The "4 + 7" volume-based procurement is a "large group purchase" led by the Chinese government, with the aim of reducing the price of medicines by trading volume for price. Although the "4 + 7" drugs had passed the national consistency evaluation, the adverse drug reactions need to be further evaluated to ensure the safety of the "4 + 7" drugs with low prices. We aimed to analyze the occurrence characteristics and related influencing factors of adverse reactions of psychiatric drugs under the chinese drug volume-based procurement policy(4 + 7 policy), and provide references for clinical medication.137 cases of adverse drug reactions of four psychotropic drugs reported under the "4 + 7" policy in Wuxi Mental Health Center in 2020 were collected. The gender and age of patients, related "4 + 7" drugs, involving organs / systems, clinical manifestations, distribution of new / serious adverse reactions, clinic outcomes were analyzed.Among the 137 cases of adverse drug reactions, the incidence of adverse drug reactions was the highest in patients aged 61-70 (25.38%). Mainly involved 4 "4 + 7" psychiatric drugs, of which olanzapine tablets caused the most adverse reactions (54, 39.24%). The adverse reactions mainly involved the digestive system, nervous system, cardiovascular system, blood and lymphatic system, among which the digestive system was the most common (61, 44.53%). A total of 8 cases (6.16%) of new and 26 cases of serious adverse reactions were reported, all of which led to the prolongation of disease course. Except for the transient side effects, most of that were improved or cured with no death, disability or teratogenicity after stopping or reducing the dose with symptomatic treatment.Since more and more drugs will be included in "4 + 7" for clinic, clinical pharmacists should strengthen the publicity and training of the knowledge of "4 + 7" drugs, strengthen the monitoring of adverse drug reactions, and provide timely feedback to the clinic, in order to achieve early prevention, early identification, timely diagnosis and reasonable intervention of the adverse drug reactions under the context of "4 + 7" policy. 

/pdf/reevaluation-of-adverse-drug-reactions-of-psychiatric-drugs-29np2ozn.pdf

Reevaluation of adverse drug reactions of psychiatric drugs under the chinese drug volume-based procurement policy

Aim To assess the efficacy of intravitreal triamcinolone (IVTA) as an adjunct to the combination of anti-vascular endothelial growth factor (VEGF) for the management of diabetic macular edema (DME) Methods A total of 51 patients with visual disabilities causing by DME from two sites were retrospectively collected and assigned to two groups according to the therapeutic method: intravitreal conbercept (IVC) combined with focal laser (24 eyes) and IVC combined with focal laser and IVTA (27 eyes) Best-corrected visual acuity (BCVA), the required number of IVCs, central retinal thickness (CRT), the mean costs of treatment burden and safety were compared over 12mo Results From baseline to month 1 through month 12, IVC combined with focal laser and IVTA improved the mean average change in BCVA superior to IVC combined with focal laser (+520 vs +271 letters) At month 12, 2083% of the IVC combined with focal laser and 3704% of IVC combined with focal laser and IVTA arms gained more than 10 BCVA letters During the period, the mean CRT decreased significantly in the IVC combined with focal laser and IVTA arm (-2459 µm) compared to the IVC combined with focal laser arm (-9845 µm) The average of 645 and 125 conbercept injections performed in the IVC combined with focal laser and IVC combined with focal laser and IVTA arms, respectively The mean cost of treatment burden for 12mo was $624744±406918 in the IVC combined with focal laser arm and $167919±54273 in the IVC combined with focal laser and IVTA arm, with a statistically significant difference Apart from occasional minor subconjunctival hemorrhage, no other significant ocular adverse events (AEs) were observed in either group during the12-month period Conclusion It is effective and cost-effective to treat DME by utilizing triamcinolone as an adjunct to the combination of anti-VEGF

/pdf/triamcinolone-as-an-adjunct-to-the-combination-of-anti-vegf-4qv1mfs4nq.pdf

Triamcinolone as an adjunct to the combination of anti-VEGF for the management of diabetic macular edema

Cost-effectiveness analyses typically ignore healthcare system resource constraints. Ophthalmology is affected by resource constraints because of increasing disease prevalence and the use of resource-intensive treatments. This study evaluated the impact of resource constraints on the cost-effectiveness of faricimab 6 mg, compared with aflibercept 2 mg and ranibizumab biosimilar 0.5 mg, for treating wet age-related macular degeneration (wAMD) or diabetic macular oedema (DMO) over a 5-year horizon. 

https://link.springer.com/content/pdf/10.1007/s40123-024-00999-8.pdf

Economic Assessment in Resource-Constrained Systems: Individual-Level Simulation Model in Wet Age-Related Macular Degeneration and Diabetic Macular Oedema

Background China’s National Reimbursement Drug List (NRDL) has become the primary route for drug reimbursement in China. More recently, the authority has made pharmacoeconomic evaluation an integral part of the application for NRDL inclusion. The underlying financial conflict of interests (FCOI) of pharmacoeconomic evaluations, however, has the potential to influence evidence generated and thus subsequent decision-making yet remains poorly understood. Methods We searched for studies published between January 2012 and January 2022 on the 174 drugs added to the 2017–2020 NRDLs after successful negotiation. We categorised the study’s FCOI status into no funding, industry funding, non-profit funding and multiple fundings based on authors’ disclosure and assessed the reporting quality of included studies using the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. We compiled descriptive statistics of funding types and study outcomes using t-tests and χ2 tests and conducted multivariate regression analysis. Results We identified 378 records and our final sample included 92 pharmacoeconomic evaluations, among which 69.6% were conducted with at least one funding source. More than half (57.6%) of the evaluations reached favourable conclusions towards the intervention drug and 12.6% reached a dominant result of the intervention drug over the comparison from model simulation. The reporting quality of included studies ranged from 19 to 25 (on a scale of 28), with an average of 22.3. The statistical tests indicated that industry-funded studies were significantly more likely to conclude that the intervention therapy was economical (p<0.01) and had a significantly higher proportion of resulting target drug economically dominated the comparison drug (p<0.05). Conclusion The study revealed that FCOI bias is common in published pharmacoeconomic evaluations conducted in Chinese settings and could significantly influence the study’s economical results and conclusions through various mechanisms. Multifaceted efforts are needed to improve transparency, comparability and reporting standardisation.

