An analysis and reflection on the key updates to the ICER value assessment framework in the United States_Chinese Journal of Evidence-Based Medicine

Authors：

LI Pengbo ¹ , HE Xiaojun ¹ , JIANG Gan ¹ , ZHENG Yu ¹ , LI Muzhi ¹ , YU Yanan ¹ ,  DANG Haixia ²

1. Institute of Clinical Basic Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
2. Research Center for the Development of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;

Corresponding?author：

DANG Haixia, Email: danghaixia@126.com

Keywords：

ICER; Value assessment; Value assessment framework; Health technology assessment

DOI：

10.7507/1672-2531.202512059

Video：

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Abstract Full text Figures/Tables Video References Cited by

The Institute for Clinical and Economic Review (ICER) has long been committed to promoting fair pricing and equitable access in U.S. healthcare, and has developed a value assessment framework to guide this work. ICER’s value assessment framework was first conceived in 2015 and subsequently updated in 2017 and 2020. This study introduces the ICER value assessment framework (2023). It focuses on elucidating the major revisions within three key areas: cost-effectiveness analysis, health technology assessment (HTA) methods related to health equity and patient engagement, and discusses these changes in light of their central methodological implications. The aim is to provide informative insights and methodological references that may be of value for the development and refinement of HTA practices in China.

Citation： LI Pengbo, HE Xiaojun, JIANG Gan, ZHENG Yu, LI Muzhi, YU Yanan, DANG Haixia. An analysis and reflection on the key updates to the ICER value assessment framework in the United States. Chinese Journal of Evidence-Based Medicine, 2026, 26(5): 565-571. doi: 10.7507/1672-2531.202512059 Copy

