Objective To study the influencing factors in the process of national medical insurance negotiation and drug pricing from the dualistic equilibrium perspective,and to provide reference for the harmonious management of...Objective To study the influencing factors in the process of national medical insurance negotiation and drug pricing from the dualistic equilibrium perspective,and to provide reference for the harmonious management of drug pricing in China.Methods Through the literature analysis and policy review,the pricing subject,pricing basis and price control system in the pricing process of medical-accessed medicines were analyzed from the perspective of binary equilibrium and harmonious management.Results and Conclusion It is found that four balances in the drug pricing process,two balances in pricing basis and three balances in price control system need to be considered,respectively.Drug pricing is the key content of national medical insurance access,which is also the hotspot of the policy in the pharmaceutical fields in recent years.Drug pricing not only reflects the value of drugs,but also reflects a lot of top-level designs of binary equilibriums in medical insurance policy.While the rational design of drug pricing requires the joint efforts of the government,pharmaceutical companies and relevant experts to comprehensively consider many equilibriums,so as to improve the relevant systems.展开更多
The China Basic Medical Insurance Program was created in 1999 with three objectives:equal accessibility,affordability,and quality.Today,it has become the biggest medical insurance program in the world,covering 95%of C...The China Basic Medical Insurance Program was created in 1999 with three objectives:equal accessibility,affordability,and quality.Today,it has become the biggest medical insurance program in the world,covering 95%of China's population.Since 2015,China's healthcare ecosystem has been reshaped by increasing innovation,which has in turn been driven by regulatory reform,enhancement of research and development capability,and capital market development.There has also been improved regulatory efficiency to reduce lags in launching drugs.In 2022,nearly 20%of novel active substances launched globally were from China.China has also risen to become the second biggest contributor to innovation in terms of pipelines.Using a“fast-follow”strategy,many locally developed innovative drugs can compete with products from multinational companies in their quality and pricing.However,China's pharmaceutical and biotechnology industry will continue to face challenges in pricing and reimbursement,as well as a shortened product lifecycle with rapid price erosion.The government has already accelerated the timeline for updating the drug reimbursement list and is willing to create a high-quality medical insurance program.However,some obstacles are hard to overcome,including reimbursement for advanced therapies,limited funding and an increasing burden of disease due to an aging population.This article reviews the trajectory of medical innovation in China,including the challenges.Looking forward,balancing affordability and innovation will be critical for China to continue the trajectory of growth.The article also offers some suggestions for future policy reform,including optimizing reimbursement efficiency with a focus on highquality solutions,enhancing the value assessment framework,payer repositioning from“value buyer”to“strategic buyer”,and developing alternative market access pathways for innovative drugs.展开更多
