OBJECTIVES: Turkey has a highly regulated pharmaceutical market with profound challenges for market approval, pricing and reimbursement decisions. The external and internal reference pricing procedures, low value of exchange rate used in pricing, high statutory discounts required from companies during reimbursement applications, the complex system with imported drugs and alternative reimbursement mechanisms have contributed to the decreased willingness of companies to launch new molecules or new indications for already available ones. This study’s main aim is to have a picture of the new molecule and indication reimbursement trends of Turkey in comparison to FDA approvals between 2010-2021.

METHODS: A thorough search was made on the FDA’s web sites and all new molecules or new indications for previously approved molecules were listed from 2010. For each case, the name of the approved molecule, indication, ATC class and approval year were recorded. After having a comprehensive list for FDA, the reimbursement status of each molecule and indication was checked with the two positive lists (Attachment 4/A and Attachment 4/C) of the Social Security Institution (SGK).

RESULTS: Between 2010-2021, 912 new molecules or indications were approved by the FDA. The Turkish Ministry of Health (MoH) has granted market approval to 26.6% of these approvals and the SGK has granted reimbursement status to 23.5% of these products/indications. There was a steep decline in reimbursement decisions starting from 2014 when the pricing and reimbursement rules became very stringent. The reimbursement rates are 43.59%, 30.38%, 35.94%, 20.69%, 7.89%, 5.71% and 1.64% for 2014, 2015, 2016, 2017, 2018, 2019 and 2020 respectively.

CONCLUSIONS: Our analysis has shown that as of 2022, only 25% of molecules or indications approved by the FDA since 2010 are available or reimbursed in Turkey. The decline in approval and reimbursement percentages from 2014 reflects the impact of market access rules.