Peculiarities of real-world data application for health technology assessment in Asian countries
https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.199
Abstract
The article is devoted to the study of regulatory approaches to the sphere of real-world data (RWD) and real world evidence (RWE) in the countries of the Asia-Pacific Region (China, South Korea, Japan, Taiwan, etc.) and examples of their practical application for health technology assessment. The peculiarities of collecting and gaining access to RWD/RWE in Asian countries, prerequisites for the development of this direction, adopted regulations, developed methodological guidelines, promising areas of application, and clinical and economic research based on country-specific data are considered. The existing practices in Asian countries represent valuable experience, some of which could be considered for implementation in the national practice.
About the Authors
B. B. Kondratyeva
Center for Healthcare Quality Assessment and Control
Russian Federation
Russian Federation
Bela B. Kondratyeva – Leading Expert, Department of Methodological Support for Comprehensive Assessment of Technologies in Healthcare
10/5 Khokhlovskiy Passage, Moscow 109028, Russia
F. V. Gorkavenko
Center for Healthcare Quality Assessment and Control;
Russian Medical Academy of Continuing Professional Education;
Sechenov University
Russian Federation
Russian Federation
Filipp V. Gorkavenko – Deputy Head of Department of Methodological Support for Comprehensive Assessment of Technologies in Healthcare; Assistant Professor, Chief of Chair of Healthcare Organization and Public Health with a Course in Health Technology Assessment; Applicant, Chair of Pharmacology, Nelyubin Institute of Pharmacy
10/5 Khokhlovskiy Passage, Moscow 109028, Russia
2/1 bldg 1 Barrikadnaya Str., Moscow 123242, Russia
8 bldg 2 Trubetskaya Str., Moscow 119991, Russia
V. V. Omelyanovskiy
Center for Healthcare Quality Assessment and Control; Russian Medical Academy of Continuing Professional Education;
Financial Research Institute;
Semashko National Research Institute of Public Health
Russian Federation
Russian Federation
Vitaliy V. Omelyanovskiy – Dr. Med. Sc., Professor, Director General; Chief of Chair of Healthcare Organization and Public Health with a Course in Health Technology Assessment; Head of Center for Healthcare Finance; Chief Researcher, Department of Economic Research in Healthcare
WoS ResearcherID: P-6911-2018; Scopus Author ID: 6507287753
10/5 Khokhlovskiy Passage, Moscow 109028, Russia
2/1 bldg 1 Barrikadnaya Str., Moscow 123242, Russia
3/2 Nastasyinskiy Passage, Moscow 127006, Russia
12 bldg 1 Vorontsovo Pole Str., Moscow 105064, Russia
References
1. Caro J.J., Speckman J.L. Existing treatment strategies: does noncompliance make a difference? J Hypertens Suppl. 1998; 16 (7): S31–4.
2. Neal R.D., Heywood P.L., Morley S. Real world data – retrieval and validation of consultation data from four general practices. Fam Pract. 1996; 13 (5): 455–61. https://doi.org/10.1093/fampra/13.5.455.
3. Hariton E., Locascio J.J. Randomised controlled trials – the gold standard for effectiveness research: Study design: randomized controlled trials. BJOG. 2018; 125 (13): 1716. https://doi.org/10.1111/1471-0528.15199.
4. Kim H.S., Lee S., Kim J.T. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci. 2018; 33 (34): e213. https://doi.org/10.3346/jkms.2018.33.e213.
5. Chen D. Real-world studies: bridging the gap between trial-assessed efficacy and routine care. J Biomed Res. 2022; 36 (3): 147–54. https://doi.org/10.7555/JBR.36.20220040.
6. Lou J., Kc S., Toh K.Y., et al. Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward. Int J Technol Assess Health Care. 2020; 36 (5): 474–80. https://doi.org/10.1017/S0266462320000628.
7. Vorobyev P.A. (Ed.) Clinical and economic analysis. 3rd ed. Мoscow: Newdiamed; 2008: 778 pp. (in Russ.).
8. Real World Evidence/RWE Solutions Market by Component (Dataset (Claims, Clinical, Pharmacy, Patient), Services), Therapeutic Area (Oncology, Cardiovascular, Neurology), End User (Pharma, Medtech, Payers, Providers) Covid-19 Impact – Global Forecast to 2026. Available at: https://www.marketresearch.com/MarketsandMarkets-v3719/RealEvidence-RWE-Solutions-Component-30004805/ (accessed 29.03.2023).
9. NMPA issued the announcement on the Guidelines for real-world evidence to support drug development and review (Interim). Available at: http://english.nmpa.gov.cn/2020-01/07/c_456245.htm (accessed 29.03.2023).
10. Real-world evidence regulatory landscape in Asia Pacific: Australia, China, Japan, South Korea, and Taiwan. Available at: https://globalforum.diaglobal.org/issue/june-2022/real-world-evidenceregulatory-landscape-in-asia-pacific-australia-china-japan-south-koreaand-taiwan/ (accessed 29.03.2023).
11. Medical Affairs Professional Society. Expert opinions on the collection and use of real-world evidence (RWE) in China and Korea. Available at: https://medicalaffairs.org/real-world-evidence-china-korea/ (accessed 29.03.2023).
12. Guidelines for using RWE for supporting pediatric drug research & development and evaluations. Available at: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20200901104448101.html (in Chinese) (accessed 29.03.2023).
