Negotiations on the National Medical Insurance Drug List Ended, "Sky-Priced Drugs" Become the Focus

During this year’s “Double 11” shopping festival, in addition to the eye-catching promotional activities on e-commerce platforms, a national-level “bargaining” also attracted attention, that is, the 2021 National Medical Insurance Drug Catalog Negotiation (hereinafter referred to as the National Medical Insurance) Negotiation)
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From November 9th to 11th, the three-day negotiation attracted the attention of the industry and the public.
Akilunza injection passed the formal review, the PD-1 antibody drug "price war" was fierce, and 20 innovative drugs entered the national medical insurance negotiation.
The popularity of other topics has risen
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On December 3, the National Medical Insurance Administration and the Ministry of Human Resources and Social Security issued the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)" (hereinafter referred to as the "2021 Drug Catalog")
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The "2021 Drug Catalog" contains a total of 2,860 types of Western medicines and proprietary Chinese medicines, including 1,486 types of Western medicines, 1,374 types of proprietary Chinese medicines, and 892 types of decoction pieces of Chinese medicine that can be paid for by the fund
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A total of 74 drugs were added to the catalog, of which 7 drugs were directly transferred to the catalog, 67 were negotiated into the catalog; 11 drugs were removed from the catalog
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Judging from the negotiation situation, the average price of 67 drugs that entered the list of negotiations was reduced by 61.
71%
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Among these 67 drugs, there are 17 anti-tumor drugs and 7 rare disease drugs (see Figure 1)
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It is worth noting that the previously concerned "700,000 yuan per shot of sky-high price drug" spinal muscular atrophy treatment drug Noxinasheng sodium injection, and the treatment of Fabry disease with an annual treatment cost of more than one million yuan, Agarose Enzyme alpha injection concentrated solutions have successfully entered the "Drug List 2021", creating a precedent for high-value rare disease drugs to be included in medical insurance
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Public opinion trends and main points of concern: November 1st-December 2nd is the monitoring period.
Public opinion related to the national medical insurance negotiations showed a "mountain-like" development feature (see Figure 2).
The CAR-T product Akilunzai injection passed Formal review has attracted much attention, and public opinion has a clear peak on November 10
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The high-priced CAR-T drug passed the formal review and did not enter the negotiation link.
On November 10, the media reported on the scene of the national medical insurance negotiation.
In addition, it also focused on the CAR-T product Akirensai injection through the formal review.
For example, the headline number "Beijing Hotspot" released "National Medical Insurance Negotiations Opened Million Yuan "Anti-Cancer Medicine" as the Focus", and China Business News published "1.
2 million CAR-T may not participate in medical insurance negotiations
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" At the same time, public opinion also pays attention to the following aspects
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One is to pay attention to the problem of CAR-T product medical insurance payment
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"The era of gene therapy is coming, how can the most expensive therapy get medical insurance?" published by the WeChat public account "Pharmaceutical Economic News" "It is proposed that the United States, the United Kingdom, Israel, Canada, Japan, Italy and other countries and regions have included Novartis’s CAR-T cell therapy drug Kymriah in their national health insurance
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CAR-T products enter medical insurance in China, and there are currently two major problems
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One is that CAR-T products are generally approved for marketing conditionally, and there are uncertainties in efficacy and safety.
It is difficult to determine the scope of patient application, how many patients have a positive response to the efficacy, how long the efficacy can last, and the medical value that can ultimately be achieved
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The second is that the main cost of CAR-T therapy is a one-time occurrence, but the curative effect needs long-term observation to determine
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For such high one-time medical expenses, China has not yet established a medical insurance payment mechanism.
In addition to bringing greater pressure and risks to local medical insurance in the current period, if refractory indications are statistically managed using the outcome risk sharing model, the cost is high and implementation The difficulty is greater
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At present, the most recommended method in the industry is to pay by disease type, that is, the manufacturer and the medical insurance department jointly discuss the medical insurance payment limit for a certain indication of the treatment within a certain range and within a certain period of time, thereby alleviating the damage caused by CAR-T therapy to the medical insurance fund.
Burdens and risks
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Second, it is believed that the price of CAR-T products can be halved on the existing basis, and the accessibility is expected to be greatly improved
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For example, the "1.
2 million yuan anti-cancer drug" CAR-T published by the Economic Observer website failed to be selected for medical insurance: Will the price be at least reduced by half? According to the report, CAR-T products are highly personalized medicines, involving a series of complex processes such as apheresis, transportation, reinfusion of patient cells, and treatment and monitoring of patients.
In the short term, it is impossible to quickly reduce costs through mass production
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Previously, the media continued to pay attention to the high price of Akilunza injection.
Practitioners believed that the price of the product itself might be reduced to half of the current price; coupled with the combined effect of medical insurance and commercial insurance, the patient's self-paid part is expected to be 200,000 yuan Within, the applicable population will greatly increase
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The third is that it is a good start for CAR-T products to pass the preliminary formal review
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For example, the "1.
2 million yuan per injection" anti-cancer drug entered into the medical insurance negotiations, which was published by the Beijing News.
com, is a success in itself.
According to the formal review, the price of the drug will be gradually reduced in the future, and the medical insurance fund will be It is a foreseeable effect to enter the medical insurance catalog to make preparations
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The article proposes that the direct effect of medical insurance negotiations is to promote a substantial drop in drug prices, and the indirect effect is to activate the market and trigger healthy competition between similar drugs, thereby promoting the improvement of drug quality and lower prices
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The article believes that Akilunzai injection has been included in the medical insurance negotiation vision this time, and it has taken a key step to enter the medical insurance catalog
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On the Weibo platform, "1.
2 million yuan of anti-cancer drug is expected to enter the medical insurance negotiation" "1.
2 million yuan of anti-cancer drug has not entered the medical insurance negotiation link" successively ranked 2nd and 3rd in the hot search list, with a total reading volume of over 410 million person-times
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Netizens have polarized views on this matter
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One is to express regret that the drug did not enter the negotiation link and support the inclusion of the drug in medical insurance as soon as possible
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The second is that medical insurance is not a panacea, and it does not support the incorporation of high-priced drugs into medical insurance
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The PD-1 antibody drug race track is crowded, and the product price is "involved.
" In the national medical insurance negotiations over the years, PD-1 antibody drugs have been the most concerned varieties
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Since the beginning of this year, the competition for PD-1 inhibitors has become increasingly fierce
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In the context of gradual homogeneity, companies have to fight a "price war" to occupy more markets
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In 2019, Cinda Bio's Sintilimab successfully entered the medical insurance drug list with a 64% price drop, and the annual treatment cost was reduced from approximately 280,000 yuan to 96,700 yuan
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In 2020, all the PD-1 antibody drugs of Hengrui Medicine, BeiGene, and Junshi Bio will enter the medical insurance with an average price drop of 78%, and the annual treatment cost will be reduced to about 50,000 yuan
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At present, there are 10 types of PD-(L)1 mAbs on the market in China, including 8 types of PD-1 mAbs and 2 types of PD-L1 mAbs
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As the pressure of competition continues to increase, the annualized cost of PD-(L)1 monoclonal antibody continues to decrease
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In August of this year, Kangfang’s Paimrizumab and Yuheng Pharmaceutical’s Seprlizumab were launched.
The initial price of the former is as low as RMB 4,875/100 mg, and the drug-giving plan is superimposed, and the annual cost is no more than RMB 39,000.

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It is generally believed in the industry that continuously lower product pricing will bring greater competitive pressure to the subsequent market
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What is the future of domestic PD-1 inhibitors in the "Beware of the heavy-duty trap of medical insurance" published by Baijia "Sina Pharmaceutical"? According to the report, not all drugs can achieve a substantial increase in sales through "quantity for price" after being included in the medical insurance.
After some drugs are included in the medical insurance, the sales will not increase but fall
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On the one hand, the previous market share was relatively large, and the space after being included in medical insurance was limited; on the other hand, competitors were also included in medical insurance, and fierce competition weakened the advantage of medical insurance
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For example, the sales of infliximab after entering the medical insurance showed a downward trend, while the sales of adalimumab, which was included in the medical insurance, showed an upward trend in the same year
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The article believes that the future market is full of opportunities and challenges in the context of PD-1 antibody drug "involution"
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The indications of domestic PD-1 inhibitors are rapidly expanding, and companies have accelerated their overseas expansion
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However, the growth rate of PD-1 inhibitors may slow down, low-price competition makes the "involution" more serious, and the contradiction between high-priced R&D and low-priced sales is a major challenge facing companies
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20 innovative drugs entered the national medical insurance negotiations for the first time The national medical insurance negotiations have become an important catalyst for the increase in the volume of innovative drugs
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According to the "Blue Book on the Progress and Effectiveness of China's Medical Insurance Drug Administration Reform" issued by the Science and Technology Development Center of the Chinese Pharmaceutical Association on November 3, 4 of the 34 innovative drugs that were launched from 2016 to 2020 were included in the catalog when the 2017 medical insurance catalog was adjusted.
