尼洛替尼纳入医保用于伊马替尼耐药或不耐受的髓性白血病患者治疗的预算影响分析
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摘要
目的:通过评估二代酪氨酸激酶抑制剂靶向药物(Tyrosine Kinase Inhibitors, TKIs)尼洛替尼纳入医保对医保预算产生的影响,为医保目录药品的遴选决策、医保药品谈判及确定医保支付价格提供借鉴和参考。方法:构建预算影响分析模型,测算将尼洛替尼纳入医保报销系统后,未来5年对医保总预算的影响。结果:在全国范围内,TKIs特药、住院费用、门诊费用以及总费用,每年支出各减少1 575.2万元、3 484.2万元、51.4万元及5 110.7万元,每千万人口中伊马替尼耐药性或不耐受患者的慢性髓性白血病患者生存期内(QALY1)多获得35.0个质量调整生命年(quality-adjusted life year,QALY)。结论:相比伊马替尼原研药,尼洛替尼纳入医保后,具有明显的经济性,然而将伊马替尼仿制药纳入医保后,尼洛替尼在不同的价格变动下,一定程度上会对医保基金造成经济负担。
Objective: By assessing the impact of nilotinib on the medical insurance budget, it provided references for the decision-making of medical insurance catalog drugs, negotiating medical insurance drugs and determining the price of medical insurance. Methods: Establishing a budget impact analysis model to measure the impact of nilotinib on the Medicare reimbursement system over the next 5 years. Results: Nationally, annual expenditures of TKIs, hospitalization expenses, outpatient expenses and total expenses were reduced by 15.75 million yuan, 34.842 million yuan, 0.514 million yuan and 51.107 million yuan. More than 35.0 QALYs were acquired within the lifetime(QALY1) of ImR/ImI CML patients per 10 million people. Conclusion: Compared with HDI, NIL has obvious economic benefits after being included in the medical insurance.
Objective: By assessing the impact of nilotinib on the medical insurance budget, it provided references for the decision-making of medical insurance catalog drugs, negotiating medical insurance drugs and determining the price of medical insurance. Methods: Establishing a budget impact analysis model to measure the impact of nilotinib on the Medicare reimbursement system over the next 5 years. Results: Nationally, annual expenditures of TKIs, hospitalization expenses, outpatient expenses and total expenses were reduced by 15.75 million yuan, 34.842 million yuan, 0.514 million yuan and 51.107 million yuan. More than 35.0 QALYs were acquired within the lifetime(QALY1) of ImR/ImI CML patients per 10 million people. Conclusion: Compared with HDI, NIL has obvious economic benefits after being included in the medical insurance.
引文
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[9]何旭,相维,张方.2012-2014年药物经济学评价文献的质量评估--依据我国药物经济学评价指南(2011版)[J].我国药物经济学,2015(8):12-17.
[10]陈诚诚,刘跃华.特药纳入我国医疗保障体系的价值判断与方法[J].社会保障研究,2017(2):62-68.
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[2]DEININGER M.Resistance to imatinib:mechanisms and management[J].Journal of the national comprehensive cancer network,2005,3(6):757-768.
[3]O’BRIEN S G.Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia[J].N Engl j med,2010,362(24):2251-2259.
[4]O’BRIEN S,BERMAN E,BORGHAEI H,et al.NCCNclinical practice guidelines in oncology:chronic myelogenous leukemia[J].Journal of the national comprehensive cancer network,2009,7(9):984-1023.
[5]COLLET D,GELMAN A,CARLIN J B,et al.Modelling survival data in medical research[M].Boca Raton:Chapman&Hall/CRC,2003.
[6]ROUSSELOT P H,FACON T,PAQUETTE R,et al.Dasatinib or high-dose imatinib for patients with chronic myelogenous leukemia chronic-phase(CML-CP)resistant to standarddose imatinib:2-year follow-up data from START-R[J].Journal of clinical oncology,2008,26(15):431-436.
[7]KANTARJIAN H M,GILES F,GATTERMANN N,et al.Nilotinib(formerly AMN107),a highly selective BCR-ABL tyrosine kinase inhibitor,is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance[J].Blood,2007,110(10):3540-3546.
[8]JABBOUR E,KANTARJIAN H M,JONES D,et al.Imatinib mesylate dose escalation is associated with durable responses in patients with chronic myeloid leukemia after cytogenetic failure on standard-dose imatinib therapy[J].Blood,2009,113(10):2154-2160.
[9]何旭,相维,张方.2012-2014年药物经济学评价文献的质量评估--依据我国药物经济学评价指南(2011版)[J].我国药物经济学,2015(8):12-17.
[10]陈诚诚,刘跃华.特药纳入我国医疗保障体系的价值判断与方法[J].社会保障研究,2017(2):62-68.
[11]SULLIVAN S D,MAUSKOPF J A,AUGUSTOUSKI F,et al.Bugdget impac analysis-principles of good practcie;report of the I SPOR 2012 audget impact analysis good practice ii task force[J].Value in health,2014,17(1):5-14
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