Health Technology Assessment in Saudi Arabia - Expectations for Oncology Product Eligibility Based on Predicate Canadian HTA
Author(s)
Zuzanna Opuchlik, MSci, Karl Freemyer, MBA;
FIECON, London, United Kingdom
FIECON, London, United Kingdom
Presentation Documents
OBJECTIVES: Vision 2030 is the Kingdom of Saudi Arabia’s plan to diversify the country economically, socially, and culturally. Life sciences is center stage in this evolution with a vibrant pharmaceutical and provider environment. Concerning new pharma product launch, an HTA process has been proposed for all new pharmaceutical products exceeding 75,000 Riyals per quality adjusted life year (QALY) gained. With Saudi Arabia being an attractive market for pharmaceutical companies, it is crucial to plan for success. This research aims to assess what proportion of new product launches in Saudi Arabia will potentially qualify for HTA based on QALY inclusion criteria.
METHODS: A retrospective review of the Global Data competitive intelligence database identified 38 oncology drugs approved by the regulators (FDA/EMA) between 2020 and 2024. CADTH assessments were used to source available QALY values for these treatments (n=22). CADTH was chosen as the comparable assessment framework due to list prices for new medicines in Canada bearing affinity to those in Saudi Arabia (list prices in the US can be nearly 3 times higher than in comparison countries). The QALYs for each treatment were converted from Canadian dollars to Riyals and compared to the threshold (75,000 Riyals/QALY) in Saudi Arabia to determine what proportion of treatments would qualify for HTA.
RESULTS: Out of the 22 new oncology products evaluated by CADTH between 2020-2024, 100% (22/22) would have breached the 75,000 Riyals/QALY threshold and qualified for HTA assessment in Saudi Arabia.
CONCLUSIONS: These findings underscore the significance of preparing for the emerging HTA process in Saudi Arabia. Products with high list prices (e.g. oncology, rare disease, specialty) will require special consideration, absent a QALY threshold modifier (which has not been announced to date). Early recognition of opportunities and understanding of the HTA process are essential for successful market access strategies in this emerging market.
METHODS: A retrospective review of the Global Data competitive intelligence database identified 38 oncology drugs approved by the regulators (FDA/EMA) between 2020 and 2024. CADTH assessments were used to source available QALY values for these treatments (n=22). CADTH was chosen as the comparable assessment framework due to list prices for new medicines in Canada bearing affinity to those in Saudi Arabia (list prices in the US can be nearly 3 times higher than in comparison countries). The QALYs for each treatment were converted from Canadian dollars to Riyals and compared to the threshold (75,000 Riyals/QALY) in Saudi Arabia to determine what proportion of treatments would qualify for HTA.
RESULTS: Out of the 22 new oncology products evaluated by CADTH between 2020-2024, 100% (22/22) would have breached the 75,000 Riyals/QALY threshold and qualified for HTA assessment in Saudi Arabia.
CONCLUSIONS: These findings underscore the significance of preparing for the emerging HTA process in Saudi Arabia. Products with high list prices (e.g. oncology, rare disease, specialty) will require special consideration, absent a QALY threshold modifier (which has not been announced to date). Early recognition of opportunities and understanding of the HTA process are essential for successful market access strategies in this emerging market.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA89
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas