evaluation; laboratory control and advertising control; inspection of industrial sites. The Agency also coordinates vigilance activities relating to all products for which it is relevant.

  • Haute Autorité de Santé (HAS): The French National Authority for Health was set up by the French government in August 2004 in order to bring together under a single roof a number of activities designed to improve the quality of patient care and to guarantee equity within the healthcare system. HAS activities are diverse. They range from assessment of drugs, medical devices, and procedures to publication of guidelines, accreditation of healthcare organizations and certification of doctors. All are based on rigorously acquired scientific expertise. Training in quality issues and information provision are also key components of its work program. HAS is an independent public body with financial autonomy. It is mandated by law to carry out specific missions on which it reports to Government and Parliament. It liaises closely with government health agencies, national health insurance funds, research organisms, unions of healthcare professionals, and patients' representatives.

  • Commission Nationale d’Evaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS):  The purpose of the CNEDiMTS as part of HAS body is to provide scientific opinion concerning the usefulness, interest and good use of medical devices and other non-drug healthcare products. Since July 2010, CNEDiMTS took over the mission of assessing medical and surgical procedures (with either diagnostic or therapeutic purpose) that were previously assessed by a separate HAS specialist committee.

   ORGANIZATIONS WHO DETERMINE THE REIMBURSEMENT

  • Health Ministry:  : The Health Minister determines if a device will be admitted to reimbursement, based on the appraisal by the CNEMiDTS, the price or tariff is fixed by the CEPS. To date, the reimbursement rate is 60%.

  • CEPS (Comité Economique des Produits de Santé):The Economic Committee on Health Care Products  is composed of representatives of the concerned departments in the Health ministry (Department for Public health Direction Générale de la Santé – Department for Social Security - Direction de la Securité Sociale), the Ministry of Industry, the ministry of Finance and representatives of the mandatory health insurances and the complementary insurances. It determines the price or the tariff after negotiation with the manufacturer.

  • UNCAM (Union Nationale des Caisses d’Assurance Maladie): The UNCAM is a new public health care organizational system following reform law of 12 August 2004. Its first purpose is the coordination of the three mandatory sickness funds, links with complementary scheme and with health care professionals, to obtain a better health insurance management. Its second purpose is the intervention in negotiation of agreements with medical professionals in decision concerning prescription drug, medical devices and medical or other professional procedures.

    In addition, UNCAM is the decision making body for coding and fixing medical procedures tariffs, on the basis of HAS appraisals and after negotiation with health professionals unions within a specific committee (Commission de hiérarchisation des actes et procédures, CHAP).

2. Regional and Hospital levelS

  • Agences Régionales de Santé (regional health agencies): they result from the combination of previous hospital regional agencies (set up in 1996), regional statuary health insurances (CRAM) and their unions (URCAM) and state regional health authorities (DRASS). Their role is to plan hospital and ambulatory resources in the region according to the population needs, to implement national health plans at regional level, to contract with hospitals for optimizing the health care provision to the population and negotiate their budgets for the part not financed by the DRGs. Part of the contracts are related to appropriate utilization of costly drugs and medicals devices (Contrat de bon usage des soins).
  • Comité des Médicaments et des Dispositifs Médicaux Stériles (COMEDIMS): Committees for drugs and sterile medical devices have been in place in all hospitals since 2000. Their role is to fight against iatrogenic accidents by better monitoring drug prescription and delivery and consumption, to decide for enlisting drugs or medical devices on the hospital formulary, which is based on national guidelines  and eventually completed by medico-economic assessment.

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REGUALTOR PATHWAY/MARKET APPROVAL PROCESS

The first step to ensure market access of a medical device is its certification by a notified body in order to obtain CE mark.

Based on the New Approach, rules relating to the safety and performance of medical devices were harmonized in the EU in the 1990s. The core legal framework consists of 3 directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC] regarding in vitro diagnostic medical devices. They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC which will be in application from March 20th 2011.

CE mark ensures that medical devices are in accordance to these European directives and represents the first mandatory step to French market access, whether the device is funded directly by Health Insurance through its enlistment on a positive list or funded indirectly through DRG tariffs.

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REIMBURSEMENT AND COVERAGE/ PAYEMENT FLOW MAP AND PROCUREMENT PROCESS

1. DRG funding

Since 2004, a DRG funding scheme in both the public and private sectors has been implemented in France. Therefore, most devices are included in the DRG tariff funded by the Health Insurance. In that case, hospitals are purchasers in the context of public tender regulation and there is no health technology assessment at national level. It is the role of COMEDIMS (Comité des Médicaments et des Dispositifs Médicaux Stériles), a subcommittee of the Hospital Medical Committee (CME: Commission Médicale d’Etablissement) set in every hospital or group of hospitals  to proceed to the assessment for enlisting on the hospital formulary and decide for the purchasing.  Hospitals are increasingly grouping in procurement organizations to obtain lower prices and encouraged to do so by the Ministry of Health.
Some innovative and/or costly devices are not included in DRG funding and reimbursed separately from a specific budget. In that case, prices are regulated by the government (cf § 4.2) and procurement by hospital is managed by negotiations which may result in discounted prices. This funding is generally temporary and ends up when the device is included in a new DRG or the tariff of an existing DRG is updated.

2. Enlistment on the LPPR, a positive reimbursement list

Reimbursement by the MHI for a medical device used in ambulatory care or too expensive to be funded with DRGs tariffs is submitted to enlisting on  a positive list, the  LPPR  (« Liste des Produits et Prestations Remboursables» ie list of devices and medical procedures). (2)

This list has 4 chapters (4 “titles”):

  • Title I: medical devices for treatments and devices for life care, dietetic food and dressing articles
  • Title II: external prostheses and ortheses
  • Title III: implantable medical devices
  • Title IV: physical handicap vehicles

To be listed in the LPPR, two different pathways exist:

  • Listing under “generic line” (ligne générique)which is the general rule (i.e. hip prosthesis, ceramic) to which a tariff for reimbursement is attached. Generic lines describe a class of products, their intended use, and their technical characteristics without mentioning any trade name.

    A medical device conforming with the LPPR generic line description, does not go through an assessment by the CNEDIMTs; the manufacturer only needs to label its product with the corresponding LPPR code. The device will therefore be reimbursed by Mandatory Health Insurance at the existing tariff. The only requirement for the manufacturer is to declare it to the Health Products Safety Agency (AFSSAPS) to ensure proper post marketing surveillance (materiovigilance) of the device.

    It has been recently decided all existing generic lines to be reviewed by CNEDiMTS over a period of ten years. Each year there is a preset reassessment program which is known through a ministerial order . A reappraisal will then be mandatory every 5 years. This will allow to ensure that the description (indication and/or technical description) corresponds to the rapid evolution of MDs.

  • Listing under the medical device own trade name, where they are specifically designated and described.  Trade name listing is necessary or recommended when the device is: a) innovative and presents some characteristics that makes it different from the existing generic description, b) presumed to impact Health care expenditure or c) requires a specific follow-up for safety issues.
A two steps process is to be followed, after the manufacturer has submitted a dossier in line with the recommended format:

  1. Technical assessment by the National Committee for Medical Devices and Technologies Assessment (CNEDiMTS - Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé), one of the specialist committees within the  HTA agency (Haute Autorité de Santé). CNEDiMTS will assess:

    • Whether a trade name listing is appropriate, given the innovative characteristics of the device

    • Whether the expected service (service attendu) that should be delivered by the new device is sufficient to grant reimbursement (yes or no), based on its impact on disease or handicap, its safety profile, its interest for public health; eventually technical specifications or restrictions  for utilisation by only qualified hospital departments or specialists will be determined;

    • What is the added value for the patient (ASR - amélioration du service rendu)  graded as major (grade I), important (grade II), moderate (grade III) minor (grade IV) or absent (grade V)  versus existing strategies, whether they are other MDs or pharmaceuticals or medical procedures; the assessment will be based mainly on clinical evidence, possibly completed by expert opinions;

    • What is the number of patients who might benefit the device, based on epidemiological data; 

    The CNEDiMTS’ appraisal will be published on the HAS website. If the opinion is positive the negotiation with the CEPS will proceed.

