The HAS / CNEDiMTS route explained science, law, and real-world decisions
France operates one of the most structured and evidence-based reimbursement systems for medical devices in Europe. Access is not negotiated informally, nor is it driven solely by innovation narratives. Instead, reimbursement hinges on a formal national Health Technology Assessment (HTA) pathway centred on clinical value, comparator-based evidence, and public health relevance. LPPR reimbursement in France is the formal national pathway through which medical devices obtain statutory reimbursement following clinical assessment by HAS and CNEDiMTS.
This article provides an authoritative, science-grounded guide to how manufacturers secure reimbursement via the LPPR (Liste des Produits et Prestations Remboursables) and why many fail despite strong technologies.
LPPR reimbursement in France is the formal national pathway through which medical devices and medical aids obtain statutory reimbursement following clinical assessment by HAS and CNEDiMTS. Access to LPPR reimbursement is determined first by Service Attendu (SA), which establishes eligibility, and then by Amélioration du Service Attendu (ASA), which influences pricing and funding conditions.
What is the LPPR and why does it exist
The LPPR is France’s national reimbursement list for medical devices and medical aids that require explicit identification, conditions of use, and a negotiated tariff or price, rather than being indirectly funded within hospital activity payments (DRGs).
In practical terms, LPPR listing is required when a device:
- Represents a distinct technology or indication
- Requires clear clinical conditions of use
- Has budgetary implications that cannot be absorbed invisibly into tariffs
- Needs nationally consistent reimbursement
Once listed, reimbursement applies across France, under the conditions specified in law.
The institutions that govern the process
The LPPR pathway is run by four national bodies, each with a non-overlapping role:
- French National Authority for Health (HAS)
Oversees the process and publishes official decisions - National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS)
Performs the clinical evaluation (SA and ASA) - Economic Committee for Healthcare Products (CEPS)
Negotiates prices and tariffs after clinical approval - Assurance Maladie
Funds reimbursement once listing is activated
This separation is deliberate: clinical legitimacy is assessed before price is discussed.
The scientific core of the LPPR process: SA and ASA
LPPR reimbursement in France: step-by-step process
Step 1 Service Attendu (SA): the eligibility gate
The CNEDiMTS first assesses the Service Attendu (SA), meaning the actual or expected clinical benefit of the device for the claimed indication(s).
This assessment considers:
- Severity of the disease or condition
- Demonstrated efficacy and safety
- Balance of benefit and risk
- Place in the therapeutic or diagnostic strategy
- Public health relevance
The outcome is binary:
- SA sufficient → the device is eligible for LPPR listing
- SA insufficient → rejection; reimbursement is not possible
SA is the single most critical decision in the French system.
No amount of innovation, AI, or engineering sophistication can compensate for insufficient SA.
Step 2 Amélioration du Service Attendu (ASA): pricing leverage
If and only if SA is sufficient, CNEDiMTS then evaluates the Amélioration du Service Attendu (ASA), i.e. the incremental clinical value compared with the most relevant comparator used in routine French practice.
ASA is graded as:
| ASA level | Meaning |
|---|---|
| I | Major clinical improvement |
| II | Significant improvement |
| III | Moderate improvement |
| IV | Minor improvement |
| V | No clinical improvement |
ASA does not usually determine whether a device can be listed.
Instead, it defines the ceiling of pricing ambition during negotiations with CEPS.
This distinction is frequently misunderstood by non-French manufacturers.
The end-to-end LPPR pathway in practice
LPPR reimbursement in France: step-by-step process
Step 0 — Decide whether LPPR is the right route
LPPR is appropriate when a technology:
- Needs explicit national recognition
- Has defined conditions of use
- Carries material budget impact
- Cannot rely on silent hospital funding
Step 1 Build the dossier (structure matters)
HAS publishes a formal dossier matrix and submission guidance. A successful dossier is not a data dump; it is a structured scientific argument that allows CNEDiMTS to conclude:
- The indication is coherent and clinically anchored
- The comparator reflects real French practice
- The evidence supports SA sufficiency
- Any claimed incremental benefit is measurable and comparative
Increasingly, HAS also scrutinises organisational and pathway impacts (workflow, care coordination), particularly where these are claimed as part of the value proposition.
Step 2 Pre-submission meeting (optional but strategic)
Manufacturers may request a pre-submission meeting with HAS to clarify:
- Comparator choice
- Evidence expectations
- Methodological issues
While HAS does not provide “strategy advice”, this step often prevents avoidable misalignment later.
