The Health Technology Assessment And Management For The Different Stages Of Health Technology In China

Health technology includes health-care drugs, equipments, procedures of internal medicine & surgical and the relevant management system and logistic support system. The development process of Health technology involves the development stage, the acceptance stage, and application stage and obsolete period. The management of Health technology need go through the whole development process of health technology to increase the capacity of health technology for disease prevention and treatment and reduce the negative impact of health technology.With the objective needs of effective technology to deal with the population aging, the demand of chronic disease and the revolution of modern science and technology in twentieth Century, new health technologies come out one after the other and shorten the duration of replacement.For setting up the first barrier for the risk of new technolog, we need the technology accessment before the new technology is used or use widespread. But the systematic assessment of new technology is still in its early stage in China. If we need implement timely and systematically, the first step about new health technology assessment is horizontal scanningfor understanding what health new technology need to be evaluated.In the application phase of health technology are the most widely applied.With safety and effectiveness assessment, it is very importance to conduct the health economic evaluation under the background of building of health universal insurance in China. "The guideline of pharmacoeconomics in China " released In the early 2011, which means the new stage for the economic evaluation of health technologies in China. After the development for 15 years, the availability of data for health economics research becomes the motive force of improving the quality of research. The new technology emerges in an endless stream means many original technologies is possible to be replaced. By scanning new technology and evaluating of existing technology, we can eliminated the health technology with poor safety, effectiveness and economy to guarantee the patients with the safe, effectiveness, cost-effectiveness health technology.It is the three stages-- active management of the new technology, effective management of the existing technology and reasonable elimination of the obesolate technology to guarantee the patients with the safe, effectiveness, cost-effectiveness health technology. The overall technology management for different stages of the technology will guarantee the safety use of health technology. This research will focus on the case study in the new direction and methodology within the three stages.Objective:This study focus on the case studies with the key points or empty area of the assessment and management of the three stages. With the experience and learning of case studies, the feasibility of new approaches and the proposal for the management of the technology has been studied for the completation of the technology management.Through the case study of horizon scanning for the biotechnology in China, the feasibility of horizon scanning for the new technology will be studied for the reference of future assessment and management of new technology. A study for disease burden of stroke explores the availability and feasibility of data for economic evaluation with the new approaches; A study on the assessment of the intravascular low intensity laser irradiation technology will provide the experience for the technology assessment of obsolete technology and proposal for the management of obsolete technology.Research frameworkThis research is divided into three parts, respectively, through case study to explore the application of horizontal scanning for the new technology, the data availability of the health economics evaluation for the existing technology and methodology and framework for the technology assessment of obsolete technology. (Fig 1) in the three studies, using horizon scanning for the biotechnology, stroke disease burden and intravascular low intensity laser irradiation technology as of three empirical studies to help explore these three areas of research new methods/framework. The specific research contents and methods of the research could be found in the subpart of the research paper. Fig 1 research frameworkPart 1 the feasibility of implementing horizon scanning of new technology in China Technology development, technology quantity and the public about the demand of new technology rise, increasing calls for accelerated on emerging technologies for decision making. Biological technology, nuclear technology and computer technology are known as twentieth Century three technical revolution. Biological technology the rapid development of the area, on the future of health care effect, at the same time, because of its advanced nature and ethics of technology management requirements are relatively high, the field of biotechnology horizontal scanning for our health new technology horizontal scanning provide empirical research experience. This research aims to biotechnology horizontal scanning as an case study, by focusing on technology selection, priority attention to technology use and policy environment evaluation for the health of new technology of horizontal scanning accumulation of empirical research experience, so as to the health of new technology of horizontal scanning in China provide the basis for the feasibility.Research content and framework:According to three steps research route early detection, produce prediction and development policy, evaluate the new priority health technology in biological technology by colligating many-sided information on its acceptability and utilizing environment. In order to accumulate experience and provide reference for future technology management and the implementation of horizon scan. Research methods include 1) literature retrieval and tracing; 2) expert consultation; and 3) drug application status analysis.The results of horizontal scanning show that 1) literature tracing, patents and network information indicate that vaccine, stem cells and monoclonal antibody are the focus of the biotechnology development in recent years; 2) the forecast of China Ministry of science and technology and Torch Program etc. show that the direction of biopharmaceutical including targeted therapy consists with vaccine and monoclonal antibody in literature tracing; 3) experts believe that biopharmaceutical is more feasible and important than stem cell therapy or tissue microarray in application; 4) analysis of biological industry reveal that biopharmaceutical is the vanguard of biotechnology entering into clinical practice. Thus biopharmaceutical is considered as a techneque need priority assessment.Biotechnology Pharmaceuticals has 8 categories including hormones, growth factors, cytokines, monoclonal antibodies, vaccines, blood products, nucleic acid products and tissue engineering products. Biotechnology Pharmaceuticals is quiet different from common small molecular chemicals in the physical and chemical properties, immunological and toxicological properties, metabolic processes, formulation etc. Recently, the priority development of international new biotechnology Pharmaceuticals has five types:monoclonal antibodies, antisense gene drugs, gene therapy agent, soluble therapeutic protein drugs and vaccines. The number of new biologic drug United