The Norwegian process for implementation of medical products and the associated tenders.
The Norwegian health care system has developed within the context of welfare policy, where equality and fairness are highly valued. The country's system is founded on the principles of universal access, de-centralization and free choice of provider. It is financed by taxation, together with income-related employee and employer contributions and out-of-pocket payments (co-payments).
About 10 percent of the population has private insurance, mainly to gain quicker access to, and greater choice of private providers. Private insurance policies cover fewer than 5 percent of elective services in the country.
There are three levels in the Norwegian health care system: the central State, the four regional authorities and the municipalities. The main responsibility for the provision of health care services lies with the four RHAs and the 422 municipalities. Health technology assessments (HTAs) are used systematically to inform decision-making regarding the adoption of new technologies. The system has two levels: decisions at the national level made jointly by the four RHAs, and decisions at the local hospital level.
The Norwegian Medicines Agency (NOMA) determines which medications to reimburse for outpatients. For new drugs, the agency determines whether a prescription drug should be covered by evaluating its cost-effectiveness in comparison with that of existing treatments. The agency also decides the maximum price of drugs. HELFO, the Norwegian Health Economics Administration, is responsible for the actual reimbursement of all services, medical devices and pharmaceuticals.
While there are no specific regulations at the manufacturer level in Norway, there are two pricing procedures. External price referencing is the key mechanism for setting maximum prices, while internal price referencing is used for stepped prices (Trinnprismodellen) once generic competition arises for a substitutable medicine.
NoMA sets maximum prices for all prescription-only medicines (POM) at pharmacy purchasing price (PPP) level. In practice, the maximum pharmacy retail price (PRP) is regulated as well, since the NoMA regulates the pharmacies’ mark-up on the PPP. The maximum price is set based on external reference pricing. The price set by the NoMA is the permitted maximum. However, products can freely be sold at a lower price than the maximum price.
The agency revises the price of the top-selling active ingredients on a yearly basis. This is to make sure that the price level in Norway stays at the right level compared to the reference countries.