Market Access Overview
Once a pharmaceutical product is granted MA (Marketing Authorisation) for France the company can file an application for national reimbursement.
Reimbursement in France is based on three major steps:
step 1: choose which reimbursement list to be placed on, depending on the company’s strategy
step 2: technical assessment by the CT – Commission de la Transparence (Transparency Committee) and the economic assessment by the CEESP – Commission Évaluation Économique et de Santé Publique (Committee for Economic and Public Healthcare Evaluation), if needed
step 3: fixing the reimbursement rate by the NHI – (National Health Insurance) and the pricing negotiation with the CEPS – Comité Economique des Produits de Santé (Economic Committee of Healthcare Products)
The price of a new pharmaceutical product is set following the reimbursement rate fixation, given the reimbursement rate proposed by the UNCAM – Union Nationale des Caisses d’Assurance Maladie (National Association of Health Insurance Funds). Final drug lists, reimbursement rates and prices are decided upon under the MoH (Ministry of Health).
The SMR – Service Médical Rendu (Medical Benefit) assesses the intrinsic value of the drug and appraises whether the drug should be reimbursed and what could be the reimbursement rate. This assessment is based on five factors:
- severity of the disease and its impact on morbidity and mortality
- clinical efficacy/effectiveness and adverse effects of the drug
- the preventive, curative or symptomatic nature of the drug
- position in the therapeutic strategy in relation to other available therapies
- public health impact (burden of disease, health impact at the community level, transposability of clinical trial results)
Based on the assessment of these criteria, there are four SMR levels, three of which are sufficient to have a favourable opinion for inclusion on the list of reimbursable drugs:
- major / important
- low / weak
If the SMR is sufficient (I-III), the ASMR – Amélioration du Service Médical Rendu (Improvement in Medical Benefit) is then discussed. This is a comparative assessment of existing therapies and will be used to provide a basis for pricing in comparison with alternatives. If it is the first product in its class, the evaluation is done in comparison with products of the same pharmacological class that are already enlisted.
The ASMR appraisal directly takes into account:
- clinical pertinence of the main criterion
- the evidence
- the quantity effect and its clinical significance
There are five levels of ASMR, assessing some progress in relation to available treatments or existing care:
- ASMR I – Major (I) – innovative product of significant therapeutic benefit and demonstration of effect on mortality in a severe disease
- ASMR II – Important (II) – product of therapeutic benefit, in terms of efficacy and/or reduction in side effects
- ASMR III – Moderate (III) – already existing product, where equivalent pharmaceuticals exist; moderate improvement in terms of efficacy and/or reduction in side effects
- ASMR IV – Minor (IV) – minor improvement in terms of efficacy and/or utility
- ASMR V – No Improvement (V) – no improvement over current treatments shown but still granted recommendations to be listed (if the costs are less than the comparators)
Cautionary MAP InsightsIn France, unlike most European countries, pricing and reimbursement are carried out simultaneously instead of following one after another. They both follow the HTA assessment and the initial economic evaluation.
Following MA (Marketing Authorisation) by the EMA (European Medical Agency) or the ANSM – Agence Nationale de Sécurité du Médicament et des Produits de Santé (National Agency for Medicines and Health Products Safety), pharmaceutical products can be placed on the reimbursement lists. All drugs are assessed by HAS – Haute Autorité de Santé (High Authority of Health), regardless of whether they are marketed or not, before they can be included on the positive reimbursement lists for:
- Hospital pharmacies
- Community pharmacies
Reimbursement is based on the determination and assessment of three elements:
- Target population eligible for treatment (in the reimbursement scheme)
To be placed on one (or both) of these lists, companies must follow 3 steps:
- step 1: choose which reimbursement list to be placed on, depending on the company’s strategy
- step 2: technical assessment by the CT – Commission de la Transparence (Transparency Committee) and the economic assessment by the CEESP – Commission Évaluation Économique et de Santé Publique (Committee for Economic and Public Healthcare Evaluation), if needed
- step 3: fixing the reimbursement rate by the NHI – (National Health Insurance) and the pricing negotiation with the CEPS – Comité Economique des Produits de Santé (Economic Committee of Healthcare Products)
Drugs are reassessed every 5 years in order to remain on the reimbursement list for community pharmacies.
A pharmaceutical company may set its own price for a drug that has received marketing authorisation. For this to be reimbursed by the CNAM – Caisse Nationale de l’Assurance Maladie (National Health Insurance Fund), reimbursement status must initially be granted by the CT.
Reimbursement prices are determined by the CEPS though the HAS opinion has a major impact on the reimbursement rate and drug price. The price fixation depends on the reimbursement list (hospital or community pharmacy list).
France is also one of the leading countries for new and innovative treatments with its ATU – Autorisations temporaires d’utilisation (Temporary Authorisation for Use) for drugs without marketing authorisation, and RTU – Recommandations Temporaires d’Utilisation (Temporary Recommendation for Use) for drugs with authorisation in a different indication, giving patients earlier access to certain products under special circumstances.