What Is Real-World Evidence (RWE) and How Does It Shape Market Access in France?

Real-world evidence (RWE) is clinical evidence about how a medicine performs once it is used outside a controlled trial, built from real-world data (RWD): hospital records, reimbursement databases, patient registries, connected devices. In France it is no longer a supporting document. The Haute Autorité de Santé (HAS) increasingly relies on RWE to address uncertainties that remain after pivotal clinical trials, and these findings can influence reimbursement reassessments and pricing decisions.

What is the difference between real-world data and real-world evidence?

RWD is the raw material: electronic health records, medical and pharmacy claims, disease registries, and data from apps and wearables. RWE is the evidence generated from those data, such as treatment persistence rates, hospitalisation rates, or survival estimates in routine clinical practice, calculated against a predefined comparator using a predefined methodology.

The distinction matters because having access to large amounts of data does not automatically produce evidence that regulators or payers will accept. A company can hold an enormous dataset and still fail to answer the specific question decision-makers are asking: does this therapy improve outcomes for the patients who will actually receive it in routine practice, and is the benefit worth the cost to the healthcare system?

Why does market access in France depend on RWE?

Because the French system continues evaluating medicines after they reach the market, not only before. To obtain reimbursement, a company submits a dossier to the HAS, which assesses clinical benefit (SMR) and added clinical value compared with existing treatments (ASMR). The CEPS then negotiates the price based on those assessments. When the available clinical evidence is limited, for example because of a small pivotal population, a surrogate endpoint, or an indirect comparison, the HAS may grant reimbursement while requiring a post-registration study (étude post-inscription). According to the HAS, the clinical benefit is reviewed at reassessment, generally within five years.

Many companies underestimate how frequently these requests occur. According to an exhaustive retrospective study of HAS appraisals from 2016 to 2021, published in the International Journal of Technology Assessment in Health Care, a post-registration study was requested in 17 percent of 600 positive reimbursement opinions. The requests were not random: they were associated with a mild or moderate clinical benefit (SMR), an added clinical value ranging from major to minor (ASMR), prior availability through an early access programme, and specific therapeutic areas such as neurology, pulmonology and endocrinology. The authors describe two recurring profiles: products where the size of the clinical benefit is uncertain, and innovative products expected to bring a substantial benefit but still carrying open questions.

Waiting until the HAS publishes its opinion to start planning such a study is often too late, since generating meaningful real-world evidence takes several years while pricing discussions have already begun.

What data powers RWE in France?

France has one of the world's most comprehensive healthcare databases. The Système National des Données de Santé (SNDS) links reimbursement and hospital records for around 99% of the population, representing approximately 67 million people. Combined with the PMSI hospital database, it allows researchers to follow patient pathways from diagnosis to outcome, evaluate treatment persistence, and estimate healthcare costs across the national system rather than within a single centre.

Accessing these data, however, remains complex. Studies require CNIL authorisation, HDS-certified hosting, and teams familiar with the coding structure of French claims databases. The richness of the data comes with equally significant technical and regulatory challenges.

Is RWE only a French or European concern?

No, and this has important implications for how evidence-generation programmes are planned. According to the FDA, its dedicated RWE programme has supported more than 35 drug and biologic applications and over 250 medical device authorisations since 2016. In December 2025, the agency finalised guidance that no longer requires identifiable individual patient-level data for certain device submissions and opens a conditional pathway for de-identified real-world data, reflecting a growing willingness to accept robust real-world evidence. The EMA has also incorporated patient registries and RWD into its post-authorisation framework, notably through its Patient Registries Initiative and the DARWIN EU network. As a result, and as a review of RWE developments and perspectives notes, a study designed to satisfy HAS requirements can often contribute to evidence packages prepared for other regulatory authorities as well.

How should pharma teams build a defensible RWE dossier?

Start with the payer's research question rather than the data already available. Define the comparator, endpoints, and study population before analysing the dataset, since studies designed around existing data instead of a predefined methodology are far less convincing to assessors. Ensure every result can be traced back to an official source, as unverifiable evidence quickly loses credibility. Finally, plan post-registration evidence generation before market entry so that reassessment becomes part of a long-term evidence strategy instead of a last-minute response.

A reliable data infrastructure also makes this process much easier. Tekkare's ReaLifeData supports custom RWE studies using French public databases (PMSI and SNDS) through in-house analysts, while OIP Healthcare and OIP PharmAnalyze bring together complementary information such as international pricing, epidemiology, and competitive intelligence in a single environment. Every figure remains linked to its original source, making the evidence easier to verify throughout the assessment process.

In France, RWE has become a central component of reimbursement decisions. Evidence generation continues well beyond market entry, and reassessments increasingly rely on data collected in routine clinical practice. Companies that prepare this evidence early are generally in a stronger position during price negotiations and subsequent reassessments than those that only begin once additional evidence has been requested.

 

Sources

KEEP EXPLORING

Want to see Tekkare's data platform in action?

Book a meeting