1.	肖非易, 李雪, 李睿, 等. 衛生技術評估在我國醫保決策領域應用的挑戰與對策. 中國醫療保險, 2025, (1): 109-116.
2.	Institute for Clinical and Economic Review. What is ICER? When was ICER founded? 2025.
3.	Institute for Clinical and Economic Review. Value assessment framework. 2023.
4.	Institute for Clinical and Economic Review. Value assessment framework. 2017.
5.	Institute for Clinical and Economic Review. Value assessment framework. 2020.
6.	Institute for Clinical and Economic Review. ICER evidence rating matrix: a user’s guide. 2017.
7.	National Council on Disability. Quality-adjusted life years and the devaluation of life with disability: part of the bioethics and disability series. 2019.
8.	Smith WS. The US shouldn’t use the ‘QALY’ in drug cost-effectiveness reviews. 2019.
9.	Andrade G. Quality-adjusted life years and disability. The Palgrave encyclopedia of disability. Cham: Springer Nature Switzerland, 2024.
10.	Goss Sawhney T, Thakur N. Drug cost-effectiveness assessments require standards for rigor and inclusion. J Health Econ Outcomes Res, 2023, 10(1): 28-30.
11.	Institute for Clinical and Economic Review. The QALY: rewarding the care that most improves patients' lives. 2026.
12.	Rowen D, Dixon S, Hernández-Alava M, et al. Estimating informal care inputs associated with EQ-5D for use in economic evaluation. Eur J Health Econ, 2016, 17(6): 733-744.
13.	Mukuria C, Rowen D, Hernández-Alava M, et al. Predicting productivity losses from health-related quality of life using patient data. Appl Health Econ Health Policy, 2017, 15(5): 597-614.
14.	Kogut SJ, Campbell JD, Pearson SD. The influence of US drug price dynamics on cost-effectiveness analyses of biologics. Value Health, 2023, 26(3): 378-383.
15.	胡宏飛, 周挺, 李馮, 等. 健康價值評估中質量調整生命年的替代及優化方法介紹與比較. 中國新藥雜志, 2024, 33(19): 1969-1975.
16.	Emond SK, Fischer CK. Institute for Clinical and Economic Review's role in the US health care system: centering the patient perspective. Health Aff Sch, 2025, 3(4): qxaf071.
17.	Diaby V, Ali AA, Montero AJ. Value assessment frameworks in the United States: a call for patient engagement. Pharmacoecon Open, 2019, 3(1): 1-3.
18.	Howard L, Kennedy A, Lappin D, et al. Taking stock of PFDD: envisioning a vibrant future for patient-focused drug development. 2020.
19.	顧一純, 董文星, 何江江, 等. 衛生技術評估中健康公平性評價框架的國際經驗及啟示. 健康發展與政策研究, 2025, 28(6): 746-752.
20.	Institute for Clinical and Economic Review. ICER publishes white paper recommending health technology assessment methods that support health equity. 2023.
21.	Agboola F, Wright AC. A framework for evaluating the diversity of clinical trials. J Clin Epidemiol, 2024, 169: 111299.
22.	Schandelmaier S, Briel M, Varadhan R, et al. Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses. CMAJ, 2020, 192(32): E901-E906.
23.	謝春艷, 王海銀, 王美鳳等. 基于價值的戰略購買: 健康中國背景下醫保治理的現代化轉向. 中國衛生事業管理, 2022, 39(5): 348-352.
24.	顏建周, 雷璐倩, 邵蓉. 典型發達國家藥品上市價值評估的分析及應用. 中國醫藥工業雜志, 2019, 50(12): 1514-1518.
25.	李惟妙, 韓晟, 史錄文, 等. 歐洲聯合臨床評估實踐及對我國的啟示. 藥學進展, 2025, 49(5): 330-336.
26.	Chen W, Zhang L, Hu M, et al. Use of health technology assessment in drug reimbursement decisions in China. BMJ, 2023, 381: e068915.
27.	國家藥監局藥審中心. 關于發布《患者報告結局在藥物臨床研發中應用的指導原則(試行)》通告(2021年第62號). 2021.
28.	國家藥監局藥審中心. 《以患者為中心的藥物臨床試驗設計技術指導原則(試行)》通告(2023年第44號). 2023.
29.	國家醫療保障局. 《國家基本醫療保險、工傷保險和生育保險藥品目錄(2024年)》通告(2024年33號). 2024.
30.	國家醫療保障局. 《真實世界醫保綜合價值評價試點工作的通知》通告(2025年15號). 2025.
31.	劉國恩. 中國藥物經濟學評價指南(2020). 北京: 中國市場出版社, 2020.
32.	國家醫療保障局. 《國家基本醫療保險、工傷保險和生育保險藥品目錄(2021年)》通告(2021年50號). 2021.
33.	國家醫療保障局. 2025年國家基本醫療保險、生育保險和工傷保險藥品目錄及商業健康保險創新藥品目錄調整工作方案. 2025.
34.	胡嘉浩, 王嘉韻, 陳茜, 等. 衛生技術評估中公平性的評價與思考. 中國衛生經濟, 2024, 43(1): 11-16.
35.	國家醫療保障局. 2024年全國醫療保障事業發展統計公報. 2024.
36.	Su L, Liu S, Li G, et al. Trends and characteristics of new drug approvals in China, 2011-2021. Ther Innov Regul Sci, 2023, 57(2): 343-351.
37.	曾添筑, 顏建周, 邵蓉. 美國藥物臨床試驗人群多樣性改善實踐對我國的啟示. 中國新藥與臨床雜志, 2024, 43(10): 759-764.
38.	蕭惠來. FDA提高臨床試驗人群多樣性的指導原則介紹. 藥物評價研究, 2021, 44(6): 1215-1223.
39.	國家藥監局藥審中心. 中國新藥注冊臨床試驗進展年度報告(2024年). 2024.
40.	湯虹, 張金鐘. 藥物臨床試驗孕婦受試者風險防控. 中國醫學倫理學, 2017, 30(3): 267-272.
41.	陳沐, 許俐嫻, 彭平, 等. 90例中國境外輸入性新型冠狀病毒肺炎臨床特征分析. 臨床肺科雜志, 2021, 26(2): 163-167.
42.	中共中央, 國務院. 關于深化醫療保障制度改革的意見. 2020.
43.	國家醫療保障局. 談判藥品續約規則. 2025.
44.	王處淵, 謝雁鳴, 王連心, 等. 真實世界25 338例腸惡性腫瘤患者中西藥聯合應用特征分析. 中國中醫基礎醫學雜志, 2015, 21(12): 1544-1549.
45.	國家醫療保障局. 2025年國家基本醫療保險、工傷保險和生育保險藥品目錄調整申報指南. 2025.
46.	陳怡, 翁夢婷. 基于社會價值視角的我國醫保談判藥品價值評價探索. 中國衛生經濟, 2025, 44(10): 63-68.
47.	路云. 基于價值醫療的地方藥品集采質量水平綜合評價體系研究. 中國醫療保險, 2023, (12): 5-12.
48.	Domecq JP, Prutsky G, Elraiyah T, et al. Patient engagement in research: a systematic review. BMC Health Serv Res, 2014, 14: 89.
49.	高一城, 劉芷含, 陶立元, 等. 健康公平性在指南制訂中的思考與方法學建議. 協和醫學雜志, 2023, 14(6): 1319-1324.

