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OBJECTIVE To analyze the implementation experience of France’s additional list system for innovative medical products， and to provide reference for China to support medical institutions to use innovative medical products. METHODS Taking France as a case study， using policy analysis method， this paper systematically studied the practice of establishing additional list system to compensate for innovative medical products in France under diagnosis-related group （DRG） payment， including the establishment background， selection procedure and implementation effect. The suggestions were provided on the medical insurance payment methods for innovative medical products in China. RESULTS & CONCLUSIONS The additional list system established a compensation and payment system for innovative medical products with significant clinical efficacy but high treatment cost， covering four stages： application， evaluation， payment and adjustment， which effectively reduced the drug burden on medical institutions， promoted the use of innovative pharmaceutical products by medical institutions， and stimulated the innovation drive of the pharmaceutical industry， but at the same time brought payment pressure to the medical insurance fund. With the rapid spread of our DRG/diagnosis-intervention packet payment reform of China， some regions have also explored the establishment of a compensation and payment mechanism for innovative medical products， but there are still imperfections. We can refer to the implementation experience of the French additional list system and establish an effective compensation and payment system for innovative medical products starting from the establishment of selection criteria， the selection of compensation mode and the implementation of dynamic adjustment.
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OBJECTIVE：To learn from the experience of foreign listed chimeric antigen receptor T lymphocyte （CAR-T） products in signing risk sharing agreements in medical insurance access ，so as to provide references for relevant decisions of medical insurance departments in China. METHODS ：Taking 9 risk sharing agreements of CAR-T products marketed in the United Kingdom，France，Italy and Germany as samples ，the international experience of medical insurance payment of CAR-T products were analyzed from six dimensions ，such as agreement types ，monitoring indicators ，data collection metho ds，agreement periods ， payment conditions and payment methods. Some suggestions were put forward for the medical insurance access of these products in China. RESULTS & CONCLUSIONS ：Four sample countries generally signed risk sharing agreements of medical insurance access （financial agreement and performance-based agreement ）with pharmaceutical enterprises ；the indicators such as progressive disease and progression-free survival were collected by using data collection system or clinical research data ，so as to monitor the efficacy and safety of CAR-T products. The agreement periods and payment conditions were determined according to different agreement types；“medical insurance advance payment ”or“pharmaceutical enterprise advance payment ”combined with “staged payments ” were adopted for risk control. Solving the risk of medical insurance funds caused by “efficacy uncertainty ”is the core issue of CAR-T product access. The induction of risk sharing agreements may be the way to solve this problem ，and the scientific design of the various elements of risk sharing agreements is a prerequisite to ensure that the agreement is operational.
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@#The access negotiations of National Reimbursement Drug List (NRDL) in China from 2017 to 2019 effectively improved the availability and affordability of high-value innovative drugs. However,the actual outpatient reimbursement of most negotiated drugs is lower,which affects the patients" health insurance funds. In this paper,97 negotiated drugs in 337 overall planning cities were selected as samples to analyze the outpatient reimbursement for negotiated drugs. The results showed that the reimbursement level of 40 negotiated drugs was less than 50% in over 70% cities,which can be mainly interpreted as absence or imperfection of outpatient reimbursement policies for special diseases. Finally,this paper puts forward suggestions and protocols for improving the outpatient medical insurance through realizing outpatient overall planning,improving outpatient reimbursement policies for special diseases,and exploring innovative payment,ensuring the achievement of the access to NRDL.
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In the process of deepening the reform of the medical and health system, purchasing process as an important link to control health care costs, has an important influence on the formation of drugs and medical consumables value chain. Compared with drugs, medical consumables have the characteristics of complex and diverse models, varieties, manufacturers, etc. So the purchasing system of medical consumables is urgently needed to establish and standardize the procurement. This paper, regarding the classification of procurement as the research object, analyzes the necessity of material classification, and referring to the typical medical consumables purchase mode, probes the existing problem and puts forward some suggestions and solutions to improve the classification system of medical consumables.
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China , Commerce , Equipment and Supplies , EconomicsABSTRACT
It aimed to analyze the price disclosure system of genetic drugs in Australia.Based on the analysis of background and historical evolution,it tracked each step of price disclosure on the basis of descriptive statistics and analvsis so as to provide reterences for constructing the price disclosure system of genetic drugs led by market factor under the effective conduct of future medical reform policy in China.
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OBJECTIVE:To study the legislative evolution and causes of biologics data protection system in the United States, and provide reference for designing biologics data protection system in China. METHODS:Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS & CONCLUSIONS:After legislative discussion evolu-tion and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world's firststrong protectionstandard of biologics data protection system,and determined the 12-year data protection period. The legisla-tive basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Cur-rently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the ba-sis of establishing data protection system.
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In the progress of the new healthcare reform, China has carried out a series of reform exploration in the drug distribution system.But fluctuating markups of drugs are still the main cause of high drug price.In order to simplify the distribution procedure, the National Health and Family Planning Commission proposed to encourage the implementation of two-receipt system nationwide.As the important part of the price system of drug circulation, drug distribution system made a great impact on the implementation of two-receipt system policy.Focusing on two provinces namely Fujian and Shaanxi provinces, this paper will discuss the typical drug distribution system in china.This paper has evaluated the main body and operation pattern in the implementation of two-receipt system, and by analyzing the benefits and drawbacks, in the same provinces.It has put forward the optimized distribution mode and provided policy suggestions for strengthening the two-receipt distribution system.
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In 2015 , policy reforms on centralized drug purchasing system have been released one by one , and the quality of medicines has been highly valued .Centralized drug purchasing system distinguishes different qualities of drugs mainly through bidding grouping , in order to achieve “uality priority”.However , there are yet some existing problems in group bidding policy at present , such as lack of a unified hierarchy , no scientific indicators and so on , which inevitably weaken the leading role of centralized purchasing policy over the quality of medicines .This paper , focuses on the study of group bidding , and the existing main problems are found through the statistical analysis of rel-evant policies introduced in different provinces .Finally, it explores some optimization strategies for “Group Bidding”which is of paramount importance .
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@#This paper explores the relevance between data protection system and drug availability through the American lamotrigine(lamictal® )case. Results indicated that drug data protection system delays the marketing of genetics, hinders the pricing regulation of innovative drugs timely and effectively, and affects drug availability severely. With reference to America, it is urgent to design the scope of data protection system reasonably, and set the first generic drug regime and other supporting measures so as to reduce the negative effects of drug data protection system and improve the health benefits of the public.