The Norwegian Medicines Agency has issued guidelines for pharmacoeconomic analyses since 2002, with revised versions in 2012 and 2018. 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).
Which guidelines (the updated ones or the previous ones from 2018) to follow in submitting documentation will be optional from May 20th through November 20th 2020. Please note that the Norwegian Medicines Agency can request supplementary documentation in line with the new guidelines before November 20th, if deemed necessary for the case.
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 Specialist Health Service ("Nye metoder").
The guidelines were updated on May 20th 2020. The changes are explained in the log of amendments to the guidelines.
See the guidelines for the submission of documentation for single technology assessment (STA) of pharmaceuticals, updated May 20th 2020 (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
- calculation of severity
- 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