Abstract

AimThat clinical trial (RAINBOW) showed that a 7.4 months overall survival benefit with the combination therapy with ramucirumab (RAM) and paclitaxel (PAC) as second-line therapy for patients with recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma, compared with placebo (PLA) plus paclitaxel. We performed an analysis to assess the cost-effectiveness of RAM from a Chinese perspective and recognized the range of drug costs.MethodsBy building a Markov model to estimate quality-adjusted life-years (QALYs), life-years (LYs) and lifetime costs. Transition probabilities, costs and utilities were estimated for the published literature, Chinese health care system and local price setting. We performed threshold analyses and probabilistic sensitivity analyses to evaluate the uncertainty of the model.ResultsCompared with PLA strategy, RAM strategy provided an incremental survival benefit of 1.22 LYs and 0.64 QALYs. The probabilistic sensitivity analysis showed that when RAM costs less than $151 or $753 per 4 weeks, the incremental cost-effectiveness ratio (ICER) approximated the willingness-to-pay threshold (WTP), suggesting that there was 50% likelihood that the ICER for RAM + PAC would be less than $44528.4 per QALY or $48121 per QALY, respectively.ConclusionsFor patients with advanced gastric or gastro-oesophageal junction adenocarcinoma who fail first-line chemotherapy, our results are conducive to the multilateral drug price guidance negotiations of RAM in China.

Highlights

  • The probabilistic sensitivity analysis showed that when RAM costs less than $151 or $753 per 4 weeks, the incremental cost-effectiveness ratio (ICER) approximated the willingness-to-pay threshold (WTP), suggesting that there was 50% likelihood that the ICER for RAM + PAC would be less than $44528.4 per quality-adjusted life-year (QALY) or $48121 per QALY, respectively

  • For patients with advanced gastric or gastro-oesophageal junction adenocarcinoma who fail first-line chemotherapy, our results are conducive to the multilateral drug price guidance negotiations of RAM in China

  • [13] In 2010, the RAINBOW trial showed that, after failure of first-line chemotherapy, combination therapy with RAM and PAC, significantly increased overall survival (OS) and health-related quality of life (HR-QOL) for advanced gastric cancer patients who had been previously treated, compared to PAC strategy. [12, 14, 15] the combination of RAM and PAC as a second-line treatment regimen for advanced gastric or gastro-oesophageal junction adenocarcinoma patients was included in the 2015 Chinese National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology section on gastric cancer. [16]

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Summary

Introduction

Gastric cancer is the second most common malignancy in the world and the sixth leading cause of cancer mortality (8.2% of all the cancer deaths). [1, 2] According to valid statistics, each year, there are approximately 325,000 people die from gastric cancer in China. [3] Since 2012, China has had the highest incidence of new cases of gastric cancer in the world. [4] According to the latest reports, there were 7,872,000 new cases in 2018. [2] Pharmacoeconomic model studies have shown that the per capita disease-related expenditure of gastric cancer patients is about 30 thousand yuan per year, [5, 6] which is 12 times the per capita health expenditure in China, and that the annual expenditure is about 20 billion 370 million yuan.Given the impetus to control the cost of gastric cancer treatment and accelerate the application of precision medicine in clinical practice, pharmacogenomics (PGx) has become increasingly important in the precision medicine of gastric cancer. [7] VEGF and VEGFR2 are associated with the pathogenesis and poor prognosis of gastric cancer. [8,9,10] The Current clinical application of VEGF monoclonal antibody such as trastuzumab and VEGFR2 antagonist such as RAM are benefit for patients with advanced gastric cancer and gastroesophageal cancer. [11, 12]Currently, the chemotherapy, which base on fluoropyrimidine and platinum are the universally accepted first-line treatments for gastric cancer. [13] In 2010, the RAINBOW trial showed that, after failure of first-line chemotherapy, combination therapy with RAM and PAC, significantly increased overall survival (OS) and health-related quality of life (HR-QOL) for advanced gastric cancer patients who had been previously treated, compared to PAC strategy. [12, 14, 15] the combination of RAM and PAC as a second-line treatment regimen for advanced gastric or gastro-oesophageal junction adenocarcinoma patients was included in the 2015 Chinese National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology section on gastric cancer. [16]Several studies have concurrently established that RAM has been approved in the United States, Europe and Japan, but it has not yet been approved by the China Food and Drug Administration (CFDA). [15, 17] The RAINBOW trial showed that RAM+PAC could enhance OS and PFS for patients with advanced gastric cancer. [13] In 2010, the RAINBOW trial showed that, after failure of first-line chemotherapy, combination therapy with RAM and PAC, significantly increased overall survival (OS) and health-related quality of life (HR-QOL) for advanced gastric cancer patients who had been previously treated, compared to PAC strategy. [12, 14, 15] the combination of RAM and PAC as a second-line treatment regimen for advanced gastric or gastro-oesophageal junction adenocarcinoma patients was included in the 2015 Chinese National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology section on gastric cancer. RAM + PAC does prolong overall survival in gastric cancer patients, to date there has not been any pharmacoeconomic evaluation of this treatment and has no available information about the price of RAM in China mainland. This study can help the government in multilateral drug price guidance negotiations of RAM

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