China is a major country in liver cancer , with about 466,000 new cases and 422,000 deaths every year, accounting for more than 50% of the world's total. With the continuous development of our country's economy, the incidence rate of colorectal cancer among our residents has also been increasing. The latest data from the National Cancer Center shows that in 2015, there were 376,000 new patients with colorectal cancer in my country and 191,000 deaths. The two major malignant tumors of have become major malignant diseases that seriously threaten people's lives and health due to the increasing number of patients.
Traditionally, cancer treatment is mainly based on surgery, chemotherapy and radiotherapy. In recent years, molecular targeted drugs have developed rapidly, and the emergence of new targeted drugs has brought new hope to tumor patients. Stivarga is a new oral multi-targeted therapeutic drug , targeting angiogenesis, matrix and oncogenic receptor tyrosine kinase (RTK). Regorafenib tablets were first developed by Bayer Healthcare Co., Ltd. , with the trade name Byvango, and are being studied as a potential treatment option for various tumor types.
In September 2012, FDA approved the marketing application for regorafenib tablets (40mg), for the treatment of patients who have previously received chemotherapy based on fluorouracil, oxaliplatin and irinotecan, as well as those who have previously received or not received chemotherapy. Suitable for patients with metastatic colon cancer who receive anti-VEGF therapy and anti-EGFR therapy (RAS wild-type).
In March 2017, regorafenib was approved for marketing in China. According to information on the NMPA official website, Bayer 's regorafenib tablets are the only ones approved for marketing in China. Currently, no domestically produced regorafenib tablets have been approved. As the first oral multi-kinase inhibitor, regorafenib combines the convenience of oral administration and simplicity of dose adjustment. It is an indispensable targeted therapy option for Chinese patients with metastatic colorectal cancer.
On October 10, 2018, regorafenib was officially included in the National Medical Insurance Category B reimbursement list, bringing good news to patients with advanced colorectal cancer, gastrointestinal stromal tumor (GIST), and liver cancer in China. On January 1, 2022, the new version of the medical insurance catalog was officially implemented. Regorafenib, as a Class B drug in the medical insurance, is included in the scope of medical insurance: 1. Second-line treatment of hepatocellular carcinoma; 2. Third-line treatment of metastatic colorectal cancer; 3. Third-line treatment of gastrointestinal stromal tumors .
The price of regorafenib was 10,080 yuan per box when it was first launched. Under normal circumstances, three boxes are needed per month, and the monthly cost is a little more than 30,000. After the medical insurance price reduction, the price of is 196 yuan (40mg/tablet) and is 65,488 yuan/box, a decrease of 45.56%. The recommended dose of is 160mg taken orally once a day, and the first 21 days of each 28-day course of treatment are taken. That is, the price of taking regorafenib for one month (one course of treatment) is 16,464 yuan.
In the past, regorafenib was not widely used due to its high price. Only a small number of patients could use it, and it was out of reach for most cancer patients. Nowadays, regorafenib has officially entered the medical insurance catalog, and according to the national medical insurance policy, 70% to 80% can be reimbursed; secondly, through government negotiations, the price of regorafenib has been significantly reduced to about half of the original price, and the out-of-pocket expenses have dropped significantly; thirdly, it turns out that Mainly purchased through pharmacy channels, now it can be purchased directly in hospitals and reimbursed through medical insurance, which greatly improves convenience.
Currently, the marketing registration application for domestically produced regorafenib tablets is also in progress. Domestic Yangzijiang Pharmaceutical , Nanjing Zhengda Tianqing , Qilu Pharmaceutical , Sichuan Kelun, Beijing Shuanglu, Shanghai Chuangnuo, Jiangsu Hao The listing registration applications of Sen and other companies were handled by CDE.
I believe that with policies, technology and attractive sales, the approval of domestically produced regorafenib tablets is just around the corner!
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