1. 肖非易, 李雪, 李睿, 等. 衛生技術評估在我國醫保決策領域應用的挑戰與對策. 中國醫療保險, 2025, (1): 109-116.
2. Institute for Clinical and Economic Review. What is ICER? When was ICER founded? 2025.
3. Institute for Clinical and Economic Review. Value assessment framework. 2023.
4. Institute for Clinical and Economic Review. Value assessment framework. 2017.
5. Institute for Clinical and Economic Review. Value assessment framework. 2020.
6. Institute for Clinical and Economic Review. ICER evidence rating matrix: a user’s guide. 2017.
7. National Council on Disability. Quality-adjusted life years and the devaluation of life with disability: part of the bioethics and disability series. 2019.
8. Smith WS. The US shouldn’t use the ‘QALY’ in drug cost-effectiveness reviews. 2019.
9. Andrade G. Quality-adjusted life years and disability. The Palgrave encyclopedia of disability. Cham: Springer Nature Switzerland, 2024.
10. Goss Sawhney T, Thakur N. Drug cost-effectiveness assessments require standards for rigor and inclusion. J Health Econ Outcomes Res, 2023, 10(1): 28-30.
11. Institute for Clinical and Economic Review. The QALY: rewarding the care that most improves patients' lives. 2026.
12. Rowen D, Dixon S, Hernández-Alava M, et al. Estimating informal care inputs associated with EQ-5D for use in economic evaluation. Eur J Health Econ, 2016, 17(6): 733-744.
13. Mukuria C, Rowen D, Hernández-Alava M, et al. Predicting productivity losses from health-related quality of life using patient data. Appl Health Econ Health Policy, 2017, 15(5): 597-614.
14. Kogut SJ, Campbell JD, Pearson SD. The influence of US drug price dynamics on cost-effectiveness analyses of biologics. Value Health, 2023, 26(3): 378-383.
15. 胡宏飛, 周挺, 李馮, 等. 健康價值評估中質量調整生命年的替代及優化方法介紹與比較. 中國新藥雜志, 2024, 33(19): 1969-1975.
16. Emond SK, Fischer CK. Institute for Clinical and Economic Review's role in the US health care system: centering the patient perspective. Health Aff Sch, 2025, 3(4): qxaf071.
17. Diaby V, Ali AA, Montero AJ. Value assessment frameworks in the United States: a call for patient engagement. Pharmacoecon Open, 2019, 3(1): 1-3.
18. Howard L, Kennedy A, Lappin D, et al. Taking stock of PFDD: envisioning a vibrant future for patient-focused drug development. 2020.
19. 顧一純, 董文星, 何江江, 等. 衛生技術評估中健康公平性評價框架的國際經驗及啟示. 健康發展與政策研究, 2025, 28(6): 746-752.
20. Institute for Clinical and Economic Review. ICER publishes white paper recommending health technology assessment methods that support health equity. 2023.
