A systematic review on reporting quality of economic evaluations for negotiated glucose-lowering drugs in China national reimbursement drug list.

BACKGROUND: This study aimed to examine the reporting quality of existing economic evaluations for negotiated glucose-lowering drugs (GLDs) included in China National Reimbursement Drug List (NRDL) using the Consolidated Health Economic Evaluation Reporting Standards 2013 (CHEERS 2013). METHODS: We performed a systematic literature research through 7 databases to identify published economic evaluations for GLDs included in the China NRDL up to March 2021. Reporting quality of identified studies was assessed by two independent reviewers based on the CHEERS checklist. The Kruskal-Wallis test and Mann-Whitney U test were performed to examine the association between reporting quality and characteristics of the identified studies. RESULTS: We have identified 24 studies, which evaluated six GLDs types. The average score rate of the included studies was 77.41% (SD:13.23%, Range 47.62%-91.67%). Among all the required reporting items, characterizing heterogeneity (score rate = 4.17%) was the least satisfied item. Among six parts of CHEERS, results part scored least at 0.55 (score rate = 54.79%) because of the incompleteness of characterizing uncertainty. Results from the Kruskal-Wallis test and Mann-Whitney U test showed that model choice, journal type, type of economic evaluations, and study perspective were associated with the reporting quality of the studies. CONCLUSIONS: There remains room to improve the reporting quality of economic evaluations for GLDs in NRDL. Checklists such as CHEERS should be widely used to improve the reporting quality of economic researches in China.

Insights from Japan’s cost-effectiveness analysis policy on pricing for China’s NRDL access / 中国药房

The cost-effectiveness analysis policy for drugs was institutionalized in Japan since 2019， realizing quantitative adjustment of price across varieties. A hierarchical categorization approach was adopted to select medicines with high expected annual sales. For selected medicines， adjustments were made to the premium and profit components within the existing price structure based on a pre-defined incremental cost-effectiveness ratio （ICER） threshold， effectively resolving the issue of inconsistent criteria and magnitudes caused by subjective judgment. Meanwhile， incentive measures like evaluation exemption or threshold enhancement were granted for specific medicines. Besides， a price adjustment mechanism， which was allowed for upward and downward adjustments， involving tiered ICER threshold and quantified formulas， had been established for the premium and profit components of drug price. In China’s National Reimbursement Drug List （NRDL） access， certain issues remained to be addressed： insufficient clarity in the quantitative mechanism of price formation， incomplete price adjustment measures， and lagging in the communication channels. It is recommended that the following measures could be referred to when further improving the scientificity and fairness of drug pricing during China’s NRDL access， such as enhancing the ICER threshold for medicines catering to special populations， quantifying criteria and extents for price adjustment， granting preferential pricing policies to pharmaceutical companies that present high-quality evidence of effectiveness， preceding communication channels with pharmaceutical companies， as well as exploring a price floor mechanism for the drugs with excessive price reduction.

Access to innovative drugs and the National Reimbursement Drug List in China: Changing dynamics and future trends in pricing and reimbursement.

BACKGROUND AND OBJECTIVES: Multiple reforms aimed at improving the Chinese population's health have been introduced in recent years, including several designed to improve access to innovative drugs. We sought to review current factors affecting access to innovative drugs in China and to anticipate future trends. METHODS: Targeted reviews of published literature and statistics on the Chinese healthcare system, medical insurance and reimbursement processes were conducted, as well as interviews with five Chinese experts involved in the reimbursement of innovative drugs. RESULTS: Drug reimbursement in China is becoming increasingly centralized due to the removal of provincial pathways, the establishment of the National Healthcare Security Administration and the implementation of the National Reimbursement Drug List (NRDL), which is now the main route for drug reimbursement in China. There is also an increasing number of other channels via which patients may access innovative treatments, including various types of commercial insurance and special access. Health technology assessment (HTA) and health economic evidence are becoming pivotal elements of the NRDL decision-making process. Alongside the optimization of HTA decision making, innovative risk-sharing agreements are anticipated to be increasingly leveraged in the future to optimize access to highly specialized technologies and encourage innovation while safeguarding limited healthcare funds. CONCLUSIONS: Drug public reimbursement in China continues to align more closely with approaches widely used in Europe in terms of HTA, health economics and pricing. Centralization of decision-making processes for public reimbursement of innovative drugs allows consistency in assessment and access, which optimizes the improvement of the Chinese population's health.

Health Technology Assessment in China's Health Care Sector: Development and Applications.

