TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS

Abstract

Objective: Drug licensing, price, and reimbursement are essential for medical access. This study examines US, EU, and Turkish reimbursement for innovative medicines and evaluates Türkiye's recent licensing and reimbursement decisions. Material and Method: Nivolumab, an anticancer medicine, and Evolocumab, a hyperlipidemia treatment, were studied. Web-based searches of FDA, EMA, and TİTCK offical websites revealed authorized indications and approval dates for chosen medications. Result and Discussion: Nivolumab has been authorized for 11 indications by the FDA and 10 by the EMA, although it is only approved for 8 in Türkiye. Evolocumab has been authorized for three indications by the FDA, three by the EMA, and two in Türkiye. Nivolumab was approved in Türkiye an average of 24.0 months after the FDA and 20.4 months after the EMA. In Türkiye, the indications for this medicine were reimbursed 27.6 and 25.2 months later, respectively. The FDA and EMA authorized the indications for evolocumab in Türkiye 10 months and 13.2 months later, respectively. The FDA and EMA authorized evolocumab's single reimbursement indication in Türkiye after 72.0 and 74.4 months, respectively. Our investigation found that some patient groups were given priority by limiting pharmaceuticals with high budget expectations, and these prioritizing decisions were made to secure patients' access to therapy.