​​The Norwegian Medicines Agency has issued guidelines for pharmacoeconomic analyses since 2002. Since 2018, the revisions have been in accordance with the principles adopted in the Priority-setting White Paper (Prioriteringsmeldingen), the new Regulation on Medicinal Products (Legemiddelforskriften) and Blue Prescription Regulation (Blåreseptforskriften). The guidelines were last revised in October 2021. See log for changes.

Guidelines and template

The guidelines and associated template for submission must be used when preparing and submitting documentation for single technology assessments of medicines for decisions concerning public sector funding via the National Insurance scheme and the Regional Health Authorities ("Nye metoder").

See the guidelines for the submission of documentation for single technology assessment (STA) of pharmaceuticals, updated October 2021 (PDF)

The guidelines set out guidance concerning matters such as:

  • literature searches and the selection of relevant documentation
  • documentation of efficacy and safety
  • documentation of relative efficacy
  • documentation of health-related quality of life
  • efficacy, adverse events and quality of life data used as input to the model
  • pharmacoeconomic analyses
  • modelling
  • calculation of severity
  • uncertainty
  • budget impact

More information and documents on:

  • Principles for severity calculations – prevention or treatment? (Norwegian link: “Bruk av beregningsprinsippene for forebygging eller behandling ved beregning av APT»)
  • Infectious disease control and prevention and antimicrobial resistance in HTAs. (Norwegian link: “Rapport - Smittevern og resistens i metodevurderinger.pdf”)
  • STA for vaccines. (Norwegian link: “hurtig metodevurdering av vaksiner ”)
can be found on the Norwegian version of this page.

Oppdatert: 22.10.2021

Publisert: 16.01.2019

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