21. Agboola F, Wright AC. A framework for evaluating the diversity of clinical trials. J Clin Epidemiol, 2024, 169: 111299.
22. Schandelmaier S, Briel M, Varadhan R, et al. Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses. CMAJ, 2020, 192(32): E901-E906.
23. 謝春艷, 王海銀, 王美鳳等. 基于價值的戰略購買: 健康中國背景下醫保治理的現代化轉向. 中國衛生事業管理, 2022, 39(5): 348-352.
24. 顏建周, 雷璐倩, 邵蓉. 典型發達國家藥品上市價值評估的分析及應用. 中國醫藥工業雜志, 2019, 50(12): 1514-1518.
25. 李惟妙, 韓晟, 史錄文, 等. 歐洲聯合臨床評估實踐及對我國的啟示. 藥學進展, 2025, 49(5): 330-336.
26. Chen W, Zhang L, Hu M, et al. Use of health technology assessment in drug reimbursement decisions in China. BMJ, 2023, 381: e068915.
27. 國家藥監局藥審中心. 關于發布《患者報告結局在藥物臨床研發中應用的指導原則(試行)》通告(2021年第62號). 2021.
28. 國家藥監局藥審中心. 《以患者為中心的藥物臨床試驗設計技術指導原則(試行)》通告(2023年第44號). 2023.
29. 國家醫療保障局. 《國家基本醫療保險、工傷保險和生育保險藥品目錄(2024年)》通告(2024年33號). 2024.
30. 國家醫療保障局. 《真實世界醫保綜合價值評價試點工作的通知》通告(2025年15號). 2025.
31. 劉國恩. 中國藥物經濟學評價指南(2020). 北京: 中國市場出版社, 2020.
32. 國家醫療保障局. 《國家基本醫療保險、工傷保險和生育保險藥品目錄(2021年)》通告(2021年50號). 2021.
33. 國家醫療保障局. 2025年國家基本醫療保險、生育保險和工傷保險藥品目錄及商業健康保險創新藥品目錄調整工作方案. 2025.
34. 胡嘉浩, 王嘉韻, 陳茜, 等. 衛生技術評估中公平性的評價與思考. 中國衛生經濟, 2024, 43(1): 11-16.
35. 國家醫療保障局. 2024年全國醫療保障事業發展統計公報. 2024.
36. Su L, Liu S, Li G, et al. Trends and characteristics of new drug approvals in China, 2011-2021. Ther Innov Regul Sci, 2023, 57(2): 343-351.
37. 曾添筑, 顏建周, 邵蓉. 美國藥物臨床試驗人群多樣性改善實踐對我國的啟示. 中國新藥與臨床雜志, 2024, 43(10): 759-764.
38. 蕭惠來. FDA提高臨床試驗人群多樣性的指導原則介紹. 藥物評價研究, 2021, 44(6): 1215-1223.
39. 國家藥監局藥審中心. 中國新藥注冊臨床試驗進展年度報告(2024年). 2024.
40. 湯虹, 張金鐘. 藥物臨床試驗孕婦受試者風險防控. 中國醫學倫理學, 2017, 30(3): 267-272.
41. 陳沐, 許俐嫻, 彭平, 等. 90例中國境外輸入性新型冠狀病毒肺炎臨床特征分析. 臨床肺科雜志, 2021, 26(2): 163-167.
42. 中共中央, 國務院. 關于深化醫療保障制度改革的意見. 2020.
43. 國家醫療保障局. 談判藥品續約規則. 2025.
44. 王處淵, 謝雁鳴, 王連心, 等. 真實世界25 338例腸惡性腫瘤患者中西藥聯合應用特征分析. 中國中醫基礎醫學雜志, 2015, 21(12): 1544-1549.
45. 國家醫療保障局. 2025年國家基本醫療保險、工傷保險和生育保險藥品目錄調整申報指南. 2025.
46. 陳怡, 翁夢婷. 基于社會價值視角的我國醫保談判藥品價值評價探索. 中國衛生經濟, 2025, 44(10): 63-68.
47. 路云. 基于價值醫療的地方藥品集采質量水平綜合評價體系研究. 中國醫療保險, 2023, (12): 5-12.
48. Domecq JP, Prutsky G, Elraiyah T, et al. Patient engagement in research: a systematic review. BMC Health Serv Res, 2014, 14: 89.
49. 高一城, 劉芷含, 陶立元, 等. 健康公平性在指南制訂中的思考與方法學建議. 協和醫學雜志, 2023, 14(6): 1319-1324.

Chinese Journal of Evidence-Based Medicine

An analysis and reflection on the key updates to the ICER value assessment framework in the United States

Abstract Full text Figures/Tables Video References Cited by

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