Development of Economic Evaluation Studies (EEs) in Saudi Arabia

Problem Statement: Presently, the healthcare landscape of Saudi Arabia is transitioning from volume-based healthcare to value-based healthcare (VBHC) paradigms to align with the national transformation vision for 2030. To follow the VBHC concept, value-based pricing, value-based procurement, and health technology assessment, emerge as crucial endeavors. The Economic Evaluation Studies (EEs) Guideline was developed to ensure fair pricing of medicines based on their value.

Description: The Saudi Food and Drug Authority (SFDA) is responsible for the registration and pricing of medicines at the national level. Moreover, to achieve Vision 2030's goals of VBHC, implementing tools like EEs is crucial for progress. SFDA follows a scientific approach and is in line with international benchmarks, as well as not intersecting with the scope of work of government agencies and healthcare institutions in the Kingdom. Six countries with VBHC were followed, e.g., United Kingdom and Canada, evaluating several key parameters, e.g., analytical technique, outcome measures, and sensitivity analyses. In 2023, the first draft of EEs was published to all stakeholders in the healthcare system (semi-governmental agencies, healthcare institutions, and pharmaceutical industries) to receive their scientific comments. After a grace period of time and a series of workshops with stakeholders, adjustments were made to the draft of EEs, and the implementation of the guidance will be applied gradually in the coming years.

Lessons Learned: Encouragement of all stakeholders to publish the first unified guidelines for EEs in Saudi Arabia and difficulty in implementing the guidance immediately since there are low capabilities to perform such studies.

Stakeholder Perspective: The majority of comments from healthcare institutions and pharmaceutical industries were related to reimbursement, which is beyond SFDA’s scope. The reimbursement process in Saudi Arabia is decentralized. Therefore, SFDA clarified that it’s optional for healthcare institutions to depend on the EEs published by SFDA at the reimbursement stage.