Health economic evaluations of long-term rhythm-control antiarrhythmic drugs for treating atrial fibrillation: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

LI Fuming ^1,2 , LIU Shimeng ^1,2 , XIA Yu ^1,2 , XIAO Dunming ^1,2 ,  CHEN Yingyao ^1,2

1. School of Public Health, Fudan University, Shanghai 200032, P. R. China;
2. National Health Commission Key Laboratory of Health Technology Assessment (Fudan University), Shanghai 200032, P. R. China;

Corresponding author：

CHEN Yingyao, Email: yychen@shmu.edu.cn

Keywords：

Atrial fibrillation; Rhythm control; Antiarrhythmic drug; Health economics evaluation; Systematic review

DOI：

10.7507/1672-2531.202207121

Video：

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Objective To systematically review the health economic evaluations of using long-term rhythm-control antiarrhythmic drugs (AAD) for patients with paroxysmal or persistent atrial fibrillation (AF). Methods Databases including PubMed, EMbase, Scopus, CNKI, SinoMed, WanFang Data, and official websites of well-established health technology assessment (HTA) institutions were electronically searched to present the economic evaluations of AAD and the recommendations of HTA institutions based on drug economy from inception to April 23^rd, 2022. Two reviewers independently screened the literature, extracted data and systematic review was then performed. Results A total of 19 studies were included, including 11 cost-effectiveness or cost-utility analysis studies and 8 official documents from HTA institutions. Only 5 (45.5%) economic evaluations were of relatively high quality, and English language studies were of higher quality than Chinese language studies ones. The included studies lacked elements that CHEERS 2022 concerns, such as health economics analysis plans, equity and distributional effects, engagement with patients and other stakeholders and the impact on the study. Dronedarone and amiodarone were the main focus of the evaluation, and the study results showed that dronedarone was cost-effective compared with other drugs in different study designs and national settings. However, there were differences between the recommendations of HTA agencies and the results of economic evaluation studies. Conclusion The completeness of health economics evaluations needs to be improved, along with the quality of clinical evidence in the field of AF-AAD for Chinese patients. Additionally, the informational value of drugs should be thoroughly investigated through budget impact analysis and distributional cost-effectiveness analysis to provide evidence of high-quality studies for decision-makers in China.

Citation： LI Fuming, LIU Shimeng, XIA Yu, XIAO Dunming, CHEN Yingyao. Health economic evaluations of long-term rhythm-control antiarrhythmic drugs for treating atrial fibrillation: a systematic review. Chinese Journal of Evidence-Based Medicine, 2022, 22(12): 1400-1409. doi: 10.7507/1672-2531.202207121 Copy

