Serpik V.G. 5015

Budget impact analysis for pharmacological therapy of chronic myeloid leukemia (cml) with nilotinib as the secondline treatment

Budget impact analysis and cost-effectiveness analysis for the therapy of chronic myeloid leukemia (CML) by tyrosine kinase inhibitors were performed by means of a developed analytical model of decisionmaking. This analysis defined potential budget impact of nilotinib as the second-line therapy in the frame of drug reimbursement program for subjects with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher’s disease, tumors of the lymphoid, haemopoietic and related tissues, multiple sclerosis, as well as for patients subjects to organ (tissue) transplantation (hereafter reimbursement program for high-cost drugs). Budget impact analysis has shown that conversion from imatinib to nilotinib for all subjects with chronic myeloid leukemia (CML) in Russian Federation receiving second-line therapy, based on theoretic consumption, would lead to RUR 1.985 billion increase of the federal budget (compared to imatinib only). Taking into account the actual nilotinib consumption, budget of the Scenario 1 does not exceed the real cumulative amount for chronic myeloid leukemia (CML) treatment in the framework of the reimbursement program for high-cost drugs and regional subsidized drug lists. In addition, it was demonstrated that nilotinib compared to imatinib can be characterized as a strictly preferable drug from the costeffectiveness analysis point of view, as it has a lower cost - effectiveness ratio.
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