Suitability of Nordic Real-World Data to Support US Regulatory Decision-Making
Author(s)
Geale K, Toresson Grip E, Ortsäter G
Quantify Research, Stockholm, Sweden
OBJECTIVES: The 21st Century Cures Act significantly increased the relevance of real-world data (RWD) and real-world evidence in regulatory decision making for drugs and biologics by the US Food & Drug Administration (FDA). The Nordic countries are globally renowned for the depth, breadth, and quality of local RWD. This research aims to assess the suitability of Nordic RWD to support FDA regulatory decision making. METHODS: The FDA’s considerations for the use of registries, electronic health records, and claims data published in draft guidance documents for industry were reviewed. An assessment of Nordic RWD characteristics was made with reference to the FDA’s considerations. The suitability of Nordic RWD to support regulatory decision-making in relation to each consideration was assessed alongside key factors impacting the assessment. RESULTS: Nordic RWD has high coverage and comprehensiveness since much of the data are collected in the context of a broad, universal welfare system. Nordic RWD is also likely to fulfil the FDA’s consideration regarding data linkage and synthesis as all Nordic citizens have a unique personal identification number, prevalent across RWD sources. The validity of diagnosis codes in patient registries is high for many diagnoses, and in disease areas of unknown validity, validation can be conducted through retrospective chart reviews. Challenges relating to the use of Nordic RWD in a US context may include differences in the availability of drugs or biologics in Nordic formularies, patient pathways and standards of care. CONCLUSIONS: Manufacturers looking to support regulatory applications or satisfy post-approval requirements should consider the use of Nordic RWD due to its high quality, comprehensiveness and transparency. The generalizability of Nordic healthcare settings should be assessed in relation to US clinical practice. This assessment should be revisited following the issuance of the FDA’s final guidance.
Conference/Value in Health Info
2022-11, ISPOR Europe 2022, Vienna, Austria
Value in Health, Volume 25, Issue 12S (December 2022)
Code
HPR128
Topic
Health Policy & Regulatory, Study Approaches
Topic Subcategory
Approval & Labeling, Electronic Medical & Health Records, Registries
Disease
No Additional Disease & Conditions/Specialized Treatment Areas