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Background: Quality measurements in primary healthcare (PHC) have become an essential component for improving diabetes outcomes in many high-income countries. However, little is known about their implementation within the Chinese health-system context and how they are perceived by patients, physicians, and policy-makers. We examined stakeholders' perceptions of quality and performance measurements for primary diabetes care in Shanghai, China, and analyzed facilitators and barriers to implementation. Methods: In-depth interviews with 26 key stakeholders were conducted from 2018 to 2019. Participants were sampled from two hospitals, four community healthcare centers (CHCs), and four institutes involved in regulating CHCs. The Consolidated Framework for Implementation Research (CFIR) guided data analysis. Results: Existing quality measurements were uniformly implemented via a top-down process, with daily monitoring of family doctors' work and pay-for-performance incentives. Barriers included excluding frontline clinicians from indicator planning, a lack of transparent reporting, and a rigid organizational culture with limited bottom-up feedback. Findings under the CFIR construct "organizational incentives" suggested that current pay-for-performance incentives function as a "double-edged sword," increasing family doctors' motivation to excel while creating pressures to "game the system" among some physicians. When considering the CFIR construct "reflecting and evaluating," policy-makers perceived the online evaluation application - which provides daily reports on family doctors' work - to be an essential tool for improving quality; however, this information was not visible to patients. Findings included under the "network and communication" construct showed that specialists support the work of family doctors by providing training and patient consultations in CHCs. Conclusion: The quality of healthcare could be considerably enhanced by involving patients and physicians in decisions on quality measurement. Strengthening hospital-community partnerships can improve the quality of primary care in hospital-centric systems. The case of Shanghai provides compelling policy lessons for other health systems faced with the challenge of improving PHC. [ABSTRACT FROM AUTHOR]

This study aims to systematically review the studies on the cost-effectiveness of stereotactic body radiotherapy (SBRT) in the treatment of non–small-cell lung cancer (NSCLC). A systematic literature search was performed in databases from 2000 through April 2021. The search terms included 'economics,' 'cost,' 'cost effectiveness,' 'SBRT,' and all names for NSCLC. Two reviewers independently screened the titles, abstracts and full texts to determine the studies for the final sample. The quality of the included studies was assessed using the Quality of Health Economic Studies checklist. Eleven studies were identified and included in our final review. SBRT was reported to be a cost-effective (5 of 5) option compared to conventional radiotherapy, radiofrequency ablation, and best supportive care for medically inoperable, early-stage NSCLC. However, the identified studies revealed that no single treatment was found to be more cost-effective than others between SBRT and surgical interventions. The key drivers of this cost-effectiveness were the cost of the treatment, utility value, and the rate of surgical mortality. SBRT may be considered a more cost-effective strategy for medically inoperable, early-stage NSCLC. Considering the limited studies available, more related research should be conducted to further validate these results. [ABSTRACT FROM AUTHOR]

