BUDGET IMPACT ANALYSIS OF FITUSIRAN FOR THE TREATMENT OF HEMOPHILIA A AND B IN PEDIATRIC AND ADULT PATIENTS IN SAUDI ARABIA
Author(s)
Hana Abdullah Alabdulkarim, BSc, MSc, PhD1, Abdullah Alshehry, PharmD, MBA, BCPS2, Amal BinDos, RPh,MHHA3, Tareg Owaida, MD, FRCPA4, Yasser Albarkah, BSc, MSc, PhD5, Ibtisam H. Alharbi, PharmD, MSc6, Ibrahim Abdulaziz Alsaagi, MSc, PharmD7, Abdulrahman Nugali, PharmD8, Wedad Alnemari, MSc, Pharm.D9.
1Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia, 2King Fahd Medical City, Riyadh, Saudi Arabia, 3King Fahad Medical City, Riyadh, Saudi Arabia, 4King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, 5Ministry of Defense Health Services, Riyadh, Saudi Arabia, 6Ministry of Defense Health Services, Jeddah, Saudi Arabia, 7King Saud University Medical City, Riyadh, Saudi Arabia, 8HEPA Solutions, Jeddah, Saudi Arabia, 9Sanofi, Riyadh, Saudi Arabia.
1Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia, 2King Fahd Medical City, Riyadh, Saudi Arabia, 3King Fahad Medical City, Riyadh, Saudi Arabia, 4King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, 5Ministry of Defense Health Services, Riyadh, Saudi Arabia, 6Ministry of Defense Health Services, Jeddah, Saudi Arabia, 7King Saud University Medical City, Riyadh, Saudi Arabia, 8HEPA Solutions, Jeddah, Saudi Arabia, 9Sanofi, Riyadh, Saudi Arabia.
OBJECTIVES: As a subcutaneous small-interfering RNA therapy, fitusiran suppresses antithrombin synthesis to restore hemostatic balance in patients with hemophilia A or B, independent of inhibitor status. This analysis evaluated the financial implications of fitusiran formulary inclusion for eligible pediatric and adult patients (≥12 years) with hemophilia A and B in Saudi Arabia, from a public payer perspective.
METHODS: A prevalence-based budget impact model over a 5-year analytic horizon compared two scenarios: current standard-of-care without fitusiran versus a revised scenario incorporating fitusiran at projected market share uptake from Year 1 to Year 5. The eligible population was estimated at 2,612 patients in Year 1 (Hemophilia A: 1,994; Hemophilia B: 618), increasing to 2,763 by Year 5. Direct costs encompassed drug acquisition from SFDA 2025 list prices, administration, and non-drug disease management expenditures sourced from public hospital business centers and validated by local clinical experts. All costs are reported in USD (1 USD = 3.75 SAR). Deterministic sensitivity analyses were performed.
RESULTS: Fitusiran formulary introduction was projected to generate cumulative 5-year budget savings of $64.3M relative to the current scenario (total costs: $2.79B vs. $2.86B). Year 1 savings alone amounted to $38.1M, attributable predominantly to decreases in pharmacy and administration expenditures ($64.5M over 5 years). Incremental drug acquisition costs were systematically offset by downstream reductions in pharmacy, medication, and administration costs across both hemophilia subtypes and inhibitor-status subgroups.
CONCLUSIONS: Formulary adoption of fitusiran in Saudi Arabia is projected to yield substantial budget savings for public payers over 5 years, underpinned by reductions in pharmacy, medication, and administration costs across hemophilia A and B subpopulations. These findings provide compelling economic evidence supporting fitusiran's formulary listing and reimbursement within the Saudi healthcare system.
METHODS: A prevalence-based budget impact model over a 5-year analytic horizon compared two scenarios: current standard-of-care without fitusiran versus a revised scenario incorporating fitusiran at projected market share uptake from Year 1 to Year 5. The eligible population was estimated at 2,612 patients in Year 1 (Hemophilia A: 1,994; Hemophilia B: 618), increasing to 2,763 by Year 5. Direct costs encompassed drug acquisition from SFDA 2025 list prices, administration, and non-drug disease management expenditures sourced from public hospital business centers and validated by local clinical experts. All costs are reported in USD (1 USD = 3.75 SAR). Deterministic sensitivity analyses were performed.
RESULTS: Fitusiran formulary introduction was projected to generate cumulative 5-year budget savings of $64.3M relative to the current scenario (total costs: $2.79B vs. $2.86B). Year 1 savings alone amounted to $38.1M, attributable predominantly to decreases in pharmacy and administration expenditures ($64.5M over 5 years). Incremental drug acquisition costs were systematically offset by downstream reductions in pharmacy, medication, and administration costs across both hemophilia subtypes and inhibitor-status subgroups.
CONCLUSIONS: Formulary adoption of fitusiran in Saudi Arabia is projected to yield substantial budget savings for public payers over 5 years, underpinned by reductions in pharmacy, medication, and administration costs across hemophilia A and B subpopulations. These findings provide compelling economic evidence supporting fitusiran's formulary listing and reimbursement within the Saudi healthcare system.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE737
Topic
Economic Evaluation, Health Technology Assessment, Real World Data & Information Systems
Topic Subcategory
Budget Impact Analysis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)