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dc.contributor.authorHagen, Gunhild
dc.contributor.authorWisløff, Torbjørn
dc.date.accessioned2021-09-03T09:14:08Z
dc.date.available2021-09-03T09:14:08Z
dc.date.issued2021-08-16
dc.description.abstractDecisions on uptake of medicines and medical devices on health insurance schemes are increasingly based on a health technology assessment (HTA) process. In Norway, the process has included reimbursement of outpatient medicines for two decades. During the past years, in-patient medicines, medical devices and more recently vaccines are all included in the HTA system. In the present article, we outline the Norwegian HTA system 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 these legal, ethical and organisational aspects of the intervention. Although several combinations of aspects are possible, the most common is an assessment of the relative effectiveness and cost-effectiveness of the intervention. Randomised controlled trials have long been considered the mainstay for assessment of clinical effectiveness 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 central components of HTA with special emphasis on different observational data sources, such as the unique Norwegian health registries. We finally speculate on future directions for use of observational data in HTA, both in a global and Norwegian setting.en_US
dc.identifier.citationHagen, Wisløff. Registry data for use in health technology assessments in Norway- Oppourtunities and challenges. Norsk Epidemiologi. 2021;29(1-2):19-27en_US
dc.identifier.cristinIDFRIDAID 1916890
dc.identifier.doi10.5324/nje.v29i1-2.4042
dc.identifier.issn0803-2491
dc.identifier.issn1891-5477
dc.identifier.urihttps://hdl.handle.net/10037/22378
dc.language.isoengen_US
dc.publisherNTNU Open Access Journalsen_US
dc.relation.journalNorsk Epidemiologi
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2021 The Author(s)en_US
dc.subject.hrcsGenerell helserelevans: Evaluering av behandlinger og terapeutiske intervensjoner
dc.subject.hrcsGeneric Health Relevance : Evaluation of Treatments and Therapeutic Interventions
dc.subject.hrcsGenerell helserelevans: Helse- og velferdsøkonomi
dc.subject.hrcsGeneric Health Relevance : Health and welfare economics
dc.subject.hrcsGenerell helserelevans: Forskningsdesign og metodologi
dc.subject.hrcsGeneric Health Relevance : Research design and methodologies
dc.subjectVDP::Medisinske fag: 700::Helsefag: 800::Epidemiologi medisinsk og odontologisk statistikk: 803en_US
dc.subjectVDP::Midical sciences: 700::Health sciences: 800::Epidemiology, medical and dental statistics: 803en_US
dc.subjectVDP::Medisinske fag: 700::Helsefag: 800::Helsetjeneste- og helseadministrasjonsforskning: 806en_US
dc.subjectVDP::Midical sciences: 700::Health sciences: 800::Health service and health administration research: 806en_US
dc.subjectVDP::Medisinske fag: 700::Helsefag: 800::Samfunnsmedisin, sosialmedisin: 801en_US
dc.subjectVDP::Midical sciences: 700::Health sciences: 800::Community medicine, social medicine: 801en_US
dc.subjectEvidensbasert kunnskapsoppsummering / Evidence based reviewsen_US
dc.subjectHelseøkonomisk evaluering / Health Economic Evaluationen_US
dc.subjectRegisterstudier / Registry studiesen_US
dc.subjectmetodevurdering / health technology assessementen_US
dc.titleRegistry data for use in health technology assessments in Norway- Oppourtunities and challengesen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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