France Liste en Sus Guide 2026: MedTech Reimbursement Add-on

Navigating Inpatient Reimbursement in the French Healthcare System (2026 Update)

This is the second article in our European reimbursement series. The first article, "A Shortcut to Medical Device Reimbursement in Germany," explored the NUB process.

You plan on getting your product approved in Europe and complete the MDR (Medical Device Regulation) process. You know France presents the 2nd largest market for medical devices in Europe and you already have a few French physicians interested in using your product. But, how can you get the French payers, aka health insurance funds (caisses d’assurance maladie) to pay for it - fast?

Here is one possible, intermediate mechanism, designed to serve as a gateway for introducing innovative medical devices into the French inpatient reimbursement system.

This article is part of Mediclever’s medical device reimbursement resources.

Last updated: January 30, 2026

1. The Problem: The Inpatient Catch-22

Reimbursement for a hospital inpatient stay in the US is determined according to a Medicare Severity Diagnosis Related Group (MS-DRG). Similarly, reimbursement for a hospital inpatient stay in France is determined according to a Groupe Homogène de Séjour (GHS).

In both cases, if a new device does not fit into an existing GHS, the hospital may not be properly reimbursed for its added cost and thus may not want to use it. On the other hand, forming a new GHS code to reflect the added costs associated with your new device requires data collection of procedure utilization. But since your device doesn’t currently fit into one of the French GHS codes, hospitals are reluctant to use it, and therefore it will never reach sufficient utilization to justify the creation of a new GHS code.

Sounds like a Catch-22, right?

To encourage entry of new and innovative technologies into the French healthcare system, innovative devices may be added to the “add-on list” (“liste en sus”), which provides hospitals with the required financial incentive to use a new device, before it is properly reimbursed under the GHS system. Most medical device companies are unaware of this mechanism that could shorten their time-to-market and even increase their chances of influencing the payment rate of a relevant GHS code in the future.

2. French GHS System

The French DRG system, or GHS system, groups several parameters to classify each patient's stay in a Homogeneous Group of Patients (Groupe Homogène de Maladies, GHM). Thereafter, each GHM is associated with its financial counterpart, the GHS.

The GHS system is a 'leaning system', relying on quantitative data supplied to the Technical Agency of Information on Hospitalization (ATIH). For example, the data gathered during 2024 is what is applied in the current 2026 GHS catalog. This two-year data lag underscores why the liste en sus is essential for innovations that have emerged since the last data collection cycle.

3. Liste en Sus

To get listed on the liste en sus, the product needs to get listed on France's list of reimbursable products (Liste des Produits et Prestations Remboursables, LPPR), under the product’s trade name (rather than under a general description).

The validity of the request for inclusion on the LPPR is evaluated by the national Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), which is part of the HAS. The device’s reimbursement tariff, in addition to the hospital GHS tariff, is then negotiated between the healthcare products pricing committee (CEPS) and the manufacturer. Inclusion using the brand name is intended to be temporary; as soon as a competitor appears, inclusion using the generic description form could be justified.

4. Application for Inclusion on the Liste en Sus

In the case of an initial request for inclusion, the guidance of CNEDiMTS is based on specific assessments of the product’s clinical and public health value.

4.1 Assessment of the Expected Service (SA)

Assessment of the SA (Service Attendu) is by indication and is essentially based on:

Evaluation of the risk/benefit ratio
The role of the device within the therapeutic strategy
Its benefit to public health

4.2 Assessment of Improvement of Expected Service (ASA)

If the SA is sufficient, CNEDiMTS evaluates the ASA (Amélioration du Service Attendu) in relation to a comparable gold standard. This assessment classifies the added clinical value according to the following 5-level scale:

Level I: Major clinical improvement.
Level II: Important clinical improvement in terms of therapeutic efficacy and/or reduction in side effects.
Level III: Moderate clinical improvement in terms of therapeutic efficacy and/or reduction in side effects.
Level IV: Minor clinical improvement in terms of therapeutic efficacy and/or reduction in side effects.
Level V: Absent improvement, but the product is still eligible for reimbursement based on its clinical equivalence to existing solutions.

4.3 Setting the Tariff

Tariffs take into account SA, ASA, prices of comparable products, and predicted sales volume. By law, the process should not exceed 6 months, though in practice it may take longer if additional data is required by CEPS.

5. Statistics and Post-Marketing Requirements

The review process is rigorous. In current data from HAS (2025), while many devices are submitted, only approximately 25% to 30% of products successfully achieve the ASA I, II, or III ratings that facilitate easier inclusion on the Liste en Sus. This highlights the importance of a well-prepared clinical dossier.

To maintain the listing, manufacturers must resubmit every three years to demonstrate real-life data from post-marketing studies. Failure to provide sufficient evidence may result in a drop in the "service rendu" rating and reimbursement level.

This data emphasizes that while the gateway exists, success depends on a robust evidence strategy.

6. Benefits and Disadvantages

Benefits:

Inclusion on the liste en sus could lead to immediate increase in procedure and sales volume.
As opposed to the equivalent NUB process in Germany, the manufacturer and not each individual hospital, negotiates the added reimbursement, which is then applicable for all hospitals, for up to 3 years.
The manufacturer negotiates the rate, not the hospitals, ensuring a more favorable and stable price nationwide.

Disadvantages:

The process requires review of at least two separate agencies (CNEDiMTS for clinical value and CEPS for pricing), which lengthens the process and requires substantial resources from the manufacturer's side.
On an annual average, only a small percentage of new products receive an ASA level of I or II that justifies separate reimbursement.

7. Summary: Strategic European Market Access

The French healthcare system provides the liste en sus to cope with the built-in delays of standard GHS integration. As we explored in our guide to medical device reimbursement in Germany (NUB), these short-term gateways are critical for innovative companies.

Utilizing these mechanisms in 2026 can help international companies obtain reimbursement in Europe faster and build the clinical utilization data required for a permanent GHS code. To verify GHS codes or develop the technical dossier for inclusion in the liste en sus, contact Mediclever today.

More on reimbursement in France

For a broader overview of the market, visit our dedicated France Medical Device Reimbursement country page.

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Frequently Asked Questions

How long does it take to obtain reimbursement in France?

If no existing reimbursement mechanism or product group applies, developing a new reimbursement pathway may take several years. However, in the case of the 'liste en sus', the process is legally intended to take approximately 6 months, though real-world timelines often extend depending on the negotiation with CEPS.

Is the reimbursement in Europe similar for all EU countries?

No. While regulatory approval is harmonized via the CE marking, reimbursement remains a national responsibility. Each country, including France with its GHS and 'liste en sus', maintains its own unique mechanisms and decision-making bodies.

Our product is already reimbursed in the USA. Will it help us obtain reimbursement in Europe?

There is no formal link between the systems. However, high-quality data generated in the US can be foundational for the French dossier, provided it is relevant to French clinical practice and the therapeutic strategies evaluated by CNEDiMTS.

France Liste en Sus Guide 2026:
Add-on Medical Device Reimbursement