Clinical development of tumor necrosis factor-alpha inhibitors for ankylosing spondylitis

There is no radical cure for ankylosing spondylitis,a chronic inflammation in joint,till now.Tumor necrosis factor-alpha（TNF-α） inhibitors can block the cascade in inflammatory chain and improve clinical symptom.Among these biological agents,three of them are marketed in China：etanercept,infliximab and adalimumab.Some of the research progresses between 2014 and 2016 are summarized including treatment application,side effects of drugs,and comprehensive research of TNF-α inhibitors.

Status quo of resource allocation of Chinese grass-roots food and drug administrations: from 2011 to 2016

County grass-root food and drug administrations （CGFDA） undertake the front-line supervision of food and drug safety, whose resource allocation is vital to the regulation efficiency and performance. In this article, we aimed to analyze the status quo of resource allocation of CGFDA from the aspects of regulatory organization, staff, funding and equipment using official panel data from 2011 to 2016. The results illustrated that the total amount of regulatory resources of CGFDA was increased annuall y, reaching a rather large scale. However, many problems still existed in its allocation. Therefore, a series of measures should be taken to optimize the resource allocation of CGFDA, such as improving the network of institutional CGFDA, increasing the recruitment requirements on educational level and major, reallocating the structure of resources and guaranteeing the resource demand in less-developed areas.

Stakeholder analysis of clinical trials in China： a structural equation model

Stakeholder analysis was conducted to define stakeholders and their role in clinical trials; a conceptual model and hypotheses regarding the relationship of each stakeholder were then constructed based on pharmaceutical regulations in China and interviews with experts; Amos 17.0 was utilized to test the model and path analysis. We found that government and hospital are the most powerful stakeholders, while the public and sponsor have little impact on clinical trials. Further measures should be taken by sponsors to promote the development of clinical trials, and the public should be more involved in clinical research.

The effects of the National Drug Pooled Procurement(NDPP)pilot program in China

In 2018,the Chinese government identified four municipalities and seven sub-provincial cities for the implementation of the National Drug Pooled Procurement(NDPP)pilot program(the“4+7”policy).In the present study,we analyzed the effects of the“4+7”policy with data of 25 pilot drugs from the National Healthcare Security Administration(NHSA)from the aspects of drug price,volume,and expenditure.After the implementation of the policy,the average price of total and winning drugs was decreased by 54.47%and 73.82%,respectively,while the DDDc of non-winning drugs was decreased by only 1.54%,and the DDDc of uncertificated generic drugs was increased 83.18%.The DDDs indicating the volume of total and winning drugs was increased by 21.18%and 353.98%,respectively,and the DDDs of non-winning drugs was decreased by 61.35%.The costs of total and non-winning drugs were decreased by 44.83%and 61.94%,respectively,and the cost of winning drugs was increased by 18.87%.The“4+7”policy reduced the price and cost of pilot drugs and improved the affordability and accessibility of drugs.However,there were also problems with unexpected excessive price increases of uncertificated generic drugs and relatively high prices of non-winning products.Therefore,we highly suggested promoting the normalization and institutionalization of pooled drug procurement,enhancing the administrative capacity of local procurement platforms,and strengthening monitoring the price of non-winning,especially for the uncertificated generic drugs.

Effects of drug procurement under cap price policy in Sanming

To study the effects of drug procurement under cap price policy (DPUCP)in Sanming,changes in drug category,price, availability and corporate structure were analyzed using purchasing data of the 7th and 8th centralized drug procurement in Fujian Province and the 1st drug procurement under cap price in Sanming,and a field investigation was conducted.(1)The amounts of bid-winning drugs and pharmaceutical makers decreased sharply,leading to optimization of drug category and supplier structure. (2)The procurement could meet clinical demands,though a small percentage of drugs were out of stock.(3)Drug prices fell in general,with 10%decline in domestic drugs with a unit package price over RMB 5yuan,a slight price reduction in imported drugs,and some price increase in cheap domestic drugs with a unit package price under RMB 3yuan.DPUCP policy in Sanming optimized procurement drug category and supplier structure,reduced price,and improved industrial structure.However,problems still existed,such as shortage of some drugs and little price reduction in imported and brand-name drugs.

Effects of drug purchasing under joint price caps policy in Fujian Province,China

To evaluate the long-term effect of Drug Purchasing under Joint Price Caps Policy in Fujian Province on price,prescription volume,medical insurance expense and patient’s burden a total of 59968 reimbursement records,during the period of 2012.1-2018.8,were processed into monthly data and analyzed through interrupted time series(ITS)regression models.The ITS analysis showed that after the implementation of the policy,(1)the price of competitive drugs was significantly increased by 128.9%(P<0.01),while the price of non-competitive drugs was significantly decreased by 18.9%(P<0.01).(2)The prescription volume of sample drugs was decreased by 32.3%(P<0.01),and that of competitive drugs was decreased by 45.9%(P<0.01),while that of non-competitive drugs was increased by 19.1%(P<0.01).(3)There was no significant change in the monthly medical insurance expense per capita of sample drugs.(4)There was no significant effect on the overall patient’s burden,while the out-of-pocket payment per capita of competitive drugs was increased by 81.4%(P<0.01).

Pharmacists’perceptions of generic drugs in China

Perceptions of Chinese pharmacists towards generic drugs were evaluated by a cross-sectional study from Aug.2018 to Dec.2018.Online survey tool Sojump was adopted to release the questionnaires using convenience sampling.A total of 577 questionnaires by pharmacists were analyzed.A meaningful proportion of pharmacists expressed negative perceptions of generic drugs,such as perceiving generics as less effective,less safe and more likely to cause side effects compared to their branded equivalents.Educational campaigns that focus on misperceptions of generic drugs may be necessary.

Analysis of reimbursement policy for outpatient chronic diseases in basic medical insurance for urban residents in China provincial capitals

Reimbursement policy for outpatient chronic diseases is an important part of the basic medical insurance scheme in China. The reimbursement policy for outpatient chronic diseases in basic medical insurance for urban residents of provincial capitals in China were analyzed from the perspectives of disease types, benefits package, qualification and health service access. Proposals to improve policy design, establish standardized disease inclusion criteria and set reasonable benefits package, strengthen management and complete supporting policy, strengthen policy coordination were put forward according the existing problems such as fragmented policy, great difference in disease types and benefit package, supervision difficulty, incomplete policy framework and lack of policy coordination.

Research on the sharing mechanism of drug price information in China-from the perspective of intergovernmental information sharing

Establishment of sharing mechanism for drug price information to guarantee the construction of a unified cross-departmental price information platform is a new national policy after Chinese government abandoned drug price control. Based on the theory of intergovernmental information sharing, this study aimed to investigate the drug price information sharing mechanism in China through literature research and stakeholder interviews, which included institution guarantee mechanism, department coordination mechanism and technical support mechanism.