Deployment of drug supervision work in 2023

From January 5th to 8th, 2023, the new national medical insurance negotiation was successfully completed. According to the list of preliminary examination drugs, this negotiation will involve 343 varieties, including 145 original varieties in the list and 198 new varieties outside the list.
The first day categories: antiviral drugs, respiratory drugs, anesthetic drugs, digestive drugs and nutritional drugs, etc.
The second day category: drugs for chronic diseases, cardiovascular, orthopedics, autoimmune diseases, etc.
The third day categories: drugs for rare diseases, tumors, etc.
The fourth day category: Chinese patent medicine, PD-1, double antibody, ADC, CAR-T, etc.
■Tumor drugs
In terms of indications, the number of anti-tumor and immunomodulators that passed formal review was the largest, totaling 89.
Roche's Emmett trastuzumab, Pertuzumab, Vemurafenib Tablets, BeiGene's Belintuomab, Carfilzomib, Stuximab, Tislelizumab, GlaxoSmithKline's mepolizumab and others participated. In addition, 4 antibody-drug conjugates (ADCs) participated, including 1 Rongchang Biological Vidicumumab and Roche Emmett Trastuzumab, Pfizer Oga Imotuzumab and Takeda Vitex Butuximab is a product of three multinational pharmaceutical companies outside the catalogue.
In terms of rare disease drugs,
there are 19 eligible rare disease drugs outside the list, involving Biogen, Sanofi, Novartis, Roche, Takeda, BeiGene and other companies, covering Fabry disease, Pompe disease, Gaucher disease, Pulmonary hypertension, spinal muscular atrophy (SMA), multiple sclerosis (MS) and other rare diseases.
Takeda Pharmaceutical’s hereditary angioedema treatment drug lanariumab, Gaucher disease treatment drug velaglucerase α for injection, Sanofi’s laronisase concentrated solution for injection for mucopolysaccharidosis, Velaglucerase α, a therapeutic drug for Gaucher disease, has passed the preliminary review.
■PD-1 competition is fierce
Three drugs, camrelizumab for injection (Hengrui Medicine), tislelizumab (BeiGene), and sintilimab (Innovent Biologics), which have entered the national medical insurance catalog, have made some progress. Also participating in the negotiations were Junshi Biotech’s toripalimab, Akeso Biotech’s cardonirizumab, Fuhong Henlius’ PD-1 monoclonal antibody, and Corning Jerry’s/Studi’s/Simcere’s PD-L1 monoclonal antibody. anti.
According to previous national talks, the price reduction of PD-(L)1 is about 50%. At present, the involution of PD-1 is serious, and the market pressure is huge. "Price for market" has become one of the important ways of marketization and commercialization.
■Pfizer’s P drug was unsuccessful.
This year, Azivudine Tablets, Naimatevir Tablets/Ritonavir Tablets Combination Packaging (Paxlovid), and Qingfei Paidu Granules have passed the company’s self-declaration, form review, expert review, etc. program, participated in the negotiations. Among them, Azivudine Tablets and Qingfei Paidu Granules were successfully negotiated, but Paxlovid failed due to the high quotation of the manufacturer Pfizer Investment Co., Ltd.
After Azivudine Tablets and Qingfei Paidu Granules were included in the National Medical Insurance Drug List through this negotiation, there are more than 600 kinds of drugs in the National Medical Insurance Drug List for the treatment of fever, cough and other new crown symptoms.
■Pharmaceutical company executives lead the team.
Many corporate executives and other heavyweights personally lead the team. Bian Xin, President of Roche Pharmaceuticals China; Osram, Global Vice President and General Manager of China Region of AbbVie; Yin Min, CCO of BeiGene Greater China; Dong Lijun, Executive Vice President and Chief Operating Officer of Luoxin Pharmaceuticals; Zhang Hong, Deputy General Manager, Director of Government Affairs and Business Division, Greater China; Paul Koolenbrander, Vice President of Merck China Pharmaceutical Health, Head of Cardiovascular, Metabolism and Endocrinology Division; Pfizer Global Biopharmaceutical Business Group China Vice President and Head of Market Access, Qian Yun, etc.
Policies
■Health and Health Commission: Standards for Medical Equipment Equipping in Class II and Class III Hospitals On
January 7, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council issued the "Notice on Printing and Distributing Operational Guidelines for the Prevention and Control of Novel Coronavirus Infection".
It is pointed out that it is necessary to strengthen the reserve of critical medical resources in secondary hospitals. Second-level general hospitals should set up independent intensive care departments, and second-level infectious disease hospitals and children's specialized hospitals should set up intensive care units. Second-level hospitals should build and renovate intensive care units according to standards, ensure that power supply, oxygen supply facilities, life monitoring, and rescue treatment equipment are in good condition, and that each intensive care unit can be used at any time.
