Registry data for use in health technology assessments in Norway – Opportunities and challenges

Decisions on uptake of medicines and medical devices on health insurance schemes are increasingly based ona health technology assessment (HTA) process. In Norway, the process has included reimbursement of outpatientmedicines for two decades. During the past years, in-patient medicines, medical devices and morerecently vaccines are all included in the HTA system. In the present article, we outline the Norwegian HTAsystem including its central components and partners. HTA as a scientific approach puts evidence on efficacy,safety and value of interventions into a broader perspective, explicitly considering relevant factors, among theselegal, ethical and organisational aspects of the intervention. Although several combinations of aspects arepossible, the most common is an assessment of the relative effectiveness and cost-effectiveness of theintervention. Randomised controlled trials have long been considered the mainstay for assessment of clinicaleffectiveness pre-launch, while registry data have been used to inform safety post-lunch, by pharmacovigilance.Recently, we have seen a move towards more use of “real world evidence”, i.e. data from non-RCT sources,mainly from registries. A model-based approach is often used to assess cost-effectiveness, in this context,different types of evidence from different sources are often synthesized. In this paper we describe the centralcomponents of HTA with special emphasis on different observational data sources, such as the unique Norwegianhealth registries. We finally speculate on future directions for use of observational data in HTA, both in aglobal and Norwegian setting.