Dataset Information

Prices and Clinical Benefit of National Price-Negotiated Anticancer Medicines in China.

ABSTRACT:

Background

High prices of anticancer medicines have increased the economic burden for both patients and health insurance systems. Since 2017, China has implemented national price negotiations for medicines, relying on evidence from health technology assessments. We aim to assess the relation between negotiated price and value of anticancer medicines listed in China's National Reimbursement Drug List (NRDL).

Methods

For all price-negotiated anticancer medicines and corresponding indications listed in the latest NRDL between 2017 and 2020, we collected their clinical outcomes data, including overall survival (OS) and progression-free survival (PFS), in supporting trials. Pearson correlation coefficient was calculated to estimate the association between the daily cost and clinical benefit of each indication.

Results

In total, 75 indications of 46 branded anticancer medicines were included for analysis. The median daily costs for the anticancer therapies that had gone through negotiation in 2017-2020 were US$87.6, US$71.8, US$58.9, and US$39.7, respectively. For indications supported by randomized trials, no correlation between daily costs and OS and PFS benefit of the price-negotiated cancer therapies was observed (N = 41, r = -0.05, and N = 49, r = 0.04, respectively). For cancer indications newly listed in NRDL in 2020, the association between their daily cost and OS benefit was -0.78 (N = 4, p = 0.221) and 0.01 (N = 8, p = 0.986) before and after the price negotiation.

Conclusion

Though the negotiation policy decreased prices of anticancer medicines in China, no statistically significant correlation was observed between their daily costs and clinical benefits. A more transparent and credible pricing approach needs to be established to promote value-based anticancer medicines and healthcare system efficiency.

SUBMITTER: Zhang Y

PROVIDER: S-EPMC9270265 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

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:BackgroundChina implemented the national drug price negotiation (NDPN) policy to include 17 innovative anticancer medicines in the national reimbursement drug list in 2018. We aimed to assess the impact of this policy on the utilization, cost, and accessibility of anticancer medicines.MethodsWe obtained monthly medicine procurement data from 1039 hospitals from October 2017 to December 2019. We examined changes in availability, utilization, defined daily dose cost (DDDc), and affordability of the medicines using descriptive statistics and controlled interrupted time series analysis, measuring utilization by defined daily doses (DDDs). Cetuximab and raltitrexed were compared separately for the same indication.ResultsThe mean availability of 17 negotiated anticancer medicines was 28.78% after the NDPN, amounting to an increase of 25.22%. The availability increased by 7.88% (95% confidence interval (CI) = 4.31%, 11.45%, P < 0.001) immediately and by 1.23% (95% CI = 0.81%, 1.64%, P < 0.001) per month after policy implementation. Compared with the control group, the utilization of the medicines increased by 11.44 DDDs (95% CI = 2.42, 20.46, P = 0.014) immediately and by 3.54 DDDs (95% CI = 2.47, 4.60, P < 0.001) per month after policy implementation, while the DDDc decreased by US$109.09 (95% CI = 68.14, 150.05, P < 0.001) immediately and remained stable thereafter. The results on cetuximab and raltitrexed were similar. Availability and utilization differed among regions in east, middle, and west China. Out-of-pocket costs decreased by 17.35 times the catastrophic health expenditures to 1.99 times, but the affordability ratio for 14 negotiated medicines was still greater than 1.ConclusionsThe NDPN policy improved the availability, utilization, and affordability of anticancer medicines. China's experience in NDPN provides a reference for other countries. However, the availability and affordability of anticancer medicines still need further improvement.