1.	中国研究型医院协会, 中国医师协会房颤专家委员会. 心房颤动外科治疗中国专家共识2020版. 中华胸心血管外科杂志, 2021, 37(3): 129-144.
2.	GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet, 2020, 396(10258): 1204-1222.
3.	吴静静, 杨莉. 城市地区房颤脑卒中患者住院费用分析. 中国药房, 2013, 24(22): 2017-2020.
4.	中华医学会心电生理和起搏分会, 中国医师协会心律学专业委员会, 中国房颤中心联盟心房颤动防治专家工作委员会. 心房颤动: 目前的认识和治疗建议(2021). 中华心律失常学杂志, 2022, 26(1): 15-88.
5.	Sun Y, Zhu J, Ma C, et al. Stroke risk status, anticoagulation treatment, and quality-of-life in Chinese patients with atrial fibrillation: China Registry of Atrial Fibrillation (CRAF). Cardiovasc Ther, 2019, 2019: 7372129.
6.	张景瑞, 李昌义, 马长生. 心房颤动节律控制时代如何用好抗心律失常药物. 中华内科杂志, 2021, 60(4): 289-293.
7.	范长生, 王丽莉, 吴久鸿. 医保目录动态调整背景下完善创新药准入的思路探讨. 中国医疗保险, 2020, (5): 63-67.
8.	Husereau D, Drummond M, Augustovski F, et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Value Health, 2022, 25(1): 3-9.
9.	Husereau D, Drummond M, Augustovski F, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 explanation and elaboration: a report of the ISPOR CHEERS II Good Practices Task Force. Value Health, 2022, 25(1): 10-31.
10.	Willke RJ, Pizzi LT. CHEERS to updated guidelines for reporting health economic evaluations. Value Health, 2022, 25(1): 1-2.
11.	Eckman MH, Falk RH, Pauker SG. Cost-effectiveness of therapies for patients with nonvalvular atrial fibrillation. Arch Intern Med, 1998, 158(15): 1669-1677.
12.	Catherwood E, Fitzpatrick WD, Greenberg ML, et al. Cost-effectiveness of cardioversion and antiarrhythmic therapy in nonvalvular atrial fibrillation. Ann Intern Med, 1999, 130(8): 625-636.
13.	Åkerborg Ö, Nilsson J, Bascle S, et al. Cost-effectiveness of dronedarone in atrial fibrillation: results for Canada, Italy, Sweden, and Switzerland. Clin Ther, 2012, 34(8): 1788-1802.
14.	Nilsson J, Åkerborg Ö, Bégo-Le Bagousse G, et al. Cost-effectiveness analysis of dronedarone versus other anti-arrhythmic drugs for the treatment of atrial fibrillation-results for Canada, Italy, Sweden and Switzerland. Eur J Health Econ, 2013, 14(3): 481-493.
15.	Berg J, Sauriol L, Connolly S, et al. Cost-effectiveness of dronedarone in patients with atrial fibrillation in the ATHENA trial. Can J Cardiol, 2013, 29(10): 1249-1255.
16.	Reynolds MR, Nilsson J, Akerborg O, et al. Cost-effectiveness of dronedarone and standard of care compared with standard of care alone: US results of an ATHENA lifetime model. Clinicoecon Outcomes Res, 2013, 5: 19-28.
17.	Tesic D, Kostic M, Paunovic D, et al. Analysis of the cost-effectiveness of dronedarone versus amiodarone, propafenone, and sotalol in patients with atrial fibrillation: results for Serbia. Kardiol Pol, 2015, 73(4): 287-295.
18.	Kim M, Kim W, Kim C, et al. Cost-effectiveness of rate- and rhythm-control drugs for treating atrial fibrillation in Korea. Yonsei Med J, 2019, 60(12): 1157-1163.
19.	Zhang M, Ren Y, Wang L, et al. Cost-effectiveness of dronedarone and amiodarone for the treatment of chinese patients with atrial fibrillation. Front Public Health, 2021, 9: 726294.
20.	邢建生. 2种用药方案治疗心房颤动的成本-效果分析. 中国药房, 2008, (14): 1046-1047.
21.	高胜男, 李雪靖, 刘国强. 国产盐酸决奈达隆片治疗阵发性/持续性房颤的成本-效果分析. 世界临床药物, 2021, 42(3): 202-207.
22.	National Institute for Health and Care Excellence. Dronedarone for the treatment of non-permanent atrial fibrillation. Available at: https://www.nice.org.uk/guidance/ta197/resources/dronedarone-for-the-treatment-of-nonpermanent-atrial-fibrillation-pdf-82598561647045.
23.	Canadian Agency for Drugs and Technologies in Health. Ablation procedures for rhythm control in patients with atrial fibrillation: clinical and cost-effectiveness analyses. Available at: https://www.cadth.ca/sites/default/files/pdf/H0491_Ablation_Procedures_with_Atrial_Fibrillation_tr_e.pdf.
24.	Canadian Agency for Drugs and Technologies in Health. Dronedarone hydrochloride. Available at: https://www.cadth.ca/sites/default/files/cdr/complete/cdr_complete_Multaq_May-31-2010.pdf.
25.	Institute for Clinical and Economic Review. Atrial fibrillation: an assessment of atrial fibrillation (AF), the most common cardiac arrhythmia in the US. Available at: http://icerorg.wpengine.com/wp-content/uploads/2020/10/Atrial-Fibrillation-Final-09-24-10.pdf.
26.	Haute Autorité de Santé. CORDARONE 16092020 SUMMARY CT16356 18389. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2021-03/cordarone_16092020_summary_ct16356_18389.pdf.
27.	Haute Autorité de Santé. MULTAQ - CT 10281 - English version. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2012-11/multaq_ct_10281.pdf.
28.	Haute Autorité de Santé. RYTHMOL 16092020 SUMMARY CT16355 18390. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2021-03/rythmol_16092020_summary_ct16355_18390.pdf.
29.	Haute Autorité de Santé. SOTALEX 16092020 SUMMARY CT16396 18475. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2021-03/sotalex_16092020_summary_ct16396_18475.pdf.
30.	Hohnloser SH, Crijns HJ, van Eickels M, et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med, 2009, 360(7): 668-678.
31.	马长生, 刘晓霞. 心房颤动进入节律控制时代. 中华心血管病杂志, 2021, 49(3): 205-206.
32.	Kirchhof P, Camm AJ, Goette A, et al. Early rhythm-control therapy in patients with atrial fibrillation. N Engl J Med, 2020, 383(14): 1305-1316.
33.	Cookson R, Griffin S, Norheim OF, et al. Distributional cost-effectiveness analysis comes of age. Value Health, 2021, 24(1): 118-120.
34.	Cookson R, Mirelman AJ, Griffin S, et al. Using cost-effectiveness analysis to address health equity concerns. Value Health, 2017, 20(2): 206-212.
35.	Avanceña ALV, Prosser LA. Examining equity effects of health interventions in cost-effectiveness analysis: a systematic review. Value Health, 2021, 24(1): 136-143.

