Cost-Effectiveness of Blinatumomab Plus Chemotherapy vs Chemotherapy in Adults Newly Diagnosed with Philadelphia-Negative B-Cell Acute Lymphoblastic Leukemia in Italy

Gianni Ghetti,1 Luca Castello,1 Linet Awino Odonde,1 Serena De Fazio,2 Andrea Stella,2 Angela Bruno,3 Emanuele Marchionne,3 Massimiliano Bonifacio4 1Department of Health Economics and Outcomes Research, AdRes, Turin, Italy; 2Department of Value & Access, Amgen Italy srl, Milan, Italy; 3Department of Medical Affairs, Amgen Italy srl, Milan, Italy; 4Department of Engineering for Innovation Medicine, University of Verona, Verona, ItalyCorrespondence: Gianni Ghetti, Department of Health Economics and Outcomes Research, AdRes, Via Cervino 75, Turin, 10155, Italy, Tel +39 011 76 51 239, Email g.ghetti@adreshe.comBackground: While chemotherapy is the standard treatment for adults with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (ALL), long-term remission remains difficult to achieve. Blinatumomab, an immunotherapy drug, has shown survival benefits when alternated with consolidation chemotherapy in patients with CD19-positive Ph- B-cell ALL, but its economic value had not been assessed in Italy.Methods: This study evaluated the cost-effectiveness of alternating blinatumomab with standard consolidation chemotherapy compared with chemotherapy alone, using data from the ECOG-ACRIN E1910 Phase III trial. A model was developed to estimate lifetime health outcomes and costs from the perspective of the Italian National Health Service.Results: Patients who received blinatumomab lived on average 5.06 years longer and gained 4.56 more quality-adjusted life years, but incurred higher healthcare costs, with an incremental cost of € 165,401 per patient, primarily due to drug acquisition. The incremental cost-effectiveness ratio (ICER) was € 36,261 per quality-adjusted life year gained, within the range of values typically considered acceptable in Italy. These results were confirmed in sensitivity analyses, with the ICER ranging from € 28,082 to € 49,034 under various assumptions.Conclusion: The alternation of blinatumomab with chemotherapy provides a substantial clinical benefit at a cost that is likely acceptable to the Italian healthcare system. These findings support the value of blinatumomab in improving outcomes in adult patients newly diagnosed with Ph- CD19-positive B-cell ALL. Results were consistent across sensitivity analyses, supporting the robustness of the findings.