Today (December 13), the National Health Insurance Administration and the Ministry of Human Resources and Social Security officially announced the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalogue (2023) (referred to as the "2023 National Medical Insurance Drug Catalogue"). A total of 126 new drugs have been added to the national medical insurance drug catalogue, involving drugs in the fields of anti-tumor, rare disease, chronic disease, antiviral and other diseases, and the average price reduction has been reduced by 61 through medical insurance negotiations7%。The new version of the National Medical Insurance Catalogue will be implemented from January 1, 2024.
15 drugs for rare diseases were included, and the innovative drugs "zero time difference" benefited Chinese patients.
In the field of rare diseases, which has attracted much attention, 15 rare disease drugs have been included in the catalogue, covering 16 rare disease diseases, filling the gap in drug protection for 10 diseases, increasing the inclination and support for innovative drugs, and solving the pain point of "unaffordable drugs" for patients with rare diseases.
For example, as a breakthrough innovative drug in the field of myasthenia gravis in China in the past 30 years, the world's first FCRN antagonist agamod injection (hereinafter referred to as "agamod") was successfully included in the 2023 National Medical Insurance Drug List, becoming the only FCRN antagonist in China that can be reimbursed by medical insurance.
In June this year, agamod was approved by the State Food and Drug Administration, and it was officially launched in China in September, promoting the domestic myasthenia gravis** to enter a new era of biological targeting, and this time it was successfully included in the national medical insurance drug list, which is expected to benefit more patients with generalized myasthenia gravis in China. Professor Zhao Chongbo, deputy director and chief physician of the Department of Neurology of Huashan Hospital affiliated to Fudan University, said that as an innovative drug for rare diseases, it took less than half a year for agamod to be included in the medical insurance from its listing to its inclusion in the medical insurance, which reflects the country's greater support for innovative drugs with huge unmet clinical needs and demonstrates the country's care for patients with rare diseases. The inclusion of agamod in the medical insurance will change the dilemma of patients in the past who "look forward to new drugs and sigh", help more patients use new drugs and good drugs as soon as possible, so that patients can return to their daily lives as soon as possible.
In the field of rare diseases, patients also ushered in good news, Boehringer Ingelheim's innovative targeted biologics Shenglizzo (pesolimab injection) was included in the national medical insurance list for the treatment of generalized pustular psoriasis (English abbreviation GPP).
GPP is a rare, severe, or persistently occurring disease with a prevalence of 1403 100,000 people, estimated to have about 20,000 patients in China, the clinical manifestations are ** extensive outbreak of pustules, accompanied by pain, may be accompanied by high fever and other systemic symptoms. ** Failure to do so may lead to liver and kidney damage, and can also be life-threatening due to secondary infection and organ failure. Shenglizo is the first drug approved for the use of GPP attacks in China. Xingrong Chen, General Manager of Boehringer Ingelheim Greater China, said, "The successful inclusion of Shenglizo in the medical insurance catalogue only one year after being approved to enter the Chinese market with zero time difference demonstrates the attention of the company to patients with rare diseases, and once again thanks the country for its strong measures to deepen the reform of the medical security system." ”
Rufang Huang, founder of the Center for Rare Diseases, said, "The inclusion of St. Lizzo in the medical insurance catalogue has greatly reduced the financial burden of patients and improved the accessibility of patients to innovation**, which is of great significance to families suffering from diseases. ”
Also under Boehringer Ingelheim, the innovative targeted drug for pulmonary fibrosis Vega is included in the latest catalogue for the indication of chronic fibrotic interstitial lung disease with a progressive phenotype (PPF, progressive pulmonary fibrosis). Vega is the world's first and only innovator drug approved for PPF. So far, all three approved indications of Vegat have entered the national medical insurance list, which will benefit a wider range of Chinese pulmonary fibrosis patients.
A number of new anti-cancer drugs have been included, and it is expected that more cancer patients will usher in a "new life."
In China, the incidence of breast cancer ranks first among female malignant tumors, and about 70% of patients are hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer. However, in recent years, breakthroughs in cell cycle-dependent kinase (CKD4 6) inhibitors have optimized endocrine**, and endocrine combined with CKD4 6 inhibitors** is rewriting the HR+ HER2- advanced breast cancer landscape**. This time, Novartis China's innovative breast cancer drug Carilon (Rebociclib Succinate Tablets) was successfully included in the latest medical insurance drug list, which further improved the accessibility of drugs and benefited more Chinese breast cancer patients.
Zhang Ying, President and Managing Director of Novartis China, said that breast cancer is one of the key disease areas that Novartis continues to focus on and explore, and thanks to the country's support for innovation, Rebociclib was approved in China in January 2023, and it took less than 12 months to achieve medical insurance access this time.
Professor Shao Zhimin, chief physician of the Department of Breast Surgery of Fudan University Cancer Hospital, said that after reboxiclib is included in the 2023 National Medical Insurance Catalog, it will save patients the best cost and help them achieve a longer survival period and a better quality of life.
In China, the incidence and mortality of lung cancer have ranked first among malignant tumors for many years, and the report released by the National Cancer Center shows that the number of new lung cancer patients in China in 2022 has reached 8280 thousand. This time, the innovative PD-1 inhibitor Tyvyt (generic name: sintilimab injection) jointly developed by Eli Lilly and Innovent Biologics has added a seventh indication to the NRD, namely for patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have failed an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)** and are positive for epidermal growth factor receptor (EGFR) gene mutations**.
Tyvyt is the world's first and only approved PD-1 inhibitor for this indication, and the other indications of Tyvyt have been successfully renewed, achieving medical insurance coverage for all seven indications, including squamous and non-squamous non-small cell lung cancer, hepatocellular carcinoma, gastric adenocarcinoma, esophageal squamous cell carcinoma, and classical Hodgkin lymphoma.
Also in the field of lung cancer, AstraZeneca's third-generation EGFR-TKI-targeted drug Tagrisso, generic name: osimertinib mesylate tablets, referred to as "osimertinib") has been successfully admitted to the medical insurance list, which is suitable for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) replacement mutation in stage IB-IIIA.
About 45 in our country9% of patients with non-small cell lung cancer have EGFR mutations, osimertinib, as the world's first third-generation EGFR-TKI targeted drug, entered China in 2017 and has been approved for second-line and first-line indications for patients with locally advanced or metastatic non-small cell lung cancer, and both have been included in the medical insurance catalogue The third-generation EGFR-TKI targeted drug means that osimertinib continues to reduce the economic burden of non-small cell lung cancer patients with EGFR-sensitive mutations in China from early to late stage. Chen Kangwei, general manager of AstraZeneca's oncology division in China, said that he is grateful for including the third indication of osimertinib in the postoperative adjuvant of early-to-mid-stage lung cancer into the medical insurance, and hopes to help more early-to-mid-stage lung cancer patients usher in "** hope and help them return to society."
Author: Tang Wenjia.
Text: Tang Wenjia: This newspaper's data map Editor: Tang Wenjia Responsible editor: Jiang Peng.
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