1. 中国研究型医院协会, 中国医师协会房颤专家委员会. 心房颤动外科治疗中国专家共识2020版. 中华胸心血管外科杂志, 2021, 37(3): 129-144.
2. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet, 2020, 396(10258): 1204-1222.
3. 吴静静, 杨莉. 城市地区房颤脑卒中患者住院费用分析. 中国药房, 2013, 24(22): 2017-2020.
4. 中华医学会心电生理和起搏分会, 中国医师协会心律学专业委员会, 中国房颤中心联盟心房颤动防治专家工作委员会. 心房颤动: 目前的认识和治疗建议(2021). 中华心律失常学杂志, 2022, 26(1): 15-88.
5. Sun Y, Zhu J, Ma C, et al. Stroke risk status, anticoagulation treatment, and quality-of-life in Chinese patients with atrial fibrillation: China Registry of Atrial Fibrillation (CRAF). Cardiovasc Ther, 2019, 2019: 7372129.
6. 张景瑞, 李昌义, 马长生. 心房颤动节律控制时代如何用好抗心律失常药物. 中华内科杂志, 2021, 60(4): 289-293.
7. 范长生, 王丽莉, 吴久鸿. 医保目录动态调整背景下完善创新药准入的思路探讨. 中国医疗保险, 2020, (5): 63-67.
8. Husereau D, Drummond M, Augustovski F, et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Value Health, 2022, 25(1): 3-9.
9. Husereau D, Drummond M, Augustovski F, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 explanation and elaboration: a report of the ISPOR CHEERS II Good Practices Task Force. Value Health, 2022, 25(1): 10-31.
10. Willke RJ, Pizzi LT. CHEERS to updated guidelines for reporting health economic evaluations. Value Health, 2022, 25(1): 1-2.
11. Eckman MH, Falk RH, Pauker SG. Cost-effectiveness of therapies for patients with nonvalvular atrial fibrillation. Arch Intern Med, 1998, 158(15): 1669-1677.
12. Catherwood E, Fitzpatrick WD, Greenberg ML, et al. Cost-effectiveness of cardioversion and antiarrhythmic therapy in nonvalvular atrial fibrillation. Ann Intern Med, 1999, 130(8): 625-636.
13. Åkerborg Ö, Nilsson J, Bascle S, et al. Cost-effectiveness of dronedarone in atrial fibrillation: results for Canada, Italy, Sweden, and Switzerland. Clin Ther, 2012, 34(8): 1788-1802.
14. Nilsson J, Åkerborg Ö, Bégo-Le Bagousse G, et al. Cost-effectiveness analysis of dronedarone versus other anti-arrhythmic drugs for the treatment of atrial fibrillation-results for Canada, Italy, Sweden and Switzerland. Eur J Health Econ, 2013, 14(3): 481-493.
15. Berg J, Sauriol L, Connolly S, et al. Cost-effectiveness of dronedarone in patients with atrial fibrillation in the ATHENA trial. Can J Cardiol, 2013, 29(10): 1249-1255.
16. Reynolds MR, Nilsson J, Akerborg O, et al. Cost-effectiveness of dronedarone and standard of care compared with standard of care alone: US results of an ATHENA lifetime model. Clinicoecon Outcomes Res, 2013, 5: 19-28.
17. Tesic D, Kostic M, Paunovic D, et al. Analysis of the cost-effectiveness of dronedarone versus amiodarone, propafenone, and sotalol in patients with atrial fibrillation: results for Serbia. Kardiol Pol, 2015, 73(4): 287-295.
18. Kim M, Kim W, Kim C, et al. Cost-effectiveness of rate- and rhythm-control drugs for treating atrial fibrillation in Korea. Yonsei Med J, 2019, 60(12): 1157-1163.
19. Zhang M, Ren Y, Wang L, et al. Cost-effectiveness of dronedarone and amiodarone for the treatment of chinese patients with atrial fibrillation. Front Public Health, 2021, 9: 726294.
