ASSESSING COST SAVINGS FROM FIRST GENERIC ENTRY IN SAUDI ARABIA: A REAL-WORLD BUDGET IMPACT ANALYSIS (2021-2024)
Author(s)
Esraa A. Almudaiheem, MSc HEOR1, Sultan A. Al-Harbi, EMBA2, Mohammad A. Alowairdhi, MBA, MSc3.
1Senior Pricing & Pharmacoeconomics Expert, Saudi FDA, Riyadh, Saudi Arabia, 2Head of Pricing Department, Saudi FDA, Riyadh, Saudi Arabia, 3Director, Pricing & Pharmacoeconomics Directorate, Saudi FDA, Riyadh, Saudi Arabia.
1Senior Pricing & Pharmacoeconomics Expert, Saudi FDA, Riyadh, Saudi Arabia, 2Head of Pricing Department, Saudi FDA, Riyadh, Saudi Arabia, 3Director, Pricing & Pharmacoeconomics Directorate, Saudi FDA, Riyadh, Saudi Arabia.
OBJECTIVES: The Saudi Food and Drug Authority (SFDA) regulates pharmaceutical pricing to ensure affordability and availability, with Pricing Rules mandating price reductions for branded drugs after generic entry. Generic entry often causes shifts in market dynamics, affecting both brand and generic sales as well as medication costs. However, evidence quantifying the economic savings from these measures is limited. This study aims to asses cost savings and policy effectiveness.
METHODS: A retrospective descriptive Budget Impact Analysis using IQVIA real-world sales data. All products with a first generic entry between 2020 and 2024 were examined (n = 120). Products were excluded if generic and brand sales were already present in 2020, or if sales data were unavailable (n = 54), leaving 66 products included in the final analysis. A deterministic static model was applied to compare expected spending (assuming no generic substitution) with actual spending. Generic uptake was calculated based on sales value.
RESULTS: Total estimated savings: SAR 488.01 million, representing a 15% reduction in spending. Overall generic uptake: 8% across all products. No savings were observed in Antipsychotics.
CONCLUSIONS: The observed savings validates SFDA’s post-generic entry pricing framework as an effective cost-containment strategy. However, low generic uptake in some classes suggests the need for complementary policies, such as strengthening substitution policies, prescriber incentives, public awareness, or tendering mechanisms to enhance market competition. Continued monitoring using real-world data can inform pricing strategies and future reforms.
METHODS: A retrospective descriptive Budget Impact Analysis using IQVIA real-world sales data. All products with a first generic entry between 2020 and 2024 were examined (n = 120). Products were excluded if generic and brand sales were already present in 2020, or if sales data were unavailable (n = 54), leaving 66 products included in the final analysis. A deterministic static model was applied to compare expected spending (assuming no generic substitution) with actual spending. Generic uptake was calculated based on sales value.
RESULTS: Total estimated savings: SAR 488.01 million, representing a 15% reduction in spending. Overall generic uptake: 8% across all products. No savings were observed in Antipsychotics.
CONCLUSIONS: The observed savings validates SFDA’s post-generic entry pricing framework as an effective cost-containment strategy. However, low generic uptake in some classes suggests the need for complementary policies, such as strengthening substitution policies, prescriber incentives, public awareness, or tendering mechanisms to enhance market competition. Continued monitoring using real-world data can inform pricing strategies and future reforms.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR254
Topic
Economic Evaluation, Health Policy & Regulatory, Real World Data & Information Systems
Topic Subcategory
Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas