One shot of 700,000 changed to 30,000, how did the "sky price" be "cut down"?

The industry generally refers to drugs that cost more than one million yuan a year as high-value drugs
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Although dozens of drugs for rare diseases have been included in the medical insurance, there has never been a high-value rare disease drug in the national medical insurance before
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On December 3, the National Medical Insurance Bureau announced that 74 new drugs were included in the medical insurance, among which the high-priced "700,000 yuan per shot" drug Noxinagenic Sodium was among them, and the high-value rare disease drug agalsidase alpha injection was also included in the medical insurance.
With concentrated solutions, the previous year's cost was generally at the million yuan level
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This means that some patients with rare diseases will get the double benefit of drastically reduced prices of medicines and proportional reimbursement of medical insurance
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However, the anti-cancer drug Achilles, which has also received much attention, "1.
2 million yuan per shot", failed to enter the medical insurance negotiations
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The issue of high-value drugs entering medical insurance has once again sparked heated discussions.
Behind the frequent discussions is the urgent need for "affordable drugs" by the people
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Why are some high-value drugs included in medical insurance, but some are "turned out"? When the medical insurance catalogue is dynamically updated to realize the benefits of "vacating the cage and changing the bird" to benefit more people, where is the yardstick for calculating the "people's livelihood and economic account" between willingness and gain? Will high-value drugs enter the medical insurance system to increase the operational risk of the medical insurance fund? How to improve the accessibility of high-value drugs that are not covered by medical insurance? Xinhua Daily Telegraph reporters conducted research on this
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A needle of 700,000 yuan fell to the "floor price", "what a miracle.
" The first round of quotation dropped to more than 50,000 yuan a needle, and finally after 8 rounds of negotiations, the world's first treatment for spinal muscular atrophy (SMA) ) The Noxinagen Sodium Injection has entered the new version of the medical insurance catalog at a "floor price" of less than 33,000 yuan per injection, which is undoubtedly exciting news for patients
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Behind this miracle is the negotiation game between the National Medical Insurance Administration and the company in about 90 minutes
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In August 2020, Nosinassen Sodium Injection entered the public eye at a sky-high price of "700,000 yuan per injection", which triggered heated discussions; this year, Nosinassen Sodium Injection dropped to 550,000 yuan, which has attracted attention again
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"This is an important turning point in life for many patients
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"Xing Huanping, director of the public welfare organization Meier SMA Care Center, said that among the data of more than 2,000 patients that have been collected, 73% of the children are children under 6 years old.
If they do not use medicine, they will suffer from severe type 1 SMA.
After muscle atrophy, he could not even eat or drink, and it would even be life-threatening.
The medication can effectively curb the deterioration of his condition
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A child from Jiangxi, Mao Mao, was diagnosed with SMA at 10 months, and his condition deteriorated at the age of 2 and a half years.
The family decided to contribute money to the child.
After using Noxinassen Sodium Injection and 5 injections in more than half a year, the child's mobility has improved significantly
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"It has been a miracle that this medicine went from the domestic market to the medical insurance in two years
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"Maomao's mother said, but before the outcome of the medical insurance negotiations came out, the Maomao family had once again pooled together money to prepare for the next year's treatment costs
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"Regardless of whether I can get medical insurance or not, I must be prepared to let the child continue to take medicine
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"Previously, Nosinassen Sodium Injection has applied for the 2020 medical insurance negotiations.
However, Nossinassen Sodium, which has the largest clinical research data in the SMA field, was not included in the National Medical Insurance Drug List that year due to various factors such as excessive prices
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"Always, It is our goal to include qualified rare disease treatment drugs in the scope of medical insurance payment according to regulations
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"Huang Huabo, Director of the Medical Service Management Department of the National Medical Insurance Administration, said that a total of 7 rare disease drugs have been added to the catalog adjustment, and high-value rare disease drugs have been included in medical insurance for the first time.
So far, the 2021 edition of the National Medical Insurance Drug List has included more than 40 rare diseases.
Medication
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In addition to Noxinassen Sodium Injection, the concentrated solution of agalsidase alpha injection, which is used to treat the rare disease Fabry's disease and requires long-term use by patients, also enters the medical insurance at "far below the market price"
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Previously, this kind of The annual treatment cost of the drug exceeds one million yuan
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In response, Shan Guohong, president of Takeda China, the drug manufacturer, said that the medical insurance catalogue has been adjusted to include more innovative drugs in the field of rare diseases.
This shows to a certain extent that the relevant departments are in the medical insurance catalogue.
During the adjustment process, support the orientation of drugs with significant clinical needs and high value
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Entering medical insurance is only the first step for high-value drugs to become ordinary people
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The implementation of rare disease drugs is also the “deep water area” of the medical insurance system.
It involves the updating and implementation of local medical insurance and commercial insurance rules.
After the new medical insurance catalog is implemented, designated medical institutions and designated retail pharmacies will have a "dual channel".