Two intravenous (IV) iron formulations, ferric derisomaltose (FDI) and iron sucrose (IS), are currently available for the treatment of iron deficiency anemia (IDA) in China. Clinical studies have demonstrated that FDI has an improved efficacy and safety profile versus IS, while requiring fewer infusions to correct iron deficits. Based on these findings, the present study evaluated the costs and benefits of FDI and IS for the treatment of IDA, from a healthcare system and societal perspective in China. A patient-level model was developed to project time to hematological response and incidence of cardiovascular adverse events and hypersensitivity reactions (HSRs) associated with FDI and IS over 5 years. Costs included iron acquisition, administration, and adverse event/HSR treatment costs, based on published studies, fee schedules, and a physician survey. Health state utilities associated with adverse events, HSRs, and the number of infusions were obtained from the literature and a time trade-off survey. From a healthcare system perspective, FDI was associated with incremental costs of RMB 1,934 (purchasing power parity USD 462) and incremental quality-adjusted life expectancy of 0.078 quality-adjusted life-years (QALYs) versus IS, yielding an incremental cost-utility ratio of RMB 24,901 (USD 5,949) in the base case scenario. From a societal perspective, FDI was associated with reduced total costs and therefore dominant versus IS. Limitations included the absence of clinical data specific to China and insufficient data to model persistence with treatment. This was the first cost-utility analysis comparing FDI and IS for the treatment of IDA in China. Based on a patient-level model, FDI was found to improve quality of life and reduce administration and adverse events costs relative to IS. Using the 2020 Chinese gross domestic product per capita of RMB 72,447 (USD 17,307) as a cost-effectiveness threshold, FDI would be considered cost-effective in China. Ferric derisomaltose (FDI) was approved in February 2021 for the treatment of iron deficiency anemia (IDA) in China and allows for fast iron correction in one visit with a good safety profile. The current standard of care in China is iron sucrose (IS). Clinical and economic decision-making can benefit from having longer-term projections on the benefits and costs of new medications relative to the current standard of care, which is why we conducted the first cost-utility analysis of FDI and IS for China. We developed a patient-level model that captured the effects of the iron formulations on IDA, in addition to incidences of adverse events and hypersensitivity reactions (HSRs) associated with either formulation. Costs of the iron formulations, their administration, and of treatments for adverse events and HSR were modeled alongside the quality of life effects of IDA, adverse events, HSRs, and iron infusions. We used published clinical data and Chinese cost data to inform our model. Our results show that FDI was associated with higher quality-adjusted life expectancy than IS, regardless of the perspective of the analysis, and higher total costs from the healthcare system perspective. From a societal perspective, FDI was associated with lower costs due to reduced travel and waiting time and smaller productivity losses given there were fewer appointments. These results imply that FDI is likely good value for money for the healthcare system and indeed cost-saving for society relative to IS, which has so far been the most widely used IV iron treatment in China. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the hyperlipidemia prevention programs and policies in different countries and highlight the need of reforming the hyperlipidemia prevention policies in China to lower the growing cardiovascular disease (CVD) risk.Research Design and Methods: PubMed, Google Scholar and Cochrane were searched for global hyperlipidemia prevention policies. Government-funded policies pertaining to lipid management were considered for this review. Only those studies that evaluated the success of prevention policies on the basis of: (i) achievement of hyperlipidemia targets; (ii) improvement in Cardiovascular (CV) risk reduction; and (iii) outcomes with reduction in hyperlipidemia after implementation of the policy, were included.Results: Several global policies and programs aimed to improve CV health by highlighting lipid profile management. Implementation of the global and national policies led to improvement in cholesterol related outcomes such as availability of diagnostic measures, awareness of the risk factors, decrease in cholesterol levels, achieving healthy lifestyle to prevent CVD and improvement in availability of hypolipidemic medications, etc. Statins have been covered under reimbursement policies in many countries to improve usage and thereby preventing incidence of stroke and CVD. We observed a need for introducing new programs in China as the ongoing hyperlipidemia management policies are inadequate. The World Bank Report 2016 recommended that prevention policies in China be modeled on the US Million Hearts program.Conclusions: New hyperlipidemia prevention policies must set a time-bound target, and need to be patient and clinician centric in terms of applications, and revised periodically for long-term benefits. [ABSTRACT FROM AUTHOR]

Introduction: Frailty is one of the greatest challenges facing our aging population, as it can lead to adverse outcomes such as institutionalization, hospitalization, and mortality. However, the factors that are associated with frailty are poorly understood. We performed a systematic review of longitudinal studies in order to identify the sociodemographic, physical, biological, lifestyle-related, and psychological risk or protective factors that are associated with frailty among community-dwelling older adults. Methods: A systematic literature search was conducted in the following databases in order to identify studies that assessed the factors associated with of frailty among community-dwelling older adults: Embase, Medline Ovid, Web of Science, Cochrane, PsychINFO Ovid, CINAHL EBSCOhost, and Google Scholar. Studies were selected if they included a longitudinal design, focused on community-dwelling older adults aged 60 years and older, and used a tool to assess frailty. The methodological quality of each study was assessed using the Quality of Reporting of Observational Longitudinal Research checklist. Results: Twenty-three studies were included. Significant associations were reported between the following types of factors and frailty: sociodemographic factors (7/7 studies), physical factors (5/6 studies), biological factors (5/7 studies), lifestyle factors (11/13 studies), and psychological factors (7/8 studies). Significant sociodemographic factors included older age, ethnic background, neighborhood, and access to private insurance or Medicare; significant physical factors included obesity and activities of daily living (ADL) functional status; significant biological factors included serum uric acid; significant lifestyle factors included a higher Diet Quality Index International (DQI) score, higher fruit/vegetable consumption and higher tertile of all measures of habitual dietary resveratrol exposure; significant psychological factors included depressive symptoms. Conclusions: A broad range of sociodemographic, physical, biological, lifestyle, and psychological factors show a longitudinal association with frailty. These factors should be considered when developing interventions aimed at preventing and/or reducing the burden associated with frailty among community-dwelling older adults. [ABSTRACT FROM AUTHOR]