States FDA approved annually remained stable in 1996-2006; until the end of 2005, there are 18 kinds of approved gene engineering vaccines and drugs in our country,3 kinds of which having independent intellectual property rights is the class I drugs, including 8 kind of world top ten biotech drugs and the world's first gene therapy drug.According to analyzing biotechnology drug sales in a drug utilizing database in 2004-2007 and four kinds of biopharmaceuticals, the results show that these new technology is accepted quickly. Biological pharmaceutical policy environment assessment shows that government attitude on biopharmaceutical research and application is encouraging and acceptable, the formulation of laws and regulations has some foundation, and health technology managers and users has considerable enthusiasm on the new technology. Through the horizontal scanning, the policy environment assessment and the utilizing assessment provide experience and direction to biopharmaceutical assessment and management in China; and also assess the feasibility of utilizing a foreign methodology of new technology horizontal scanning in China.PartⅡThe availability of health economics data in health technology assessment of existing technologyAfter the publishcation of the guidelines of pharmacoeconomic in 2011 which could provide methodological direction and guidance for high-quality designed health economics evaluation, the availability of necessary health economics data becomes the guarantee and important premise for health economics evaluation quality. In this part, stroke disease burden research will be given as an example to discuss the availability of stroke economics evaluation data in China.In China stroke has surpassed cardiovascular disease and becomes the first cause of death. The characteristics of stroke cost are including multiple acute attack costs, secondary prevention costs and disability costs, and the subsequent cost is relatively higher. In China, average hospitalization expense rather than the total cost in the disease course of individual patient is generally used for calculating in stroke disease burden researches because of the limitation of data, and the nationwide number of stroke patients vary greatly in different researches, thus the estimated stoke disease burden also vary greatly. In this research collecting of stroke disease burden intends to be an empirical research case, cost data collected in different ways will be use to calculate the stroke disease economic burden to consider the feasibility, superiors and inferiors between different data collection ways, in order to provide evidence for further relevant studies. The research methods include epidemiological data systematic review, cost information data mining in related database and the registration accompanied prospective cost data collection.The epidemiology systemic reviews are relatively new and challenging field, through which shows that in China the incidence of stroke is in 43.5～629/100,000 person year, the prevalence is in 0.79%～7.73%, the mortality is at 71.56～117.2/100,000. Considering uneven quality of epidemiological studies and diversity of epidemiological data, a systematic review can help to concentrate epidemiological data range relatively by selecting the unbiased data of same standard according to uniform criteria which benefits to application of epidemiologic data in the health economics.Database mining result shows that it is feasible to obtain hospitalization costs and inventory of stroke patients through electronic databases in tertiary hospitals and community health service centers, while it is troublesome in the outpatient data for non-standard diagnosis information. The greatest difficulty in process of data mining is lack of effective support from a integrity database, mainly from the following aspects:1) Mismatch between different hospital information systems. Information from different hospital system cannot be superimposed directly for their respective setting factors, which increased the difficulty of collecting data. And there is great difference of the electronic information system between community health service centers and tertiary hospitals.2) Impossibility of collecting disease cost data of outpatient as the diagnosis information is unrequited to input into the outpatient electronic information system in two hospitals.3) In China patients may visit in different hospitals without an integrity database like the United States of America, which affect quality and efficiency of health economics research by data mining.Accompanied cost data collection, based on hospital multi-center stroke registry, is prospective and following-up whole course cost collection compared with simple inpatient cost collection. As a systematic method of cohort study, it is a clinical research method lying between traditional systematic case analysis study and population based study. In this research we found that this method is less cost and more efficient, mainly saves the time of patient enrollment. But we also found a common problem in the prospective study that the follow-up rate is low.Part III Management of obsolete health technology ---with Intravascular Low Intensity Laser Irradiation therapy as an exampleEliminating health technology refers to any health technology in use for one or more indications, whose clinical benefit, safety or cost-effectiveness has been significantly superseded by other available alternatives. In China there is little case about health technology obsoleted through official channels, and there is also lack of researches on how to determine the elimination of health technology and how to eliminate the health technology by health technology assessment in academic circles. In this part intravascular low intensity laser irradiation therapy (ILLLI) is took as an example. The effectiveness and safety of ILLLI are estimated by systematically reviewing the published literature both domestic and foreign about the safety and efficacy of ILLLI, and combining with the technical management experience, the theoretical management framework of eliminating health technology assessment will be proposed. Research methods are systematic review and expert consultation.The results of systematic review show that the mechanism of ILLLI is unclear and the indications are uncertain; although there are a large number of clinical study literatures, high quality research is still lack to confirm the efficacy and safety of ILLLI. There are many key problems need to solve on how to use of this technique correctly and normative. Besides indeterminacy of the effect, there is also indeterminacy of the indications and technical standards, thus brings a certain degree of clinical abuse. The framework of obsoleting health technology assessment is proposed based on the ILLLI researching experience. The identification of the health technology need to be obsoleted is to and establish obsoleted technology supervising network by experts feedback based on clinicians and researchers network; expert and research group draft out indicator system of obsolete health technology to determine priority assessment, including nine indicators related to disease status, effectiveness, safety, economic and so on; assess available evidence of the health technology by reviewing existing evidence systematically, and understand clinical use by experience of clinical experts, it is feasible to provide evidence for decision-making in the stage.