In France, certain drugs are covered by the National Health Insurance system. They are referred to as reimbursable drugs. Obtaining reimbursement is not based solely on a product’s therapeutic value. It involves a specific regulatory process, involving several authorities and affecting the price, prescription conditions, and patient access to the drug.
The reimbursement request must be submitted by the pharmaceutical company that markets the drug.
Assessment by the Transparency Committee
The French National Authority for Health (HAS), through its Transparency Committee, assesses each specialty based on:
- Actual benefit (Service Médical Rendu – SMR), which determines the applicable reimbursement rate (15%, 30%, 65%, or 100%).
- Drugs whose SMR is considered insufficient are not reimbursable.
The price of a reimbursable drug is then set by the Economic Committee for Health Products (CEPS), following negotiations with the pharmaceutical company, based on:
- The Improvement in Medical Service Rendered (Amélioration du Service Médical Rendu – ASMR), which ranks the product in relation to comparators already available, with 5 ASMR levels : from I (major therapeutic progress) to V (no improvement).
This price, combined with the reimbursement rate, subsequently determines the registration of the drug on the regulatory lists that allow it to be covered by Health Insurance :
- List of specialties reimbursable to Social Security Insured (City list): drugs available in community pharmacies, covered by Social Security based on a price negotiated with the CEPS and a reimbursement rate determined according to the SMR.
- List of pharmaceutical specialties approved for use by communities (Hospital list): drugs used in hospitals, covered through the standard hospital budget (GHS), without price negotiation with CEPS, as hospitals manage their own budgets and tenders.
- Supplementary List (“Liste en sus”): expensive and innovative drugs administered in hospitals, excluded from the GHS budget, reimbursed on an invoice basis, with prices negotiated directly with CEPS, taking into account their therapeutic value and impact on hospital costs.
A drug only becomes eligible for standard reimbursement after publication in the Official Journal. Note that some medicines are tacitly included on the hospital list. This is the case for medicines under compassionate use or early access programs. According to these prescription and dispensing conditions, the medication must be prescribed by a healthcare professional (doctor, midwife, dental surgeon, chiropodist, nurse) on a prescription in accordance with the regulations and within the limits of prescription rights. It is then dispensed to the patient either in community pharmacies or hospitals.
Obtaining reimbursement is not just an administrative formality: it is a key step that determines access to the French market. The pharmaceutical company must prepare a solid dossier and anticipate the authorities’ expectations, while ensuring that the product is correctly positioned in relation to existing alternatives. An unfavorable reimbursement or reimbursement obtained within a restrictive framework can limit the drug’s adoption by prescribers and hinder its access to patients.
Article written by Lamya SAOUSSEN, Junior Regulatory Affairs and External Communication Advisor