13. Guidelines for RWD used to generate RWE. Available at: https://www.ccfdie.org/cn/yjxx/yphzp/webinfo/2021/05/1621403172287125.htm (in Chinese) (accessed 29.03.2023).
14. Guidelines for the conduct of pharmacoepidemiological studies in drug safety assessment with medical information databases. Available at: https://www.pmda.go.jp/files/000240951.pdf (accessed 29.03.2023).
15. Postmarketing regulations in Japan and real world data utilization for drug safety assessment. 2017. Available at: https://www.pmda.go.jp/files/000225776.pdf (accessed 29.03.2023).
16. Amendment of ministerial ordinance on good post-marketing study practice for drugs. 2017. Available at: https://www.pmda.go.jp/files/000220766.pdf (in Japanese) (accessed 29.03.2023).
17. Questions and answers (Q&A) on Points to consider for ensuring the reliability in utilization of data from registry or medical information database in applications for marketing approval and re-examination for drugs. Available at: https://www.pmda.go.jp/files/000249053.pdf (accessed 29.03.2023).
18. Amendments to the Act on securing quality, efficacy and safety of products including pharmaceuticals and medical devices. Available at: https://www.mhlw.go.jp/content/11120000/000666295.pdf (accessed 29.03.2023).
19. Basic principles on utilization of registry for applications. Available at: https://real-world-evidence.org/basic-principles-on-utilization-ofregistry-for-applications/ (accessed 29.03.2023).
20. Establishment of comprehensive plans for drug safety management (2020–2024) to guarantee healthy living for the public. Available at: https://www.mfds.go.kr/eng/brd/m_61/view.do?seq=7&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=14 (accessed 29.03.2023).
21. Burns L., Roux N.L., Kalesnik-Orszulak R., et al. Real-world evidence for regulatory decision-making: guidance from around the world. Clin Ther. 2022; 44 (3): 420–7. https://doi.org/10.1016/j.clinthera.2022.01.012.
22. Lin L.W., Ahn J., Bayani D.B.S. Use of real-world data and realworld evidence to support drug reimbursement decision-making in Asia (REALISE). Available at: https://hiper.nus.edu.sg/wp-content/uploads/2021/05/REALISE-Abridged-guidance-for-users-ofHTA_20201104-version-1.0-2.pdf (accessed 29.03.2023).
23. Hampson G., Towse A., Dreitlein W.B., et al. Real-world evidence for coverage decisions: opportunities and challenges. J Comp Eff Res. 2018; 7 (12): 1133–43. https://doi.org/10.2217/cer-2018-0066.
24. Chen C.H. Using real-world data/evidence in regulatory decision making. Available at: https://www.pmda.go.jp/files/000226215.pdf (accessed 29.03.2023).
25. Suwantika A.A., Zakiyah N., Kusuma A.S.W., et al. Impact of Switch options on the economics of pneumococcal conjugate vaccine (PCV) introduction in Indonesia. Vaccines. 2020; 8 (2): 233. https://doi.org/10.3390/vaccines8020233.
26. Shin S., Kim Y.H., Hwang J.S., et al. Economic evaluation of prostate cancer screening test as a national cancer screening program in South Korea. Asian Pac J Cancer Prev. 2014; 15 (8): 3383–9. https://doi.org/10.7314/apjcp.2014.15.8.3383.
27. Voon H.Y., Shafie A.A., Bujang M.A., Suharjono H.N. Cost effectiveness analysis of carbetocin during cesarean section in a high volume maternity unit. J Obstet Gynaecol Res. 2018; 44 (1): 109–16. https://doi.org/10.1111/jog.13486.
28. Sabirin J., Md Fuzi S.A. Single use dialyser versus reuse dialyser. Available at: https://www.moh.gov.my/moh/hta/HTA-Single_use_dialyser.pdf (accessed 29.03.2023).
29. Pempa, Luz A.C.G., Luangasanatip N., et al. Economic evaluation of rotavirus vaccination in children of Bhutan. Vaccine. 2020; 38 (32): 5049–59. https://doi.org/10.1016/j.vaccine.2020.05.035.
30. Chugh Y., Dhiman R.K., Premkumar M., et al. Real-world costeffectiveness of pan-genotypic Sofosbuvir-Velpatasvir combination versus genotype dependent directly acting anti-viral drugs for treatment of hepatitis C patients in the universal coverage scheme of Punjab state in India. PloS One. 2019; 14 (8): e0221769. https://doi.org/10.1371/journal.pone.0221769.
31. Cheng H.M., Chiou L.J., Chen T.C., et al. Real-world costeffectiveness of drug-eluting stents vs. bare-metal stents for coronary heart disease – а five-year follow-up study. Health Policy. 2019; 123 (2): 229–34. https://doi.org/10.1016/j.healthpol.2018.11.010.
32. Chow I.H.I., Tang C.H., You S.L., et al. Cost-effectiveness analysis of human papillomavirus DNA testing and Pap smear for cervical cancer screening in a publicly financed health-care system. Br J Cancer. 2010; 103 (12): 1773–82. https://doi.org/10.1038/sj.bjc.6605974.
Review
For citations:
Kondratyeva B.B., Gorkavenko F.V., Omelyanovskiy V.V. Peculiarities of real-world data application for health technology assessment in Asian countries. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023;16(4):671-680. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.199
Views: 464
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Email this article 