Clinical comprehensive evaluation system of drugs: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

DAI Zeqi , JING Chengyang , WU Xue , ZHANG Le ,  LIAO Xing

Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;

Corresponding?author：

LIAO Xing, Email: okfrom2008@hotmail.com

Keywords：

Clinical comprehensive evaluation of drug; Value assessment; Evaluation system; Chinese patent medicine

DOI：

10.7507/1672-2531.202302039

Video：

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Objective To systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. Methods The PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. Results A total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. Conclusion The research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.

Citation： DAI Zeqi, JING Chengyang, WU Xue, ZHANG Le, LIAO Xing. Clinical comprehensive evaluation system of drugs: a systematic review. Chinese Journal of Evidence-Based Medicine, 2023, 23(7): 776-782. doi: 10.7507/1672-2531.202302039 Copy

1.	Zhang M, Bao Y, Lang Y, et al. What is value in health and healthcare. A systematic literature review of value assessment frameworks. Value Health, 2022, 25(2): 302-317.
2.	國家衛生健康委辦公廳. 關于規范開展藥品臨床綜合評價工作的通知. 中華人民共和國國家衛生健康委員會公報, 2021, (7): 21-28.
3.	國家藥物和衛生技術綜合評估中心. 關于心血管病、抗腫瘤、兒童藥品臨床綜合評價技術指南公開征求意見的公告. 2021.
4.	Institute of Medicine (US) Roundtable on Value & Science-Driven Health Care. Value in health care: accounting for cost, quality, safety, outcomes, and innovation. Washington (DC): National Academies Press (US), 2010.
5.	元唯安, 張俊華, 劉建平, 等. 中成藥臨床綜合評價指南(2022年版試行). 中國中藥雜志, 2023, 48(1): 256-264.
6.	中國中醫科學院中醫臨床基礎醫學研究所, 北京中醫藥大學東直門醫院, 中華醫學會雜志社指南與標準研究中心, 等. 多維度多準則中成藥綜合評價技術指導原則. 中國循證醫學雜志, 2022, 22(7): 751-755.
7.	張強, 王志飛, 謝雁鳴, 等. 中成藥臨床綜合評價技術規范. 世界中醫藥, 2021, 16(22): 3394-3397, 3403.
8.	束雅春, 田磊, 譚喜瑩. 醫療機構中成藥品種遴選與臨床應用評價指標體系構建江蘇專家共識. 中國藥房, 2022, 33(2): 129-135.
9.	程杰, 關勝江, 曹俊嶺, 等. 醫療機構中成藥遴選專家共識(第一版). 中國藥學雜志, 2022, 57(18): 1580-1586.
10.	黨海霞, 劉駿, 李兵, 等. 中成藥價值評估指標體系研究. 中國新藥雜志, 2021, 30(11): 961-970.
11.	王絢, 張永, 許靜. 基于德爾菲法構建中藥注射劑上市后再評價指標體系. 中國醫院藥學雜志, 2021, 41(1): 85-88.
