Reassessment of restricted reimbursement status

The 2016 amendment of the Health Insurance Act lays down that the Pharmaceuticals Pricing Board shall reassess the restricted reimbursement status of medicinal products included in the reference price system. According to the entry-into-force provision of the Act, the extent of the reimbursement status of all products included in the reference price system before 1 January 2016 shall be reassessed at once. After that, the extent of the reimbursement status of products included in any new reference price group shall be reviewed once every reference price period.

In addition to the assessment based on authority initiative, holders of marketing authorisations can apply for extension of reimbursement status for medical products included in the reference price system.

New reference price groups from 1 January 2016 onwards

The Pharmaceuticals Pricing Board shall reassess the extent of restricted reimbursement status of medicinal products when a product is included in a reference price group. The assessments will be made by the initiative of the Pricing Board.

The assessments apply to all medicinal products with restricted reimbursement status included in the new reference price group, and all different sales packaging under the same trade name, including also reimbursed packaging outside the reference price system. The Pharmaceuticals Pricing Board will publish a list of medicinal products with restricted reimbursement status to be reassessed every reference price period.

A restriction can be removed if there are no more grounds for restricting the reimbursement status on the basis of the Health Insurance Act.  When a restriction is removed, the extent of the reimbursement must correspond to the therapeutic indication approved for the product. The decision of removal will enter into force in the beginning of the fourth reference price period after the establishment of the reference price group.

Medicinal products included in the reference price system before 1 January 2016

The Pharmaceuticals Pricing Board will also reassess the extent of the reimbursement status of medicinal products with restricted reimbursement status included in the reference price group already before 1 January 2016. The decision on the reimbursement status of these products will enter into force on 1 July 2016.