Over the past fifty years, the health status of the people in China has improved dramatically. The medical system in China, the Cooperative Medical System (CMS), has provided health care to the rural population by means of 'barefoot doctors,' who provide both preventive and curative care. Patients who are seriously ill are referred to communal health centers and, if need be, are then sent to county hospitals, which serve from 200,000 to 600,000 people. However, over the past 10 years, the CMS has been in a decline, both financially and politically. The number of rural Chinese who were covered by the system has declined from 85 percent in 1975, to 40 percent in 1985. There are several possible reasons for the decline including: the lack of money after economic change in China in 1980; the control of the preventable diseases; or political changes. To understand the reasons for the decline, surveys were conducted among the villagers, the barefoot doctors, and the local administrators in three counties, Fengxian, Shanggoa, and Loaan. The three counties ranged in economic status from poor to good. The people and the doctors were found to be satisfied with the health care system. Overall, the CMS was found to be in a good financial state and its use did not decline to the same extent in all areas. In Fengxian, which is a relatively affluent county, the CMS is still prevalent. In areas where the services of the CMS have declined, the health of individuals, as measured by infant mortality, immunization coverage, and the incidence of infectious diseases, has diminished. Villagers now spend more on health care, while less money is available to train the doctors. Therefore, the decline of the CMS is not due to poor medical care, financial problems, lack of accessibility, inadequate facilities, nor to dissatisfactions with the system. It appears that the reason for the decline is because local community leaders thought it was no longer backed by the central government. Local administrators may not want to pay for preventive services unless they are backed by the government. National commitment and community involvement are both necessary for the health care system to be effective. (Consumer Summary produced by Reliance Medical Information, Inc.), Introduction Since 1949, when the People's Republic of China was founded, indices of health in that country have improved dramatically; for example, from 1950 to 1982, the infant mortality rate [...]

Objectives: In 2009, the Chinese government launched a national healthcare reform programme aiming to control healthcare expenditure and increase the quality of care. As part of this programme, a new drug pricing reform was initiated on 1 June 2015. The objective of this study was to describe the changing landscape of drug pricing policy in China and analyse the potential impact of the reform. Methods: The authors conducted thorough research on the drug pricing reform using three Chinese databases (CNKI, Wanfang, and Weipu), Chinese health authority websites, relevant press releases, and pharmaceutical blogs and discussion forums. This research was complemented with qualitative research based on targeted interviews with key Chinese opinion leaders representing the authorities' and prescribers' perspectives. Results: With the current reform, the government has attempted to replace its direct control over the prices of reimbursable drugs with indirect, incentive-driven influence. Although the exact implementation of the reform remains unclear at the moment, the changes introduced so far and the pilot project designs indicate that China is considering adaptation of some form of internal and external reference pricing policies, commonly used in the Organisation for Economic Co-operation and Development countries. Several challenges related to the potential new mechanism were identified: 1) the risk of hospital underfunding, if hospital funding reform is not prioritised; 2) the risk of promoting the use of cheap, low-quality drugs, if a reliable quality control system is not in place and discrepancy between the available drugs is present; 3) the risk of increasing disparity in access to care between poor and rich regions, in case of country-wide price convergence; and 4) the risk of industry underinvestment, resulting in reduced competition, issues with quality and sustainability of supply, and potentially negative social impact. Conclusions: Foreign pricing policies cannot be transferred to China without prioritising historical, cultural, and economic contextualisation. Otherwise, the new policy may be counterproductive and affect the whole healthcare chain, as well as the health outcomes of Chinese patients. [ABSTRACT FROM AUTHOR]

Universal coverage of health services is required to ensure social equity and justice, particularly for China, which is a developing country with an enormous population. Since the 1980s, the Chinese [...]