20. 邢建生. 2种用药方案治疗心房颤动的成本-效果分析. 中国药房, 2008, (14): 1046-1047.
21. 高胜男, 李雪靖, 刘国强. 国产盐酸决奈达隆片治疗阵发性/持续性房颤的成本-效果分析. 世界临床药物, 2021, 42(3): 202-207.
22. National Institute for Health and Care Excellence. Dronedarone for the treatment of non-permanent atrial fibrillation. Available at: https://www.nice.org.uk/guidance/ta197/resources/dronedarone-for-the-treatment-of-nonpermanent-atrial-fibrillation-pdf-82598561647045.
23. Canadian Agency for Drugs and Technologies in Health. Ablation procedures for rhythm control in patients with atrial fibrillation: clinical and cost-effectiveness analyses. Available at: https://www.cadth.ca/sites/default/files/pdf/H0491_Ablation_Procedures_with_Atrial_Fibrillation_tr_e.pdf.
24. Canadian Agency for Drugs and Technologies in Health. Dronedarone hydrochloride. Available at: https://www.cadth.ca/sites/default/files/cdr/complete/cdr_complete_Multaq_May-31-2010.pdf.
25. Institute for Clinical and Economic Review. Atrial fibrillation: an assessment of atrial fibrillation (AF), the most common cardiac arrhythmia in the US. Available at: http://icerorg.wpengine.com/wp-content/uploads/2020/10/Atrial-Fibrillation-Final-09-24-10.pdf.
26. Haute Autorité de Santé. CORDARONE 16092020 SUMMARY CT16356 18389. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2021-03/cordarone_16092020_summary_ct16356_18389.pdf.
27. Haute Autorité de Santé. MULTAQ - CT 10281 - English version. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2012-11/multaq_ct_10281.pdf.
28. Haute Autorité de Santé. RYTHMOL 16092020 SUMMARY CT16355 18390. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2021-03/rythmol_16092020_summary_ct16355_18390.pdf.
29. Haute Autorité de Santé. SOTALEX 16092020 SUMMARY CT16396 18475. Available at: https://www.has-sante.fr/upload/docs/application/pdf/2021-03/sotalex_16092020_summary_ct16396_18475.pdf.
30. Hohnloser SH, Crijns HJ, van Eickels M, et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med, 2009, 360(7): 668-678.
31. 马长生, 刘晓霞. 心房颤动进入节律控制时代. 中华心血管病杂志, 2021, 49(3): 205-206.
32. Kirchhof P, Camm AJ, Goette A, et al. Early rhythm-control therapy in patients with atrial fibrillation. N Engl J Med, 2020, 383(14): 1305-1316.
33. Cookson R, Griffin S, Norheim OF, et al. Distributional cost-effectiveness analysis comes of age. Value Health, 2021, 24(1): 118-120.
34. Cookson R, Mirelman AJ, Griffin S, et al. Using cost-effectiveness analysis to address health equity concerns. Value Health, 2017, 20(2): 206-212.
35. Avanceña ALV, Prosser LA. Examining equity effects of health interventions in cost-effectiveness analysis: a systematic review. Value Health, 2021, 24(1): 136-143.

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Health economic evaluations of long-term rhythm-control antiarrhythmic drugs for treating atrial fibrillation: a systematic review

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