Milushewa Petya, Doneva Miglena, Petrova Guenka
Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
SAGE Open Med. 2020 Aug 18;8:2050312120951067. doi: 10.1177/2050312120951067. eCollection 2020.
This study aims to analyze the reimbursement and cost of biological therapy for severe asthma in Bulgaria during 2014-2019 from the perspective of the National Health Insurance Fund.
It is a retrospective, Marco-costing, top-down study of the expenditures for biological products for severe asthma. The changes in the cost paid by the National Health Insurance Fund per year, per product, and per patient during 2015-2020 were systematized and calculated. The utilization of biologicals was analyzed by calculating the defined daily dose/1000inh/day. Three databases were searched-the European Medicines Agency for the date of marketing authorization of biological products, National Council of Prices and Reimbursement for the date of their respective inclusion in the positive drug list, and National Health Insurance Fund about the number of patients with asthma, reimbursed sum for all asthma patients, and number of packages sold of biological products.
At the end of 2019, five international non-proprietary names of biologicals with indication for severe asthma had received European marketing authorization, and three of them were included in the Bulgarian positive drug list-omalizumab, mepolizumab, and benralizumab with a 75% reimbursement. Upon their introduction into the positive drug list, the reimbursed expenditures for asthma therapy started to increase from 27 million in 2014 to 33 million BGN in 2019 (€13.5-€16.5 million). The cost of therapy with biologicals rose from 16% to 24% of all anti-asthmatic medicines budget. The National Health Insurance Fund database reported that between 47,000 and 52,000 of patients with asthma, 466 are on biological therapy. The yearly cost of one asthma patient ranges between 512 and 615 BGN (€258-€307), and the yearly per-patient cost of severe asthma is 16,666 BGN (appr. €8333). Total utilization in defined daily dose/1000inh/day increases from 0.0199 to 0.0383 from 2015 to 2019.
The access to biological therapy through the reimbursement system has improved during the last 3 years. The cost of therapy is posing a high burden on the National Health Insurance Fund and on the patients and is expected to increase due to the small number of patients on biological therapy currently in comparison to all reimbursed asthmatics.
本研究旨在从国家健康保险基金的角度分析2014 - 2019年保加利亚重度哮喘生物治疗的报销情况和费用。
这是一项对重度哮喘生物制品支出的回顾性、宏观成本核算、自上而下的研究。对2015 - 2020年期间国家健康保险基金每年、每种产品和每位患者支付的费用变化进行了系统化整理和计算。通过计算限定日剂量/1000居民/天来分析生物制品的使用情况。搜索了三个数据库——欧洲药品管理局获取生物制品上市许可日期，国家价格和报销委员会获取其各自被列入阳性药品清单的日期，以及国家健康保险基金获取哮喘患者数量、所有哮喘患者的报销金额和生物制品销售包装数量。
2019年底，有5种有重度哮喘适应症的生物制品国际非专利名称获得了欧洲上市许可，其中3种被列入保加利亚阳性药品清单——奥马珠单抗、美泊利单抗和贝那利珠单抗，报销比例为75%。在它们被列入阳性药品清单后，哮喘治疗的报销支出从2014年的2700万开始增加到2019年的3300万保加利亚列弗（1350万 - 1650万欧元）。生物制品治疗费用占所有抗哮喘药物预算的比例从16%上升到24%。国家健康保险基金数据库报告称，在47000至52000名哮喘患者中，有466人接受生物治疗。一名哮喘患者的年度费用在512至615保加利亚列弗之间（258 - 307欧元），重度哮喘患者的年度人均费用为16666保加利亚列弗（约8333欧元）。从2015年到2019年，限定日剂量/1000居民/天的总使用量从0.0199增加到0.0383。
在过去3年中，通过报销系统获得生物治疗的机会有所改善。治疗费用给国家健康保险基金和患者带来了沉重负担，并且由于目前接受生物治疗的患者数量与所有报销的哮喘患者相比很少，预计费用还会增加。
