Specific reference price groups

A reference price group is also established if the reference price group contains at least two reimbursable medicinal products available on the market and at least one of them is biosimilar, parallel-imported or parallel-distributed product.

Medicinal products included in the above-mentioned reference price group come within the scope of the reimbursement status and price application procedure, as well as the price notification procedure set out in the reference price system. These products can only remain reimbursable if the marketing authorisation holder submits the price notification concerning the reference price system on a quarterly basis and an application for extending the reimbursement status and the validity of the wholesale price.

The reimbursement status and the reasonable wholesale prices of the medicinal products included in the above-mentioned reference price group are determined in accordance with the decision in effect at the time. The reasonable wholesale price approved for the medicinal products in question corresponds to the maximum wholesale price under the reference price system.

An exceptional reference price group is established if the reference price group includes a medicinal product for which the marketing authorisation authority has, on the basis of other medical use, approved an indication that substantially differs from that of the generic products and the marketing authorisation holder has notified the Pharmaceuticals Pricing Board of this substantially different indication within the specified deadline. An indication that accounts for an estimated one fifth of the reimbursable total sales of the medicinal product in question is considered a substantially different indication.

The marketing authorisation holder must submit a notification of the substantially different indication of the medicinal product no later than 38 days before the start of the reference price period during which the product is included in the reference price group for the first time and a generic product is also included in the group. The details of the substantially different indication and its share of the reimbursable total sales of the medicinal product and a document stating that it has not been possible to approve the indication in question for the generic product must be attached to the notification. If the notification is submitted after the specified deadline, the product will be included in the reference price group in a normal manner and it is no longer possible to include it in the exceptional reference price group.

The reimbursement status and the reasonable wholesale prices of the medicinal products included in the exceptional reference price group are determined in accordance with the decision in effect at the time. The reasonable wholesale price approved for the medicinal products in question corresponds to the maximum wholesale price under the reference price system.

Medicinal products included in the exceptional reference price group come within the scope of the reimbursement status and price application procedure, as well as the price notification procedure set out in the reference price system. These products can only remain reimbursable if the marketing authorisation holder submits the price notification concerning the reference price system on a quarterly basis and an application for extending the reimbursement status and the validity of the wholesale price.

Exceptional reference price groups are marked with a reference price group code starting with 88 in the decisions on reference price groups, reference prices and products included in the reference price groups issued by the Pharmaceuticals Pricing Board.