Implementation of risk-sharing agreements in Saudi Arabia: Comparison and reflection on the NICE Model

In recent years, healthcare spending has increased, due to factors such as aging population, lifestylebased diseases, and high-cost health technologies. These factors have put enormous pressure on policymakers to curtail costs and shift towards value-based healthcare system. In this system, drug companies must demonstrate the value of their products in real-world settings. However, evidence may not be available at the time of product launch, leading to delays in reimbursement decisions and access of patients to products. To address this gap, risk-sharing agreements (RSA) have been introduced between manufacturers and payers. The most common type of RSA is the financial-based agreement which may take various forms such as annual sales caps, price-volume agreements, and comparator rebates. These agreements allow for rapid access to innovative medications. Another type of RSA is the outcome-based agreement which ties reimbursement to the real-world outcomes of products. These agreements are more complex, but they are expected to grow rapidly with the availability of real-world data. In the Middle East, the use of RSA is limited, although it is expected to increase with the ongoing shift towards a value-based healthcare system and introduction of health technology assessment. Saudi Arabia is leading these efforts in the region. This study was aimed at describing the current status of RSAs, trends in utilization of RSAs, and challenges of RSA implementation in Saudi Arabia (KSA). Real-world examples of RSAs in various healthcare sectors are also provided. Overall, the use of RSA facilitates access to innovative medications while ensuring value for money and efficient utilization of limited healthcare resources.