Step 3 CNEDiMTS evaluation and publication of the opinion
CNEDiMTS issues a formal Avis, published publicly by HAS, which states:
- SA conclusion (sufficient or insufficient)
- ASA grade (I–V)
- Comparator used
- Approved indication(s)
- Conditions of use
This opinion is the scientific anchor for everything that follows.
Step 4 Pricing and tariff negotiation with CEPS
Only after a favourable CNEDiMTS opinion does pricing discussion begin with CEPS.
CEPS considers:
- ASA level
- Comparator prices
- Budget impact
- Expected volumes
- International reference pricing
You do not “sell” innovation to CEPS.
You negotiate within the boundaries defined by CNEDiMTS science.
Step 5: Ministerial decree and reimbursement activation
Once agreement is reached, an arrêté is published in the Journal Officiel, formally listing the device on the LPPR with:
- Reimbursement conditions
- Duration of listing
- Applicable tariff or price
This legal act is the true “go-live” moment for reimbursement.
December 2025 decisions: what success actually looks like
In December 2025, CNEDiMTS issued four favourable opinions for new LPPR registrations with add-on reimbursement, illustrating how the system works in reality.
GORE TAG Thoracic Branch Endoprosthesis W. L. Gore & Associates
- SA: sufficient
- ASA: IV (minor improvement)
- Comparator: hybrid surgical approach combining left subclavian artery revascularisation and thoracic endoprosthesis placement
This decision recognises clinical utility while clearly framing the device as an incremental, not transformative, improvement.
Vercise Genus P32 (non-rechargeable DBS) Boston Scientific
- SA: sufficient
- ASA: V (no improvement)
- Comparator: Vercise Genus P16 non-rechargeable DBS system
Here, reimbursement eligibility is secured, but pricing leverage is intentionally constrained due to the absence of added clinical value.
What these decisions reveal about the French system
These cases illustrate several structural truths:
- France reimburses clinical benefit, not novelty
- SA sufficiency opens the door; ASA defines how wide it opens
- ASA IV–V listings are common — and legitimate
- Comparator choice is often the single decisive factor
- Add-on reimbursement is compatible with modest incremental value
How to find authoritative LPPR decisions yourself
Authoritative LPPR decisions are published by the French National Authority for Health (HAS) and are accessible to the public. However, they can only be reliably identified when searched using official French terminology. Generic English searches rarely surface the underlying HTA decisions.
When searching the HAS website, use French terms only, prioritising the following:
Core decision documents (highest value)
- Avis CNEDiMTS
- Avis Produits et Prestations
These terms surface the formal CNEDiMTS opinions that contain:
- Service Attendu (SA) conclusions
- ASA grading (I–V)
- Comparator rationale
- Approved indications and conditions of use
LPPR-specific search terms
- inscription LPPR
- demande d’inscription sur la LPPR
- nouvelle inscription LPPR
- renouvellement d’inscription LPPR
These terms help identify both new listings and renewals, which are often reassessed against updated standards of care.
Clinical evaluation keywords
- Service Attendu
- SA suffisant
- Amélioration du Service Attendu
- ASA I / ASA II / ASA III / ASA IV / ASA V
- comparateur pertinent
- place dans la stratégie thérapeutique
These terms allow you to interrogate how and why a device was assessed the way it was.
What a correct LPPR decision looks like
A genuine LPPR decision document will always:
- Explicitly state the SA conclusion
- Specify the ASA level
- Identify the comparator
- Define the indication(s) retained
- Be published as an Avis by HAS
If a document does not include SA and ASA conclusions, it is not an LPPR decision
To verify that an LPPR decision has resulted in live reimbursement, cross-check the HAS opinion with the corresponding ministerial decree (arrêté) published in the Journal Officiel. Only publication in the Journal Officiel activates reimbursement.
Understanding how to access primary LPPR decisions allows manufacturers, clinicians, and investors to:
- Analyse precedent decisions
- Reverse-engineer successful dossiers
- Understand pricing constraints before CEPS negotiations
This is the difference between studying the French system and operating within it.
LPPR reimbursement in France: submission checklist
- Define a precise LPPR reimbursement indication that is clinically coherent, tightly delimited, and explicitly anchored in current French clinical practice and care pathways, avoiding over-broad or aspirational claims.
- Demonstrate sufficient Service Attendu (SA) through robust clinical and safety evidence that clearly establishes a favourable benefit–risk profile, the severity of the condition addressed, and a well-defined place in the therapeutic or diagnostic strategy.
- Identify and justify the relevant French comparator, ensuring it reflects real-world standard practice in France and provides a credible basis for comparative assessment of Amélioration du Service Attendu (ASA).
