Impact of medical insurance access negotiation on the utilization of innovative anticancer drugs in China: an interrupted time series analysis

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Abstract

Background

The high costs of innovative anticancer drugs hinder a number of cancer patients’ access to these drugs in China. To address this problem, in 2018, the medical insurance access negotiation (MIAN) policy was implemented, when the prices of 17 innovative anticancer drugs were successfully negotiated and they were therefore included in the reimbursement list. This study aimed to explore the impact of the MIAN policy on the utilization of innovative anticancer drugs.

Methods

With monthly data on drug expenditures and defined daily doses (DDDs) of each innovative anticancer drug from January 2017 to December 2019, interrupted time series analysis was employed to estimate both the instant (change in the level of outcome) and long-term (change in trends of outcomes) impacts of the MIAN policy on drug utilization in terms of drug expenditures and DDDs. Our sample consists of 12 innovative anticancer drugs.

Results

From January 2017 to December 2019, the monthly drug expenditures and DDDs of 12 innovative anticancer drugs increased by about 573% (from US$8,931,809.30 to US$51,138,331.09) and 1400% (from 47,785 to 668,754), respectively. Overall, the implementation of the MIAN policy led to instant substantial increases of US$8,734,414 in drug expenditures and 158,192.5 in DDDs. Moreover, a sharper upward trend over time was reported, with increases of US$2,889,078 and 38,715.3 in the monthly growth rates of drug expenditures and DDDs, respectively. Regarding individual innovative anticancer drugs, the most prominent instant change and trend change in drug utilization were found for osimertinib, crizotinib, and ibrutinib. In contrast, the utilization of pegaspargase was barely affected by the MIAN policy.

Conclusions

The MIAN policy has effectively promoted the utilization of innovative anticancer drugs. To ensure the continuity of the effects and eliminate differentiation, supplementary measures should be carried out, such as careful selection of drugs for medical insurance negotiations, a health technology assessment system and a multichannel financing mechanism.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12913-023-10393-y.

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Most cited references 36

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Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

Hyuna Sung, Jacques Ferlay, Rebecca Siegel … (2021)

This article provides an update on the global cancer burden using the GLOBOCAN 2020 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer. Worldwide, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred in 2020. Female breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%), colorectal (10.0 %), prostate (7.3%), and stomach (5.6%) cancers. Lung cancer remained the leading cause of cancer death, with an estimated 1.8 million deaths (18%), followed by colorectal (9.4%), liver (8.3%), stomach (7.7%), and female breast (6.9%) cancers. Overall incidence was from 2-fold to 3-fold higher in transitioned versus transitioning countries for both sexes, whereas mortality varied <2-fold for men and little for women. Death rates for female breast and cervical cancers, however, were considerably higher in transitioning versus transitioned countries (15.0 vs 12.8 per 100,000 and 12.4 vs 5.2 per 100,000, respectively). The global cancer burden is expected to be 28.4 million cases in 2040, a 47% rise from 2020, with a larger increase in transitioning (64% to 95%) versus transitioned (32% to 56%) countries due to demographic changes, although this may be further exacerbated by increasing risk factors associated with globalization and a growing economy. Efforts to build a sustainable infrastructure for the dissemination of cancer prevention measures and provision of cancer care in transitioning countries is critical for global cancer control.

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First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

Benjamin Solomon, Tony Mok, Dong-Wan Kim … (2014)

The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer (NSCLC) is unknown. We conducted an open-label, phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease. Patients were randomly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy (pemetrexed, 500 mg per square meter of body-surface area, plus either cisplatin, 75 mg per square meter, or carboplatin, target area under the curve of 5 to 6 mg per milliliter per minute) every 3 weeks for up to six cycles. Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy. The primary end point was progression-free survival as assessed by independent radiologic review. Progression-free survival was significantly longer with crizotinib than with chemotherapy (median, 10.9 months vs. 7.0 months; hazard ratio for progression or death with crizotinib, 0.45; 95% confidence interval [CI], 0.35 to 0.60; P<0.001). Objective response rates were 74% and 45%, respectively (P<0.001). Median overall survival was not reached in either group (hazard ratio for death with crizotinib, 0.82; 95% CI, 0.54 to 1.26; P=0.36); the probability of 1-year survival was 84% with crizotinib and 79% with chemotherapy. The most common adverse events with crizotinib were vision disorders, diarrhea, nausea, and edema, and the most common events with chemotherapy were nausea, fatigue, vomiting, and decreased appetite. As compared with chemotherapy, crizotinib was associated with greater reduction in lung cancer symptoms and greater improvement in quality of life. Crizotinib was superior to standard first-line pemetrexed-plus-platinum chemotherapy in patients with previously untreated advanced ALK-positive NSCLC. (Funded by Pfizer; PROFILE 1014 ClinicalTrials.gov number, NCT01154140.).