Objective: To estimate the clinical and economic benefits of memantine treatment initiated in moderate Alzheimer's disease (AD) in China, compared with initiation in severe AD only. Methods: A Markov model with a 5-year time horizon simulated moderate patients' progression through health states. Two groups were compared: patients receiving memantine from the moderate stage (i.e., at model entry), continuing treatment when reaching the severe stage; patients initiating memantine only when they developed severe disease. Results: After 5 years, fewer patients receiving memantine from the moderate stage were severe (49%), dependent (59%) or aggressive (47%) compared with moderate patients who initiated treatment from severe stage only (58, 67 and 55%, respectively). Total cost of care was lower for treatment from moderate stage (67 billion RMB) when compared with treatment from severe stage (73 billion RMB). Conclusions: In China, AD treatment with memantine from the moderate stage could result in substantial cost savings. [ABSTRACT FROM AUTHOR]

Summary Objectives The goal of this study was to provide a comprehensive analysis of the potential health impact of universal vaccination of infants with the 7-valent pneumococcal conjugate vaccine (PCV7) in China. Methods A decision-analytic model designed for pneumococcal disease and outcomes of pneumococcal infection was populated with local age-specific incidence and mortality data to estimate the expected health benefits of vaccinating birth cohorts of approximately 16 million infants per year over a 10-year time horizon in China. The model incorporates both the direct impact on vaccinated children and the indirect effect of herd protection on unvaccinated children and adults. Results The model predicts that more than 16.2 million cases of pneumococcal disease and 709 411 deaths could be prevented in China over the initial 10-year period following the introduction of the PCV7 vaccine. The majority of these health benefits are due to the indirect effectiveness of the vaccine on the unvaccinated population, resulting in approximately 10.8 million cases prevented and 636 371 lives saved over 10 years. Conclusions The results suggest that a policy of universal PCV7 vaccination among infants in China would have a substantial positive public health impact on the population of China. [ABSTRACT FROM AUTHOR]

Purpose: Treatment process attributes can affect health state utilities associated with therapy. For intravenous iron, used to treat iron deficiency and iron deficiency anemia, research into process attributes is still lacking. This study estimated utilities associated with process attributes for intravenous iron infusions., Methods: An online survey including seven health state vignettes and time trade-off tasks was administered to participants, who were not patients living with iron deficiency or iron deficiency anemia, from a Chinese online panel. Vignettes used an identical description of iron deficiency and iron deficiency anemia but differed in the annual number of infusions, infusion duration, and infusion-associated risk of hypophosphatemic osteomalacia. Disutilities and their rate of change as the number of infusions increased were examined using a power model., Results: The survey was completed by 1091 participants. The highest utilities were observed for one annual infusion of 15-30 minutes or 30-60 minutes, without risk of hypophosphatemic osteomalacia (0.754 and 0.746, respectively). In comparison, more infusions and infusions with a risk of hypophosphatemic osteomalacia were associated with lower utilities. Utility continued to decrease, but at a diminishing rate, as the annual number of infusions increased, with utility decrements of 0.006 and 0.002, respectively, when going from zero to one and from four to five infusions per year. All marginal disutilities were small (values <0.01)., Conclusion: This study suggested that treatment attributes of intravenous iron infusions affect health state utilities. Using intravenous iron formulations that allow for fewer and shorter infusions without the risk of hypophosphatemic osteomalacia can reduce the number of visits required and increase patients' quality of life., Competing Interests: SH and DW have received honoraria from Pharmacosmos China for participation in advisory board meetings conducted by Pharmacosmos China. JW and YZ have nothing to disclose. MB is a Managing Partner at Incentive Partners ApS, which received consultancy fees from Pharmacosmos for the development and implementation of the survey. JP is an employee of, and RFP is a director at Covalence Research Ltd., which received consultancy fees from Pharmacosmos for the development of the marginal disutility model and the preparation of this manuscript. The authors report no other conflicts of interest in this work., (© 2023 Hu et al.)

