Evaluating The Value And Budget Impact Analysis Of Daratumumab For The Treatment Of Patients With Transplant-ineligible Newly Diagnosed Multiple Myeloma

Purpose: Multiple myeloma(MM)is a biologically heterogeneous disease of the plasma cells,and the second most common haematological malignancy in the world after non-Hodgkin’s lymphoma.There is currently no health technology assessment of daratumumab in transplant-ineligible newly diagnosed multiple myeloma(TNE NDMM).By evaluating the value from efficacy,safety and cost-effectiveness of daratumumab in TNE NDMM,and based on the perspective of medical insurance payment,to comprehensive evaluate the impact of daratumumab in the medical insurance catalogue on the budgetary impact of the medical insurance fund,and to provide a reference for policy makers.Methods:(1)The efficacy and safety network meta-analysis of daratumumab in TNE NDMM were estimated using Win BUGS 1.4 software package;(2)Long-term economic evaluation of regimens Daratumumab,bortezomib,melphalan and prednisone(D-VMP)and Lenalidomide and dexamethasone(Rd)by using Markov model in Tree Age Pro 2017 based on efficacy and safety network meta-analysis results;(3)The budget impact model was constructed to assess the health care budgets changes in the 3 years after daratumumab was listed in Chinese national reimbursement system by Excel 2016.Results: Daratumumab,lenalidomide and dexamethasone(DRd),D-VMP and Bortezomib,lenalidomide and dexamethasone(RVd)showed better efficacy than Rd in Progression-free survival(PFS),and RVd showed better efficacy than Rd in Overall survival(OS)in patients with TNE NDMM.The incremental costs per QALY gained with D-VMP versus Rd were ￥1540011.51,indicated that D-VMP is not a cost-effective alternative to Rd as initial treatment for TNE NDMM,but when the price of daratumumab is reduced 60.44%,D-VMP would be in willingness to pay (WTP)(triple per capita Gross Domestic Product,￥212676).In the budget impact analysis,it is assumed that daritutuzumab was listed in health care system in 2021.In scenario 1,D-VMP will replace all market share of Rd,total health care budgets in 3 years after daratumumab was listed in would increase by 1.16-4.92 billion RMB.In scenario 2,assuming D-VMP will partial substitution market share of Rd,total health care budgets in 3 years after daratumumab was listed in would increase by 0.44-2.39 billion RMB.Conclusion: The treatments based on daratumumab have better efficacy in TNE NDMM,but because not cost-effective and daratumumab listed in health care system will increase the overall health insurance fund spending.It is recommended that reduction through health insurance negotiations and list in health care system to benefit more patients.