Pricing of medicines
Norway has a statutory pricing policy for prescription-only medicines (POM) with MA for human use. The policy is currently put into practice by the maximum price regulation and the stepped-price (“trinnpris”) regulation.
The maximum price regulation at pharmacy purchase price (PPP) level, regulated in the Norwegian Act on Medicinal Products, was implemented in 2002. Before entering the Norwegian market, the Marketing Authorisation Holder (MAH) must apply for a maximum price with the Norwegian Medicines Agency
The Stepped price model (Trinnprismodellen) with generic competition was introduced in 2005 to reduce costs incurred by the National Insurance Scheme (NIS) and patients in relation to the use of generic medicines. Since august 2021 there has also been a stepped price model for biosimilars.
In the stepped price models – for generic or biosimilar medicines, the price of a pharmaceutical product is reduced stepwise through predefined rates. This occurs after the pharmaceutical product has lost patent protection and hence is exposed to generic or biosimilar competition. The Stepped price model for generic medicines has been modified four times after its introduction with the aim of reducing medicine prices.