12.	石秀園. 我國藥品臨床綜合評價認知現狀及決策轉化影響因素研究. 昆明: 昆明醫科大學, 2021.
13.	楊萍, 魯松, 董憲喆, 等. 藥品綜合評價方法研究進展. 中國藥物警戒, 2022, 19(7): 803-806.
14.	國家衛生健康委藥物政策與基本藥物制度司. 藥品臨床綜合評價管理指南(2021年版試行).
15.	王海銀, 符雨嫣, 覃肖瀟, 等. 藥品臨床綜合評價: 保障臨床基本用藥合理使用. 中國衛生, 2021, (8): 72-73.
16.	趙琨. 我國藥品臨床綜合評價從管理走向技術規范. 國家衛生健康委衛生發展研究中心官網, 2022.
17.	Lakdawalla DN, Doshi JA, Garrison LP, et al. Defining elements of value in health care-a health economics approach: an ISPOR special task force report [3]. Value Health, 2018, 21(2): 131-139.
18.	Goetghebeur MM, Cellier MS. Can reflective multicriteria be the new paradigm for healthcare decision-making. The EVIDEM journey. Cost Eff Resour Alloc, 2018, 16(Suppl 1): 54.
19.	石秀園, 趙銳, 李璠, 等. 構建我國藥品臨床綜合評價工作機制的思考. 中國藥房, 2020, 31(23): 2828-2833.
20.	郎驛天, 柴青青, 廖雅慧, 等. 國內外抗腫瘤藥物臨床價值評估體系比較. 中國藥房, 2022, 33(11): 1287-1294.
21.	劉鑫, 唐彥, 左瑋, 等. 國外孤兒藥綜合評價概述及啟示. 臨床藥物治療雜志, 2020, 18(6): 85-88.
22.	北京協和醫院罕見病多學科協作組, 中國罕見病聯盟. 多準則決策分析應用于罕見病藥品臨床綜合評價的專家共識(2022). 協和醫學雜志, 2022, 13(2): 235-254.
23.	Sussex J, Rollet P, Garau M, et al. A pilot study of multicriteria decision analysis for valuing orphan medicines. Value Health, 2013, 16(8): 1163-1169.
24.	Friedmann C, Levy P, Hensel P, et al. Using multi-criteria decision analysis to appraise orphan drugs: a systematic review. Expert Rev Pharmacoecon Outcomes Res, 2018, 18(2): 135-146.
25.	尚俊美, 劉鑫, 陳麗萌, 等. 多準則決策分析在孤兒藥綜合評價中的應用進展. 中國藥學雜志, 2021, 56(22): 1785-1790.
26.	Westrich K, Buelt L. Current landscape: value assessment frameworks. 2020.
27.	NCCN. Clinical practice guidelines in oncology (NCCN guidelines) with NCCN evidence blocks. 2023.
28.	劉雨晨, 吳斌. 國外抗腫瘤藥物價值評估體系的概述. 臨床腫瘤學雜志, 2018, 23(5): 472-475.
29.	Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American society of clinical oncology value framework: revisions and reflections in response to comments received. J Clin Oncol, 2016, 34(24): 2925-2934.
30.	Avalere. Patient-perspective value framework (PPVF) version 1.0. 2017.
31.	郭武棟. 如何“以價值論英雄”. 中國衛生, 2019, (10): 79-81.
32.	廖星, 郭武棟, 曹莊, 等. 應用衛生技術評估開展中成藥臨床綜合評價. 中國中藥雜志, 2020, 45(16): 3749-3758.

