Current Development and Practice of Pharmacoeconomic Evaluation Guidelines for Universal Health Coverage in China

Yue, Xiaomeng; Li, Yuxiang; Wu, Jiuhong; Guo, Jeff J.

doi:10.1016/j.vhri.2020.07.580

Cited by 57 publications

(41 citation statements)

References 12 publications

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“…To increase access to high-value, high-price drugs and reduce the economic burden of patients, price negotiation has been required since 2017 by the National Healthcare Security Administration (NHSA) when the pharmaceutical manufacturer of a new drug applies for coverage on the National Reimbursement Drug List (NRDL) in China ( 28 ). Donafenib will join the 2021 NRDL negotiation.…”

Section: Discussionmentioning

confidence: 99%

The Cost Effectiveness of Donafenib Compared With Sorafenib for the First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma in China

Meng

Cao

Zhou

et al. 2022

Front. Public Health

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BackgroundRecent clinical trials have demonstrated that donafenib has superior efficacy and safety compared with sorafenib in Chinese patients with unresectable or metastatic hepatocellular carcinoma (HCC). The objective of this study was to assess the cost effectiveness of donafenib compared with sorafenib for the treatment of patients with unresectable or metastatic HCC in China.MethodsA three-state partitioned survival model was developed to perform a cost-effectiveness analysis comparing donafenib and sorafenib from a Chinese healthcare payer's perspective. The model adopted a lifetime horizon and a 4-week cycle length. Survival data were derived from the ZGDH3 study and fitted with standard parametric functions for extrapolation beyond the trial period. Cost data were obtained from the mean price of publicly listed online bids in 2021 and medical service prices across provinces in China. Utility data were obtained from previous literature. The cost and health outcomes were discounted at an annual rate of 5%. Deterministic and probabilistic sensitivity analyses (PSAs) were carried out to verify the robustness of the model.ResultsCompared with sorafenib, donafenib incurred a higher cost (US$22,330.23 vs. US$14,775.92) but yielded more quality-adjusted life years (1.045 vs. 0.861 QALYs). The incremental cost-effectiveness ratio (ICER) for donafenib was US$41,081.52 per QALY gained (ICER = US$13,439.10/QALY). The PSA results indicated that at a willingness-to-pay threshold of 3 times the GDP in China, the probability of donafenib being cost effective was 16.9%. The ICER (US$13,439.10/QALY) decreased when the branded price of sorafenib was used in the model.ConclusionsDonafenib is unlikely to be cost effective compared with sorafenib for the first-line treatment of unresectable or metastatic HCC in China. Reducing the price of donafenib can increase the possibility of it being cost effective in the future.

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Section: Discussionmentioning

confidence: 99%

The Cost Effectiveness of Donafenib Compared With Sorafenib for the First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma in China

Meng

Cao

Zhou

et al. 2022

Front. Public Health

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“…Only six of the fourteen LMICs (Colombia, Cuba, Egypt, Malaysia, the Philippines, and Thailand) conducted reviews to generate evidence in developing their guidelines, and only five followed up this step by the deliberative process (Cuba, Egypt, Malaysia, the Philippines, and Thailand) (22;25;29;34;35;37). Other countries followed incomplete steps, that is, either a workshop, or international support, or a review (Bhutan, Brazil, China, Colombia, India, Indonesia, and Mexico) (18–21;31;33;34). Furthermore, while the AGREE enterprise provides a structured, systematic, and standardized methodological framework for developing and reporting HSG (11), we could not identify any country, except Cuba, following it.…”

Section: Discussionmentioning

confidence: 99%

The development process of economic evaluation guidelines in low- and middle-income countries: a systematic review

