On March 27, 2025, the Turkish Medicines and Medical Devices Agency (“Agency”), issued an announcement regarding the first application procedures for the pricing of authorized pharmaceuticals subject to alternative reimbursement models.
As per the provisions outlined in the legal framework for the pricing of medicinal products, the Decision on the Pricing of Medicinal Products for Human Use numbered 2017/9901 (“Decision”), and the Communiqué on the Pricing of Medicinal Products for Human Use (“Communiqué”) dated September 29, 2017, the pricing structure for human medicinal products that have a marketing authorization follows a specific set of guidelines. These rules establish pricing rules depending on whether the product is locally manufactured or imported.
Under the Social Security Institution General Health Insurance Alternative Reimbursement Regulation (“AR Regulation”), which was published in the Official Gazette on May 12, 2023, decisions may be made regarding the determination of differentiated reference prices and warehouse sale prices.
According to Article 12 of the Communiqué, the Price Evaluation Commission may determine medicine prices and/or profit margins for medicines subject to procurement through alternative reimbursement models, by using different pricing models such as differentiated pricing or payment of service fees per box to warehouses/retail pharmacies, without being bound by the provisions of this Decision and the Communiqué.
In this regard, price approval applications under the AR Regulation that include a request for differentiated pricing must meet the following requirements:
- Applications must be made using the application document types titled:
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- "Initial Price Evaluation and Publication in the Price List Application – For Those Not Submitting Original Documents", and
- "Initial Price Evaluation and Publication in the Price List Application – For Those Submitting Original Documents/Cost Cards."
- In the cover letter of the application, it must be explicitly stated that the application is being made under the AR Regulation with a request for a differentiated reference price, and that there is a request for the approved prices not to be published in the detailed drug price list on the Agency's website.
According to recent regulatory guidance, pharmaceutical companies that apply for differentiated pricing under the AR Regulation may receive official approval documents for their drug prices. While these approvals will be issued to the applicants, the prices will not appear in the publicly accessible detailed price list until the Price Evaluation Commission finalizes a decision.
With the approved document, companies will be permitted to apply for a sales permit from the Drug Licensing Department.
With the issuance of the announcement, the procedures and principles regarding the price application process before the Agency for medicines with marketing authorizations subject to the alternative reimbursement model have been clarified. The application and evaluation steps for differentiated pricing requests have been set out in detail; in particular, it has been noted that the prices of treatment options not covered by the standard reimbursement scheme may remain confidential.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
