Application Scenarios and Paths of Real-World Data in Innovative Drug Medical Insurance Admission

China Health Insurance ›› 2024, Vol. 0 ›› Issue (11) : 28-33.

China Health Insurance ›› 2024, Vol. 0 ›› Issue (11) : 28-33. DOI: 10.19546/j.issn.1674-3830.2024.11.003
Observation & Discussion

Application Scenarios and Paths of Real-World Data in Innovative Drug Medical Insurance Admission

Author information +
History +

Abstract

The process of innovative drug medical insurance admission in China is gradually accelerating, but the risk of admission decision-making is also increasing. Standardizing the application of real-world data can provide important evidence for medical insurance admission assessment, thereby reducing decision-making risks. This article analyzes the advantages and disadvantages of real-world data and application scenarios in medical insurance access, summarizes current policy frameworks and guidelines at home and abroad, and proposes research standards and application paths for real-world data in China's innovative drug medical insurance access, providing references for the application of real-world data research in medical insurance access.

Key words

real-world data / innovative drugs / medical insurance admission / application scenarios / research standard / application path

Cite this article

Download Citations
Application Scenarios and Paths of Real-World Data in Innovative Drug Medical Insurance Admission[J]. China Health Insurance. 2024, 0(11): 28-33 https://doi.org/10.19546/j.issn.1674-3830.2024.11.003

References

[1] FDA. Use of real-world evidence to support regulatory decision-making for medical devices[EB/OL].[2024-06-24]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices.
[2] FDA. Real-world evidence[EB/OL].[2024-07-08]. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence.
[3] Health Canada. Regulatory review of drugs and devices: strengthening the use of real world evidence for drugs[EB/OL]. (2018-08-22)[2024-06-24]. https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/improving-review-drugs-devices/strengthening-use-real-world-evidence-drugs.html.
[4] NICE. Overview | NICE Real-World Evidence Framework | Guidance | NICE[EB/OL].[2024-06-24]. https://www.nice.org.uk/corporate/ecd9/chapter/overview.
[5] HAS. Real-world studies for the assessment of medicinal products and medical devices[EB/OL].[2024-06-24]. https://www.has-sante.fr/jcms/p_3284524/en/real-world-studies-for-the-assessment-of-medicinal-products-and-medical-devices.
[6] NMPA.国家药监局关于发布真实世界证据支持药物研发与审评的指导原则(试行)的通告(2020年第1号)[EB/OL].(2020-01-07)[2024-06-25]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/ypggtg/ypqtggtg/20200107151901190.html.
[7] DIJKGRAAF M G W, HAUKOOS J, ITANI K M F. Practical guide to design choice of randomized clinical trials in surgery[J]. JAMA surgery, 2022, 157(12): 1154-1155.
[8] BEAULIEU-JONES B K, FINLAYSON S G, YUAN W, et al. Examining the use of real-world evidence in the regulatory process[J]. Clinical pharmacology and therapeutics, 2020, 107(4): 843-852.
[9] ZISIS K, PAVI E, GEITONA M, et al.Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process[J]. Journal of pharmacy & pharmaceutical Sciences, 2024, 27: 12302.
[10] KIM H S.Dark Data in real-world evidence: challenges, implications, and the imperative of data literacy in medical research[J]. Journal of Korean medical science, 2024, 39(9): e92.
[11] 柏柳安宁,夏结来,王陵,等.真实世界研究中的常见偏倚及其控制[J].中国临床药理学与治疗学,2020,25(12):1422-1428.
[12] FRANKLIN J M, SCHNEEWEISS S.When and how can real world data analyses substitute for randomized controlled trials?[J]. Clinical pharmacology and therapeutics, 2017, 102(6): 924-933.
[13] 马文昊,王诗淳,靳英辉,等.真实世界研究的发展与展望[J].中国循证心血管医学杂志,2023,15(10):1266-1271.
[14] 石舒原,赵厚宇,刘佐相,等.增强真实世界证据可信度与应用价值的国际研究经验与启示[J].医药导报,2023,42(1):24-31.
[15] 郭武栋,刘梦娜.对国家医保药品目录调整工作的回顾与思考[J].中国卫生质量管理,2023,30(1):89-92.
[16] 黄涛,李灿,黄先琴,等.真实世界数据用于药品医保决策的国内外政策分析[J].中国循证医学杂志,2024,24(5):510-515.
[17] YAP T A, JACOBS I, BAUMFELD ANDRE E, et al.Application of real-world data to external control groups in oncology clinical trial drug development[J]. Frontiers in oncology, 2021 (11): 695936.
[18] GRAY C M, GRIMSON F, LAYTON D, et al.A framework for methodological choice and evidence assessment for studies using external comparators from real-world data[J]. Drug safety, 2020, 43(7): 623-633.
[19] GREGG E W, PATORNO E, KARTER A J, et al.Use of real-world data in population science to improve the prevention and care of diabetes-related outcomes[J]. Diabetes care, 2023, 46(7): 1316-1326.
[20] NICE. Overview | Pembrolizumab for Untreated Pd-L1-Positive Metastatic Non-small-Cell Lung Cancer | Guidance | NICE[EB/OL].[2024-07-09]. https://www.nice.org.uk/guidance/ta531.
[21] KIM H S, LEE S, KIM J H.Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records[J]. Journal of Korean medical science, 2018, 33(34): e213.
[22] 朱莉莎,颜建周,张伶俐,等.英国、比利时罕用药医保准入机制及其对我国的启示[J].卫生经济研究,2016(8):48-51.
[23] KOKKOTOU E, ANAGNOSTAKIS M, EVANGELOU G, et al.Real-world data and evidence in lung cancer: a review of recent developments[J]. Cancers, 2024, 16(7): 1414.
[24] PRATT N, CAMACHO X, VAJDIC C, et al.The Medicines Intelligence Centre of Research Excellence: co-creating real-world evidence to support the evidentiary needs of Australian medicines regulators and payers[J]. International journal of population data science, 2021, 6(3): 1726.
[25] XU J, WU W, ZHANG X, et al.The use of real-world evidence for regulatory decisions in China[J]. Clinical pharmacology and therapeutics, 2024, 116(1): 82-95.
[26] CDA. Guidance for Reporting Real-World Evidence | CDA-AMC[EB/OL].[2024-07-08]. https://www.cadth.ca/guidance-reporting-real-world-evidence.
[27] 姚晨,王斌,朱赛楠,等.基于真实世界研究项目电子源数据存储库的审核查验路径和要点研究[J].中国食品药品监管,2023(10):68-80.
[28] 金鑫瑶,郑文科,张俊华,等.推进真实世界研究的透明化[J].世界中医药,2019,14(12):3106-3110.
[29] JAMA evidence. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3rd ed | JAMA evidence | McGraw Hill Medical[EB/OL].[2024-06-25]. https://jamaevidence.mhmedical.com/Book.aspx?bookId=847.
[30] 孟蕊,芮明军,王欣恬,等.不同决策分析模型在抗肿瘤药物经济学评价中的应用——以加拿大CADTH为例[J].中国药房,2021,32(14):1752-1757.
[31] 黄丽红,王永吉,王素珍,等.倾向性评分方法及其规范化应用的统计学共识CSCO生物统计学专家委员会RWS方法学组[J].中国卫生统计,2020,37(6): 952-958.

Accesses

Citation

Detail

Sections
Recommended

/