  2. Tariffs fixing: after negotiating with the manufacturer, the Economic Committee for Health Care Products (CEPS: Comité Economique des Produits de Santé”) will set a tariff for reimbursement by the MHI (the price can be higher, but the reimbursement rate will apply to this tariff) or a price (the manufacturer is not allowed to sell the MD above the fixed price, to which the reimbursement rate will be applied). Price or tariffs fixing will take into account the ASR  (a higher grade will facilitate a high premium over existing strategies) and the costs for development and production. Eventually, reimbursement will be submitted to commitments by the manufacturer to set up a registry or produce further clinical evidence.

    When many devices presenting similarities are listed with trademarks, the CEPS may consider creating a new generic description and set a common tariff.  

Exhibit 1: French Pricing & Reimbursement (PR) process for medical devices

According to the law, the timelines for the whole process should be 180 days but in reality it may take much longer, especially when filing for a device for the first time. The 2009 CEPS annual report stipulates a delay of 398 days for a first filing. Exhibits 2 show the filing process for a first time application with its timeline in mean days.

Exhibit 2: Average application processing times in 2009 (in number of days) (3)

From application to final opinion by the CNEDiMTS

Transfer from the CNEDiMTS to the CEPS

From reception by the CEPS to 1st review by the CEPS

From 1st review by the CEPS to publication in the Official Journal

Total

154 days

19 days

70 days

155 days

398 days

3. Reimbursement of a device ThRough A MEDICAL procedure

When the medical device is delivered to the patient only within a medical procedure that is not already coded for reimbursement, the enlistment of the new procedure is mandatory in order to obtain MD reimbursement in ambulatory or hospital setting. Currently (September 2011), medical procedure that are used in hospital and not associated with a new code are not submitted to HTA. However, a draft bill is discussed in Parliament that plans to make HTA mandatory also for those medical devices.

In that case, appraisal by HAS consists of a single assessment report and conclusions of the appraisals are transmitted to the two reimbursement and pricing decision making bodies: CEPS and ministry of health for LPPR, UNCAM for medical procedure coding. Concerning procedures, depending on their nature, they are are enlisted on various lists:

  • NGAP » General list of professional procedure. It can concern nurse and dentist procedure for instance.
  • CCAM » Common classification of medical procedure. This list concerns any medical procedure perform in an ambulatory setting or within hospital.
  • NABM » Medical biological procedure, mainly related to any biological diagnosis procedure.

HAS is required to appraise a procedure either by the National Health Insurance funds (UNCAM) or by scientific societies. Health ministry, the National Complementary Health Insurance funds (UNOCAM) or the National Cancer Institute (INCa) can also ask for the assessment of a new procedure. It is important to mention that, when needed, industrial can (should) initiate the procedure through the relevant scientific society.

Based on HAS appraisal, the Committee of grading of Medical Procedure (CHAP: commission de hiérarchisation des actes professionnels) managed by the Health Insurance Union (UNCAM: Union Nationale des Caisses d’Assurance Maladie) will fix reimbursement tariffs and rates for medical procedures after negotiation with Health professional unions.

The following exhibits summarize the French market access pathways and the national decision makers.

Exhibit 3: The French market access pathway for medical device

The French market access pathway

 

Exhibit 4: Decisions makers at national level FUSIONNER CNEDiMTS et CEAP

Decision makers

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DATA REQUIREMENTS (HTA, PAYMENT DECISIONS)

The CNEDiMTS requires the company to submit a technical dossier including : technical description of the technology and its mode of action, eventually specifications for use, for which indication reimbursement is required, the severity of the targeted condition, the clinical evidence allowing to assess effectiveness and risk graded  according to the level of scientific evidence (from observational case series up to randomized clinical trials /meta-analysis), existence of  alternatives  whether medication, surgical procedure or other devices and comparison with those,  estimates of the size and characteristics of the target population, based on epidemiology and/or market research data.   Cost/effectiveness analysis is not required but may be submitted

The CEPS requires the company to submit an economic dossier including: price or tariff required for the reimbursement, sales forecasts up to the market stabilization, price or tariff justification based on cost minimization versus existing alternatives, sales, prices  and reimbursement status in other EU countries. Are also required breakdown of costs for manufacturing and distribution, information about the company  (location in France and foreign countries for manufacturing and commercialization, number of employees, turn-over, French sales of products reimbursed by the statutory health insurance). No formal cost/effectiveness analysis or budget impact analysis is formally required but it can be considered by the CEPS in its decision process. 

