Evaluating The Value Of Daratumumab For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma

Background: Multiple myeloma(MM)is a malignant disease of clonal plasma cell proliferation.It is the second most common hematologic malignancy after non-Hodgkin's lymphoma.Daratumumab(DARA)can be used to treat patients with relapsed/refractory multiple myeloma(RRMM),but the value of it has not been evaluated.Objectives: Through the comprehensive evaluation of the clinical value of DARA for the treatment of RRMM patients,it aims to guide clinicians and patients to choose the right medication and promote the rational use of novel drugs.It also provides scientific,standardized and rationalized recommend-ations for policy-making agencies.Methods:The following analytical methods are mainly used in the study:1.Meta-analysis and pooled analysis: Meta and pooled analysis of the clinical efficacy and safety data of DARA using R(3.3.1)software;2.Semi-Markov model analysis: based on the clinical data of CASTOR And the POLLUX trial to evaluate the cost-effectiveness of the triple-drug regimen with DARA within Markov model using Tree Age Pro 2017;3.The retrospective epidemiological method was used to investigate the general information of myeloma patients,medical expenditure of hospitalization per year.WHO/HAI standard survey method and catastrophic expenditure evaluation method was used to assesses the affordability of high-priced drugs.Results:The following contents are the main results in the study:1.(1)The study included six clinical trials with a total of 1,389 patients.(2)Patients who treated with DARA had a better response rate and longer survival time.(3)Common adverse events were neutropenia,thrombocytopenia,anemia,and pneumonia.2.(1)The economic analysis found that the ICUR of the DARA treatment(DRd and DVd)were not cost-effective from the perspective of U.S.payer;(2)The sensitivity analysis showed that the utility value of disease progression,and the cost of adverse events treatment are the most important factors;(3)Situational analysis found that when the DARA is reduced to the current 60%,the ICUR for the triple-drug regime for DARA added to Vd will be within the U.S.WTP($150,000/QALY);when DARA is reduced to the current 37 %,would be in Guangzhou's WTP(triple per capita GDP,$63,081).3.(1)The study included 1,675 inpatient records,and 467 inpatients.Among the patients,the number of male and elderly were found to be higher.The prevalence rate was about 1.92/100,000.The median annual hospitalization costs was 27,992.80 RMB.The drug costs accounted for 61.0% of the average annual hospitalization economic burden.(2)The personal affordance analysis are following: according to the WHO/HAI standard survey method,when lenalidomide,bortezomib,and DARA are reduced in price,the affordance of patients increases significantly.According to the catastrophic expenditure evaluation method,disastrous expenditure would happen within 10.00%,5.0%,20%(DARA,male)and 15%(DARA,female)urban patients,and 80.0%,30.0%,90%(DARA,male,respectively).)and 85%(DARA,female)rural patients.Conclusion: It's the first time to conduct evaluation of the clinical value for DARA by establishing drug clinical value assessment methodological system.It provides advice for clinicians and myeloma patients,and the government decision-making department.It also provides systematic methodological support for the development of insurance drug reimbursement catalogs and health programs.