Reimbursement Processes in France

FRANCE

Description of Healthcare System

In France, the general conditions of the reimbursement system are established by law and implemented principally at national level by governmental bodies. When marketing authorization is granted either by the EMEA or the French Medicine Agency (AFSSAPS), the company has to apply for reimbursement on positive lists to obtain funding by the mandatory health insurance (assurance maladie obligatoire). There are two lists : one for retail pharmacies reimbursable drugs (Liste des Spécialités remboursables aux Assurés Sociaux) and one for hospital drugs (Liste des Spécialités agréées aux collectivités). A pharmaceutical product can be listed on the two lists.

Reimbursement Approval Process and Time Frame

Pharmaceuticals are enlisted in two steps:

Step 1 is the technical assessment by la Haute Autorité de Santé (HAS) which hosts a commission previously known as the Commission de la Transparence and now Commission d’Evaluation des Médicaments.
Step 2 is the enlisting on the lists with price fixing by the Comité Economique des Produits de Santé (CEPS) and reimbursement rate fixing by the Union Nationale des Caisses d’Assurance Maladie (UNCAM).

Step 1 : technical assessment

The Commission d’Evaluation des Médicaments gives an opinion on the following items : the Medical Benefit (SMR) : it appraises whether the drug should be reimbursed and what could be the reimbursement rate
The Improvement of Medical Benefit assessment (ASMR) : the grading provides a basis for price fixing in comparison with alternatives;
The target population eligible for treatment in the reimbursement scheme

In some cases, the committee recommends reimbursement is restricted in contrast with MA for a selection of indications, certain groups of patients, or granted only when prescribed by a specialised doctor or when the patient is complying to a test. The committee also requires the company commitment to perform studies for assessing real life effectiveness or drug utilisation after admission to reimbursement.

The Medical Benefit (SMR) assessment:

The product’s medical benefit or therapeutic value (SMR) and is based on five criteria:

Efficacy and Safety
Position of the medicine in the therapeutic strategy and the existence or absence of therapeutic alternatives
Severity of the disease
Type of treatment : preventive, curative or symptomatic
Public Health Impact

According to the assessment of these five criteria, the Commission d’Evaluation des Médicaments appraises a Medical Benefit level. There are five levels:

Major
Important
Moderate
Weak
Insufficient to justify a reimbursement

Medicines of which level is insufficient are recommended not to be registered on the reimbursable list. The final decision is taken by the Health Minister.

The following table shows the Medical Benefit granted in 2005:

Source: Activity Report of the French Health Authorities (HAS), 2005.

The Improvement of Medical Benefit (ASMR) assessment

The second item appraised by the Commission d’Evaluation des Médicaments is the result of a comparative assessment of the new product with existing product or therapies: the Improvement of Medical Benefit (ASMR). Unless the product is first in its class, the evaluation is done in comparison with products of the same pharmaco-therapeutic class that are already enlisted .

There are five ASMR levels:

Major innovation
Important improvement
Significant improvement
Minor improvement
No improvement

The following table shows the Medical Benefit granted in 2005:

Source: Activity Report of the French Health Authorities (HAS), 2005.

Step 2 : The Pricing and Reimbursement Decision

Considering the opinion of the Commission d’Evaluation des Médicaments, the reimbursement rate is fixed by a decision of the Union Nationale des Caisses d’Assurance Maladie (UNCAM) within rate limits defined by decree. (Since the Law of 2004, August 13th)

The following table shows the various rates according the SMR:

		Severity of the disease
		High	Low
Medical Benefit (SMR)	Major or Important	65%	35%
	Moderate or Weak	35%	35%

A reimbursement rate of 15% was created in 2005 for the veinotonic drugs.
It remains valid until 2008, date on which these products will not be excluded of reimbursement.

The drugs recognized like irreplaceable and particularly expensive are reimbursable at 100% (eg HIV drugs).

