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.

Publisert: 16.01.2019

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