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

ABSTRACT: 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.

SUBMITTER: Liu W

PROVIDER: S-EPMC6369556 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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

Liu Wenbin W Shi Lizheng L Sawhney Monika M Gu Xiaoli X Chen Yingyao Y

BMC health services research 20190211 1

<h4>Background</h4>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 Dr ...[more]

PMID: 30744609

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Project description:BACKGROUND:Essential medicines lists and related policies are intended to meet the priority health needs of populations and their implementation is associated with more appropriate use of medicines. The World Health Organization (WHO) recommends that countries carefully select the medicines to be included in their national essential medicines lists. Lists that are used to prioritize access to important treatments should not include medicines that have been withdrawn elsewhere because of an unfavourable benefit-to-harm balance; however, countries still list and use medicines that have been withdrawn worldwide. The objective of this study was to determine whether the national essential medicines lists of 137 countries include medicines that have been withdrawn in other countries. METHODS AND FINDINGS:We performed an audit of national essential medicines lists for medicines that had been withdrawn. Medicines withdrawn from worldwide markets between 1953 and 2014 were identified using a systematic review of published literature and regulatory documents. The reviewers used sources including the WHO's database of drugs, PubMed, and the websites of regulatory agencies to obtain information regarding adverse effects associated with the medicines, the year of first withdrawal, markets of withdrawal, and the level of evidence supporting each withdrawal. We recorded the number of countries with a withdrawn medicine included in their national medicines list, the number of withdrawn medicines included in each nation's list, and the number of national essential medicines including each withdrawn medicine. 97 medicines were withdrawn in at least one country but still included in one more national essential medicines list. Of 137 countries with a national essential medicines list, 136 lists included at least one withdrawn medicine, with 54% of the lists containing 5 or fewer withdrawn medicines, and 27% including 10 or more withdrawn medicines. 11 medicines were withdrawn worldwide but still included on at least one national essential medicines list. Countries with longer essential medicines lists had more withdrawn medicines included in their lists. CONCLUSIONS:This study found that withdrawn medicines are included in all but one national essential medicines list, representing a need for more stringent processes for selecting and removing medicines on these lists. Countries may wish to apply special scrutiny to medicines withdrawn in other nations when selecting medicines to include on their lists.

Project description:Providing universal access to high-cost medications like anticancer drugs is not an easy feat. Although basic medical insurance has covered over 95% of China's population since 2012, reimbursement for high-priced medicines is limited. In 2015, the Chinese government proposed establishing an open and transparent price negotiation mechanism for some patented and expensive drugs, where oncology was among the prioritized areas. In 2016, three drugs (gefitinib, icotinib, and tenofovir disoprox) underwent negotiation with the government, eventually reducing their prices by over 50% so that they could be prioritized during reimbursement processes. Focusing on anticancer medicines, this study comprehensively summarizes the progress in drug price and national reimbursement negotiation in China. Furthermore, we investigated the changes and development regarding negotiated anticancer medicines from quantity negotiated, classification, indication coverage, utilization, and procurement spending. Our findings could provide a reference for follow-up negotiations and reimbursement policies for high-value anticancer medications in other countries. From 2016 to 2021, 82 anticancer medicines were newly incorporated into the national reimbursement drug list (NRDL) via 6 rounds of negotiation. The majority of these were innovative pharmaceutics (ie, protein kinase inhibitors (28) and monoclonal antibodies (13)). Drug pricing and national reimbursement negotiation led to a marked decrease in prices and a sharp increase in the utilization of negotiated anticancer medicines. Following negotiations, the defined daily doses (DDDs) of innovative anticancer medicines experienced remarkable growth. Their proportion in total anticancer drugs DDDs also increased from 3.4% in 2014 to 20.9% in 2019. However, although drug prices decreased substantially after the negotiations, insurance spending still showed an upward trend owing to the significant increase in utilization. This calls for the government to carefully monitor the rational use of these expensive medicines and explore innovative payment models.

Project description:ObjectiveSince 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.MethodsNational 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.ResultsThe 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 (β2 = 2.1126), which ascended more sharply after the implementation of NRDLN (β3 = 0.3656). There was a decreasing level in DDDc before July 2017 (β2 = -108.7213), together with a significant decline in the slope associated with the implementation of NRDLN (β3 = -4.8332). Compared to Traditional Chinese Medicines, the availability of Western Medicines was higher and increased at a higher rate (β3 = 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.ConclusionThe 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.

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

Publications

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

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