Pricing and reimbursement: a checklist for bringing an outpatient prescription medicine onto the Finnish market

The Finnish pricing and reimbursement system for outpatient prescription medicines slightly differs from other Nordic countries. The better a pharmaceutical company is acquainted with the Finnish system, the better their chances are to introduce the medicine to Finnish patients. We compiled a checklist of basic issues to be considered, when your company is planning to bring an outpatient prescription medicine onto the Finnish market.

1. A pharmaceutical company can introduce a new outpatient prescription medicine onto the Finnish market as soon as the authorities have granted a marketing authorisation for the medicinal product.
2. If rapid uptake of the product among doctors and patients is desired, it can be introduced to the market without reimbursement. In this case, the pharmaceutical company is free to determine the price of the product.
3. Inclusion in the reimbursement system is sought for the majority of outpatient prescription medicines introduced onto the Finnish market. In this case, the authorities decide on the reasonableness of the price of the medicine.
4. When inclusion of the medicine in the reimbursement system is desired, the pharmaceutical company must submit a pricing and reimbursement application for a basic reimbursement status and wholesale price of the medicinal product to the Pharmaceuticals Pricing Board. In their decision, the Pharmaceuticals Pricing Board will, among other things, consider the therapeutic value of the medicine, the costs of medicinal treatment compared to its benefits, as well as statements from their own expert panel and the Social Insurance Institution.
5. The reasonable wholesale price and reimbursement status confirmed by the Pharmaceuticals Pricing Board are valid for a pre-defined time period, at the most up to five years. The pharmaceutical company must submit a renewal application to the Pharmaceuticals Pricing Board six months prior to the expiring of the reimbursability.
6. When the product is included in the reimbursement system, the Social Insurance Institution will pay part of the price of the medicine, once the initial annual deductible of the patient has been reached. The amount of the reimbursement depends on the reimbursement class of the medicine.
7. The pharmaceutical company must always sell the product to outpatient pharmacies with the same wholesale price. The company is not allowed to grant any price reductions based on, for example, the purchased amounts.
8. If the product is granted a new indication, pack size, strength or pharmaceutical form, a reimbursement status must be sought separately for each case from the Pharmaceuticals Pricing Board.
9. If the medicine is included in the reference price system, its reimbursement status is automatically maintained as long as the product belongs to the reference price group without interruptions. For products included in the reference price system, the pharmaceutical company must submit a price notification to the Social Insurance Institution, which then communicates the information to the Pharmaceuticals Pricing Board and to instances maintaining the prices.