Substitution of Medicines and Medication Packages
Substitution of medicines means replacing a medicine with another that contains the same active substance or the same combination of active substances, the same strength, and typically the same pharmaceutical form.
If medicines are deemed substitutable, the Danish Medicines Agency forms packaging substitution groups in accordance with the guidelines below.
These groups are fixed, meaning that all medicine packages within a group should be substitutable with each other, and substitution cannot occur with packages outside the group. The grouping at the packaging level is based on the following guidelines, in prioritized order:
- There must be no more than a 25 % (10 % for dispensing groups A, A§4, NBS, and BEGR) deviation in packaging size between the smallest and the largest package within the group.
- As many medicine packages as possible should be placed in the same substitution group.
- If not all possible medicine packages can be included in the group (cf. point 1), the package with the greatest percentage deviation from the other packages in the group is removed.
- The percentage calculation is based on the smallest package size in the group.
There will always be medicine packages that fall outside the substitution groups due to the large variation in packaging sizes available on the market.
The above guidelines are established to place as many medicine packages as possible in a single group, thereby creating the largest possible groups and increasing the potential for competition within the groups.
A-, B-, and C-prices
The medicine package with the lowest price in the packaging substitution group is marked as "A-price." The medicine package that does not have the lowest price but is still within the minimum price threshold is marked as "B-price." The minimum price threshold is 5 DKK if the A-price is 100 DKK or less. If the A-price is more than 100 DKK but less than 400 DKK, the minimum price threshold is 5% of the A-price. If the A-price is 400 DKK or more, the minimum price threshold is 20 DKK. The medicine package that falls outside the minimum price threshold is marked as a "C-price." More information on the minimum price threshold can be found in the Prescription Regulation § 62, paragraph 4, no. 1.
The marking of A-, B-, or C-price is determined based on the dispensing price per unit (e.g., price per tablet) and remains fixed for the 14-day period during which the price is valid.
Pharmacies are required to offer the citizen the package in the packaging substitution group with the lowest price. The citizen can always request either the prescribed medicine package or any other medicine package within the packaging substitution group. In this case, however, the citizen must pay the price difference between the package with the lowest price and the dispensed package. If the doctor has indicated "no substitution" ("ej S") on the prescription, substitution must not occur, and the pharmacy is required to dispense the prescribed medicine package.
Reimbursement Groups
A reimbursement group is a substitution group of medicine packages that are eligible for reimbursement.
In each reimbursement group, the reimbursement price is set as the price of the medicine package with the lowest price in the group that has not been reported as experiencing a supply shortage.
New reimbursement prices are recalculated every weekday based on supply shortage reports from pharmaceutical wholesalers. If the medicine package with the lowest price in a reimbursement group is reported as experiencing a supply shortage by at least one pharmaceutical wholesaler, this medicine package can no longer serve as the basis for the reimbursement price. A new reimbursement price is then set based on the price of the cheapest medicine package in the reimbursement group that has not been reported as experiencing a supply shortage. This ensures that citizens can always receive full reimbursement for the cheapest available medicine package.
The current established reimbursement prices can be accessed at www.medicinpriser.dk.