Developing an early scientific advice framework for health technology assessment in Saudi Arabia: insights from...

Early Scientific Advice (ESA) is an independent, non-binding guidance from Health Technology Assessment (HTA) bodies or regulatory authorities to manufacturers before market entry. Unlike company sponsored advisory boards focused on commercial purposes. Saudi Arabia lacks a formal ESA framework representing a policy gap as the country adopts value-based care and evidence-driven reimbursement. This study address gap by proposing a Saudi ESA framework informed by global best practices and stakeholder input.

A narrative review literature review was conducted across PubMed, Embase, Scopus, and a grey literature to examine established ESA systems, followed by a roundtable with 15 experts representing policymakers, regulators, clinicians, HTA experts, industry, payers, and academia, ensuring multi-stakeholder input.

Benchmarking ESA models implemented by National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), and European Medicines Agency (EMA) and integrated roundtable consensus, four key pillars for the Saudi ESA were identified: (1) scope covering both pharmaceuticals and medical devices to support local of new technologies; (2) timing varies for ESA pharmaceuticals, it can be positioned before drug registration during the late stages of clinical development, phase 2 and 3 for diseases of high local relevance, such as rare diseases to align evidence pre-submission while for medical devices ESA would occur primarily in the post-marketing stage; (3) governance positioning the HTA centrally because of its role in value assessment and reimbursement; (4) patients' involvement, facilitated through structured questionnaires, to ensure real-world perspective.

The four ESA pillars (scope, timing, governance, patients' involvement) synthesize current international ESA practices and input from local experts, providing a structured foundation to support efficient evidence generation and alignment between regulatory and reimbursement requirements. Pilot evaluation is still required to validate anticipated benefits.