People's Daily Online, Beijing, February 21 (Reporter Cui Yuanyuan) Cancer is a major public health problem that seriously threatens people's health, and it is also a major "pain point" for people's livelihood in the current society. Over the past year, the CPC Central Committee and the State Council have attached great importance to cancer prevention and treatment. In order to improve people's health and well-being, achieve early screening, early diagnosis and early treatment of cancer, ensure that patients use high-quality and inexpensive drugs, in the establishment and improvement of cancer diagnosis and treatment system, continue to optimize cancer diagnosis and treatment mode, accelerate the approval and listing of new drugs, support and encourage research and innovation, and national negotiations to purchase in quantity More first-aid good drugs were included in the medical insurance, and remarkable achievements were made in solving the difficulties of negotiating anti-cancer drugs in hospital admission and prescribing, which improved the security and treatment of patients and reduced the drug burden of patients.
Can the price of anti-cancer drugs fall again in 2019? Would it be better to buy? Will it be faster to market urgently needed drugs? Can it be more convenient to accept standardized cancer treatment? On the 19th, at the regular policy briefing of the State Council, the heads of four departments, namely the National Health Commission, the Ministry of Finance, the National Medical Security Bureau and the State Food and Drug Administration, summarized the cancer prevention and control work in 2018, and determined the next work priorities based on the problem.
Promote early diagnosis and treatment to make cancer prevention more standardized and convenient
Experience at home and abroad shows that early prevention, early screening and early treatment have significant effects on reducing the incidence and mortality of cancer. In terms of cancer prevention and control, China has adhered to the principle of prevention first, strengthened early screening and early detection, and actively promoted early diagnosis and treatment, which has achieved certain results.
According to the data of the National Health Commission, after the establishment of the annual report system of tumor registration, 574 tumor registration offices have been set up nationwide, covering 438 million people, which has comprehensively grasped the incidence, death, survival and development trend of cancer in China.
After carrying out cancer screening, early diagnosis and early treatment in high incidence areas in rural areas, Huaihe River basin, and some cities, as well as the screening of rural women for "two cancers", the early diagnosis rate of cancer in the project area now exceeds 80%, the treatment rate reaches 90%, the cancer mortality rate of screening population decreases by 46%, and the cost of early diagnosis and treatment of early cases is nearly 70% less than that in the middle and late stages.
At the same time, the National Cancer Center, Regional Cancer Diagnosis and Treatment Center and Key Cancer Clinical Specialty Construction were also carried out, and a cancer diagnosis and treatment and rehabilitation system with tumor hospitals, general hospital oncology departments, grass-roots medical and health institutions, rehabilitation hospitals, and hospice care centers as the main body was initially formed.
"Next, we will promote the full coverage of tumor registration in all counties and districts across the country, build a national cancer big data platform, build a nationwide cancer case registration system, promote data exchange and sharing with relevant monitoring systems, timely grasp the dynamics of cancer incidence in China, and carry out targeted prevention and control work." Li Bin, deputy director of the National Health Commission, said.
Li Bin said that in order to further standardize cancer diagnosis and treatment, screening, early diagnosis and early treatment guidelines will be developed for key cancers such as upper gastrointestinal cancer, colorectal cancer, and cervical cancer with high incidence and relatively mature screening means and technical schemes, and more efforts will be made to promote them. For cancer with immature screening technologies such as liver cancer and low cost-effectiveness of lung cancer screening, we will focus on joint research and optimize the screening technology scheme. At the same time, we will gradually expand the coverage of high-risk cancer screening and early diagnosis and treatment, and create conditions for universal cancer opportunistic screening.
Through technical training, counterpart support, telemedicine and other means, we should also improve the cancer screening, early diagnosis and early treatment capabilities of grass-roots medical and health institutions, especially county and district level medical and health institutions, strengthen the mastery of cancer prevention knowledge and skills in the training of public health physicians, promote the popularization of appropriate technologies, and promote the regional balanced development of cancer diagnosis and treatment capabilities.
Promote the development of children's tumor, imaging and other weak disciplines, strengthen the allocation of human resources in relevant disciplines, and comprehensively improve the ability of various disciplines related to tumor diagnosis and treatment.
We will continue to promote the establishment of a "single disease, multidisciplinary" diagnosis and treatment model, integrate the technical strength of all relevant professions, clarify the indications and development conditions of surgery, radiotherapy and chemotherapy, determine the best diagnosis and treatment plan, and implement individualized treatment. Promote the mature application of new technologies, strictly manage the quality of new technologies, and ensure medical quality.
We will continue to increase the publicity of cancer prevention and anti-cancer science, actively promote the healthy lifestyle action of the whole people, improve the health literacy level of the people, and prevent the occurrence of cancer.
