The clinical dossier submitted to the French National Authority for Health (HAS) is central to determining the level of clinical value recognised for your product: ASMR for a medicine and ASA for a medical device. The methodological quality of the dossier and the objective presentation of product-specific clinical evidence directly influence subsequent price negotiations with the CEPS.
Preparation of HAS Clinical Dossiers
What Does the HAS Expect from a Clinical Dossier?
The Transparency Committee and the CNEDiMTS expect an objective presentation of the product’s clinical value and its ability to address an unmet medical need. A systematic literature review, an epidemiological analysis of the target population and a rigorous demonstration of clinical benefit compared with existing alternatives are essential components of every dossier.
The level of evidence, determined by the quality of the clinical demonstration (including trial design), and the magnitude of the treatment effect (based on measured absolute and relative clinical differences) are the main determinants of ASMR/ASA ratings. Failure to meet these methodological standards is a common reason for a dossier being rejected or receiving an unfavourable assessment.
Requirements differ when preparing a reimbursement dossier for an in vitro diagnostic (IVD) medical device assessed by CEDiag. For applications for inclusion in the RIHN or NABM, the two relevant reimbursement pathways, the assessment focuses on the medical procedure itself, whether it is a diagnostic procedure or a companion diagnostic associated with targeted therapy.
Systematic Literature Review: The Foundation of the Clinical Rationale
A rigorous systematic literature review identifies all available evidence relating to the product and its comparators, providing the basis for a transparent and reproducible clinical rationale — an essential methodological requirement for HAS submissions.
Comparator Selection: A Strategic Decision, Not Just a Methodological One
The choice of comparator largely determines the ASMR or ASA rating awarded by the HAS. A comparison with placebo may increase the likelihood of obtaining a higher rating; however, the comparator must be consistent with clinical practice in France.
An inappropriate comparator, or one challenged by the HAS, can undermine the entire dossier, regardless of the quality of the product’s clinical evidence. Comparator selection should therefore be anticipated from the market research stage, well before submission.
Anticipating SMR/ASMR or SA/ASA Ratings
The clinical rationale should aim to achieve the highest level of recognised clinical value that the available evidence can genuinely support. Overestimating this value without sufficiently robust data may result in an unfavourable assessment and undermine credibility during subsequent negotiations.
Furthermore, where uncertainty remains regarding a healthcare product’s benefit-risk balance, the HAS may refuse reimbursement through the French statutory health insurance system, even if the product has obtained marketing authorisation or CE marking, by assigning an insufficient SMR or SA rating.
Particular attention should therefore be paid to anticipating SA/ASA and SMR/ASMR ratings from the initial market research stage.
Common Reasons for Dossier Rejection or Reimbursement Refusal
– A dossier that fails to meet the HAS submission requirements
– A disputed or inconsistant clinical comparator
– Insufficiently mature clinical evidence or a study design that does not meet HAS methodological expectations
– Uncertainty regarding clinical benefit in light of significant risks to patients, sometimes affecting only a subgroup within the population for which reimbursement is sought
How We Can Help
We prepare clinical dossiers in accordance with HAS requirements. From comparator selection to structuring the clinical rationale, we help our clients secure the highest level of recognised clinical and/or economic value supported by the evidence.
Our experience in market research and in-depth understanding of HAS decision-making processes enable us to tailor each dossier for maximum impact.
Frequently Asked Questions
What is the difference between a HAS clinical dossier and a CEPS pricing dossier?
The HAS clinical dossier establishes the product’s relative clinical value (SMR/ASMR or SA/ASA). The CEPS pricing dossier builds on this assessment to develop the economic rationale supporting price negotiations.
How long does the CT or CNEDiMTS take to assess a clinical dossier?
Each committee has its own schedule and workload. Regulatory timelines generally provide for the review and assessment of dossiers within three months, and many submissions are assessed considerably faster through simplified procedures.
However, for new products or innovative new indications, assessment timelines may exceed 120 days.
How does the EU Health Technology Assessment Regulation (HTAR) affect clinical dossier assessment by the CT or CNEDiMTS?
The European Health Technology Assessment Regulation (HTAR), which became applicable on 12 January 2025, establishes a regulatory framework for health technology assessments across the European Union. Its implementation strengthens cooperation between the HAS and its European counterparts.
HAS assessments increasingly reflect the European analytical framework based on the PICO methodology (Population, Intervention, Comparator and Outcomes). This approach is closely aligned with the framework already used by the HAS and is expected to become increasingly central to assessments over the coming years.
We therefore recommend adopting the PICO methodology when preparing clinical dossiers for France, if it has not already been applied within a European assessment framework.
Can a dossier be resubmitted following an unfavourable HAS assessment?
Yes. A new submission is possible, generally after additional evidence has been generated to address the concerns raised by the relevant HAS committee.