China's health system is facing severe challenges from social transition and the double burden of population aging and non-communicable diseases. Addressing the tension between the public's increasing demand for health services and the limited availability of medical resources has become a critical issue for health care policymakers and medical insurance fund administrators. In promoting its medical insurance system reform, China is actively developing health technology assessment (HTA) with principles and applications adapted to the Chinese context. This study aims to analyze the evolution of HTA in China with a focus on context, actors, process, content, and challenges encountered through applying a modified verson of Walt and Gilson's policy triangle framework. Currently, HTA plays an indispensable part in the reform of China's health care and medical insurance system, especially in the formulation and adjustment of the National Reimbursement Drug List (NRDL). While HTA is increasingly used in China, there remain challenges, such as the slow development of HTA related disciplines, lack of an independent national HTA authority, and limited scope in the use of HTA. Despite the identified challenges, HTA has the potential to support a wide range of applications in China's health care sector, building on the progress achieved over the last three decades.

Impact of the National Reimbursement Drug List Negotiation Policy on Accessibility of Anticancer Drugs in China: An Interrupted Time Series Study.

Objective: Since 2016, the Chinese government has been regularly implementing the National Reimbursement Drug List Negotiation (NRDLN) to improve the accessibility of drugs. In the second round of NRDLN in July 2017, 18 anticancer drugs were included. This study analyzed the impact of the NRDLN on the accessibility of these 18 anticancer drugs in China. Methods: National hospital procurement data were collected from 2015 to 2019. As measurements of drug accessibility, monthly average of drug availability or defined daily dose cost (DDDc) was calculated. Interrupted time series (ITS) analysis was employed to evaluate the impact of NRDLN on drug accessibility. Multilevel growth curve models were estimated for different drug categories, regions or levels of hospitals. Results: The overall availability of 18 anticancer drugs increased from about 10.5% in 2015 to slightly over 30% in 2019. The average DDDc dropped from 527.93 CNY in 2015 to 401.87 CNY in 2019, with a reduction of 23.88%. The implementation of NRDLN was associated with higher availability and lower costs for all 18 anticancer drugs. We found an increasing level in monthly drug availability (ß2 = 2.1126), which ascended more sharply after the implementation of NRDLN (ß3 = 0.3656). There was a decreasing level in DDDc before July 2017 (ß2 = -108.7213), together with a significant decline in the slope associated with the implementation of NRDLN (ß3 = -4.8332). Compared to Traditional Chinese Medicines, the availability of Western Medicines was higher and increased at a higher rate (ß3 = 0.4165 vs. 0.1108). Drug availability experienced a larger instant and slope increase in western China compared to other regions, and in secondary hospitals than tertiary hospitals. Nevertheless, regional and hospital-level difference in the effect of NRDLN on DDDc were less evident. Conclusion: The implementation of NRDLN improves the availability and reduces the cost of some anticancer drugs in China. It contributes to promoting accessibility of anticancer drugs, as well as relieving regional or hospital-level disparities. However, there are still challenges to benefit more patients sufficiently and equally. It requires more policy efforts and collaborative policy combination.

Policy Updates on Access to and Affordability of Innovative Medicines in China.

INTRODUCTION: In China, efforts to qualify innovative medical products for reimbursement used to be subject to substantial delays after regulatory approval due to fiscal and bureaucratic barriers. In this review, we surveyed the Chinese government's most recent initiatives to improve access to innovative medicines from both the regulatory and the reimbursement aspects, which not only accelerated the launching of drugs in the Chinese market but also expanded the reimbursement coverage of such products. We also provided a discussion of the current challenges. AREAS COVERED: We provided a comprehensive review of the updates in China's national reimbursement listing policies of medicines. EXPERT OPINION: As the most recognized regulatory shortcuts, priority and conditional approvals have expedited the authorization of many innovative medicines. In addition, the national negotiation process was institutionalized to enable timely access to innovative medicines through the National Reimbursement Drug List, leading examples of which were new anticancer drugs. Other impactful reimbursement policies in recent years included dynamic updates of the National Reimbursement Drug List, manufacturer-initiated reimbursement coverage applications, and parallel fund robustness tests and pharmacoeconomic analyses for price estimation. Recent administrative efforts have substantially improved the access to and affordability of innovative medicines in China. Nevertheless, standardized and transparent evidence appraisal processes need to be established for informed decision making in the future.

