Reassessment of restricted reimbursement status

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.

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.