, 1 variety is negotiated in 2018, 9 varieties will enter the medical insurance catalog in 2019, and 12 varieties will be included in the medical insurance catalog in 2020
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In addition to the gradual increase in the proportion of innovative drugs entering the medical insurance catalog, the cycle of innovative drugs from listing to entering the medical insurance is decreasing year by year
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Judging from the list released by the National Medical Insurance Administration in July this year, 271 varieties passed the formal review this year, of which 93.
02% of the drugs were new drugs approved for marketing after 2016
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A number of securities institutions estimate that about 20 innovative drugs will participate in the national medical insurance negotiations for the first time
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Comparing the treatment categories of the top 20 products used in the first quarter of 2015 and 2021, the proportion of therapeutic products with definite curative effects and clinically necessary products has increased
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Anti-tumor drugs and immunomodulators account for the majority, which is in line with the adjustment and change of the drug structure of medical institutions in China in recent years
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The media are mostly optimistic about more and more innovative drugs entering medical insurance
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First, it is believed that the entry of innovative drugs into medical insurance is expected to improve the problem of difficult access and achieve rapid penetration of hospitals and pharmacies
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The "Medical Insurance Negotiations Are Coming to the Competition of Domestic Innovative Drugs" published by the Baijia No.
"China Youth Network" stated that after entering the medical insurance, it will be difficult for the drug to obtain the recommendation application of the clinician, pass the preliminary selection of the department, and even pass the hospital drug selection meeting.
The reduction will lay a good foundation for the drug to be used in medical institutions in the future; on the other hand, in May this year, the National Medical Insurance Bureau and the National Health Commission issued the "Guiding Opinions on Establishing and Improving the "Dual Channel" Management Mechanism for Drugs in National Medical Insurance Negotiations" , After the drug enters the medical insurance catalog, it is expected to accelerate the product volume in the pharmacy through the "dual channel" mechanism
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Second, it is believed that the introduction of innovative drugs into medical insurance can achieve a win-win situation for enterprises and patients
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"Five batches of drugs saved 250 billion yuan in national centralized procurement of five batches of drugs, and more innovative drugs "run" into medical insurance" published by the WeChat public account "China Business News" stated that after the establishment of the National Medical Insurance Agency, drug access and high-value innovative drug prices The negotiation mechanism is linked, and one access has achieved the dual purpose of catalog adjustment and substantial cost reduction, including the drug renewal negotiation mechanism during the patent period, which has further reduced the price of drugs, the availability of drugs and the affordability of patients Sex is constantly improving
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Huang Bin, vice president of AstraZeneca China, said that thanks to preferential and encouraging policies such as the provision and use of medical insurance drugs and "dual-channel" reimbursement, companies see that the stability of volume for price can bring reasonable returns to companies
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The product volume effect provides companies with stable and clear market expectations, and strengthens companies' confidence in vigorously carrying out technological innovation and their determination to increase R&D investment
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Public opinion comments During this year's "Double 11" shopping festival, not only the e-commerce platform, but also the national medical insurance negotiation table are lively
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More and more domestically-made innovative drugs enter the market for negotiation and enter the medical insurance drug catalogue through volume-for-price, in order to quickly open the market and increase sales
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Price negotiation can not only improve the availability of medicines, but also enhance the confidence of enterprises in the research and development of new drugs, and further promote the research and development of innovative drugs in China
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In addition, "explosive drugs are expected to enter medical insurance" can climb to the top three on the topic list during the lively "Double 11" shopping festival, reflecting the public's concern about drug prices to a certain extent
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Some "sky-priced drugs" (such as CAR-T drugs) passed the formal review, but did not enter the final negotiation link due to cost and other factors; while some "sky-priced drugs" (such as some anti-tumor drugs, rare disease treatment drugs) Successfully entering the medical insurance catalog, the price drop may not be as large as other drugs, only one-third of the original, but it has also greatly improved the availability of drugs
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Under the premise of "guarantee basic" medical insurance, "sky-priced medicines" cannot all be included in the medical insurance catalogue, but the national medical insurance negotiations have set a precedent.
I believe that with the efforts of medical insurance and commercial insurance, the public's access to medicines will be further improved.
promote
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(Chong Penghua, Public Opinion Monitoring Center of China Health Media Group)