Market Access in France

Market Access Overview

Sample information taken from our MAP France section

Steps to get an new innovative medicine reimbursed in the French market:

Once a pharmaceutical product is granted marketing authorisation by the EMA or the French Medicine Agency (ANSM), the company can ask to have the product considered for national reimbursement. There are 2 lists that cover reimbursement – one for reimbursable drugs dispensed by retail pharmacies and one for those dispensed by hospitals. Drugs can appear on one or both of these lists. The enlistment is in three steps:

  • Step 1 is the choice of the reimbursement lists depending on the strategy of the company
  • Step 2 is the technical assessment by the Transparency Committee (CT) and the economic assessment by the Committee for Economic and Public Health Assessment (CEESP), if needed
  • Step 3 is the fixing of the reimbursement rate by the National Union of Health Insurance Funds (UNCAM) and the pricing negotiation with the Economic Committee of Health Care Products (CEPS)

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Step 2: Technical assessment

Actual Medicinal Benefit (SMR)

The actual medical benefit (SMR) appraises whether the drug should be reimbursed and what could be the reimbursement rate. This assessment is based on five factors:

According to 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:

  • important
  • moderate
  • weak
  • insufficient

Below is an image on how the SMR and ASMR relate to each other.

Further insights on previous trends for each benefit ratings, as well as the process for orphan products and early access schemes such as ATU are available on MAP. ………………………………………….Join MAP to find out more

If what you need is not already on MAP, we will complete the additional work, usually at no extra charge

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