Key takeaways
- NEAK initiates the procedure on 1 July of each year.
- NEAK also sets out the expected prices accepted as the basis for reimbursement.
- When initiating the procedure, NEAK notifies the concerned product's marketing authorization holder or distributor that if they intend to make a price change in relation to the published price in the light of the expected price, they must do so by 20 July of the given year.
- The result of NEAK's procedure enters into force on 1 September of each year.
- NEAK initiates the first procedure exceptionally on 1 November 2022, the deadline for price change is on 20 November and the result will enter into force on 1 January 2023.
In depth
NEAK conducts procedures on its own motion to review subsidies for biological medicinal products containing an active substance subject to itemized reimbursement and biosimilar medicinal products, as a result of which it may reclassify them as medicinal products that can be ordered with price-based reimbursement. NEAK's ex officio procedures also cover those biological medicinal products that were previously included in the group of medicinal products that contain an active substance subject to itemized settlement but were later put in the category of medicinal products with price-based reimbursement.
NEAK initiates the procedure on 1 July of each year, within which it determines the range of medicinal products that can be prescribed under the given conditions, valid for one year from 1 September of the given year, and the reimbursement for the products belonging to this group.
NEAK also sets out the expected prices accepted as the basis for reimbursement in the notice on initiating the procedure. When initiating the procedure, NEAK notifies the concerned product's marketing authorization holder or distributor that if they intend to make a price change in relation to the published price in the light of the expected price, they must do so in the register operated on the NEAK website by 20 July of the given year. During the procedure, the tenderer shall remain bound to its last bid within the time limit allowed.
The marketing authorization holder shall reimburse the difference between the consumer price and the sum of maximum subsidy amount plus the subsidy that may be provided for prices 20% higher than the consumer price of the lowest daily therapeutic cost of a given group reimbursed in the same indication point, in accordance with its the subsidy-volume contract with NEAK.