1. Zhang M, Bao Y, Lang Y, et al. What is value in health and healthcare. A systematic literature review of value assessment frameworks. Value Health, 2022, 25(2): 302-317.
2. 國家衛生健康委辦公廳. 關于規范開展藥品臨床綜合評價工作的通知. 中華人民共和國國家衛生健康委員會公報, 2021, (7): 21-28.
3. 國家藥物和衛生技術綜合評估中心. 關于心血管病、抗腫瘤、兒童藥品臨床綜合評價技術指南公開征求意見的公告. 2021.
4. Institute of Medicine (US) Roundtable on Value & Science-Driven Health Care. Value in health care: accounting for cost, quality, safety, outcomes, and innovation. Washington (DC): National Academies Press (US), 2010.
5. 元唯安, 張俊華, 劉建平, 等. 中成藥臨床綜合評價指南(2022年版試行). 中國中藥雜志, 2023, 48(1): 256-264.
6. 中國中醫科學院中醫臨床基礎醫學研究所, 北京中醫藥大學東直門醫院, 中華醫學會雜志社指南與標準研究中心, 等. 多維度多準則中成藥綜合評價技術指導原則. 中國循證醫學雜志, 2022, 22(7): 751-755.
7. 張強, 王志飛, 謝雁鳴, 等. 中成藥臨床綜合評價技術規范. 世界中醫藥, 2021, 16(22): 3394-3397, 3403.
8. 束雅春, 田磊, 譚喜瑩. 醫療機構中成藥品種遴選與臨床應用評價指標體系構建江蘇專家共識. 中國藥房, 2022, 33(2): 129-135.
9. 程杰, 關勝江, 曹俊嶺, 等. 醫療機構中成藥遴選專家共識(第一版). 中國藥學雜志, 2022, 57(18): 1580-1586.
10. 黨海霞, 劉駿, 李兵, 等. 中成藥價值評估指標體系研究. 中國新藥雜志, 2021, 30(11): 961-970.
11. 王絢, 張永, 許靜. 基于德爾菲法構建中藥注射劑上市后再評價指標體系. 中國醫院藥學雜志, 2021, 41(1): 85-88.
12. 石秀園. 我國藥品臨床綜合評價認知現狀及決策轉化影響因素研究. 昆明: 昆明醫科大學, 2021.
13. 楊萍, 魯松, 董憲喆, 等. 藥品綜合評價方法研究進展. 中國藥物警戒, 2022, 19(7): 803-806.
14. 國家衛生健康委藥物政策與基本藥物制度司. 藥品臨床綜合評價管理指南(2021年版試行).
15. 王海銀, 符雨嫣, 覃肖瀟, 等. 藥品臨床綜合評價: 保障臨床基本用藥合理使用. 中國衛生, 2021, (8): 72-73.
16. 趙琨. 我國藥品臨床綜合評價從管理走向技術規范. 國家衛生健康委衛生發展研究中心官網, 2022.
17. Lakdawalla DN, Doshi JA, Garrison LP, et al. Defining elements of value in health care-a health economics approach: an ISPOR special task force report [3]. Value Health, 2018, 21(2): 131-139.
18. Goetghebeur MM, Cellier MS. Can reflective multicriteria be the new paradigm for healthcare decision-making. The EVIDEM journey. Cost Eff Resour Alloc, 2018, 16(Suppl 1): 54.
19. 石秀園, 趙銳, 李璠, 等. 構建我國藥品臨床綜合評價工作機制的思考. 中國藥房, 2020, 31(23): 2828-2833.
20. 郎驛天, 柴青青, 廖雅慧, 等. 國內外抗腫瘤藥物臨床價值評估體系比較. 中國藥房, 2022, 33(11): 1287-1294.
21. 劉鑫, 唐彥, 左瑋, 等. 國外孤兒藥綜合評價概述及啟示. 臨床藥物治療雜志, 2020, 18(6): 85-88.
22. 北京協和醫院罕見病多學科協作組, 中國罕見病聯盟. 多準則決策分析應用于罕見病藥品臨床綜合評價的專家共識(2022). 協和醫學雜志, 2022, 13(2): 235-254.
23. Sussex J, Rollet P, Garau M, et al. A pilot study of multicriteria decision analysis for valuing orphan medicines. Value Health, 2013, 16(8): 1163-1169.
24. Friedmann C, Levy P, Hensel P, et al. Using multi-criteria decision analysis to appraise orphan drugs: a systematic review. Expert Rev Pharmacoecon Outcomes Res, 2018, 18(2): 135-146.
25. 尚俊美, 劉鑫, 陳麗萌, 等. 多準則決策分析在孤兒藥綜合評價中的應用進展. 中國藥學雜志, 2021, 56(22): 1785-1790.
26. Westrich K, Buelt L. Current landscape: value assessment frameworks. 2020.
27. NCCN. Clinical practice guidelines in oncology (NCCN guidelines) with NCCN evidence blocks. 2023.
28. 劉雨晨, 吳斌. 國外抗腫瘤藥物價值評估體系的概述. 臨床腫瘤學雜志, 2018, 23(5): 472-475.
29. Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American society of clinical oncology value framework: revisions and reflections in response to comments received. J Clin Oncol, 2016, 34(24): 2925-2934.
30. Avalere. Patient-perspective value framework (PPVF) version 1.0. 2017.
31. 郭武棟. 如何“以價值論英雄”. 中國衛生, 2019, (10): 79-81.
32. 廖星, 郭武棟, 曹莊, 等. 應用衛生技術評估開展中成藥臨床綜合評價. 中國中藥雜志, 2020, 45(16): 3749-3758.

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