To develop a context-specific health technology assessment (HTA) framework tailored to the healthcare needs and system of Iran, to improve evidence-based decision-making, optimise resource allocation and support progress towards universal health coverage.

A mixed-methods Delphi consensus study conducted using a three-phase, sequential approach: document review, qualitative focus group discussions and Delphi consensus rounds. The study reporting follows the Accurate Consensus Reporting Document guideline to ensure transparent reporting of consensus methods.

A national-level study conducted in Iran’s healthcare system between January 2023 and March 2024, including perspectives from public and academic institutions, policy bodies and patient organisations.

The study involved 18 purposively selected stakeholders in three focus group discussions, including policymakers, healthcare professionals, researchers and patient representatives. Subsequently, 20 HTA experts participated in three iterative Delphi rounds to refine and reach consensus on the framework components.

Identification of core components and operational steps required to develop and implement a comprehensive HTA framework in Iran.

The final HTA framework includes nine core components: (1) establishing a national HTA body; (2) engaging stakeholders; (3) building capacity through training and research; (4) developing standard HTA methodologies; (5) implementing prioritisation and evaluation processes; (6) ensuring sustainable funding; (7) enhancing transparency and accountability; (8) promoting continuous improvement and (9) fostering innovation. Detailed operational steps and micro-activities were developed for each component. The framework achieved an 84% consensus among Delphi panellists, indicating strong agreement on its content and applicability.

This tailored HTA framework provides a structured roadmap to institutionalise evidence-based decision-making in Iran’s healthcare system. Its implementation can strengthen the efficiency, equity and sustainability of healthcare planning and policy. Pilot testing is recommended to assess feasibility and scalability, with potential to serve as a model for other low-income and middle-income countries.