Maximum prices for prescription-only medicines in Norway are set according to the regulation «Forskrift om legemidler» (chapter 12, in Norwegian). The following guidelines, based on the regulation, are used when setting maximum prices.
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The main rule when pricing a medicinal product in Norway is that it be set at the mean of the three lowest market prices of that product in a selection of countries.
If there is no price in three or more of the countries which are included in the price comparison group the price will usually be set at the mean price in the countries where a market price exists.
The countries which are normally included in the price comparison group are: Sweden, Finland, Denmark, Germany, Great Britain, The Netherlands, Austria, Belgium and Ireland.
The Norwegian Medicines Agency will set prices according to its own estimates if, on request and within specified deadlines, price details which are considered necessary for pricing the medicinal product in Norway have not been received from the Marketing Authorisation Holder (MAH).
When setting the price the Norwegian Medicines Agency will, as far as possible, follow the main rule for price setting. Some cases which deviate from the main rule are described. The list is not complete and individual assessments will therefore have to be made. The Norwegian Medicines Agency aims to ensure, as far as possible, equal treatment of each individual case that is assessed.
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Because pack sizes are not always directly comparable, price comparisons with other countries are made on the basis of units. This means that price per tablet, price per dose etc. is compared.
When setting the price, differentiation is made between price per unit in large and small packs. A pack containing 30 or fewer units is normally defined as small. Packs containing more than 30 units are defined as large.
For medicinal products which, for example, are used in the treatment of asthmatic conditions, a package containing 120 or fewer doses is normally defined as small and a package containing more than 120 doses is defined as large.
For some medicinal products it is natural to deviate from the main rule. An example of this is products which are used in the treatment of acute migraine attacks. Packages containing this type of medicines are defined as small if they contain 5 or fewer tablets, and large if they contain more than 5 tablets
For medicinal products which cannot be included in any of the groups described above the Norwegian Medicines Agency will have to determine a natural limit which can be drawn between small and large packages.
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In several of the countries which are included in the price comparison group, small pack sizes only have been registered. This means that if the main pricing rule is followed for a given strength, this may result in a lower price per tablet in a small package than in a large package. In such cases the price per tablet in the large package is set at the same level as the price per tablet in the small package. If the price per tablet is higher in a small package than in a large package the price difference is accepted provided this difference is not considered to be unreasonable.
When setting the price the Norwegian Medicines Agency will aim at ensuring that the price ratio between different strengths of a given product is reasonable.
When setting the price of a medicinal product in Norway comparison will mainly be made with the same product in the reference countries. If a medicinal product is marketed under different product names in different reference countries they will still be compared for pricing. Different varieties of the same product may also be taken into consideration when comparing prices.
The prices of medicinal products which are parallel imported to Norway are regulated so that the product is priced as requested, but limited upwards to the maximum market price of the directly imported medicinal product.
The price of generics in Norway is regulated so that the medicinal product is priced as requested, but limited upwards to the maximum market price of the reference product..
Each Marketing Authorisation Holder (MAH) is obliged, on request, to give the Norwegian Medicines Agency details of prices in other countries. The time limit for submission of price details is 21 days. The prices shall be stated at the "price to pharmacy" level.
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The price which is set by the Norwegian Medicines Agency is the permitted maximum market price to the pharmacist. The product can be freely sold at a lower price than the maximum price.
The basis of price comparisons is the actual market price in each of the individual countries in the price comparison group. Market price is defined as the price the major part of the market pays for the product.
Price comparison is based on the price in the local currency, converted to NOK. The mean exchange rate of the last six whole months, as presented by the Central Bank of Norway, is used as the basis for the comparison of prices.
The prices in Norway can be adjusted if a price alteration in one or more of the countries included in the price comparison group makes it necessary, or if a significant alteration in the exchange rates has occurred. The adjustments shall normally not occur more frequently than annually.
Exempted from this rule are the prices of new products after launching. In a two year period after launching the Norwegian Medicines Agency may request information about new prices half-yearly from the MAH in question with regard to pricing in Norway.
Withdrawal of a product from one of the reference countries may be cause for an alteration in the price in Norway. Documentation must be produced to show that a product has in fact been withdrawn from the market if this is to give cause for price changes.
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