New Alzheimer’s drug enters Medicare

Source: China Economic Net

China Economic Net, December 3. On December 3, the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)” (hereinafter referred to as the “Medical Insurance Catalog”) was announced, and 67 exclusive drugs outside the catalog were successfully negotiated. The average price reduction is 61.71%. Among them, my country’s original new drug for the treatment of Alzheimer’s disease, Mannat Sodium Capsules (trade name: “Nine Phase One”) was included in the catalog, and the price dropped from 895 yuan per box to 296 yuan, a drop of over 60%.

After the “Nine Phase One” is included in the medical insurance catalogue, the patient’s medication cost will be reduced from 3,580 yuan per month to 1,184 yuan based on 4 boxes per month. According to the national average 50% medical insurance reimbursement ratio for outpatient clinics, the patient will pay less than 600 yuan per month. Yuan, the cost of direct medication has been greatly reduced.

It is understood that the new version of the National Medical Insurance Directory will be officially implemented from January 1, 2022. In the future, patients can purchase the drug at the new price with a doctor’s prescription through channels such as medical insurance designated medical institutions and medical insurance designated retail pharmacies.

Dr. Li Jinhe, the R&D and production enterprise of “Ninth Phase One” and Executive Deputy General Manager of Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd., said that the current production capacity of “Nine Phase One” can meet the needs of about 1 million patients per year. In the future, the company will ensure new drugs After entering the medical insurance, the production and channel supply will guarantee the quality, quantity and supply under the new medical insurance execution price to meet the needs of the majority of patients.

2021 is the fourth year in a row that the National Medical Insurance Administration has carried out the negotiation of drug access in the medical insurance catalogue. The National Medical Insurance Administration stated that the main considerations for setting the application conditions for drugs outside the catalogue this time are: first, to better meet clinical needs, such as drugs for the treatment of new coronary pneumonia, drugs with changed indications, etc.; second, to better connect with the approval of new drugs, Realize the “seamless connection” between drug approval and medical insurance review, reflecting the orientation of encouraging innovation, such as newly launched drugs in recent years; the third is the connection with relevant drug management policies, considering that essential drugs are widely used in primary medical institutions, in order to ensure clinical drug use Continuity and accessibility, all national essential medicines are included in the adjustment scope.

It is understood that Alzheimer’s disease is the third leading cause of disability and death among the elderly after cardiovascular and cerebrovascular diseases and malignant tumors. However, there are only a few drugs currently used for clinical treatment in the world, and the clinical benefits are not obvious.

In the United States, a new drug for Alzheimer’s disease, aducanumab, was launched in June this year. The annual treatment cost of patients is about 56,000 US dollars, and the monthly drug cost is close to 30,000 yuan. It needs to be administered intravenously every month.

Li Jinhe said: “Since the ‘Nine Phase One’ was launched in China in December 2019, a series of post-marketing studies have been carried out. At the same time, more and more patients have used it and clinician feedback has further verified the ‘Nine Phase One’ China Phase III clinical trial. The safety and clinical efficacy value of the drug in the study. After entering the medical insurance, the cost and effect advantages of the ‘Nine Phase One’ will be further highlighted, and with the decline in drug expenditure, more patients are expected to use the drug for a long time.”

According to Li Jinhe, based on the potential of the “nine-stage one” disease course change, the curative effect will become more obvious with the prolongation of treatment time, which is expected to significantly reduce the proportion of Alzheimer’s disease patients entering the severe stage of the disease, thereby reducing the impact of the disease on patients, families and society. burden.

A survey shows that in 2015, the average annual cost of Alzheimer’s patients in my country was as high as 130,000 yuan, resulting in a total social and economic burden of about 1,140.6 billion yuan.

Chen Kaixian, academician of the Chinese Academy of Sciences and deputy chief technical engineer of the national “Major New Drug Creation” major science and technology project, said: “‘Nine Phase One’ is a major landmark achievement in new drug research and development as a major national science and technology project. , is a huge boon for patients. my country has huge unmet treatment needs in the prevention and treatment of senile dementia. In the long run, as a therapeutic drug with high clinical value, it will be included in medical insurance, which will help to slow down my country’s The overall social and economic burden in this disease area.”

In April 2020, the “Nine Phase One” international multi-center Phase III clinical trial application was approved by the U.S. Food and Drug Administration (FDA), and has since been approved by the Drug Administration of Canada, Australia, France, the Czech Republic and other 10 countries/regions , 139 clinical centers have been launched around the world, 817 patients have been screened, and 234 subjects have been randomized. The trial is planned to be completed in 2025, and the overseas new drug registration and marketing work will be carried out after that.

It is understood that Alzheimer’s disease is a serious neurodegenerative disease that causes progressive and persistent cognitive impairment in patients, and eventually loses the ability to work and live. There are about 10 million Alzheimer’s patients in my country, the largest number in the world. The accelerated aging of the population will further drive the increase in the number of patients. It is estimated that by 2050, there will be more than 40 million Alzheimer’s patients in my country.