Technical articles

Reimbursement of Health Products in France: A Public-Health and Market-Access Issue

19/03/2026

Securing reimbursement for a health product in France – whether a medicine, a Medical Device (MD) or In Vitro Diagnostic Medical Device (IVDMD) or a healthcare service – is a decisive step that is simultaneously regulatory, scientific, and strategic. Reimbursement ensures patients’ financial access to the best therapeutic solutions, facilitates the product’s integration into care pathways, and, consequently, underpins the economic and commercial viability of companies in the sector.

However, the process is rigorous, highly regulated, and often complex, requiring the compilation of a reimbursement dossier that demonstrates the product’s efficacy and safety. This article provides a concise overview of the reimbursement dossier journey, outlining its stakes, the key stakeholders involved, and its key phases.

1. Why seek reimbursement?

France’s healthcare system is founded on national solidarity. For any health product to be covered – fully or partly – by the national health insurance scheme (and, where relevant, by supplementary insurers), it must prove its usefulness, effectiveness, and safety. Reimbursement does more than assist patients financially; it also enables manufacturers to expand access to their products and secure their economic model. By contrast, a product that is not reimbursed often remains limited to specific patient groups, which can slow innovation or hinder access to appropriate therapies.

However, achieving reimbursed status is neither automatic nor guaranteed. It hinges on a rigorous evaluation of clinical benefit and cost-effectiveness, which is reviewed every five years. This assessment is always conducted relative to the most effective health products on the market that are currently considered to be “standard of care”. Accordingly, every five years, manufacturers must provide up-to-date evidence demonstrating differences in safety and efficacy between their product and the prevailing “comparator”.

2. Scope of Eligible Products and Key Specificities

In France, several categories of health products qualify for reimbursement, each subject to evaluation criteria specific to the product’s nature:

2.1. Medicines

To be reimbursed, a medicine must [1]:

Hold a Marketing Authorisation, confirming its quality, safety, and efficacy.
Be listed among the reimbursable specialties managed by the National Health Insurance Fund (Assurance Maladie). Inclusion follows an assessment by the French Health Technology Assessment (HTA, Haute Autorité de Santé, HAS) through its Transparency Committee (Commission de la Transparence, CT) based on:
- Clincial Benefit (Service Médical Rendu, SMR): evaluates the medicine’s clinical benefit for the target disease, considering disease severity, the medicine’s efficacy and adverse effects, its role in current treatment strategies, and public-health impact. The Clinical Benefit level determines the reimbursement rate: the higher the Clinical Benefit, the higher the reimbursement.
- Clinical Added Value (Amélioration du Service Médical Rendu, ASMR): gauges the medicine’s added value compared with existing treatments (innovation, additional efficacy, better tolerability, ease of use, etc.). Clinical Added Value is graded according to five levels: I (major), II (significant), III (moderate), IV (minor), and V (none). The Clinical Added Value level directly influences the medicine’s price.

2.2. Medical Devices and In Vitro Diagnostic Medical Devices

To obtain reimbursement, a MD or an IVDMD must [2, 3]:

Be CE-marked, attesting to the product’s compliance with European regulations.
In addition, it must be one of the following:
- Listed on the List of Reimbursable Products and Services (Liste des Produits et Prestations Remboursables, LPPR) for single-use devices employed in the patient’s home (outside any hospital context);
- Included in the tariff for a procedure via the Common Classification of Medical Procedures (Classification Commune des Actes Médicaux, CCAM), the General Classification of Professional Procedures (Nomenclature Générale des Actes Professionnels, NGAP), or the Nomenclature of Medical Biology Acts (Nomenclature des Actes de Biologie Médicale, NABM) for devices associated with a procedure performed by a healthcare professional;
- Included in the Diagnosis-Related Group (Groupes Homogènes de Séjour, GHS) tariff for devices used in healthcare facilities, except for implantable medical devices, which must be listed on the List of Reimbursable Products and Services – in which case they are financed at 100% in addition to the Diagnosis-Related Group tariff.

In order to do so, the MD or IVDMD must undergo evaluation by the French HTA (HAS), specifically by the National Committee for the Evaluation of Medical Devices and Health Technologies (Commission Nationale d’Évaluation des Dispositifs Médicaux et des Technologies de Santé, CNEDiMTS), based on:

Expected Benefit (Service Attendu SA), corresponding to the medical value of the device for its claimed indications. The Expected Benefit assessment considers disease severity, the product’s efficacy versus existing alternatives, impact on quality of life, and safety of use. If the Expected Benefit is deemed sufficient, the product is eligible for reimbursement, except for certain devices financed in addition to the Diagnosis-Related Group.
- Improvement of Expected Benefit (Amélioration du Service Attendu, ASA) or Improvement of Clinical Added Value (Amélioration du Service Rendu, ASR), which measures the device’s added value over the best current alternative (“comparator”), including such elements as superiority, simplicity, organisational benefit. The improvement is graded from I (major) to V (no improvement). As with medicinal products, the Improvement of Expected Benefit / Improvement of Clinical Added Value rating influences the pricing of the device.

It is important to note that there are also derogatory procedures such as the Innovation Package (“forfait innovation”) or Transitional Coverage (Prise en charge transitoire, PECT) that facilitate rapid access to innovative devices.

2.3. Other healthcare products

In certain cases, other medically-oriented products can also qualify for reimbursement, such as therapeutic-purpose cosmetics or Foods for Special Medical Purposes (FSMPs). These products are assessed on the basis of their actual therapeutic benefit, safety profile and demonstrated value to society. They must also be included on an official reimbursement list.

*Figure 1: How to obtain reimbursement for a healthcare product in France*

3. Involved Stakeholders

The success of a reimbursement dossier depends on thorough knowledge of – and effective communication with – the main institutional and decision-making bodies of the French healthcare system. The key players in market access for health products in France are:

Manufacturer / Applicant:
- Prepares and submits the technical, scientific, and administrative file requesting evaluation by the HAS and reimbursement by the Economic Committee for Health Products (Comité Économique des Produits de Santé, CEPS).
- Engages in dialogue with the authorities, justifying the product’s positioning and benefit.
- Provides additional information, participates in public hearings, and follows post-marketing feedback.
French Health Technology Assessment (Haute Autorité de Santé, HAS)
- Assesses the therapeutic value and expected clinical benefit of the product (Clinical Benefit (SMR) and Clinical Added Value (ASMR) for medicines; Expected Benefit (SA) and Clinical Added Value (ASA)for MD/IVDMDs).
- Issues an opinion that determines the reimbursement rate and coverage strategy for the product.
- May recommend additional studies and plays a long-term monitoring role.

Note: In 2023, 655 reimbursement evaluation requests for medicines and 340 requests for medical devices were submitted to the HAS.

Economic Committee for Health Products (Comité Économique des Produits de Santé, CEPS)):
- Negotiates the sales price with the manufacturer for products eligible for reimbursement, considering the level of innovation, the product’s place in the market, expected volume, and potential savings for the healthcare system.
- The Economic Committee’s decisions directly affect the reimbursement amount paid to patients and the commercial conditions for the product on the French market.
National Health Insurance Fund (La Caisse Nationale d’Assurance Maladie, CNAM) and its local branches, such as Primary Health Insurance Funds (Caisse Primaire d’Assurance Maladie, CPAM):
- As insurers, set the reimbursement level for health products and healthcare services.
- The National Health Insurance Fund also monitors consumption, oversees product use, and adjusts coverage policies.
Ministry of Health:
- Validates the final decisions.
- Ensures products are listed on the official reimbursement lists via ministerial decrees published in the Official Journal in France.

Having clarified who does what, the next section walks through the key steps required to build, submit, and monitor a successful reimbursement dossier.

4. Key Milestones in the Reimbursement Dossier Lifecycle

The reimbursement process for a health product is built on a structured regulatory pathway and the preparation of a rigorous dossier. The key stages are as follows [1, 2, 3]:

4.1. Preparation of the reimbursement application dossier

Once the MA or CE marking has been obtained and the product’s inclusion on the appropriate lists has been verified, assembly of the reimbursement dossier can begin.

The dossier must be scientifically substantiated and thoroughly documented to supply the authorities with all information required to support the reimbursement request and future coverage. It must contain solid, comparative evidence presented under well-defined criteria:

Clinical data, safety, and comparative analysis
- Efficacy: results of clinical trials, comparative studies, or scientific publications (see article https://efor-group.com/en/medical-and-scientific-writing/).
- Safety: tolerance profile, management of adverse events, patient risk.
- Place in the therapeutic arsenal: positioning of the product within the targeted pathology or need, compared with existing alternatives.
- Demonstration of Clinical Benefit and Clinical Added Value for medicines and MDs/IVDMDs: added value of the product when compared with the current best standard of care.
Need and impact analysis:
- Severity and significance of the targeted condition.
- Target population and prevalence.
- Available alternatives: whether other reimbursed solutions exist and their comparative advantages.
Organisational and economic data
- Prescription and supply modalities.
- Impact on healthcare organisation (involved professionals, training, related procedures).
- Health-economic impacts: cost-effectiveness, potential budget impact for the healthcare system.
Regulatory and commercial documentation
- Product history: international use, number of users, past withdrawals or modifications.
- Publications, full study reports, signed protocols.
- Structured literature review compliant with French Health Technology Assessment (HAS) criteria.

4.2. Submission and assessment of the dossier by the authorities

Optional early meeting and/or pre-submission with HAS.
Submission of the dossier to French Health Technology Assessment (HAS): Transparency Committee for medicines or CNEDiMTS for MD/IVDMDs.
Evaluation of Clinical Benefit and Clinical Added Value for medicines and MDs/IVDMDs, level of innovation, and clinical positioning.

4.3. Price negotiation and setting

Forwarding to Economic Committee for Health Products (CEPS) for relevant products: negotiation of the reimbursement tariff and economic conditions based on the Clinical Benefit and Clinical Added Value rating.

4.4. Listing decision and official publication

Listing on the appropriate reimbursement schedule.
Publication in the Official Journal in France.
Start of effective coverage for patients.

4.5. Post-listing follow-up

Performance of additional real-world studies if required.
Ongoing monitoring and renewal of listing based on observed data and practice.

*Figure 2: Key steps in the reimbursement process for a health product*

5. Conclusion

In France, market access for health products hinges largely on securing reimbursement. Achieving reimbursement is both a regulatory and strategic journey, critical for manufacturers and patients alike. The outcome of the French Health Technology Assessment (HAS) evaluation and the negotiated reimbursement price depends on the quality of a complex dossier that must rigorously demonstrate the added value of the proposed product compared with the current standard of care.

Beyond the technical and scientific requirements, including clinical evidence, comparative analyses, and health-economic data, compiling the dossier demands a thorough understanding of public-health priorities, the French medical landscape, and institutional expectations.

A well-structured dossier that highlights not only the individual benefit for patients but also the broader advantage for the healthcare system eases the product’s integration into routine clinical practice. It strengthens the manufacturer’s credibility, expedites decision-making by the authorities, and ultimately makes the solution accessible to the widest possible patient population.