You can see the products that generic substitution applies to in the list published by Fimea (fimea.fi). The list is published 4 times a year.
The reference price system concerns reimbursable medicinal products to which generic substitution applies. In the reference price system, the highest price for which reimbursement can be paid has been determined for the medicine. If the customer has been prescribed a product the price of which exceeds the reference price, the pharmacy must substitute the product for a product that has a price that is equivalent to the reference price or is cheaper than the reference price. However, the customer can prohibit the substitution. In such a case, reimbursement is paid on the reference price and the customer must pay the amount that exceeds the reference price himself or herself. Read more about the reference price system (hila.fi).
In generic substitution, the prescribed medicinal product is substituted at the pharmacy for a cheaper substitutable product. A product that is only included in generic substitution does not have a reference price. If the medicine that the customer buys is included in the reimbursement system, he or she will get reimbursement on the full price of the medicine.
The Pharmaceuticals Pricing Board (Hila) publishes a list of medicinal products subject to the price notification procedure 4 times a year (hila.fi) (in Finnish). The price notification procedure concerns products included in generic substitution and the reference price system as well as products undergoing a so-called transition period.
A price notification must be submitted for any product subject to the price notification procedure to Kela at the latest 21 days before the first day of each quarter. If the product is subject to the price notification procedure under the reference price system and no notification is made about the product, the product becomes non-reimbursable at the beginning of the quarter.
On the basis of the prices notified, Kela determines the price bands. In addition, Kela forwards the price notifications to Hila for determination of the reference prices.
A price notification must be submitted to Kela for any product subject to the price notification procedure even though the price of the product does not change. If the product is subject to the price notification procedure under the reference price system and no notification is made about the product, the product becomes non-reimbursable at the beginning of the quarter.
A price notification must be submitted for all products included in the price notification procedure regardless of reimbursability.
Generally available means that the product is available from the wholesalers at the time of notification and throughout the following quarter. It is important that the information in the price notification regarding the availability of the product is correct so that the cheapest price of the group of substitutable packages and the price band calculated on the basis of this lowest price are based on actual data on availability.
You can make changes to the price notification until 16:15 on the last day for submitting notifications according to the schedule.
Do as follows:
- If yes, please contact Kela. Kela will make the necessary corrections so that the product will show up in the e-service.
If a product does not show up in the e-service, you can submit price notifications to Kela on a paper form. Open and complete the price notification form.
If the product in question is not subject to the price notification procedure and its price changes at the beginning of the quarter, report the new price to the Pharmaceutical Information Centre, the Association of Finnish Pharmacies and Yliopiston Apteekki in accordance with their instructions.
Please note: The e-service for pharmaceutical companies can only be used by pharmaceutical companies that have a Finnish business ID (Y-tunnus). The service is only available in Finnish and Swedish.
Submit a price notification for the product to Kela at the latest 21 days before the first day of the quarter. If you do not submit a notification, the product becomes non-reimbursable at the beginning of the quarter.
If the wholesale price of the product is not known, you can state EUR 0.00 as the wholesale price. In that case, you will have to indicate No as data on availability.
You can cancel the reimbursability on the price notification you submit to Kela. State a higher wholesale price for the product than the confirmed maximum wholesale price and tick the section The product is withdrawn from the reimbursement system.
If none of the products in the group of substitutable packages is available throughout the quarter, Kela determines a technical price band on the basis of the cheapest reported price. In that way we can ensure that the pharmacy can substitute the medicines during the time they are available.
Submit a price notification to Kela in accordance with the schedule for quarterly notifications. If Hila confirms a lower wholesale price for the product than the reported wholesale price after the time period for filing price notifications, you must contact Kela. The wholesale price stated in the price notification must be adjusted so that it corresponds to the decision by Hila in order for the reimbursability of the product to continue.
Check if the product is on the list of substitutable products for the following quarter (fimea.fi). Fimea publishes the list 45 days before the first day of the quarter.
If the product is included on Fimea’s list, you must submit a price notification for the product to Kela at the latest 21 days before the first day of the quarter. It is not possible to report prices that take effect at the beginning of the quarter to Kela or to the pharmacy price lists after this specified date.
If the product is not included on Fimea’s list, you must submit a price notification to the Pharmaceutical Information Centre, the Association of Finnish Pharmacies and Yliopiston Apteekki in accordance with their instructions.