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 file an application with HAS for national reimbursement. There are 2 lists of reimbursable pharmaceuticals:

  1. Drugs dispensed by retail pharmacies
  2. Drugs dispensed by hospitals

Drugs can appear on one or both of these lists.

Reimbursement is based on the determination and assessment of three elements:

  1. The actual medical benefit, SMR
  2. The improvement in actual medical benefit, ASMR
  3. Target population eligible for treatment (in the reimbursement scheme)

To be placed on one (or both) of these lists, companies must follow 3 steps:

  1. Choose which reimbursement list to be placed on, depending on the company’s strategy
  2. Technical assessment by the Transparency Committee (CT) and the economic assessment by the Committee for Economic and Public Health Assessment (CEESP), if needed
  3. Fixing 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 medicinal benefit (SMR, service médical rendu) 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:

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:

  • important
  • moderate
  • weak
  • insufficient

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

Further insights into previous trends for each benefit rating, 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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