Real-world evidence (RWE) has become increasingly visible in health technology assessment (HTA) discussions across Europe. In the Nordic countries, however, its role remains distinctive — shaped by a unique combination of publicly funded healthcare, strict value-based decision-making, and exceptionally strong registry infrastructure.
Why Nordic HTA is Different?
Nordic HTA systems operate under intense cost-containment pressure, with a high degree of transparency and methodological rigor. HTA outcomes have a direct and tangible impact on national access to medicines, resulting in particularly high evidentiary standards. Even when regulatory approval is achieved—sometimes through accelerated pathways—the same evidence packages often face far more critical scrutiny from HTA bodies concerned with uncertainty, bias, and long-term value for money.
RCTs First, RWE to Complement
Randomized controlled trials (RCTs) remain the cornerstone of relative effectiveness assessment in Nordic HTA. RWE is not seen as an alternative, but as a complementary source of evidence. Its acceptance and value are greatest when it addresses clearly defined gaps: characterizing real-world patient populations, assessing the generalizability of trial results, validating comparator relevance, or informing resource use and treatment patterns for economic evaluations.
Where Does RWE Add the Most Value?
In Nordic HTA submissions, RWE is most commonly used to:
- Describe real-world patient numbers and characteristics, and assess trial generalizability
- Map treatment pathways, sequencing, and persistence
- Estimate real-world resource use and support health economic models
- Inform post-launch reassessments, managed entry, and/or risk-sharing agreements
More advanced applications—such as external or virtual control arms—are still relatively rare. When used, they often rely on aggregated data rather than state-of-the-art analytical methods, limiting their impact on HTA decision-making. As a result, a clear gap remains between methodological guidance and real-world practice.
Joint Clinical Assessments and the Future Role of RWE
With the implementation of EU Joint Clinical Assessments (JCA), the review of clinical evidence will become more harmonised across Europe, while economic evaluation and reimbursement decisions remain national responsibilities. In this setting, RWE is expected to continue playing a complementary role in the Nordics, with its impact varying by country depending on national HTA practices and tolerance for uncertainty.
To succeed, evidence generation strategies must be anchored early to JCA requirements, ensuring alignment on comparators, endpoints, and target populations. RWE can then be leveraged strategically to contextualise trial results and address any residual uncertainty at the national level.
Key Takeaway
RWE is accepted in Nordic HTA, but it is rarely decisive on its own. Its value lies in careful planning, methodological robustness, and clear alignment with national decision frameworks. As regulatory acceptance grows and experience with JCA increases, the role of RWE in Nordic HTA decision-making is likely to expand – but only for those who integrate it early and use it with purpose.