Competing Interests: Competing interests: We have read and understood BMJ’s policy on declaration of interests and have no interests to declare.

A hospital-based health technology assessment (HB-HTA) can provide the evidence needed to inform clinical decisions at the administrative level. With the implementation of a new round of medical and health care system reforms in China, such as the abolition of medical mark-ups, adoption of modern hospital management systems, reform of diagnosis related groups (DRGs) payment, and performance evaluations for public hospitals, medical institutions increasingly need HB-HTA. The development of HB-HTA in China can be divided into three phases: An initiation phase (2005-2014), a preliminary exploratory phase (2015-2017), and a rapid development phase (2018-present). HB-HTA has been used to manage medical consumables, medical devices, and medicines, but there are still problems and challenges in terms of concept recognition, the mode of development, and limited professionals and data. To promote and use HB-HTA in developing countries, we have identifies the development paths and recommendations for implementation based on a case study in China, which can be summarized as follows: enhancing the top-level design of HB-HTA, formulating HB-HTA guidelines, further promoting the main ideas of HB-HTA, concentrating on the training of evaluation personnel, establishing an HB-HTA network and paying attention to the flexibility of HB-HTA in the application process, and multi- stakeholder participation.

Aim: To evaluate the cost-effectiveness of intravitreal aflibercept compared with macular laser photocoagulation and ranibizumab for diabetic macular edema (DME) in China. Methods: A Markov model was developed to reflect the vision changes in DME patients. Parameters were estimated from VIVID-EAST trial data, published literature and physician surveys. Results: In a 20-year horizon, intravitreal aflibercept was associated with 7.825 quality-adjusted life years (QALYs) and 217,841 Chinese Yuan Renminbi (CNY), laser photocoagulation was associated with 7.189 QALYs and 135,489 CNY, and ranibizumab was associated with 7.462 QALYs and 222,477 CNY. The incremental cost-effectiveness ratios were 129,397 CNY/QALY and -12,774 CNY/QALY for intravitreal aflibercept versus laser photocoagulation and ranibizumab, respectively. Conclusion: Intravitreal aflibercept was considered as a cost-effective strategy for DME when compared with laser photocoagulation; it was considered as a dominant strategy when compared with ranibizumab.

China has initiated the special security project for rare diseases from the national strategic level since 2018. Chinese government has formulated China's First List of Rare Diseases (121 diseases included), established Expert Committee of Diagnosis, Treatment and Security of Rare Diseases and China Alliance of Rare Diseases. The government also encouraged all the provinces to include the security plan and strategies of rare diseases into key work and promoted the establishment of rare diseases clinical research center and the formulation of diagnosis and treatment guidelines. All these actions led to the further improvement of scientific research ability and diagnosis and treatment ability. In terms of the treatment drug of the 121 diseases in China's First List of Rare Diseases, 83 of them are on the market in China and 50 have been included in the national medical insurance accompanied with the tax reduction policy on rare diseases drug and several charity foundations and enterprise donation programs were developed so that drug availability and accessibility for patients are increased. However, there is no clear definition and corresponding coding of rare diseases; the economic burden of most rare diseases could not be calculated accurately because of the difficulty in diagnosis and misclassification. Regarding the service provision system, social security system of rare diseases in China needs further improvement because of the rather few kinds of rare diseases involved in the screening, low level of diagnostic ability, rather few rehabilitation programs and the lack of social caring and knowledge training. It is necessary for China to provide comprehensive and well-rounded health care and social caring for rare diseases patients. Since the formulation and implementation conditions of the policy are different among different regions, the pilot should be carried out first in regions with desired qualifications when China is formulating the rare diseases policy and then a mature national plan should be developed.

