The Norwegian Medicines Agency has issued guidelines for pharmacoeconomic analyses since 2002, updated in March 2012. The guidelines have been revised in accordance with the principles adopted in the Priority-setting White Paper (Prioriteringsmeldingen) and the new Regulation on Medicinal Products (Legemiddelforskriften) and Blue Prescription Regulation (Blåreseptforskriften).
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 15 October 2018. 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 15 October 2018 (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