Meet the urgent need of patients for new anti-cancer drugs "acceleration"
Wang Ping, Director of the Drug Registration Department of the State Food and Drug Administration, said that in 2018, the State Food and Drug Administration introduced a series of policies and measures to speed up the listing of new anti-cancer drugs. For example, to speed up the import and listing of innovative drugs, the clinical trial application system was changed from the approval system to the default system of expiration, and the imported chemical drugs were changed to customs clearance based on the inspection results of enterprises, instead of batch by batch inspection. For example, if the approval for the listing of new drugs already listed overseas in China is accelerated in an orderly manner, the requirements for the listing of drugs for rare diseases and some drugs for the prevention and treatment of diseases seriously endangering life can be submitted directly to the market, including all research materials obtained overseas, and the regulatory department will review and conclude them within three months and six months respectively. For another example, accelerate the registration and approval of new anti-cancer drugs at home and abroad to meet the urgent needs of patients, organize experts to avoid selecting new overseas drugs urgently needed clinically, improve import policies, and promote the simultaneous listing of new overseas drugs in China. The temporary import channel of anticancer drugs urgently needed in clinic should be unblocked.
These institutional reforms and comprehensive measures have achieved positive results. According to the data from the State Food and Drug Administration, 18 new anti-cancer drugs were approved in 2018, a significant increase over 2017. It includes 13 new anti-cancer drugs listed overseas and 5 new anti-cancer drugs independently innovated in China, which increases the choice of patients and better meets the clinical needs. In 2018, the average review time of new anti-cancer drugs was shortened from 24 months to 12 months.
Wang Ping said that in 2019, the State Food and Drug Administration will focus on promoting the rapid listing of new anti-cancer drugs from five aspects to benefit patients. First, it will work with the National Health Commission to further improve the approval mechanism of the special channel for new overseas drugs urgently needed clinically, continue to organize experts to select the second batch of new drugs urgently needed clinically, incorporate them into the special channel, and accelerate the listing process.
Second, it is planned to further strengthen the communication and contact with relevant pharmaceutical industry associations and multinational companies, and mobilize relevant enterprises to apply for overseas new drugs that have not been applied for in China.
The third is to further improve the policy and technical requirements for the import approval of related drugs. For new anti-cancer drugs urgently needed by the public in clinical practice, if the early and mid-term indicators of clinical trials show efficacy and can predict clinical value, they can be approved for marketing with conditions to further speed up the process of marketing.
Fourth, we will further accelerate the review and approval of new domestic anti-cancer drugs. On the one hand, we will further improve the drug priority review and approval system, including domestic drugs, and strengthen communication and service guidance. Accelerate the approval and listing of new anti-cancer drugs and anti-cancer generic drugs independently researched and developed in China through early intervention and full process guidance of review institutions. On the other hand, strengthen the cooperation and cooperation with the Ministry of Science and Technology and other departments, continue to strengthen the support for the research and development of domestic new anti-cancer drugs, improve the new drug research and development system, combine the implementation of major national science and technology special projects for the development of major new drugs, provide financial support for the research and development of domestic new anti-cancer drugs through relevant science and technology plans, and promote the development of domestic new anti-cancer drugs and the morning market.
Fifth, further strengthen the supervision of drugs, strengthen on-site inspection, spot check on the market and adverse reaction monitoring, and ensure the quality and safety of anti-cancer drugs.
Promote the price reduction of anti-cancer drugs to ensure that patients can afford, buy and use them
"The National Health Insurance Bureau attaches great importance to the negotiation of the implementation of anti-cancer drugs, and takes multiple measures together with relevant departments to ensure that eligible patients can buy, use, and reimburse the negotiated drugs." Xiong Xianjun, director of the Medical Service Management Department of the National Health Insurance Bureau, said.
It is understood that in 2018, 17 anti-cancer drugs were included in the medical insurance through negotiation, with an average price reduction of 56.7%. The prices of most imported drugs are lower than those of surrounding countries and regions, with an average price reduction of 36%.
Xiong Xianjun said that in order to break down barriers such as "difficulty in entering Huan" and "difficulty in prescribing" of anti-cancer drugs for negotiation, the Health Insurance Bureau and the National Health Commission issued a document requiring that all regions should not affect the supply and use of anti-cancer drugs on the grounds of total cost control and "drug proportion". The expenses for reasonable use of negotiated anti-cancer drugs in 2018 are not included in the general control scope of that year, and are separately accounted for and guaranteed according to regulations. When formulating the control indicators for the total amount of medical insurance in 2019, the factors of rational use of anti-cancer drugs should be considered as a whole.