Objectives: To evaluate the feasibility, discriminant validity and concurrent validity of the Health Status Classification System-Preschool (HSCS-PS) in children aged 3 years in a large community sample in the Netherlands., Design/setting: A prospective population-based cohort in Rotterdam, the Netherlands., Participants: A questionnaire was administrated to a sample of parents of 4546 children (36.7±1.5 months)., Outcome Measures: Health-related quality of life (HRQOL) of children was measured by HSCS-PS. The HSCS-PS consists of 10 original domains. Two single-item measures of 'General health' and 'Behavior' were added. A disability score was calculated by summing up all 10 original domains to describe the overall health status. Feasibility was assessed by the response rate, percentages of missing answers, score distributions and the presence of floor/ceiling effects. Discriminant validity was analysed between subgroups with predefined conditions: low birth weight, preterm birth, wheezing, Ear-Nose-Throat surgical procedures and behaviour problems. In the absence of another HRQOL measure, this study uses the single-items 'General health' and 'Behavior' as a first step to evaluate concurrent validity of the HSCS-PS., Results: Feasibility: response rate was 69%. Ceiling effects were observed in all domains. Discriminant validity: the disability score discriminated clearly between subgroups of children born with a 'very low birth weight', 'very preterm birth', with 'four or more than four times wheezing', 'at least one ear-nose-throat surgical procedures', 'behaviour problems present' and the 'reference' group. Concurrent validity: HSCS-PS domains correlated better with hypothesised parallel additional domains than with other non-hypothesised original domains., Conclusions: This study supports the feasibility and validity of the HSCS-PS among preschoolers in community settings. We recommend developing a utility-based scoring algorithm for the HSCS-PS. Further empirical studies and repeated evaluations in varied populations are recommended., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate the hyperlipidemia prevention programs and policies in different countries and highlight the need of reforming the hyperlipidemia prevention policies in China to lower the growing cardiovascular disease (CVD) risk., Research Design and Methods: PubMed, Google Scholar and Cochrane were searched for global hyperlipidemia prevention policies. Government-funded policies pertaining to lipid management were considered for this review. Only those studies that evaluated the success of prevention policies on the basis of: (i) achievement of hyperlipidemia targets; (ii) improvement in Cardiovascular (CV) risk reduction; and (iii) outcomes with reduction in hyperlipidemia after implementation of the policy, were included., Results: Several global policies and programs aimed to improve CV health by highlighting lipid profile management. Implementation of the global and national policies led to improvement in cholesterol related outcomes such as availability of diagnostic measures, awareness of the risk factors, decrease in cholesterol levels, achieving healthy lifestyle to prevent CVD and improvement in availability of hypolipidemic medications, etc. Statins have been covered under reimbursement policies in many countries to improve usage and thereby preventing incidence of stroke and CVD. We observed a need for introducing new programs in China as the ongoing hyperlipidemia management policies are inadequate. The World Bank Report 2016 recommended that prevention policies in China be modeled on the US Million Hearts program., Conclusions: New hyperlipidemia prevention policies must set a time-bound target, and need to be patient and clinician centric in terms of applications, and revised periodically for long-term benefits.

Background: Eli Lilly and the China Primary Health Care Foundation are currently implementing a patient assistance program (PAP) in China, which allows first-line nonsquamous non-small-cell lung cancer (NSCLC) patients who complete four cycles of pemetrexed induction therapy to receive free, continuous pemetrexed maintenance therapy., Objective: To estimate the cost-effectiveness of pemetrexed maintenance therapy vs basic standard care (BSC) and the economic impacts of providing a PAP for pemetrexed maintenance therapy to NSCLC patients who have completed pemetrexed induction therapy in a Chinese health care setting., Methods: We developed a novel decision-analytic model to evaluate the long-term costs and clinical efficacy of pemetrexed plus BSC vs BSC alone. We utilized a three-state (progression-free survival, progressed disease, and dead) partition survival model for both the clinical and economic aspects of the analysis. Cost and health utility estimates were derived from the literature. We performed a scenario analysis to estimate the real-world impact of introducing the PAP in China by comparing the use of the PAP vs non-PAP. Model uncertainty was evaluated using one-way and multivariate probabilistic sensitivity analysis., Results: Compared to BSC, pemetrexed plus BSC resulted in a gain of 0.22 years of life (95% credible range [CR]: 0.04-0.46) and 0.13 quality-adjusted life years (95% CR: 0.04-0.26) per patient, at an increased cost of $28,105 (95% CR: -$22,720 to $48,646) without a PAP and $3,068 (95% CR: -$1,263 to $9,163) with a PAP. The incremental cost-effectiveness ratio for pemetrexed plus BSC vs BSC alone was cost-prohibitive at $222,700 for non-PAP, but cost-effective at $24,319 with a PAP., Conclusion: Our study suggests that maintenance pemetrexed therapy following pemetrexed induction for patients with advanced NSCLC is likely to be highly non-cost-effective in the absence of a PAP, but the pending implementation of the PAP promises to make it cost-effective, with a >90% probability of cost-effectiveness at a Chinese willingness-to-pay threshold per quality-adjusted life year., Competing Interests: Disclosure BCMW, GFG, and WEF are paid consultants to Lilly Suzhou Pharmaceutical Co., Ltd. QS and JS are employees of Lilly Suzhou Pharmaceutical Co., Ltd. The authors report no other conflicts of interest in this work.