Since a bill passed in July 2009 and enforceable in March 2010, innovative medical devices or procedures can be temporarily funded through a dedicated exceptional pathway. The funding covers partial or total related to the innovation: patient stay, medical device and/or procedure as well as the costs of additional data collection.  Admission to this exceptional pathway is decided by the health ministry after the HAS has been consulted.

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ACRONYMS

Afssaps

Agence française de sécurité sanitaire des produits de santé

AMO

Assurance-Maladie Obligatoire

ARS

Agence Régionale de Santé

ASA Amélioration du service attendu

ASR

Amélioration du service rendu

CCAM

Classification Commune des Actes Médicaux

CEPS

Comité Economique des Produits de Santé

CE

Conformité Européenne

CEAP

Commission d’Evaluation des Actes Professionnels

CHAP

Commission de Hiérarchisation des Actes Professionnels

CMU

Couverture Maladie Universelle

CMU-C

Couverture Maladie Universelle Complémentaire

CNAMTS

Caisse Nationale de l’Assurance Maladie des Travailleurs Salariés

CNEDiMTS

Commission Nationale d’Evaluation des Dispositifs Médicaux et des Technologies de Santé

COMEDIMS

Comité des Médicaments et des Dispositifs Médicaux Stériles

CME Commission Médicale d’Etablissement

CRAM

Caisse Régionale d’Assurance Maladie

DRASS

Direction Régionale des Affaires Sanitaires et Sociales

DOM

Département d’Outre-Mer

DRG

Disease-related group (groupe homogène de séjours – GHS)

MG / GP

Médecin généraliste / General Practitioner

HAS

Haute Autorité de Santé

HI

Health Insurance

INCa

Institut National du Cancer

LPPR

Liste de Produits et Prestations Remboursables

MD

Medical Device

MHI Mandatory Health Insurance

NABM

Nomenclature des Actes de Biologie Médicale

NGAP

Nomenclature Générale des Actes Professionnels

RSI

Régime Social des Indépendants

SA

Service Attendu

SHI

Statutory Health Insurance

UNCAM

Union National des Caisses d’Assurance Maladie

UNOCAM

Union national des Organismes Complémentaires d’Aassurance Maladie

URCAM

Union Régionale des Caisses d’Assurance Maladie

SUGGESTED READINGS

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USEFUL LINKS

REFERENCES

  1. Ministère du Travail, de l’Emploi et de la Santé. N° 701 - Les Comptes nationaux de la santé en 2008. September 9, 2009. Available at http://www.sante.gouv.fr/no-701-les-comptes-nationaux-de-la-sante-en-2008.html. Accessed on October 18, 2011

  2. Haute Autorité de Santé . Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé visés à l'article L.165-1 du code de la sécurité sociale. 2009 available @ http://www.has-sante.fr/portail/jcms/c_412130/la-commission-nationale-devaluation-des-dispositifs-medicaux-et-des-technologies-de-sante.  Accessed on October 18, 2011

  3. CEPS. 2009-2010 Annual report. Available at : http://www.ceps-as.cz/files/ceps_annual-report_2009-2010_print.pdf. accessed on October 18, 2011

  4. Legifrance. LOI n° 2008-337 du 15 avril 2008 ratifiant l'ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du medicament. Available at: http://www.legifrance.gouv.fr/affichLoiPubliee.do;jsessionid=9C9DA5AEB4997B88BF0468ECAEDACE18.tpdjo17v_1?idDocument=JORFDOLE000018652459&type=general accessed on October 18, 2011

AUTHORS & CONTRIBUTORS

Annie Chicoye PhD, MS Political Science, Executive Director  ESSEC Institute of Health Economics and Management – ESSEC Business School Paris-Singapore
Karine Levesque, PhD,  Reimbursement manager, Abbott Vascular, Paris, France

CONTRIBUTOR
Robert Launois,PhD, Professor, REES France, Paris, France Director Europe, BioBridge Strategies, Basel, Switzerland

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