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Access to pharmaceuticals for very small patient groups with extremely severe conditions



​The Norwegian Medical Products Agency has prepared a memorandum that describes arrangements for the single technology assessment (STA) of pharmaceuticals for such patient groups.

In connection with the STA of such pharmaceuticals, the Priority-setting White Paper (Prioriteringsmeldingen) states that the following may be accepted when assessing the documentation:

  • a lower level of documentation
  • a higher level of resource use for specific interventions compared to other interventions

There are three guiding criteria regarding the assessment of whether or not a pharmaceutical is intended for the treatment of a very small patient group with extremely severe conditions. These are as follows:

  1. Very small patient group:
    a) Fewer than approx. 1 patient per 100,000 inhabitants on a global basis per pharmaceutical
    b) Fewer than approx. 50 patients in Norway per pharmaceutical
  2. Extremely severe condition: Level of severity measured as absolute shortfall corresponding to at least 30 good life years.
  3. Considerable expected benefit from the pharmaceutical: The expected benefit from the specific treatment is considerable and a minimum of two gained good life years compared to standard treatment.

All three of these indicative criteria should be fulfilled in order for a pharmaceutical to be considered under Section 14-5, third paragraph, of the Norwegian Regulation on Medicinal Products.

Read the memorandum (pdf)

Contact us

Unit for HTA and general reimbursement

22 89 77 00

Unit for HTA hospital medicines

22 89 77 00