Can Cyprus Afford Luspatercept? A Budget Impact Analysis of the Reimbursement of Luspatercept for the Management of Thalassaemia in Cyprus

Objective This study aims to estimate the budget impact of luspatercept reimbursement as an adjuvant to the standard management of β-thalassaemia major in Cyprus, from a societal perspective, and assess the financial feasibility of its inclusion in the β-thalassaemia armamentarium. Methods A 5-year horizon budget impact model was developed to determine the budget impact of reimbursing luspatercept for the management of β-thalassaemia major in Cyprus. Two treatment discontinuation scenarios were elaborated. In the first scenario, luspatercept is reimbursed complementary to best supportive care, and a dropout rate of 40% is assumed based on published real-world data, while for the second scenario a dropout rate of 25%, is assumed as per the clinical trial data. Input parameters were retrieved from the phase III clinical trial of luspatercept, literature, and expert opinion consensus. One-way sensitivity analyses were conducted for both scenarios. Results The addition of luspatercept to the standard management of β-thalassaemia major in Cyprus imparted an incremental budget impact ranging from €21,300,643 to €25,834,368, depending on the drop-out rate scenario assumed. Results were sensitive to the number of eligible patients and dose per patient. Conclusion The potential reimbursement of luspatercept will wield a substantial impact on Cyprus total pharmaceutical expenditure and it is therefore imperative to affix a reimbursement framework that will allow the payer to mitigate uncertainty stemming out of the scarce clinical data and the inherently complex therapeutic landscape of β-thalassemia management.