Background Trastuzumab,a monoclonal antibody for breast cancer,faces global accessibility challenges,primarily due to high costs.This study examines how changes in medical insurance policies and price adjustments infl...Background Trastuzumab,a monoclonal antibody for breast cancer,faces global accessibility challenges,primarily due to high costs.This study examines how changes in medical insurance policies and price adjustments influence Trastuzumab utilization in China,focusing on implementation challenges and their impact on drug accessibility and affordability.Methods This retrospective study investigated Trastuzumab utilization among HER2-positive breast cancer patients at a tertiary hospital from May 2013 to December 2022 in JX,a prefecture-level city in eastern China.Patients were stratified based on their CerbB2 indicator,because those with a 2+CerbB2 status require further FISH testing to con-firm Trastuzumab eligibility.We analyzed the utilization rates of both FISH test and Trastuzumab using logistic regres-sions,identifying factors that influence their usage.Results 766 patients were included.The utilization rate of Trastuzumab among patients with CerbB23+rose from 40.40 to 77.94%in September 2017 following the expansion of insurance coverage,and further increased to 90.41%after a price reduction in 2020.The FISH test was not covered by health insurance,and it was not avail-able in the local hospital until Trastuzumab became available in JX city.For patients with CerbB22+,the proportion undergoing the FISH test increased dramatically from 8.89 to 82.08%after the price reduction in 2020.The mere inclu-sion into basic medical insurance,regardless of insurance types,significantly increased the utilization of Trastuzumab and the FISH test.However,rural patients in JX city are still facing financial burdens with Trastuzumab’s out-of-pocket cost accounting for 62.9%of their annual disposable income in 2020.Conclusions Our findings indicate that insurance coverage and price reduction significantly increased Trastu-zumab utilization.However,failure to improve the accessibility of the FISH test can pose challenges in enhancing the uptake of Trastuzumab among eligible patients.With the expiration of Trastuzumab’s patent and the development of affordable biosimilars,there are now greater opportunities to enhance treatment access globally.These insights can inform policy makers of implementation guidance about providing financial support for breast cancer patients in other LMICs.展开更多
目的通过评估我国公开发表的医保预算影响分析(BIA)研究文献,探讨我国医保BIA研究预测的准确性,并分析其影响因素,以期为我国医保决策提供参考。方法通过PubMed、Web of Science、CNKI、万方和维普等数据库检索BIA研究的相关文献,使用...目的通过评估我国公开发表的医保预算影响分析(BIA)研究文献,探讨我国医保BIA研究预测的准确性,并分析其影响因素,以期为我国医保决策提供参考。方法通过PubMed、Web of Science、CNKI、万方和维普等数据库检索BIA研究的相关文献,使用医保预算影响分析质量评估量表对纳入研究的文献质量进行定量评估,准确性分析指标为药品销售金额预测值与其实际值的比值,使用t检验进行单因素分析、多重线性回归进行多因素分析。结果最终纳入11篇文献,文献评估得分为0.7503±0.0309。共有24项数据纳入分析,单因素分析结果显示文献评分对BIA预测准确性差异有统计学意义(P<0.05),多因素分析显示BIA预测准确性受到文献评分、年均/疗程药品成本的影响(F=7.844,P<0.05)。结论我国医保BIA相关文献质量总体较好,但在数据引用、分析内容与结果呈现等方面仍存在一定问题;研究预测结果的准确性存在欠缺,预测值普遍高于实际值。建议提高对医保BIA研究质量的重视程度,加强医保BIA准确性的相关研究。展开更多
文摘Objective To study the influencing factors in the process of national medical insurance negotiation and drug pricing from the dualistic equilibrium perspective,and to provide reference for the harmonious management of drug pricing in China.Methods Through the literature analysis and policy review,the pricing subject,pricing basis and price control system in the pricing process of medical-accessed medicines were analyzed from the perspective of binary equilibrium and harmonious management.Results and Conclusion It is found that four balances in the drug pricing process,two balances in pricing basis and three balances in price control system need to be considered,respectively.Drug pricing is the key content of national medical insurance access,which is also the hotspot of the policy in the pharmaceutical fields in recent years.Drug pricing not only reflects the value of drugs,but also reflects a lot of top-level designs of binary equilibriums in medical insurance policy.While the rational design of drug pricing requires the joint efforts of the government,pharmaceutical companies and relevant experts to comprehensively consider many equilibriums,so as to improve the relevant systems.
