Cost-Effectiveness Analysis of Crizanlizumab in Sickle Cell Disease in Iran.

Background: Sickle cell disease (SCD) prevalence is predicted to rise dramatically in the upcoming years. Although several medications have received Food and Drug Administration (FDA) approval in recent years, low- and middle-income countries (LMICs) still struggle to access these medications due to their remarkably high prices. Crizanlizumab, owing to its clinical and economic privileges, appears to be the most suitable option for addition to pharmacotherapy guidelines. However, no study has yet investigated its cost-effectiveness in Iran's healthcare system.

Methods: This cost-effectiveness evaluation was conducted in 2022 at the Pharmacoeconomic and Pharmaceutical Administration Department of the Faculty of Pharmacy at Tehran University of Medical Sciences, Tehran, Iran. A decision-tree model was designed, followed by a cost-utility analysis for crizanlizumab in two separate scenarios, targeting not only monotherapy with crizanlizumab in SCD compared with placebo, but also crizanlizumab's concomitant use with hydroxyurea compared with hydroxyurea. The study reports the outcomes from Iran's healthcare system perspective. Direct medical costs, quality-adjusted life years related to vaso-occlusive crisis, hospitalizations, and adverse effects were calculated. Incremental cost-effectiveness ratios were compared. SUSTAIN trial was the main clinical source for modeling crizanlizumab's effectiveness in SCD. A sensitivity analysis was performed to measure the sensitivity of outcomes to changes in medication costs. Microsoft Excel 2020 was utilized for calculations and modeling.

Results: Concomitant therapy with low-dose crizanlizumab added to hydroxyurea led to the lowest Incremental Cost Effectiveness Ratio (ICER) of 398,881 United States dollars (USD), exceeding Iran's accepted cost-effectiveness threshold. Sensitivity analysis results demonstrate that even a 20% reduction in the price of crizanlizumab does not lead to its cost-effectiveness in Iran.

Conclusion: Crizanlizumab administration in sickle cell disease is not found cost-effective in Iran, neither as a monotherapy nor added to hydroxyurea.