- Structure the evidence dossier explicitly against ASA evaluation criteria, ensuring that any claimed incremental benefit is comparative, clinically meaningful, and outcome-relevant, rather than descriptive, technical, or feature-based.
- Submit the LPPR reimbursement dossier to HAS / CNEDiMTS via the SÉSAME platform, fully aligned with the official dossier matrix, methodological guidance, and current CNEDiMTS expectations.
- Use the published CNEDiMTS opinion as the scientific anchor for CEPS pricing negotiations, recognising that pricing potential and funding conditions are structurally bounded by the SA conclusion and ASA grade.
France Reimburses Evidence, Not Innovation Narratives
The LPPR is not a commercial negotiation framework. It is a national, science-driven HTA pathway, deliberately designed to protect public resources by anchoring reimbursement decisions in demonstrable clinical benefit.
Through the French National Authority for Health (HAS) and the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), France applies a two-step clinical logic that is rigorous, conservative, and predictable. Service Attendu (SA) determines whether a technology merits access to national reimbursement at all. Amélioration du Service Attendu (ASA) then defines the degree to which that access can be leveraged in pricing and funding discussions.
The December 2025 LPPR decisions illustrate this logic clearly. Technologies with clear clinical utility but modest incremental advantage—including those graded ASA IV or ASA V can and do achieve national reimbursement. What changes is not access, but commercial headroom. In France, pricing ambition is earned through comparative clinical value, not asserted through novelty, branding, or international momentum.
For manufacturers, the implications are structural rather than tactical. Success in France is not achieved by persuading payers after the fact, but by engineering the evidence pathway upstream: constraining indications with precision, selecting comparators that reflect real French practice, and aligning clinical development explicitly with CNEDiMTS’ evaluation questions.
Those who understand this framework can secure predictable, national reimbursement, even for incremental technologies. Those who do not often misinterpret rejection or price compression as resistance to innovation, when in reality it reflects misalignment with French HTA science.
In short, the LPPR is France’s scientific contract with its health system. It is demanding by design, conservative by necessity, and navigable by those who treat evidence—not enthusiasm—as the decisive currency of reimbursement.
Frequently Asked Questions: LPPR reimbursement in France
What is LPPR reimbursement in France?
LPPR reimbursement in France is the national mechanism through which medical devices and medical aids obtain statutory reimbursement after clinical evaluation by the French National Authority for Health (HAS). Devices listed on the LPPR are reimbursed nationally under defined conditions of use.
Who decides LPPR reimbursement in France?
LPPR reimbursement in France is decided through a formal process led by HAS, based on clinical assessment by the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Pricing and tariffs are then negotiated separately with the Economic Committee for Healthcare Products (CEPS).
What is Service Attendu (SA) in LPPR reimbursement in France?
In LPPR reimbursement in France, Service Attendu (SA) represents the actual or expected clinical benefit of a device for a specific indication. SA is a binary eligibility gate: only devices assessed as having sufficient SA can proceed to LPPR listing and reimbursement.
What is Amélioration du Service Attendu (ASA) in LPPR reimbursement in France?
In LPPR reimbursement in France, Amélioration du Service Attendu (ASA) measures the incremental clinical value of a device compared with the most relevant comparator used in routine French practice. ASA is graded from I (major improvement) to V (no improvement) and directly influences pricing negotiations, not eligibility.
Can devices with ASA IV or ASA V obtain LPPR reimbursement in France?
Yes. LPPR reimbursement in France allows devices with ASA IV (minor improvement) or ASA V (no added improvement) to be reimbursed, provided that Service Attendu is sufficient. In such cases, reimbursement access is granted, but pricing flexibility is intentionally constrained.
When does LPPR reimbursement in France become effective?
LPPR reimbursement in France becomes effective only after publication of a ministerial decree (arrêté) in the Journal Officiel. This legal act formally lists the device on the LPPR and activates national reimbursement by statutory health insurance
Glossary of key terms: LPPR reimbursement in France
LPPR (Liste des Produits et Prestations Remboursables)
The LPPR reimbursement list in France is the national register of medical devices and medical aids that are individually listed for reimbursement by statutory health insurance. Devices on the LPPR have defined indications, conditions of use, and a nationally negotiated tariff or price.
HAS (Haute Autorité de Santé)
The French National Authority for Health (HAS) is the independent public authority responsible for health technology assessment in France. HAS publishes recommendations and formal opinions that underpin LPPR reimbursement decisions for medical devices.
CNEDiMTS
The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) is the expert committee within HAS that performs the clinical evaluation of medical devices for LPPR reimbursement in France, including assessment of Service Attendu and ASA.