文摘The China Basic Medical Insurance Program was created in 1999 with three objectives:equal accessibility,affordability,and quality.Today,it has become the biggest medical insurance program in the world,covering 95%of China's population.Since 2015,China's healthcare ecosystem has been reshaped by increasing innovation,which has in turn been driven by regulatory reform,enhancement of research and development capability,and capital market development.There has also been improved regulatory efficiency to reduce lags in launching drugs.In 2022,nearly 20%of novel active substances launched globally were from China.China has also risen to become the second biggest contributor to innovation in terms of pipelines.Using a“fast-follow”strategy,many locally developed innovative drugs can compete with products from multinational companies in their quality and pricing.However,China's pharmaceutical and biotechnology industry will continue to face challenges in pricing and reimbursement,as well as a shortened product lifecycle with rapid price erosion.The government has already accelerated the timeline for updating the drug reimbursement list and is willing to create a high-quality medical insurance program.However,some obstacles are hard to overcome,including reimbursement for advanced therapies,limited funding and an increasing burden of disease due to an aging population.This article reviews the trajectory of medical innovation in China,including the challenges.Looking forward,balancing affordability and innovation will be critical for China to continue the trajectory of growth.The article also offers some suggestions for future policy reform,including optimizing reimbursement efficiency with a focus on highquality solutions,enhancing the value assessment framework,payer repositioning from“value buyer”to“strategic buyer”,and developing alternative market access pathways for innovative drugs.
基金The research results of this article(or publication)are sponsored by the Kunshan Municipal Government(23KKSGR015)research funding.
文摘Background Trastuzumab,a monoclonal antibody for breast cancer,faces global accessibility challenges,primarily due to high costs.This study examines how changes in medical insurance policies and price adjustments influence Trastuzumab utilization in China,focusing on implementation challenges and their impact on drug accessibility and affordability.Methods This retrospective study investigated Trastuzumab utilization among HER2-positive breast cancer patients at a tertiary hospital from May 2013 to December 2022 in JX,a prefecture-level city in eastern China.Patients were stratified based on their CerbB2 indicator,because those with a 2+CerbB2 status require further FISH testing to con-firm Trastuzumab eligibility.We analyzed the utilization rates of both FISH test and Trastuzumab using logistic regres-sions,identifying factors that influence their usage.Results 766 patients were included.The utilization rate of Trastuzumab among patients with CerbB23+rose from 40.40 to 77.94%in September 2017 following the expansion of insurance coverage,and further increased to 90.41%after a price reduction in 2020.The FISH test was not covered by health insurance,and it was not avail-able in the local hospital until Trastuzumab became available in JX city.For patients with CerbB22+,the proportion undergoing the FISH test increased dramatically from 8.89 to 82.08%after the price reduction in 2020.The mere inclu-sion into basic medical insurance,regardless of insurance types,significantly increased the utilization of Trastuzumab and the FISH test.However,rural patients in JX city are still facing financial burdens with Trastuzumab’s out-of-pocket cost accounting for 62.9%of their annual disposable income in 2020.Conclusions Our findings indicate that insurance coverage and price reduction significantly increased Trastu-zumab utilization.However,failure to improve the accessibility of the FISH test can pose challenges in enhancing the uptake of Trastuzumab among eligible patients.With the expiration of Trastuzumab’s patent and the development of affordable biosimilars,there are now greater opportunities to enhance treatment access globally.These insights can inform policy makers of implementation guidance about providing financial support for breast cancer patients in other LMICs.
文摘目的通过评估我国公开发表的医保预算影响分析(BIA)研究文献,探讨我国医保BIA研究预测的准确性,并分析其影响因素,以期为我国医保决策提供参考。方法通过PubMed、Web of Science、CNKI、万方和维普等数据库检索BIA研究的相关文献,使用医保预算影响分析质量评估量表对纳入研究的文献质量进行定量评估,准确性分析指标为药品销售金额预测值与其实际值的比值,使用t检验进行单因素分析、多重线性回归进行多因素分析。结果最终纳入11篇文献,文献评估得分为0.7503±0.0309。共有24项数据纳入分析,单因素分析结果显示文献评分对BIA预测准确性差异有统计学意义(P<0.05),多因素分析显示BIA预测准确性受到文献评分、年均/疗程药品成本的影响(F=7.844,P<0.05)。结论我国医保BIA相关文献质量总体较好,但在数据引用、分析内容与结果呈现等方面仍存在一定问题;研究预测结果的准确性存在欠缺,预测值普遍高于实际值。建议提高对医保BIA研究质量的重视程度,加强医保BIA准确性的相关研究。
