Norway has revised the assessment process for medicines seeking reimbursement through the blue-prescription scheme, giving the Norwegian Medical Products Agency (Direktoratet for medisinske produkter, DMP) more flexibility over the depth of assessment. New submission rules introduced alongside the reform also tighten the point at which assessment timelines start.
From 1 July, DMP can determine the appropriate level of health technology assessment (HTA) case by case and use simplified assessments where appropriate. Previously, the regulations required similarly extensive assessment irrespective of case complexity or the consequences for national insurance expenditure. DMP expects the change to increase capacity while concentrating assessment resources on more demanding cases.
Companies must now initiate blue-prescription assessments by submitting a request to DMP. The agency will define the documentation required and publish the request, documentation order and its suitability assessment explaining the chosen assessment level. Clinicians and public bodies may also propose assessments, while DMP may proceed on its own initiative where a company does not submit evidence.
The reform also allows DMP to make group-level decisions defining eligibility for individual reimbursement where there is a substantial risk of prescribing outside the ordinary reimbursement criteria.
DMP describes the revised process as closer to the New Methods (Nye metoder) pathway for hospital medicines. That alignment became more concrete on 6 July, when DMP introduced revised single-technology assessment (STA) submission guidelines covering both national insurance reimbursement and medicines funded by the regional health authorities.
The guidelines now distinguish explicitly between ‘must’ and ‘should’ requirements. DMP validates dossiers within 14 days. If a relevant ‘must’ requirement is missing, DMP treats the documentation as not received and the assessment does not start. Missing ‘should’ information allows processing to begin but may subsequently lead to a clock stop. The accompanying submission template has also been revised to reflect the new requirements.
Together, the changes create a more differentiated assessment model while tightening expectations at submission. Less complex blue-prescription cases may require less extensive assessment, but dossier completeness now has a clearer effect on when the assessment clock starts. The common submission framework also brings the outpatient and hospital HTA interfaces closer together, while funding decisions continue through their respective reimbursement routes.
Source: Norwegian Medical Products Agency
Link: Forskriftsendring for blåreseptsaker – DMP kan behandle flere refusjonssaker (Regulatory amendment for blue-prescription cases – DMP can process more reimbursement cases)
Date: 1 July 2026
Source: Norwegian Medical Products Agency
Link: Guideline for submission of documentation for single technology assessments
Date: 6 July 2026
