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.	中國研究型醫院協會, 中國醫師協會房顫專家委員會. 心房顫動外科治療中國專家共識2020版. 中華胸心血管外科雜志, 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.	吳靜靜, 楊莉. 城市地區房顫腦卒中患者住院費用分析. 中國藥房, 2013, 24(22): 2017-2020.
4.	中華醫學會心電生理和起搏分會, 中國醫師協會心律學專業委員會, 中國房顫中心聯盟心房顫動防治專家工作委員會. 心房顫動: 目前的認識和治療建議(2021). 中華心律失常學雜志, 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.	張景瑞, 李昌義, 馬長生. 心房顫動節律控制時代如何用好抗心律失常藥物. 中華內科雜志, 2021, 60(4): 289-293.
7.	范長生, 王麗莉, 吳久鴻. 醫保目錄動態調整背景下完善創新藥準入的思路探討. 中國醫療保險, 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.	?kerborg ?, 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, ?kerborg ?, 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種用藥方案治療心房顫動的成本-效果分析. 中國藥房, 2008, (14): 1046-1047.
21.	高勝男, 李雪靖, 劉國強. 國產鹽酸決奈達隆片治療陣發性/持續性房顫的成本-效果分析. 世界臨床藥物, 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.	馬長生, 劉曉霞. 心房顫動進入節律控制時代. 中華心血管病雜志, 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.	Avance?a ALV, Prosser LA. Examining equity effects of health interventions in cost-effectiveness analysis: a systematic review. Value Health, 2021, 24(1): 136-143.

1. 中國研究型醫院協會, 中國醫師協會房顫專家委員會. 心房顫動外科治療中國專家共識2020版. 中華胸心血管外科雜志, 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. 吳靜靜, 楊莉. 城市地區房顫腦卒中患者住院費用分析. 中國藥房, 2013, 24(22): 2017-2020.
4. 中華醫學會心電生理和起搏分會, 中國醫師協會心律學專業委員會, 中國房顫中心聯盟心房顫動防治專家工作委員會. 心房顫動: 目前的認識和治療建議(2021). 中華心律失常學雜志, 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. 張景瑞, 李昌義, 馬長生. 心房顫動節律控制時代如何用好抗心律失常藥物. 中華內科雜志, 2021, 60(4): 289-293.
7. 范長生, 王麗莉, 吳久鴻. 醫保目錄動態調整背景下完善創新藥準入的思路探討. 中國醫療保險, 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. ?kerborg ?, 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, ?kerborg ?, 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種用藥方案治療心房顫動的成本-效果分析. 中國藥房, 2008, (14): 1046-1047.
21. 高勝男, 李雪靖, 劉國強. 國產鹽酸決奈達隆片治療陣發性/持續性房顫的成本-效果分析. 世界臨床藥物, 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. 馬長生, 劉曉霞. 心房顫動進入節律控制時代. 中華心血管病雜志, 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. Avance?a 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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