Attention Situation of Chinese Patent Medicine for Constipation in Traditional Chinese Medicine Diagnosis and Treatment Guidelines/Consensus and National Reimbursement Drug List / 中国实验方剂学杂志

ObjectiveTo evaluate the methodological quality of traditional Chinese medicine （TCM） diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ）tool， and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI，VIP，Wanfang Data，SinoMed，PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then，the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare （RIGHT） Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included，involving 794 experts. The scores of AGREE II were clarity of presentation（59.0%），scope and purpose（44.0%），stakeholder involvement（23.1%），rigor of development （12.1%），applicability （11.1%），and editorial independence （8.3%） from high to low. Five articles were recommended at B level（recommended after revision） and 8 articles were at C level （not recommended）. The average scores of RIGHT Statement were as follows：basic information （93.59%），background （57.69%），evidence （18.46%），recommendations （20.88%），review and quality assurance （19.23%），funding，declaration and management of interests （0.00%）， and other information （0.00%）. The included guidelines/consensus recommended a total of 27 Chinese patent medicines，among which 20 were included in the National Reimbursement Drug List，with 4 species of Class A and 16 species of Class B， accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus，accounting for 50% of all purgative drugs， and 8 were not recommended. There were prescriptions for purgation， for promoting digestion and removing food stagnation， for clearing heat and purging fire，and for warming the middle and dissipating cold，Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment，the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover，the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However， the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.

Progress on drug pricing negotiations in China.

On November 28th, 2019, the National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security (MOHRSS) of China announced the results of drug pricing negotiations. Seventy first-negotiated drugs with 60.7% average price decrease and twenty-seven re-negotiated medicines with 26.4% average price fall, involving 11 disease categories, were successfully incorporated into National Reimbursement Drug List (NRDL). Medicines that successfully get accessed to NRDL are mostly new listings with high clinical value, and more than half of them are manufactured by Chinese enterprises. Compared to the negotiated drug list of 2017, the biggest increase in western medicines is the digestive system medications (10 drugs added), and the traditional Chinese medicine is internal medicine (17 drugs added). The negotiation follows the process including preparation, examination, negotiation, and announcement. There are several innovations in the procedure, such as the parallel calculation of the floor price, the introduction to competitive negotiations, allowing companies to apply for price confidentiality, and increasing government-enterprise communication before negotiations. Incorporating patent drugs into NRDL by negotiation not only helps patients reduce the economic burden, but also encourages pharmaceutical companies to innovate.

Evidence for the effectiveness of anti-hypertensive medicines included on the Chinese National Reimbursement Drug List.

BACKGROUND: Evidence-based decision on drug list or formulary has been applied worldwide. Although the importance of scientific evidence was emphasized, the decision-making procedures for including medicines into the national reimbursement drug list were often challenged by their process opacity and relying on subjective expert opinion. This study aimed to explore and assess the evidence for the effectiveness of anti-hypertensive medicines included on the Chinese National Reimbursement Drug List (NRDL), and to provide recommendations for further improvement. METHODS: Three international evidence-based guidelines were selected to serve as reference criteria. The antihypertensive medicines included in NRDL of Urban Employee Basic Medical Insurance (UEBMI) were compared with recommended drugs in three international guidelines. Medicines recommended by at least two guidelines were considered to have sound evidence support for the effectiveness. Otherwise, published literature with high evidence grade, namely systematic review, meta-analysis and randomized controlled trial (RCT), were searched for further assessment. Medicines reported as fairly good effectiveness by literature with high evidence grade can be also considered having sound evidence for the effectiveness. Methodological quality of systematic review or meta-analysis was evaluated by AMSTAR scale and PRISMA statement. Literature quality of RCTs was assessed by Jadad scale. RESULTS: For the 97 antihypertensive medicines in NRDL, there were sound evidence supports for the effectiveness of 56 kinds of medicines. Specifically, twenty-six of them were supported by international evidence-based guidelines, twenty were supported by systematic review or meta-analysis and the other ten by RCT. However, for the rest 41 medicines, there is insufficient evidence for their effectiveness. CONCLUSIONS: Some antihypertensive medicines in NRDL did not have sufficient evidence for their effectiveness. Further evaluation and revision were required. It is also recommended to standardize decision-making procedures for inclusion of medicines, set up high quality evidence database to timely provide sound evidence, and so on.

Analysis of Medicine Utilization Variation of Inpatient Participated Insurance after Implementing the 2009 Edition of National Reimbursement Drug List / 中国卫生经济

Objective:To understand the impact of adjusting national drug reimbursement list(NDRL) have on the benefits of patient covered by Basic Health Insurance ( BHI ) , medical insurance fund expenditure and specific drug marketing . Methods: Based on the survey data of medical service utilization situation of national inpatients participated BHI, to summarize and analyze the change of drug usage from 2009 to 2011. Results: In 2011, the drug expense of the national inpatient covered by BHI is approximately 132.7 billion yuan, increased by 37% compared to that of 2009; among which, the expense of entry drug accounts for about 76% out of the total drug use. In 2011, new increased expense on drug use is 13.5 billion, which increased to 98% compared to that of 2009. Conclusion:Adjustment of NDRL had little effect on total drug expenses increasing, but lead changes of the drug expense structure; and expense on some new entry drugs increased obviously. The focus of future adjustment of NRDL could gradually transfer from guaranteeing on basic medicine use to the promotion on clinical rational drug use.