It is necessary to strengthen the preparation of critical medical resources in tertiary hospitals. Ensure that the comprehensive ICU monitoring unit is ready for use. Hospitals should speed up the construction and upgrading of comprehensive ICU monitoring units in accordance with comprehensive ICU standards, and conduct inspections one by one to ensure that power supply, oxygen supply facilities, life monitoring, and rescue treatment equipment are in good condition, and that all intensive care units can be used at any time .
■National Medical Insurance Administration: Re-pricing of new crown drugs
On January 6, the National Medical Insurance Administration issued the "Notice on Printing and Distributing the Guidelines for the Formation of Prices of New Crown Treatment Drugs (Trial)".
The National Medical Insurance Administration proposed that on the basis of independent pricing by enterprises, guide enterprises to formulate prices of new crown treatment drugs in a fair, transparent and reasonable manner. The overall cost is determined based on raw material costs, R&D costs, and period expenses, and drug prices are determined by superimposing distribution costs and profits, and price re-evaluation and dynamic adjustments are implemented after listing.
Two drugs, Azvudine and Paxlovid, which were approved for marketing in the early stage, have prominent contradictions in supply and demand and price problems. Two companies have been interviewed successively, and the companies have also taken the initiative to reduce prices. Among them, Paxlovid has been lowered from 2300 yuan per box to 1890 yuan, and has been temporarily included in the medical insurance of many provinces.
■Drug Supervision Work Deployment in 2023
On January 5, the National Drug Supervision and Management Work Conference was held in Beijing, and the drug supervision work deployment in 2023 was made.
The first is to keep integrity and solid foundation, and resolutely hold the bottom line of drug safety. Serve and guarantee the new stage of epidemic prevention and control work, strengthen the quality supervision of epidemic prevention medicines and equipment, support the production and supply of key epidemic prevention medicines and equipment, and continue to do a good job in emergency review and approval work; promote the normalization of special rectification of drug safety with a long-term mechanism, and effectively crack down on violations Criminal behavior; continue to improve the vaccine management system to ensure the quality and supply of vaccines; strengthen the quality and safety supervision of key varieties, adhere to "zero tolerance" for product quality problems, and continue to strengthen the supervision of online sales; comprehensively strengthen the investigation and resolution of risks and hidden dangers, and coordinate the use of various means Strengthen safety supervision, improve pharmacovigilance and emergency management system.
The second is to reform and innovate to promote the high-quality development of the pharmaceutical industry. Promote the creation of a rainforest-type pharmaceutical innovation ecology, accelerate the launch of new and good medicines, promote the R&D and listing of high-end innovative medical devices, release the dividends of cosmetics review and approval reform, and stimulate the vitality of regional pharmaceutical innovation; promote the inheritance and innovation of traditional Chinese medicine, improve the regulatory system of traditional Chinese medicine, and improve the traditional Chinese medicine Review and approval mechanism, strengthen international exchanges and cooperation of traditional medicines; continue to release the reform dividend of "decentralization, regulation and service", improve "Internet +" government services, expand the promotion and application of enterprise-related electronic certificates, and further optimize the business environment.
The third is to take a long-term basis and comprehensively improve drug supervision capabilities. Improve the drug regulatory quality management system, regulatory system, standard system, and scientific and technological support system, strengthen technical support capacity building, vigorously develop smart regulation and regulatory science, promote higher-level openness and higher-quality international cooperation, and accelerate the advancement of the drug regulatory system and modernize regulatory capacity.
■By 2025, more than 80% of districts and counties across the country will provide community rehabilitation services for mental
disorders , it is planned to use three years to improve the quality and level of community rehabilitation services for mental disorders, provide more equitable, accessible, systematic and continuous basic rehabilitation services for patients with mental disorders, enhance the sense of gain and happiness of patients with mental disorders and their families, and strive for the comprehensive construction of A modern socialist country creates a safe, stable, healthy and orderly social environment.
The "Notice" clarifies the annual task indicators for the coverage rate of counties (cities, districts, and banners) of community rehabilitation services for mental disorders, and the rate of registered rehabilitation service objects receiving standardized services. The "Notice" proposes six key action plans to point out the direction for comprehensively promoting the development of community rehabilitation services for mental disorders. The first is the action of optimizing the layout of service system construction; the second is the action of smooth treatment and rehabilitation referral; the third is the action of improving service supply capacity; the fourth is the action of building a professional talent team; the fifth is the action of ensuring sustainable development; the sixth is the action of optimizing the service support system .
Beijing Medical Insurance Bureau: From January, dental implants will be included in the medical insurance.
According to CCTV news, from January 1st, oral implant medical services will be included in the scope of medical insurance payment in Inner Mongolia, covering implant placement, implant crown restoration, oral cavity 22 dental medical service items such as internal bone grafting.