Sponsorship bias in published pharmacoeconomic evaluations of national reimbursement negotiation drugs in China: a systematic review

Objective: The objective of this review was to examine the role of adverse drug events (ADEs) caused by pharmacological interventions in cost-effectiveness models for diabetes mellitus, diabetic retinopathy, and diabetic macular edema. Introduction: Guidelines for economic evaluation recognize the importance of including ADEs in the analysis, but in practice, consideration of ADEs in cost-effectiveness models seem to be vague. Inadequate inclusion of these harmful outcomes affects the reliability of the results, and the information provided by economic evaluation could be misleading. Reviewing whether and how ADEs are incorporated in cost-effectiveness models is necessary to understand the current practices of economic evaluation. Inclusion criteria: Studies included were published between 2011–2022 in English, representing cost-effectiveness analyses using modeling framework for pharmacological interventions in the treatment of diabetes mellitus, diabetic retinopathy, or diabetic macular edema. Other types of analyses and other types of conditions were excluded. Methods: The databases searched included MEDLINE (PubMed), CINAHL (EBSCOhost), Scopus, Web of Science Core Collection, and NHS Economic Evaluation Database. Gray literature was searched via the National Institute for Health and Care Excellence, European Network for Health Technology Assessment, the National Institute for Health and Care Research, and the International Network of Agencies for Health Technology Assessment. The search was conducted on January 1, 2023. Titles and abstracts were screened for inclusion by 2 independent reviewers. Full-text review was conducted by 3 independent reviewers. A data extraction form was used to extract and analyze the data. Results were presented in tabular format with a narrative summary, and discussed in the context of existing literature and guidelines. Results: A total of 242 reports were extracted and analyzed in this scoping review. For the included analyses, type 2 diabetes was the most common disease (86%) followed by type 1 diabetes (10%), diabetic macular edema (9%), and diabetic retinopathy (0.4%). The majority of the included analyses used a health care payer perspective (88%) and had a time horizon of 30 years or more (75%). The most common model type was a simulation model (57%), followed by a Markov simulation model (18%). Of the included cost-effectiveness analyses, 26% included ADEs in the modeling, and 13% of the analyses excluded them. Most of the analyses (61%) partly considered ADEs; that is, only 1 or 2 ADEs were included. No difference in overall inclusion of ADEs between the different conditions existed, but the models for diabetic retinopathy and diabetic macular edema more often omitted the ADE-related impact on quality of life compared with the models for diabetes mellitus. Most analyses included ADEs in the models as probabilities (55%) or as a submodel (40%), and the most common source for ADE incidences were clinical trials (65%). Conclusions: The inclusion of ADEs in cost-effectiveness models is suboptimal. The ADE-related costs were better captured than the ADE-related impact on quality of life, which was most pronounced in the models for diabetic retinopathy and diabetic macular edema. Future research should investigate the potential impact of ADEs on the results, and identify the criteria and policies for practical inclusion of ADEs in economic evaluation. 

Adverse drug events in cost-effectiveness models of pharmacological interventions for diabetes, diabetic retinopathy, and diabetic macular edema: a scoping review

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.

Cost-effectiveness analysis of intravitreal aflibercept in the treatment of diabetic macular edema in China.

China introduced a “volume-based procurement (VoBP)” policy for medical products to contain healthcare costs and improve patient access to cost-effective products recently. The VoBP of peripheral intravenous catheters (PIVCs) was piloted in Jiangsu, Shandong and Jiangxi provinces in late 2019. The bidding of PIVCs mainly focused on their prices, while the evaluation standard on clinical performance of PIVCs was less emphasized. In this study, we aim to understand the clinical impacts associated with the utilization of different PIVCs influenced by the implementation of VoBP policy in China. Semi-structured interviews were conducted with nurses in Nanjing and Linyi, the pilot cities implementing VoBP. A total of 27 nurses who used a leading multinational corporation’s (MNC’s) PIVCs before VoBP and changed to China local brands’ PIVCs after VoBP were included as informants. In the first 15 interviews, all domains (PIVC placement, complications, product issues, and training) and corresponding concepts listed in conceptual framework were mentioned, indicating that sample size was sufficient. After the change from the MNC’s PIVCs to local brands, PIVCs used per patient increased from 2.0 to 3.5 and the average indwelling time decreased from 3.7 days to 2.1 days. Compared with the MNC’s PIVCs, those from local brands were associated with a 0.9-minute increase in PIVC insertion time and a 9% relative decrease in first stick success rate. Furthermore, increased complication rate, quality issues and hard catheter materials, and reduced product training after PIVC change were also mentioned by nurses. This study discloses that PIVC product change following the implementation of VoBP may result in unexpected issues. Therefore, establishing quality evaluation criteria and strengthening product monitoring mechanism are recommended for VoBP policy optimization on medical consumables.

/pdf/clinical-perspectives-on-the-use-of-different-peripheral-4fniz4qygd.pdf

Clinical Perspectives on the Use of Different Peripheral Intravenous Catheters with the Implementation of Volume-based Procurement in China

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Cost-effectiveness analysis of intravitreal aflibercept in the treatment of diabetic macular edema in China.

Clinical Perspectives on the Use of Different Peripheral Intravenous Catheters with the Implementation of Volume-based Procurement in China