Project description:BackgroundIn order to further regulate the price of anticancer medication and alleviate the financial burden of cancer patients, the Chinese government implemented the National Medication Price-Negotiated Policy (NMPNP) in 2017. This study aims to assess the impacts of implementation of the NMPNP on the access of anticancer medication and the financial burden for cancer patients in Shandong province, and to provide evidence to inform the design of similar policies in other developing countries.MethodsA quasi-experiment design of an interrupt time series analysis was conducted. The month of September 2017 was taken as the intervention point when the Shandong Provincial Reimbursement Drug Lists was updated based on the result of the NMPNP in 2017. The data used were the aggregated monthly claim data of cancer patients from 2016 to 2021, which were obtained from four cities in Shandong province. The outpatient and inpatient care visits per capita, proportion of OOP expenditure and medication costs in outpatient and inpatient medical costs were used as outcome variables. A segmented regression model was used to analyze the change of the access of anticancer medication and the financial burden for cancer patients.ResultsThe outpatient care visits per capita significantly decreased after the intervention. Compared to preintervention trend, the proportion of OOP expenditure in outpatient medical costs decreased by average 0.25 percentage point per month (p < 0.0001) after the intervention, however the proportion of OOP expenditure in inpatient medical costs increased by 0.02 percentage point per month (p = 0.76). Since the intervention, the proportion of medication costs in outpatient medical costs averagely rose by 0.28 percentage point (p < 0.0001), and its implementation caused the proportion of medication costs in inpatient medical costs averagely decreased 0.2 percentage point (p < 0.0001).ConclusionsThe NMPNP improved the access of anticancer medication, and relieved the financial burden of outpatient care. However, it did not effectively alleviate the financial burden of inpatient care. Additionally, the NMPNP impacted the behavior of the healthcare providers. The policymakers should closely monitor the change of providers behaviors, and dynamically adjust financial incentives policies of healthcare providers during the implementation of similar medication price negotiated policies.

Project description:BackgroundThe cost of new anticancer drugs is rising. We aimed to assess the clinical benefit and price of anti-cancer drugs approved by the US Food and Drug Administration (FDA) for advanced gastrointestinal cancers.MethodsDrugs approved between 2006 and 2017 for advanced GI malignancies were identified from FDA.gov, and their updated supporting trial data were searched. Incremental clinical benefit was quantified by using ESMO Magnitude of Clinical Benefit Scale version 1.1 (grade 0-5) and ASCO Value Framework version 2 (score range -20 to 180). Higher scores indicate larger net benefit, and substantial benefit was defined as score 4 or 5 by the European Society for Medical Oncology (ESMO). The Micromedex REDBOOK was used to estimate the monthly average wholesale price (AWP) and total drug price (TDP) over the median treatment duration per patient. Clinical benefit, AWP and TDP of each drug class were assessed.ResultsIn total, 16 GI cancer drugs received FDA approval for 24 indications, including five monoclonal antibodies (mAbs), five oral targeted therapies (TT), two immunotherapeutics (IO), three cytotoxic chemotherapies (CT), and one recombinant fusion protein (aflibercept). Most supporting trials (82%) reported overall survival benefit of less than 3 months and no significant improvement in quality of life. Only five agents (including one TT and one IO) with 21% the of approved indications met the ESMO's threshold of substantial clinical benefit. Median incremental benefit scores of TT and IO were comparable to other drug classes. However their median TDP was much higher at $153 402 and $98 208, respectively, compared to $30 330 USD per patient for CT. The estimated TDP did not correlate with clinical benefit scores.ConclusionMost FDA-approved gastrointestinal cancer drugs do not meet the ESMO threshold of substantial clinical benefit. TT and IO are estimated to carry significant drug costs, and further cost analysis of these drugs is urgently needed.

Project description:BackgroundFree access to essential medicines is a fundamental right. Governments should provide accessible and affordable medicines to people. The purpose of this study was to evaluate medicines' prices, availability and affordability in Jordan.MethodData was collected from 30 public sectors and 30 private sectors in 6 regions in Jordan. At each institution, the availability and prices data of 50 originator brand (OB) medicines and lowest-price generic (LPG) equivalent medicines were collected. Medicines' prices were compared with international reference prices (IRPs) to obtain a median price ratio (MPR). Availability of medicines was determined on the day of data collection. Affordability was calculated with regards to the daily income of the lowest-paid unskilled government employee.ResultAvailability of medicines in public and private sectors was 72% and 76% for LPGs, respectively. Median MPRs of procurement prices for OBs and LPGs in the public sector were 1.1 and 5.5 times the IRPs, respectively. Private sector OB medicines were priced 4.8 times higher than IRPs, whereas LPGs were 3.8 times higher. OBs cost 14% more than LPGs in private sector. The median MPRs of patient prices for LPGs in the public sector were lower than in the private sector (1.1 versus 7.6). Generally, medicines' prices are affordable in public sector that the lowest paid unskilled government employee need less than a 1 day income to purchase the LPGs. While in private sector, the medicine prices are not affordable. For example, the treatment of hypertension either by LPGs or OBs needs more than 1 day income by lowest paid unskilled government employee.ConclusionThis study showed good availability of LPGs in the public sector. In private sector, it showed good availability of LPGs and OBs with higher patient prices. The procurement prices in the public sector were reasonable in comparison to IRPs. Policy evaluation efforts must be directed to cut medicines prices and to improve affordability in private sector.