EARLY PERSPECTIVES ON HEALTH TECHNOLOGY ASSESSMENT IN THE KINGDOM OF SAUDI ARABIA: EXPLORATORY SURVEY INTO MARKET ACCESS IMPLICATIONS
Author(s)
Amie Devlin, MPH, PhD1, Darrin W. Benjumea, BS, MPH1, Tijana Ignjatovic, MA, PhD2, Lynn Okamoto, PharmD1;
1Genesis Research Group, Hoboken, NJ, USA, 2Genesis Research Group, New Castle, United Kingdom
1Genesis Research Group, Hoboken, NJ, USA, 2Genesis Research Group, New Castle, United Kingdom
OBJECTIVES: In July 2025, the Kingdom of Saudi Arabia (KSA) enacted health technology assessment (HTA) requirements mandating economic evaluations (EEs) in Saudi Food and Drug Authority submissions. This shifts pricing and reimbursement (P&R) decisions from clinical/comparative efficacy to economic value. Given the recency, the role of EEs in P&R decisions remains undefined, creating uncertainty, especially for rare diseases (RDs) given no RD-specific pathway. This exploratory study elicited early stakeholder perspectives on KSA’s evolving HTA.
METHODS: In October 2025, five KSA formulary decisionmakers (three national payers, two hospital pharmacists) completed an online survey via Rapid Payer Response (RPRTM). Likert-style (1=low; 5=high) and open-ended questions assessed anticipated P&R drivers and manufacturer implications (overall and RD-specific). Descriptive analyses were performed.
RESULTS: Respondents identified cost-effectiveness and disease burden/unmet need (mean: both 4.8) as key anticipated P&R drivers, followed by comparative effectiveness (4.6), budget impact (4.4), and local data (4.2). Respondents (n=5) expect international HTA guidance (e.g., NICE/CADTH) to validate local results and shape HTA processes. Most anticipated the new HTA to have a neutral or negative impact on manufacturers, highlighting greater evidence/data requirements (n=3), pricing pressure (n=3), limited access for high-cost products (n=3), longer timelines (n=3), and limited local expertise (n=1). For RDs, three anticipated improved access, though one caveated this only applies to therapies with sufficient evidence to demonstrate CE; access may be restricted for others. The other two anticipated no change or restricted access. Respondents anticipated RD-specific allowances under the new HTA: higher willingness-to-pay threshold, allowances for smaller trials, greater focus on managed-entry agreements (all n=4), greater focus on indirect costs/societal impact (n=3).
CONCLUSIONS: Early perspectives suggest KSA’s HTA may prioritize cost-effectiveness and disease burden, increasing evidence requirements and potential pricing/access pressure. Manufacturers should consider economic value early and generate robust local data to improve P&R outcomes. Ongoing evaluation of KSA HTA outcomes is essential.
METHODS: In October 2025, five KSA formulary decisionmakers (three national payers, two hospital pharmacists) completed an online survey via Rapid Payer Response (RPRTM). Likert-style (1=low; 5=high) and open-ended questions assessed anticipated P&R drivers and manufacturer implications (overall and RD-specific). Descriptive analyses were performed.
RESULTS: Respondents identified cost-effectiveness and disease burden/unmet need (mean: both 4.8) as key anticipated P&R drivers, followed by comparative effectiveness (4.6), budget impact (4.4), and local data (4.2). Respondents (n=5) expect international HTA guidance (e.g., NICE/CADTH) to validate local results and shape HTA processes. Most anticipated the new HTA to have a neutral or negative impact on manufacturers, highlighting greater evidence/data requirements (n=3), pricing pressure (n=3), limited access for high-cost products (n=3), longer timelines (n=3), and limited local expertise (n=1). For RDs, three anticipated improved access, though one caveated this only applies to therapies with sufficient evidence to demonstrate CE; access may be restricted for others. The other two anticipated no change or restricted access. Respondents anticipated RD-specific allowances under the new HTA: higher willingness-to-pay threshold, allowances for smaller trials, greater focus on managed-entry agreements (all n=4), greater focus on indirect costs/societal impact (n=3).
CONCLUSIONS: Early perspectives suggest KSA’s HTA may prioritize cost-effectiveness and disease burden, increasing evidence requirements and potential pricing/access pressure. Manufacturers should consider economic value early and generate robust local data to improve P&R outcomes. Ongoing evaluation of KSA HTA outcomes is essential.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA52
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Rare & Orphan Diseases