"It is necessary to meet the guarantee of drug supply and clinical use as soon as possible, and to get through the "last mile" of patients' medication
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Why is the anti-cancer drug of "1.
2 million yuan per shot" not covered by medical insurance? Is price the "only yardstick"? China's first CAR-T drug Akirensai injection is an anticancer drug for relapsed or refractory large B-cell lymphoma, which was approved for marketing in June this year
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A small bag of 68 ml of liquid seems to be ordinary, because the patient’s own T cells need to be used in highly complex personalized treatments.
In addition, each machine and each consumable are currently imported in accordance with international standards, which ultimately makes the price vary The cost is "rising, and the boats are rising", and the price reaches 1.
2 million yuan
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Regarding whether Akilunzai can be included in the medical insurance, it has attracted a lot of public attention before, but after the preliminary review of the negotiations, this innovative drug has not entered the negotiation link of the medical insurance catalog in 2021
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In this regard, the National Medical Insurance Bureau made a clear response: because the price far exceeded the affordability of the fund and the burden level of the common people, it was not economical and failed to pass the review, and ultimately did not qualify for negotiation
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"We are reducing the price of the product as much as possible, but it will take some time
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" said Huang Hai, president of Fosun Kate, the drug manufacturer
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"Expensive drug costs bring a heavy burden to the people, but also bring certain risks to the safety of the fund
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" Zheng Jie, head of the 2021 National Medical Insurance Negotiation Medicine Fund Measurement Expert Group, introduced that according to the limited payment scope, the current national medical insurance The annual treatment cost of all drugs in the drug catalog does not exceed 300,000 yuan
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This scene seems to be familiar.
In 2020, the sodium production of Nosina is also out of medical insurance due to factors such as too high price.
But is the price really the "only yardstick" for whether medicines can be covered by medical insurance? According to industry insiders, it is different from Nosinagen sodium, which already has mature clinical data
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As an innovative drug, CAR-T drug still has limitations in terms of scope of clinical use, clinical effects, and real-world data
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At this stage, the time to include CAR-T drugs in medical insurance is not yet ripe
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"Whether drugs can be included in medical insurance must be comprehensively considered by the insured's rational use of drugs, the clinical value of the drug, the degree of innovation, the affordability of medical insurance funds, etc.

" Zheng Jie said that the precise calculation of medical insurance negotiations pursues "reasonable prices", not blindly.
"Bargaining" pursues the "lowest price"
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In order to further improve the accuracy of the negotiation calculation, the negotiation guideline for the calculation of pharmacoeconomics was formulated for the first time, and the calculation standard was unified
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At the same time, more than 40 pharmacoeconomics experts who participated in the calculation were trained in professional systems, especially in the five dimensions of clinical efficacy, safety, economy, innovation and fairness to inspect innovative drugs, and adjust their prices respectively.
Factors
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In addition, in the 2021 medical insurance negotiations, two experts will conduct a "back-to-back calculation" for the same drug allocation
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Liu Guoen, head of the pharmacoeconomics group for medical insurance calculations in 2021 and dean of the Peking University Global Health Development Institute, said: "Although everyone's workload has doubled, the quality and scientific level of drug review has been improved
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" "Soul cut "Price" cuts off the falsely high prices of medicines
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Zheng Jie said that the medical insurance negotiation seeks a reasonable price balance point in the multi-party game of patient demand, pharmaceutical company innovation, fund affordability, etc.
, so as to benefit more insured persons while also leaving sufficient development for enterprise innovation and development.
Space
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To prop up the "hope in despair", the domestic market is emboldened by volume-for-price exchange.
In the "First List of Rare Diseases" jointly published by the National Health Commission and other departments in 2018, 121 rare diseases are involved.

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Although the incidence of these rare diseases is low, they are "100%" for every sick family.
Due to the small demand for rare disease drugs, high costs, and few alternatives, there are no medicines available or they cannot be used.
patients may be placed in despair, and into Medicare means "despair of hope"
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Prior to this, many people were not optimistic about high-value drugs entering medical insurance
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On the one hand, because many high-value drugs are effective and have a monopoly position in the field of diseases, pharmaceutical companies are not worried about profitability, so they have the confidence not to give up prices; on the other hand, drugs that are too expensive may enter medical insurance.
Infringe on the rights of more insured persons
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In this medical insurance negotiation, although the sky-high anti-cancer drug Akirensai injection with a unit price of 1.
2 million yuan passed the preliminary review, it did not enter the negotiation link of the medical insurance catalog, allowing more people to firm up the above views
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"Different from foreign countries, after many rare diseases are superimposed on China's huge population base, the drug market brought by patients to enterprises is relatively more impressive
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" said Jin Chunlin, director of the Shanghai Municipal Health and Health Development Research Center
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The health and well-being of 1.