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Resistance mechanisms to osimertinib in EGFR -mutated non-small cell lung cancer

Alessandro Leonetti, Sugandhi Sharma, Roberta Minari … (2019)

Osimertinib is an irreversible, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that is highly selective for EGFR-activating mutations as well as the EGFR T790M mutation in patients with advanced non-small cell lung cancer (NSCLC) with EGFR oncogene addiction. Despite the documented efficacy of osimertinib in first- and second-line settings, patients inevitably develop resistance, with no further clear-cut therapeutic options to date other than chemotherapy and locally ablative therapy for selected individuals. On account of the high degree of tumour heterogeneity and adaptive cellular signalling pathways in NSCLC, the acquired osimertinib resistance is highly heterogeneous, encompassing EGFR-dependent as well as EGFR-independent mechanisms. Furthermore, data from repeat plasma genotyping analyses have highlighted differences in the frequency and preponderance of resistance mechanisms when osimertinib is administered in a front-line versus second-line setting, underlying the discrepancies in selection pressure and clonal evolution. This review summarises the molecular mechanisms of resistance to osimertinib in patients with advanced EGFR-mutated NSCLC, including MET/HER2 amplification, activation of the RAS–mitogen-activated protein kinase (MAPK) or RAS–phosphatidylinositol 3-kinase (PI3K) pathways, novel fusion events and histological/phenotypic transformation, as well as discussing the current evidence regarding potential new approaches to counteract osimertinib resistance.

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Author and article information

Contributors

Qunhong Wu: wuqunhong@163.com

Yu Cui: cuiyu4640@163.com

Journal

Journal ID (nlm-ta): BMC Health Serv Res

Journal ID (iso-abbrev): BMC Health Serv Res

Title: BMC Health Services Research

Publisher: BioMed Central (London )

ISSN (Electronic): 1472-6963

Publication date (Electronic): 17 January 2024

Publication date PMC-release: 17 January 2024

Publication date Collection: 2024

Volume: 24

Electronic Location Identifier: 90

Affiliations

[1 ]Department of Social Medicine, School of Health Management, Harbin Medical University, ( https://ror.org/05jscf583) Heilongjiang, China

[2 ]GRID grid.410736.7, ISNI 0000 0001 2204 9268, Department of Material management, Fourth Affiliated Hospital, , Harbin Medical University, ; Heilongjiang, China

[3 ]Department of Epidemiology and Public Health, University College London, ( https://ror.org/02jx3x895) London, UK

[4 ]GRID grid.7445.2, ISNI 0000 0001 2113 8111, Centre for Health Economics and Policy Innovation, Department of Economics and Public Policy, , Imperial Business School, ; London, UK

[5 ]GRID grid.470848.7, ISNI 0000 0000 9379 3265, Science and Technology Development Center of the Chinese Pharmaceutical Association, ; Peking, China

[6 ]Department of Acupuncture, Second Affiliated Hospital, Heilongjiang University of Chinese Medicine, ( https://ror.org/05x1ptx12) Harbin, Heilongjiang China

[7 ]Department of Pharmaceutical Administration, School of Humanities and Social Sciences, Harbin Medical University, ( https://ror.org/05jscf583) Heilongjiang, China

Article

Publisher ID: 10393

DOI: 10.1186/s12913-023-10393-y

PMC ID: 10792910

PubMed ID: 38233857

SO-VID: b5c8bafe-9d3d-4b8c-97dd-1697c7336eac

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 17 March 2023

Date accepted : 29 November 2023

Funding

Funded by: National Social Science Foundation of China

Award ID: 19AZD013

Funded by: Natural Science Foundation of Heilongjiang Province, China

Award ID: YQ2019G003

Funded by: A cooperative project between School of Health Management, Harbin Medical University and Science and Technology Development Center of the Chinese Pharmaceutical Association

Award ID: no award number

Custom metadata

ScienceOpen disciplines: Health & Social care

Keywords: innovative anticancer drug,medical insurance access negotiation,drug expenditure,ddds,interrupted time series,china

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ScienceOpen disciplines: Health & Social care

Keywords: innovative anticancer drug, medical insurance access negotiation, drug expenditure, ddds, interrupted time series, china

Impact of medical insurance access negotiation on the utilization of innovative anticancer drugs in China: an interrupted time series analysis

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Abstract

Background

Methods

Results

Conclusions

Supplementary Information

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China Occupational Medicine

Most cited references 36

Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

Resistance mechanisms to osimertinib in EGFR -mutated non-small cell lung cancer

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