Service Attendu (SA)
In LPPR reimbursement in France, Service Attendu (SA) refers to the actual or expected clinical benefit of a device for a specific indication. SA is a binary gatekeeper: only devices with sufficient SA are eligible for LPPR listing.
Amélioration du Service Attendu (ASA)
ASA measures the incremental clinical benefit of a device compared with the most relevant comparator used in routine French practice. In LPPR reimbursement in France, ASA is graded from I (major improvement) to V (no improvement) and directly influences pricing negotiations.
Comparator (Comparateur pertinent)
The relevant comparator is the technology, procedure, or strategy that reflects current standard of care in France. Comparator choice is central to ASA assessment and is one of the most decisive scientific elements in LPPR reimbursement dossiers.
CEPS (Comité économique des produits de santé)
The Economic Committee for Healthcare Products (CEPS) is the national body responsible for pricing and tariff negotiation after a favourable CNEDiMTS opinion. CEPS uses SA and ASA conclusions as binding inputs in LPPR reimbursement negotiations.
Arrêté (Ministerial Decree)
An arrêté is the formal legal act published in the Journal Officiel that operationalises LPPR reimbursement in France. Reimbursement becomes effective only once the arrêté listing the device is published.
Journal Officiel (JORF)
The Journal Officiel de la République Française is the official legal gazette in which LPPR listings, tariffs, and reimbursement conditions are published. It marks the legal start date of reimbursement.
Add-on reimbursement (Prise en charge “en sus”)
Some LPPR devices qualify for add-on reimbursement outside hospital activity tariffs. In LPPR reimbursement in France, this mechanism allows specific high-cost or identifiable devices to be reimbursed separately from DRG-based hospital funding.
Indication (Indication revendiquée)
The claimed indication defines the patient population and clinical use evaluated by CNEDiMTS. In LPPR reimbursement in France, overly broad indications frequently weaken SA and ASA conclusions.
Conditions d’utilisation
These are the mandatory usage conditions attached to LPPR reimbursement, often specifying prescriber type, care setting, or patient eligibility. They are legally binding once published.
SÉSAME
SÉSAME is the electronic submission platform used to file LPPR reimbursement dossiers with HAS and CNEDiMTS. All formal applications for LPPR listing are submitted through this system.
Renewal (Renouvellement d’inscription LPPR)
LPPR listings are time-limited. Renewal applications require updated clinical evidence and may trigger reassessment of SA and ASA under current standards of care.
Real-world evidence (Données en vie réelle)
Real-world evidence may be requested or considered to support SA sufficiency, confirm safety, or document use conditions, particularly for renewals or post-listing reassessments in LPPR reimbursement in France.
References: LPPR reimbursement in France
The following references underpin the scientific, regulatory, and policy evidence base for LPPR reimbursement in France, including clinical assessment by HAS and CNEDiMTS, pricing via CEPS, and formal national reimbursement activation.
Haute Autorité de Santé (HAS) (2024) Medical devices assessment system in France. Paris: HAS.
Haute Autorité de Santé (HAS) (2025) Guide pour le dépôt de dossier en vue de l’inscription sur la Liste des Produits et Prestations Remboursables (LPPR). Paris: HAS.
Haute Autorité de Santé (HAS) (2025) Avis Produits et Prestations – Dispositifs médicaux. Paris: HAS.
Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS) (2025) Principes d’évaluation des dispositifs médicaux en vue de leur remboursement. Paris: HAS.
Comité économique des produits de santé (CEPS) (2024) Accords-cadres et principes de fixation des prix des dispositifs médicaux. Paris: Ministère de la Santé.
Mantovani, A., et al. (2023) ‘Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: current scenario and challenges’, Frontiers in Medical Technology, 5, pp. 1–12.
Carbonneil, C., et al. (2025) ‘French reimbursement of health technologies: assessment is at the heart of the procedure’, La Presse Médicale, 54(2), pp. 1–9.
Blanchard, S., et al. (2025) ‘Health technology assessment in France: beyond reimbursement’, La Presse Médicale, 54(3), pp. 1–8.
Loge, C., et al. (2015) ‘Factors influencing reimbursement of medical devices in France’, International Journal of Technology Assessment in Health Care, 31(3), pp. 137–145.
Journal Officiel de la République Française (2025) Arrêtés relatifs à l’inscription de dispositifs médicaux sur la LPPR. Paris: Direction de l’information légale et administrative.
Ministère des Solidarités et de la Santé (2024) Organisation du financement des dispositifs médicaux. Paris: Gouvernement français.
