Decision Makers and Decision-Making Processes Diagram
Model description and Symbols:
The ultimate decision maker is listed at the top of the model
Boxes: Decision-making bodies
Solid Arrows: Required step in decision-making process
Broken Arrows: May or may not impact decision
- Level 1 define the process at the highest level (i.e. 30,000 ft. view), to provide a baseline understanding of the primary factors which impact decisions, for users who may or may not be familiar with these processes.
- Level 2 provide additional detail on specific data requirements and tools needed to support these decisions, by country, to support the decision-making process.
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 reimbursable drugs dispensed by retail pharmacies (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.
Since 2004, hospital drugs can be listed on two additional lists: hospital drugs delivered to out-patients (“liste Retrocession”) and hospital only costly drugs that are charged to health insurance in addition to hospital stay fees based on Diagnosis Related Groups tariffs (“liste T2A”).
DECISION-MAKERS AND INFLUENCERS
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 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 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
Health Ministry: 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.
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The French population is almost universally covered (99% of the population) by statutory health insurance (Assurance-maladie), a branch of the social security system (Sécurité Sociale).
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 specialist physician or when the patient is complying with a test. The committee also requires the company commitment to perform studies for assessing real life effectiveness or drug utilization after admission to reimbursement.
The Medical Benefit (SMR) assessment:
The product’s medical benefit or therapeutic value (SMR) 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:
- Insufficient to justify a reimbursement
Medicines with insufficient level 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 levels granted in 2007:
Source: Activity Report of the French Health Authorities (HAS), June 2008.
The Improvement of Medical Benefit (ASMR) assessment
There are five ASMR levels:
The second item appraised by the Commission d’Evaluation des Médicaments is the result of a comparative assessment of the new product with existing products 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.
- Major innovation
- Important improvement
- Significant improvement
- Minor improvement
- No improvement
The following table shows the Medical Benefit granted in 2007:
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Source: Activity Report of the French Health Authorities (HAS), June 2008.
REIMBURSEMENT AND PRICING APPROVAL PROCESS
Step 2: The Pricing and Reimbursement Decision
A pharmaceutical company is required to obtain marketing authorization for a new drug to be considered for national reimbursement. The manufacturer can set the price of the new drug but for this to be reimbursed by the national health insurance fund, i.e. Caisse Nationale d’ Assurance Maladie (CNAM), reimbursement status must be granted by Commission de Transparence (Transparency Commission).
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) (See Step 2 in Decision Making Process)
All registered pharmaceuticals are subjected to Evaluation of Therapeutic Benefit (Amelioration du Service Medical Rendu, or ASMR) by Commission de Transparence (Transparency Commission), which is expressed as a classification between 1 & 6, as follows:
The ASMR evaluation is based on the expert judgment of the Transparency Commission of the Pharmaceutical Agency (Agence du Medicament). Subsequently, a reimbursement price negotiated with
Comité Economique du Médicament (CEM). The price negotiated with CEM becomes the price at which the drug is sold throughout the country, even for private prescriptions.
- Innovative product of significant therapeutic benefit
- Product of therapeutic benefit, in terms of efficacy and/or reduction in side effect profile
- Already existing product, where equivalent pharmaceuticals exist; moderate improvement in terms of efficacy and/or reduction in side effect profile
- Minor improvement in terms of efficacy and/or utility
- No improvement but still granted recommendations to be listed
- Negative opinion regarding inclusion on the reimbursement list
(Adapted from Corinne Blachier, AFSSAPS)
The following table shows the various rates according to the SMR:
||Severity of the disease
|Medical Benefit (SMR)
||Major or Important
|Moderate or Weak
A reimbursement rate of 15% was created in 2005 for the veinotonic drugs. Since the 1st of January 2008 these products are excluded from reimbursement.
The drugs recognized like irreplaceable and particularly expensive are reimbursable at 100% (e.g. HIV drugs). Patients with chronic/severe diseases listed on a list (Liste des ALD) benefit a 100 % reimbursement rate for all their medications prescribed for the disease, whatever the reimbursement rate is for other patients.
The average reimbursement rate in 2007 was 76.77% for retail pharmacist drugs (CNAMTS).
Pricing Fixing Process
The price fixing is done by the 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 approve 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 (mainly UK, Germany, Italy, Spain)
- Sales forecasts for the next three years
- Predictable or real conditions for 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. In some cases, re-evaluation is planned ahead, especially when the Commission requires
post-reimbursement additional information (clinical or observational data). 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, in 2007 the average was 282 days (not including generics – CEPS Rapport 2007).
Since January 2008, the HAS has been assigned by law to produce “medico-economic opinions” to assess the most efficient therapeutic strategies and edict recommendations accordingly. To what extent this new assignment will impact on pricing and reimbursement for drugs remains so far to be clarified.
Summary diagram for retail pharmacies medicines
Source: LEEM (the pharmaceutical industry association)
See Activity Report of the French Health Authorities (HAS), June 2009
In addition to the clinical data obtained from the clinical development program, data that can be useful for the application includes;
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- Epidemiology data
- Risk management plan
- Post launch cohort plans
- Data base analyses
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 Health Technology Assessment body
CEPS: Comité Economique des Produits de Santé / Economic Committee on Health Care Products
CEPP: Commission d’Evaluation des Produits et Prestations.
LDMI : Liste des Dispositifs Medicaux Implantables
UNCAM: Union Nationale des Caisses d’Assurance Maladie / National Union of Health Insurance Funds.
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- ÖBIG (2006). Surveying, Assessing and Analyzing the Pharmaceutical Sector in the 25 EU Member States. Available at: http://ec.europa.eu/comm/competition/mergers/studies_reports/oebig.pdf
- Sandier S, Paris V, Polton D. Health care systems in transition: France. Copenhagen, WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies, 2004. Available at: http://www.euro.who.int/document/e83126.pdf
- Pelen. Reimbursement and Pricing of Drugs in France An increasingly complex system. HEPAC Health Economics in Prevention and Care 2000; 1(1):20–23.
- Pelen. Reimbursement and Pricing of Drugs in France. HEPAC Health Economics in Prevention and Care 2000; 0(0):20–23.
Please refer to Useful links above
AUTHORS & CONTRIBUTORS
Annie Chicoye PhD , Senior Principal Director Pricing & Market Access, IMS HEALTH, Puteaux-Cedex, France
Amit Chhabra MD, MPH, Outcomes Research Reimbursment Manager, Medtronic, Europe Sarl, Tolochenaz, Switzerland
Contributors: » TO TOP
Stefan Holmstrom, MSc., Dir HEOR, Astellas Pharma Europe, Leiderdrop, The Netherlands
Nazanin Mehin, Ass Dir Health Economics and Reimbursement Argumentation, Sanofi Aventis, Paris, France
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