Organizational and economic aspects of triplet therapy of relapsed/refractory multiple myeloma in the Russian healthcare setting

E. Pyadushkina, E. Derkach, V. Ignatyeva, E. E. Yagnenkova, T. Klitochenko, Tatiana Shelekhova, A. Levanov
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引用次数: 1

Abstract

Background. The introduction of innovative drugs has significantly increased the treatment effectiveness in patients with relapsed/refractory multiple myeloma (RRMM), but the question of whether these expensive options can be financially secured remains open.Objective: to assess the cost of triplets of targeted drugs ixazomib, carfilzomib, elotuzumab and daratumumab with lenalidomide and dexamethasone used in the treatment of RRMM, and to determine possible payment options for this therapy at the level of the Russian Federation subjects.Material and methods. The cost of an annual course of treatment with the studied regimens with centralized purchases and the cost of targeted drugs per hospitalization case were calculated based on the maximum registered prices, recommended doses and treatment regimens. The normative legal acts regulating the payment of drug therapy for multiple myeloma were analyzed and possible financing channels and their limitations were identified. Using the example of the Volgograd and Saratov Regions, tariffs under the compulsory medical insurance system were calculated and their sufficiency in covering the cost of targeted therapy was estimated.Results. The cost of an annual course of triplet therapy per patient in the case of centralized procurement of drugs ranged from 5.51 million rubles (regimen with ixazomib) up to 8.03 million rubles (regimen with carfilzomib). The cost per hospitalization, depending on the number of doses, ranged from 80,667–242,000 rubles (ixazomib, 1–3 doses) in the Saratov Region up to 239,618–958,472 rubles (daratumumab, 1–4 doses) in the Volgograd Region. Possible reimbursement channels are High-Cost Nosologies (HCN), Obligatory Medical Insurance (OMI) and Regional Drug Coverage (RDC) programs, nevertheless triplet therapy cannot be purchased via the single channel and the combination of them is required. It has been shown that, in most cases, the costs for a case of targeted drug treatment in studied regions are covered by the average tariff for the corresponding diagnosis-related group (DRG), except for cases with a maximum duration in a day hospital setting. An analysis of the RDC lists and the procurement of drugs in the studied regimens at the expense of regional budgets showed that lenalidomide, ixazomib, carfilzomib, elotuzumab and daratumumab are included in the restrictive list in regions 77, 74, 66, 63 and 47, but they are purchased only in regions 15, 24, 6, 4 and 6, respectively.Conclusion. The use of a triplet with ixazomib is characterized by the lowest costs, which indicates its greater economic attractiveness relative to carfilzomib, daratumumab and elotuzumab in the treatment of patients with RRMM. The tariffs established in the current DRG model retain the possibility of paying for treatment with the high-cost medicines at the expense of the OMI funds in combination with the HCN or RDC programs. There are reasons to believe that the expansion of the list of 14 HCN program will increase the provision of patients with highly effective therapy and also reduce the financial burden on the regions.
俄罗斯医疗机构中复发/难治性多发性骨髓瘤三联疗法的组织和经济方面
背景。创新药物的引入显著提高了复发/难治性多发性骨髓瘤(RRMM)患者的治疗效果,但这些昂贵的选择能否在经济上得到保障的问题仍然存在。目的:评估靶向药物伊沙唑米、卡非佐米、埃妥珠单抗和达拉单抗三联用药与来那度胺和地塞米松治疗RRMM的成本,并确定俄罗斯联邦受试者水平上这种治疗的可能支付方案。材料和方法。根据最高注册价格、推荐剂量和治疗方案,计算研究方案集中采购的年度疗程费用和每个住院病例的靶向药物费用。分析了规范多发性骨髓瘤药物治疗支付的规范性法律行为,确定了可能的融资渠道及其局限性。以伏尔加格勒和萨拉托夫地区为例,计算了强制医疗保险制度下的关税,并估计了其足以支付目标治疗费用。在集中采购药品的情况下,每位患者每年接受三联疗法的费用从551万卢布(伊沙唑米方案)到803万卢布(卡非佐米方案)不等。每次住院的费用取决于剂量的多少,从萨拉托夫地区的80,667-242,000卢布(伊沙唑米,1-3剂)到伏尔加格勒地区的239,618-958,472卢布(达拉单抗,1-4剂)不等。可能的报销渠道是高费用病种(HCN)、强制性医疗保险(OMI)和区域药物覆盖(RDC)计划,但不能通过单一渠道购买三重治疗,需要将它们结合起来。研究表明,在大多数情况下,在所研究的区域,一个病例的目标药物治疗费用由相应诊断相关组(DRG)的平均费用支付,但在日间医院环境中最长时间的病例除外。通过对RDC清单和研究方案中花费区域预算的药品采购情况的分析,来那度胺、伊沙唑米、卡非佐米、埃妥珠单抗和达拉单抗在77、74、66、63和47地区被列入限制清单,但仅在15、24、6、4和6地区被购买。iazomib三联用药的特点是成本最低,这表明在治疗RRMM患者时,与carfilzomib、daratumumab和elotuzumab相比,iazomib具有更大的经济吸引力。现行DRG模式中确定的关税保留了以OMI基金与HCN或RDC规划相结合的方式支付高成本药物治疗费用的可能性。有理由相信,扩大14个HCN项目清单将增加向患者提供高效治疗,并减轻各地区的经济负担。
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