Page 24 - 《中国药房》2021年24期
P. 24
收集中心,选择需要监测较长时间的疾病临床终点指 2020.
标,对所有签订风险分担协议的药品进行数据收集与 [11] Centers for Medicare & Medicaid Services. National
监测。 Coverage Determination (NCD) for chimeric antigen
综上所述,如何平衡“满足患者临床需求”和“保证 receptor(CAR)T-cell therapy:110.24[EB/OL].(2021-02-16)
基金运行安全”是我国医保治理体系现代化进程中的重 [2021-05-04]. https://www.cms.gov/medicare-coverage-
database/details/ncd-details.aspx?ncdid=374&bc=CAA-
要议题。对于 CAR-T 这类新产品、新技术的医保准入,
AAAAAAAAA.
医保部门需要在充分了解产品临床价值的基础上,考虑
[12] Channel NewsAsia.“Breakthrough”therapy for the most
借鉴国际上一些有益的医保治理办法(如风险分担协
common type of leukaemia among children approved in
议等),基于充分、完整、高质量的决策证据,科学设计其
Singapore[EB/OL].(2021-04-24)[2021-08-24]. https://
医保准入模式,从而提高临床治疗药物的可及性。 www.ncis.com.sg/About-NCIS/Pages/Newsroom.aspx.
参考文献 [13] WENZL M,CHAPMAN S. Performance-based managed
[ 1 ] 王立群. CAR-T 和免疫细胞肿瘤治疗[J].中国细胞生物 entry agreements for new medicines in OECD countries
学学报,2019,41(4):540-548. and EU member states:how they work and possible im-
[ 2 ] Echemi. The world’s fifth CAR-T therapy was approved provements going forward[EB/OL].(2019-11-19)[2021-05-
by the FDA for marketing,targeting BCMA[EB/OL]. 04]. https://www.oecd-ilibrary.org/social-issues-migra-
(2021-04-14)[2021-09-09]. https://topic.echemi.com/a/ tion-health/performance-based-managed-entry-agreements-
the-worlds-fifth-car-t-therapy-was-approved-by-the-fda-for- for-new-medicines-in-oecd-countries-and-eu-member-states_
marketing-targeting-bcma_148559.html. 6e5e4c0f-en.
[ 3 ] TURTLE C J,HANAFI L A,BERGER C,et al. CD19 [14] Observatoire du Médicament des Dispositifs Médicaux et
CAR-T cells of defined CD4 ∶ CD8 composition in adult de L’Innovation Thérapeutique(Omedit)Ile de France.
+
+
B cell ALL patients[J]. J Clin Invest,2016,126(6):2123- Yescarta[EB/OL].(2019-11-04)[2021-05-04]. http://www.
2138. omedit-idf.fr/medicaments-princeps/yescarta/[Ref list].
[ 4 ] GARDNER R A,FINNEY O,ANNESLEY C,et al. In- [15] Agence Technique de L’Information Sur L’Hospitalisation.
tent-to-treat leukemia remission by CD19 CAR-T cells of Campagne tarifaire 2019-nouveaux recueils-traitements
defined formulation and dose in children and young de type CAR-T cells[EB/OL].(2019-10-23)[2021-08-23].
adults[J]. Blood,2017,129(25):3322-3331. https://www.atih.sante.fr/sites/default/files/public/content/
[ 5 ] MORENOCORTES E F,STEIN C K,LENGERKEDIAZ 3595/notice_technique_atih-371-6-2019_car-t-cells.pdf.
P A,et al. Chimeric antigen receptor T cell therapy pipe- [16] JØRGENSEN J,KEFALAS P. The use of innovative
line at a glance:a retrospective and systematic analysis payment mechanisms for gene therapies in Europe and the
from Clinical Trials.gov[J]. Blood,2019,134(Supple- USA[J]. Regen Med,2021,16(4):405-422.
ment_1):5629. [17] VREMAN R A,BROEKHOFF T F,LEUFKENS H G,
[ 6 ] What is the cost of Kymriah? [EB/OL].(2021-05-21)[2021- et al. Application of managed entry agreements for innova-
11-16]. https://www.drugs.com/medical-answers/cost- tive therapies in different settings and combinations:a fea-
kymriah-3331548/. sibility analysis[J]. Int J Environ Res Public Health,2020,
[ 7 ] JACOB B. Gilead’s second act in cell therapy gets its first 17(22):8309.
approval[EB/OL].(2020-07-24)[2021-11-16]. https://www. [18] National Institute for Health Research. Summary of issues
biopharmadive.com/news/gileads-second-act-in-cell-thera- to consider to inform the creation of the target product pro-
py-gets-its-first-approval/582295/. files and hypothetical data sets[EB/OL].(2017-02-01)[2021-
[ 8 ] MAUS M V,ALEXANDER S,BISHOP M R,et al. So- 06-23]. https://www.ncbi.nlm.nih.gov/books/NBK424722/.
ciety for immunotherapy of cancer(SITC)clinical practice [19] 国家医疗保障局.基本医疗保险用药管理暂行办法[S/
guideline on immune effector cell-related adverse events[J]. OL].(2020-07-30)[2021-11-23]. http://www.gov.cn/zhengce/
J Immunother Cancer,2020,8(2):e001511. zhengceku/2020-08/04/content_5532409.htm.
[ 9 ] JØRGENSEN J,HANNA E,KEFALAS P. Outcomes- [20] 李伟,施慧,丁锦希,等.英国癌症药物基金补偿品种的特
based reimbursement for gene therapies in practice:the 征分析及启示[J].中国医院药学杂志,2021,41(14):
experience of recently launched CAR-T cell therapies in 1379-1384.
major European countries[J]. J Mark Access Health [21] 李伟,施慧,丁锦希,等.英国癌症药物基金的疗效风险分
Policy,2020,8(1):1715536. 担协议分析[J].中国新药杂志,2021,30(17):1559-1564.
[10] 谢锦浩.社会网络对我国居民商业性医疗保险支出的影 (收稿日期:2021-06-27 修回日期:2021-11-16)
响:基于 CFPS2018 的实证分析[D].济南:山东大学, (编辑:胡晓霖)
·2962 · China Pharmacy 2021 Vol. 32 No. 24 中国药房 2021年第32卷第24期