OBJECTIVES: Nordic real-world data (RWD) offers unique and globally un-paralleled opportunities in health registry-based research. It provides virtually complete follow-up and exact censoring information on lives and health of all citizens with essentially unlimited possibilities for linkage of data on patient-level. Ability to utilize this RWD for submission to healthcare authorities globally may help to accelerate access to treatments in case of scarcity of RWD. This systematic review aimed to identify evidence indicating a global usage of Nordic RWD.

METHODS: A systematic review adhering to PRISMA guidelines was performed to identify any publications/submissions recommending or exhibiting a global usage of RWD from Denmark, Finland, Norway, or Sweden. All searches were run on 9-June-2023 and included Embase^® (from inception of database), ad-hoc Google searches, and Health technology assessment (HTA) submissions to NICE and CADTH (January-2021 and onwards).

RESULTS: A total of 1785 records from Embase^®, and 234/475 submissions from NICE/CADTH databases were retrieved. Deduplication and screening led to inclusion of 27 publications and 29 submissions (19/10: NICE/CADTH). In-depth analysis of publications revealed the top three regions utilizing the Nordic RWD as Europe (68.1%), the US (22.7%), and Israel (9%). National administrative and disease registers (63.1%) were the most reported RWD type and oncology (31.5%) was the most common disease area. RWD was most frequently utilized from Sweden (75.8%) and Denmark (59.2%); while utility/QoL (37.9%) and safety (34.7%) were the most common outcomes as per the evidence from HTAs and publications, respectively.

CONCLUSIONS: The evidence from the current review indicates global acceptability of Nordic RWD in various settings and disease areas. This encourages considering Nordic RWD in support of HTA, regulatory applications and post-approval requirements, globally. However, there exists vast untapped potential requiring additional collaborative efforts between stakeholders in industry, data holders and regulatory authorities to reap complete benefits of the Nordic RWD.