The average reimbursement rate in 2005 was 75.12% (LEEM (pharmaceutical industry association) estimation according data of the French Health Authorities.) for retail pharmacist drugs.

Pricing Approval Process

Second step is the price fixing by the Comité Economique des Produits de Santé (CEPS) after negotiation with the company and its publication in the Official Journal. All retail pharmacies reimbursable drugs have administered prices. Hospitals drugs regimen is free pricing, except for costly drugs charged to the health insurance in addition to hospital DRGs (GHS) fixed tariffs or delivered by hospital pharmacies to out-patients. In that case, companies have the obligation to declare prices to the CEPS. If the CEPS does not agree with the declared price, it fixes it after a short negotiation. Those prices are also published in the Official Journal.

The price depends mainly of:

ASMR level
Price of the local comparators
Prices of the product in other European markets
Sale forecasts for the next three years
The Predictable or real conditions of use
Size of the target population

The registration on the reimbursable list is valid during five years. At the end of this period, the Commission d’Evaluation des Médicaments re-evaluates the SMR and ASMR level and the price can be reviewed by the CEPS accordingly. The duration of the procedure (from reimbursement application to publication of reimbursement in the Official Journal) is in principle 90 days for hospital only drugs and 180 days for retail pharmacists drugs: for the latter however it is in practice an average of 250 days.

Summary diagram for retail pharmacies medecines

Table 3
Source: LEEM (the pharmaceutical industry association)

See Activity Report of the French Health Authorities (HAS), 2006

Glossary of Special Terms

SMR (Service Medical Rendu): The Medical Benefit is evaluated by the Commission d’évaluation des medicaments (previously Commission de la Transparence - Transparency Commission) . This opinion results from a multi-criteria process and takes into account not only the contribution of the medicinal product but also the severity of the disease treated and its importance in terms of public health. There are five SMR levels. The SMR determines the reimbursement rate.

ASMR (Amélioration du Service Médical Rendu): The Commission d’évaluation des médicaments also evaluates the Improvement of Medical Benefit, that is, it compares it to already existing therapies. There are five ASMR level. The ASMR is taken into account in the pricing decision.

AMM: Autorisation de Mise sur le Marché / MA : Marketing Authorization

SMR: Service Medical Rendu / Medical Benefit

ASMR: Amélioration du Service Médical Rendu / Improvement of the Medical Benefit

AFSSAPS : Agence Francaise de Sécurité Sanitaire des Produits de Santé / French Health Products Safety Agency

HAS: Haute Autorité de Santé / French National Authority for Health

CEPS: Comité Economique des Produits de Santé / Economic Committee on Health Care Products

UNCAM: Union Nationale des Caisses d’Assurance Maladie / National Union of Health Insurance Funds

Reimbursement Organizations/HTA Organizations

Health Technology Assessment Organization

HAS (Haute Autorité de Santé): 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 to accreditation of healthcare organisations 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 programme. HAS is not a government body. It is an independent public body with financial autonomy. It is mandated by law to carry out specific missions on whom 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 d’Evaluation des Médicaments: The purpose of the Commission d’Evaluation des Médicaments is to provide scientific advice concerning the usefulness, interest and good use of drugs. The opinion of the French Transparency Commission is used to assess the medical service provided by a new drug and the improvement of this medical service subsequent to its use. This opinion is taken into consideration for establishing the reimbursement rate applied by the social security organizations and the selling price set by the administration. The expert opinions and recommendations established by the Commission d’évaluation des médicaments participate in implementing good use of drugs.

AFSSAPS (Agence Française de Securité Sanitaire des Produits de Santé): 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 and medico-economic 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.

Organizations who determine the reimbursement
The Health Minister determines if a medicine will be registered on the refundable list, and the UNCAM decides of the reimbursement rate.

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 and health care reimbursement procedures.

CEPS (Comité Economique des Produits de Santé): The Economic Committee on Health Care Products fixes the medicine price after negotiation with the medicine company.