The Payment for Performance Environment for Drugs and Medical Devices in Romania

OBJECTIVES: The objective of this research is to evaluate the readiness of the Romanian health care system to use the payment for performance mechanisms in reimbursement of drugs and medical devices.

METHODS: The authors performed an analysis of the Romanian legislation regarding payment for performance for drugs and medical devices and an analysis of the existing local reimbursement models based on payment for performance looking at public data sources.

RESULTS: Regarding the payment for performance for drugs, we found that there is one functional mechanism in place and several initiatives in development. The functional mechanism of payment for performance is known as “cost-volume-result” contract and represents and outcome-based payment agreement used for patients with Hepatitis C. The model started in 2015 with 2 drugs for the treatment of Hepatitis C and evolved to cover the Hepatic Cirrhosis in 2024 (4 drugs for Hepatitis C and 4 drugs for Hepatic Cirrhosis). Others payment for performance initiatives are proposed by different stakeholders (Drugs Association, American Chamber of Commerce etc.) and are mentioned in the reimbursement of future drugs covered by the Innovation Fund (innovative oncology drugs).

Regarding the payment for performance for medical devices, there is no functional mechanism in place. There are initiatives to promote the payment for performance proposed by different stakeholders (Medical Devices Association, American Chamber of Commerce etc.) to cover the reimbursement of innovative medical devices.

CONCLUSIONS: The payment for performance is just beginning in Romania. The experience gained in the last 10 years from the utilization of the “cost-volume-result” contracts for drugs provides the started point of the future expansion of the system. The main issues in expanding the payment for performance are related to the definition of the performance for different health interventions, the availability of easy to collect data and the administrative capacity to run such a payment mechanism.