According to the data from the National Health Insurance Bureau, as of December 31, 2018, the total purchase volume of 17 national negotiated anti-cancer drugs in medical institutions and pharmacies across the country since the implementation of the new negotiated price was about 1.84 million (pills/tablets/piece), with a total purchase amount of 562 million yuan, saving 918 million yuan compared with the pre negotiation price. A total of 44600 person times were reimbursed, with an amount of 256 million yuan.
By the end of 2018, 802 tertiary general hospitals and cancer specialty hospitals nationwide had purchased the national medical insurance negotiation anticancer drugs, of which 259 hospitals had purchased more than 4 kinds of drugs to meet the drug needs of cancer patients. All 31 provinces in China have carried out special centralized procurement related work. 14 provinces, including Shaanxi and Liaoning, have established cross provincial alliances for joint price negotiation procurement, and the price of anti-cancer drugs has further decreased.
In addition, the Health Insurance Bureau further reduced the price of sub drugs, including anti-cancer drugs, through the national organization of drug centralized procurement and use pilot. Among them, the price of gefitinib, a targeted drug for lung cancer, was reduced by 77%, the price of imatinib mesylate, a targeted drug for leukemia, was reduced by 33%, and the price of pemetrexed sodium, a French drug for chemotherapy, was reduced by 67%.
In the new year, in order to promote the price reduction of anti-cancer drugs and improve the ability of medical security assistance for cancer patients, Xiong Xianjun revealed that he would continue to track and monitor the procurement and reimbursement of anti-cancer drugs negotiated by the country, pay close attention to the impact of policies such as the control indicators of medical expense growth, the control of total medical insurance, and the "proportion of drugs" on the rational use of anti-cancer drugs negotiated, It will also strengthen supervision and guidance with the Health Commission, and require medical institutions to provide corresponding drugs according to clinical diagnosis and treatment needs to avoid the situation of not providing drugs without proper reasons or letting patients purchase drugs outside the hospital. Timely take interviews, circulars and other means to urge the local and medical institutions that do not implement effectively to rectify, so as to ensure that the majority of cancer patients enjoy the benefits brought by the national anti-cancer drug price reduction policy.
Xiong Xianjun said that in 2019, a new round of adjustment of the medical insurance drug catalogue will be carried out, and those good drugs that save lives will be included in the medical insurance through expert review and drug access negotiations. With the goal of effectively protecting the basic medical rights and interests of the insured, and focusing on improving the efficiency of the use of the medical insurance fund, we should balance the clinical needs and the affordability of the medical insurance fund, and include more qualified emergency and life-saving drugs into the medical insurance drug catalog according to the prescribed procedures, so as to constantly improve the level of basic medical security.
We also need to consolidate and improve serious illness insurance, reduce the burden of high expenses on seriously ill patients, and implement preferential policies such as reducing the minimum payment line, increasing the reimbursement rate, and closing the line for people in need. We will increase medical assistance to poor patients, and form a comprehensive security system that effectively connects with basic medical insurance and serious illness insurance.
Deepen the reform of value-added tax and further open the space for drug price reduction
On February 11, the executive meeting of the State Council decided to give value-added tax preference to rare disease drugs, which is another tax reduction measure for the pharmaceutical sector after the implementation of value-added tax preference for anti-cancer drugs. It will help ensure the demand of rare disease patients, support the R&D and innovation of rare disease drugs, and further open the space for drug price reduction.
In order to support the research and development of drugs, reduce the cost burden of patients, and improve medical services, in recent years, the state has continuously increased the support of tax policies, and issued a series of value-added tax preferential policies for the pharmaceutical industry.
Xu Guoqiao, head of the Tax Administration Department of the Ministry of Finance, said: "It mainly includes the exemption of value-added tax on medical services provided to patients by hospitals and other medical institutions; medical institutions accept the entrustment of other medical institutions to provide qualified medical services without value-added tax;"; The same innovative drugs provided by drug manufacturers to patients for subsequent free use do not fall within the scope of VAT deemed sales, and VAT is not levied; For general VAT taxpayers who produce, sell, wholesale or retail anti-cancer drugs, they can choose to pay VAT according to the simple method and the 3% collection rate; The import value-added tax on imported anti-cancer drugs shall be reduced by 3%. "
Next, the Ministry of Finance will actively work with relevant departments to implement drug tax policies, support the development of the pharmaceutical industry, and effectively guarantee the drug demand of patients. In combination with the update of rare disease drugs, the list of rare disease drugs enjoying value-added tax policy for subsequent batches shall be issued in a timely manner. At the same time, in combination with the further deepening of value-added tax reform, the VAT system arrangement shall be continuously improved and the tax environment for drugs shall be optimized.
