RWE and HAS are now central topics in discussions surrounding the evaluation of healthcare products. Real-World Evidence (RWE) is playing an increasingly important role in regulatory and health technology assessment decisions across Europe.
Patient registries, hospital databases, post-market surveillance data, and observational studies are now routinely used to complement traditional clinical trials.
However, one misconception still persists: simply accumulating real-world data would be enough to convince health authorities.
In reality, the situation is far more nuanced.
The “Haute Autorité de Santé “(HAS) is increasingly integrating RWE into its assessments, but only when the methodological quality of the data is strong enough to answer a specific evaluation question.
Today, the real challenge surrounding RWE and HAS is no longer only access to data, but the scientific robustness of that data.
RWE and HAS: The Growing Role of Real-World Evidence
The HAS now recognizes the value of real-world studies throughout the lifecycle of healthcare products.
These data can notably help to:
- Document effectiveness in routine clinical practice
- Better characterize specific patient populations
- Monitor long-term safety
- Complement evidence generated by clinical trials
In the field of medical devices, this trend is particularly visible.
The role of real-world evidence in medical device evaluation has been regularly highlighted by the “Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé”. Its 2022 activity report already indicated that more than half of the evaluated submissions included real-world data, illustrating the growing importance of RWE in HAS assessments.
Not All RWE Meets HAS Expectations
In several recent evaluations, health authorities have highlighted recurring limitations in the real-world data submitted for medicines and medical devices.
The most frequently identified issues include:
- Lack of robust comparators
- Small sample sizes
- Incomplete datasets
- Methodological biases that are difficult to correct
Data generated from routine clinical practice can provide useful information, but they do not always sufficiently reduce the clinical or methodological uncertainties identified during the evaluation process.
This evolution clearly shows that the challenge surrounding RWE and HAS is no longer about the quantity of available data, but rather about methodological quality and the ability to reduce uncertainty.
RWE and HAS: Increasingly Stringent Methodological Requirements
The HAS does not reject real-world evidence.
On the contrary, the use of RWE is clearly expanding.
However, expectations are also becoming stronger regarding:
- Registry quality
- Data traceability
- Methodological relevance
- Transparency of analyses
Real-world evidence therefore does not automatically replace clinical trials.
Instead, RWE is used to complement remaining uncertainties when the data are sufficiently robust and clinically meaningful.
Medical Devices: A Particularly Favorable Environment for RWE
The medical device sector increasingly relies on real-world evidence.
Unlike pharmaceuticals, randomized clinical trials may sometimes be more difficult to conduct because of:
- Rapid technological evolution
- Operator learning curves
- Small patient populations
- Incremental innovation cycles
In this context, RWE plays a major role in:
- Post-market surveillance
- Real-world performance evaluation
- Additional studies requested by authorities
However, once again, data quality remains the determining factor.
Why Methodological Robustness Matters More Than Ever
As healthcare systems increasingly rely on real-world evidence, authorities are becoming more demanding regarding scientific rigor.
For RWE to support decision-making effectively, studies must demonstrate:
- Reliable patient selection methods
- Appropriate statistical analyses
- Sufficient follow-up duration
- Clear clinical relevance
Without these elements, real-world evidence may fail to adequately support reimbursement or market access decisions.
This is why RWE and HAS discussions now focus heavily on methodology rather than data volume alone.
Conclusion: RWE and HAS Have Become a Strategic Challenge
Real-world evidence now occupies a major place in the evaluation of medicines and medical devices.
However, the analysis of recent submissions reveals a clear trend: the HAS does not validate RWE “by default.”
What now makes the difference is:
- Methodological quality
- Ability to reduce uncertainty
- Robustness of analyses
- Clinical relevance of the generated data
In a context where real-world data are becoming increasingly important, the challenge is no longer simply collecting data, but generating evidence that is genuinely usable for regulatory and health economic decision-making.
The issues surrounding RWE and HAS have therefore become highly strategic for manufacturers seeking to integrate real-world evidence into their evaluation dossiers and market access strategies.