4 billion people and the Chinese market are just using sales to exchange the confidence of low prices
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The relevant person in charge of the National Medical Insurance Bureau introduced that the drugs included in the negotiation scope are negotiated and negotiated with enterprises on the basis of "national medical insurance usage"
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After many exclusive drugs have entered the national medical insurance drug catalog, they can basically win 90% of the domestic market, and the sales volume is very impressive
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As the first pioneer in the introduction of high-value rare disease drugs into medical insurance, the success of the medical insurance negotiations for Noxinagen Sodium Injection may be able to provide some experience for the introduction of high-value drugs into medical insurance
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But the fact that cannot be ignored is that the so-called "sky-priced medicine" is not without room for price reduction
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In June 2021, Roche's innovative neurological drug Lisporan oral solution powder, also used in the field of SMA, entered the Chinese market
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Risporan is administered according to the age and weight of the patient.
With the addition of a gift, the cost of medication for children with low body weight SMA under 2 years old is much lower than that of nocinnagenic sodium, while 80% of the age of onset of SMA patients in my country is under 2 years old
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The drug poses a challenge to the existing market of Noxinat Sodium Injection
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China's sales market and the emergence of competing products have given the national medical insurance negotiations the confidence to obtain imported high-value drugs at prices far below foreign markets, or even the lowest prices in the world.
It also makes it possible for more good drugs and new drugs to enter medical insurance
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In contrast to many people who think that the entry of high-value drugs into medical insurance is only an accident, Liu Guoen said that under the existing rules, when reviewing experts balance the value and price relationship, they will focus on diseases that are overburdened by individuals, thereby promoting the realization of some drugs.
The breakthrough in entering medical insurance has literally reduced the burden on patients
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Future medical insurance negotiations may give more "high-priced drugs" a "green light", which requires joint exploration of multi-party benefits and promotion of innovative medical insurance solutions
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The "700,000 yuan per shot" of Noxinagen Sodium Injection has passed the medical insurance last year to "successfully entered" this year, which may provide a way of thinking and reference for more "expensive drugs" to enter the medical insurance
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Entering medical insurance is not the "only correct solution" for the
universalization of high-value drugs.
"The strategic purchase pursued by medical insurance is not to fight for the'cheapest ' nor to be intimidated by the'expensive drugs' .
" Jin Chunlin said that the medical insurance is through "vacation of cages for birds.
" , To achieve the greatest common divisor of "people first and health first" in a sustainable manner
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Cao Zhuang, director of the Medical Management Office of the National Medical Insurance Research Institute of Capital Medical University, said that basic medical insurance alone cannot solve the problem of all patients using high-value drugs.
At the same time, it must play a multi-faceted role in commercial insurance and social assistance to clarify the boundaries of responsibility
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"Technological innovation can achieve a fundamental reduction in the cost and price of innovative drugs, and make full preparations for future market competition and access to medical insurance
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" Approved for listing this year, but two years ago, it has begun to deploy a long-term cost reduction development strategy, including improving the efficiency of raw materials, implementing domestic substitution, and accelerating the research and development of new technologies, with a view to ultimately achieving substantial cost reductions
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Take CAR-T products as an example.
The current technology is relatively mature in autologous CAR-T products.
One of the future directions is to study allogeneic CAR-T technology, which is commonly known as general CAR-T
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If this technology breaks through and matures, it will be possible to use T cells from healthy people to make universal CAR-T products, and at the same time provide it to more patients
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As a result, the cost is expected to be further reduced
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In addition, the "sympathetic medication" approach can not only help patients who are in urgent need of medication but cannot afford the high drug costs, but also help companies obtain more real-world verification data
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“Many innovative drugs still need a lot of real-world data to verify their safety and efficacy after they are on the market
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” Chen Hao, a senior economist at Tongji Medical College of Huazhong University of Science and Technology, said.
At the same time, no fees can be charged to patients who are willing to participate in clinical research, which can save the cost of intermediate links and provide a possibility for patients to use drugs
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Some people in the industry have also suggested that it is possible to explore the step price or financial sharing mechanism for high-value drugs, that is, to set different price levels for the purchase of 1,000 or 10,000, or to delineate certain disruptive innovations of high-value drugs.
Medical insurance pays a fixed amount, rather than undifferentiated "line", thereby enhancing the accessibility of high-value "orphan drugs", and encouraging pharmaceutical companies to work hard to develop innovative drug research and development without excessively increasing the burden of medical insurance
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"Every small group should not be given up
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" As Zhang Jinni, the negotiator of the National Medical Insurance Bureau, said at the medical insurance negotiation site, people's health is paramount, and China Medical Insurance strives to protect the health of every insured person.
This is not to give up any one.
The determination of a patient is a country’s respect for life
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With the gradual establishment of the dynamic adjustment mechanism of the national medical insurance drug catalogue, the rules for the regular access and negotiation access of drugs are gradually clarified.
Expanding inclusiveness while taking into account the needs of patients and the capacity of medical insurance funds will become a breakthrough in the medical reform.
The "unbreakable bottom line"
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