Daccache

Karam

Rizk³

et al. 2022

Int J Technol Assess Health Care

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Objectives To review the development of economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs), with the goal of assisting those developing EEGs in LMICs. Methods We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature until March 2021. We extracted data on the methods used in the EEG development process, the responsible party engaged, and the development team’s composition. We conducted a quality assessment, using the Appraisal of Guidelines for Research and Evaluation-Health Systems tool, and then carried out a relative comparison. Results Fourteen EEGs and nine studies were identified. In ten countries, the Ministry of Health was responsible for handling the development process. The majority of LMICs who developed EEGs did not explicitly report the discipline of those involved in the process. The developers of EEGs followed four main steps: conducting a review on national guidelines, organizing workshops, and getting support from international experts or from organizations. One-third of the identified EEGs failed to engage multisectoral or multidisciplinary developers, and approximately 14 percent did not follow or report any recommended step. Conclusions This study identified a scarcity of published information related to the development process and the suboptimal quality of included studies. It provides relevant material to support international organizations and developers of guidelines in LMICs in developing EEGs that fit their national context. In addition, this paper recommends a transparent approach to the design of guidelines and to reporting on the methods for developing them.

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“…To reduce the economic burden on patients, the coverage of high-value but high-price drugs by the national medical insurance has required negotiation with the National Healthcare Security Administration to reach an agreement after 2017 in China ( 50 ). At present, only vedolizumab and infliximab are approved for treating patients with UC and are listed in the National Reimbursement Drug List in China.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness Analysis of Vedolizumab Compared With Infliximab in Anti-TNF-α-Naïve Patients With Moderate-to-Severe Ulcerative Colitis in China

Zhou

Sheng²,

Guan

et al. 2021

Front. Public Health

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Objective: To evaluate the cost effectiveness of vedolizumab vs. infliximab in the treatment of anti-tumor necrosis factor-alpha (TNF-α)-naïve patients with moderate-to-severe active ulcerative colitis (UC) in China.Methods: The costs and effectiveness of vedolizumab and infliximab in the treatment of anti-TNF-α naïve patients with moderate-to-severe active UC were compared using a hybrid decision tree model and a Markov model. From the perspective of the Chinese healthcare system, this study simulated the lifetime health benefits [quality-adjusted life-years (QALYs)] and costs (USD) for patients with UC from the induction phase to the maintenance phase, with an annual discount rate of 5%. The clinical efficacy and transition probability data were based on a previously published network meta-analysis. The health utility, surgical risk, biologic drug discontinuation rate, and mortality were derived from previous literature and the Chinese statistical yearbook. The cost data were based on China's drug purchase and biding platform and the results of a survey sent to clinicians in 18 tertiary hospitals. One-way and probabilistic sensitivity analyses (PSAs) were performed to validate the robustness of the models' assumptions and specific parameter estimates.Results: The results of the base-case analyses showed that compared with infliximab, vedolizumab led to a gain of 0.25 QALYs (9.56 vs. 9.31 QALYs) and was less expensive by $7,349 ($180,138 vs. 187,487), indicating that the use of vedolizumab was a dominant strategy. The results of one-way sensitivity analyses suggested that the annual discount rate and health-state costs had the greatest impact, but the results were otherwise consistent with those of the base-case analyses. The PSAs suggested that vedolizumab had a 98.6% probability of being effective at a threshold of 3 times the gross domestic product (GDP) per capita in China in 2020.Conclusion: Compared with infliximab, vedolizumab appears to be a more cost-effective option in the treatment of anti-TNF-α naïve adult patients with moderate-to-severe, active UC in China.

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Current Development and Practice of Pharmacoeconomic Evaluation Guidelines for Universal Health Coverage in China

Cited by 57 publications

References 12 publications

The Cost Effectiveness of Donafenib Compared With Sorafenib for the First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma in China

The Cost Effectiveness of Donafenib Compared With Sorafenib for the First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma in China

The development process of economic evaluation guidelines in low- and middle-income countries: a systematic review

Cost-Effectiveness Analysis of Vedolizumab Compared With Infliximab in Anti-TNF-α-Naïve Patients With Moderate-to-Severe Ulcerative Colitis in China

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