New regulation from the Social Security Institution (SGK) on drug prices and SMA treatment criteria

Comprehensive changes made by the Social Security Institution (SGK) to the Health Implementation Communiqué (SUT) have been published in the Official Gazette and have entered into force. The regulation includes new provisions on many topics, including drug costs, reimbursement principles, criteria applied in SMA treatments, and home healthcare services.

With the new regulation, the prices of numerous drugs included in the SUT's EK-4/C drug list have been revised. While changes were made to the barcode and name information of some drugs, new drugs were added to replace products removed from the list due to cost reasons.

The article titled “Principles for the use of nusinersen sodium and risdiplam in Spinal Muscular Atrophy disease” in the communiqué was also amended. Thus, the usage and reimbursement conditions to be applied for SMA patients' access to these treatments have been redefined.

Within the scope of the regulation, new medical procedures were added to the Fee-for-Service Procedure Point List and the Diagnosis-Related Procedure Point List. Procedures added to the list include vaginal birth after cesarean section, polysomnography and multiple sleep latency test, Actinium-225 PSMA therapy, bone mineral density measurement, bronchoscopic cryobiopsy, cardiopulmonary exercise test, and pulsed field ablation.

Home healthcare services, physical therapy and rehabilitation practices, session durations, health board report requirements, and reimbursement rules were also reorganized with the new communiqué. In addition, reimbursement prices for numerous medical materials used in cardiology, cardiovascular surgery, interventional radiology, and spinal surgery were updated.

While some provisions of the decision entered into force on the date they were published in the Official Gazette, it was reported that some regulations would begin to be implemented in accordance with the schedule specified in the communiqué.