Objectives: To demonstrate the health economic impact of OM-85, a bacterial lysates based immunostimulant, for its approved indications in China., Methods: A cost-effectiveness decision tree model was constructed comparing OM-85 with the best supportive care/placebo therapy for managing the acute exacerbation of chronic bronchitis and rhinosinusitis in the Chinese population. Clinical efficacy and adverse events (AE) data were included in the model based on a thorough literature review. All localized direct treatment costs, including drug cost, AE costs, and medical treatment costs for underlining diseases were included from a Chinese third party payer perspective. A Key Opinion Leaders (KOL) survey was conducted with 20 senior physicians specialized in respiratory, ENT, allergy, and immunology fields from tertiary hospitals in Beijing, Shanghai, Guangzhou, Hangzhou, Shenyang, and Wuhan to validate the local treatment costs. Incremental cost-effectiveness ratio (ICER) was calculated based on the above efficacy and cost information., Results: OM-85 is a cost-effective therapy when compared with placebo (standard care). OM-85 can treat/prevent one additional full episode exacerbation of chronic bronchitis and one additional full episode exacerbation of rhinosinusitis with only additional costs of RMB 653 and RMB 1182.84, respectively. In comparison, each acute exacerbation of chronic bronchitis will cost RMB 4510.10, and each acute exacerbation of rhinosinuisitis will cost RMB 1807.21 in a Chinese clinical management setting. One-way sensitivity analyses were performed and the ICER result was demonstrated to be consistent., Conclusions: OM 85 reduces acute exacerbations among patients with chronic bronchitis and chronic rhinosinusitis when compared with Placebo (standard care). From a Chinese payer perspective, OM 85 is a cost-effective therapy in the clinical management of both chronic bronchitis and rhinosinusitis in the adult population.

Objective: To analyze the achievements, issues and policy recommendations for implementing essential medicine system in China after a 3-year effort., Methods: Policy documents analysis and Literature reviews are conducted., Results: From 2009-2011, a series of national essential medicine (EM) policies has been established which contain EM list, organizing production, quality assurance, pricing, tendering and procurement, distribution, rational use, monitoring and evaluation, etc. About 98.8% government-run primary healthcare institutions and 41.5% village health posts are conducting zero-mark-up policy while buying EMs. The average cost per visit, per admission, and per description in outpatient and inpatient departments has declined. The issues with the national EM list cannot meet the requirements of clinical practice at the local level, all provinces have to increase additional 64-455 EMs in their local supplementary list; the limitation of EML in primary healthcare institutions causes patients to transfer directly to secondary or tertiary hospitals to search appropriate treatment; there is no defined regulation or legislation regarding the responsibility and accountability of government to compensate for the financial loss after implementing a zero mark-up policy in primary healthcare institutions. In the future, some innovative reform should be taken into account, such as revising EML, quality assurance, control margins within the distribution system, differential pricing and internal reference-based pricing, waive taxes and import duties of EMs, and separation between prescribing and dispensing in public hospital reform., Conclusions: Establishing a national essential medicine system is a difficult task to accomplish. The role of the zero-mark-up policy of EMs is to cut off the economic profit chain among different stakeholders. Using pharmaceutical profit to subsidize hospital revenue will be gradually eliminated in China.