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The 2022 national medical insurance on-site negotiations, which have been postponed for more than a month, officially kicked
off today (5th).
According to the "List of Declared Drugs Approved by the Adjustment of the Catalogue of Drugs of National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance in 2022" (hereinafter referred to as the "List") previously released by the National Health Insurance Administration, a total of 343 drugs officially passed the formal review
.
The scene is direct: the scene is crowded, and the company does not leave without saying a word
The scene is direct: the scene is crowded, and the company does not leave without saying a wordThe lowest temperature of the day was -6°C, and the hands and feet were cold after standing outside for 10 minutes, but the entrance to the National People's Congress Conference Center was still crowded and bustling
.
The 21st Century Business Herald learned at the scene that all parties in the industry are more concerned about this medical insurance negotiation, and the National People's Congress Conference Center is located in Xihuangchenggenbei Street, Xicheng District, Beijing, with a total of 57 cars
parked on the street about 200 meters today.
are parked on the street about 200 meters away.
Photo / National People's Congress Conference Center, National Medical Insurance Negotiation Site, photographed by 21st Century Business Herald reporter Wu Yinggang
Although the lowest temperature of the day was -6°C, and the hands and feet were cold after standing outside for 10 minutes, the entrance of the National People's Congress Conference Center was still crowded and bustling, with a total of more than 70 people standing on both sides of the street in groups of threes and fives, and the number of people continued to increase, almost all of them discussing the varieties and prices of medical insurance negotiations
.
Photo / The entrance of the National People's Congress Conference Center is crowded, photographed by Lin Yunxiao, an intern of the 21st Century Business Herald
Photo / The entrance of the National People's Congress Conference Center is crowded, photographed by Lin Yunxiao, an intern of the 21st Century Business Herald
Photo / Enterprise representatives prepare to enter, 21st Century Business Herald reporter Wu Yinggang photo
About an hour and a half later, between 9:55 and 10 a.
m.
, three companies seemed to have completed negotiations, walked out of the National People's Congress Conference Center one after another, quickly got on the bus, and left the scene
without saying a word.
According to relevant media reports, on the morning of January 5, a total of about 10 pharmaceutical companies participated in the negotiations, including Baxter, Kelun Pharmaceutical, Otsuka Pharmaceutical, etc
.
without saying a word.
Photo / Enterprise representatives walked out of the National People's Congress Conference Center one after another, taken by Wu Yinggang, an intern of the 21st Century Business Herald
Photo / Enterprise representatives walked out of the National People's Congress Conference Center one after another, photographed by Lin Yunxiao, an intern of the 21st Century Business Herald
However, compared with 2021, there will be significantly less
news released at the medical insurance negotiation site in 2022.
The 2021 medical insurance negotiation is located in Yinbao Jianguo Hotel, Shijingshan District, Beijing, and the enterprises will be notified on the spot and enter the negotiation in order, so you can understand the list of companies entering the market and the varieties that may participate in the negotiation, but in this medical insurance negotiation, the company representatives either enter by car, or get off the bus to enter directly, so the specific number of enterprises participating in this medical insurance negotiation is unknown
.
news released at the medical insurance negotiation site in 2022.
Multiple blockbuster products participate in "soul bargaining"
Multiple blockbuster products participate in "soul bargaining"Combing through the list, it can be found that 143 of the 183 Western medicines participating in the medical insurance negotiations are exclusive products, accounting for about 78%, and 14 of the 15 proprietary Chinese medicines are exclusive products, accounting for about 93.
3%.
It is worth mentioning that the blockbuster innovative products participating in the "soul bargaining" include the world's first PD-1/CTLA-4 bispecific antibody cardunimab injection independently developed by Akeso, the PD-1 serplulimab approved by Henlius in March 2022, the PD-L1 inhibitor Envolimab injection approved by Corning Jerry/Sidi/Simcere Pharmaceutical in November 2021, the CAR-T relmacel injection with millions of yuan per injection, and Hengrui Pharmaceutical's carrelizumab injection , BeiGene's tislelizumab, Innovent Cindilimab injection, Junshi Biologics teripulimab and other domestic PD-1 monoclonal antibody indications, in addition to a number of high-value rare disease drugs, as well as the current high-profile two new crown oral drugs domestic azvudine and imported PAXLOVID and so on
.
.
As more and more blockbuster innovative products are expected to enter the medical insurance catalog through negotiation, this is a great boon
for the majority of patients.
Jin Chunlin, director of the Shanghai Health and Health Development Research Center, pointed out to the 21st Century Business Herald reporter that in the past two years, innovative drugs have been approved for clinical application, and drugs have soon been included in the medical insurance catalogue after they are listed, which also means that the entry threshold for medical insurance negotiations has been relaxed for innovative drugs, and medical insurance is willing to give innovative drugs more access opportunities and focus on unmet clinical needs
.
However, on the one hand, there is an urgent clinical need, on the other hand, the reality of limited medical insurance funds, how to balance the investment in innovative drug research and development, the income, and the extent of price reduction have also become the focus
of the industry.
.
"It is worth thinking
about how to meet the clinical needs of patients with the highest 'cost performance'.
After all, evaluating the medical insurance inclusion criteria of a drug needs to be evaluated
from the dimensions of safety, effectiveness, economy, appropriateness, fairness, and innovation.
Jin Chunlin said that for some products that focus on the unmet clinical needs of patients, do have fundamental innovation, and first-in-class, medical insurance negotiations can appropriately relax the standards, so as to encourage domestic enterprises with real R&D strength to focus on innovative R&D, enhance the innovation power of domestic enterprises, and promote the transformation
of Chinese medicine from imitation to innovation, from a manufacturing country to an innovative country.
about how to meet the clinical needs of patients with the highest 'cost performance'.
Deppon Securities believes that due to the influence of macro liquidity, the relevant targets of innovative drugs have been deeply adjusted, and there is a high probability of improvement
in 2023.
At the same time, a new round of national medical insurance negotiations has been launched, and large domestic varieties may enter the period of expansion
.
Meet the clinical needs of patients with the highest "cost performance"
Meet the clinical needs of patients with the highest "cost performance"In recent years, with the dynamic adjustment of the national medical insurance catalog, more and more high-quality innovative drugs have been included in the medical insurance catalog
.
According to the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalogue (2021) released by the National Health Insurance Administration last year, a total of 117 drugs were included in the scope of negotiation, and finally 94 drugs (67 off-list and 27 in the list) were successfully negotiated, with an overall success rate of 80.
34%.
The average price reduction of 67 drugs outside the list was 61.
71%, of which the highest reduction was 93.
97%.
Among them, 4 domestic "Internet celebrity" PD-1 products were included in the medical insurance catalog, and the medical insurance negotiations mainly revolved around new indications
.
Including Innovent Cindilimab, the addition of "first-line squamous non-small cell lung cancer (NSCLC) + first-line non-squamous lung cancer.
"
NSCLC+ first-line liver cancer" 3 indications; BeiGene's tislelizumab adds "first-line squamous NSCLC+ first-line non-scaly.
"
NSCLC+ second-line liver cancer" 3 indications; Hengrui Pharmaceutical's carrelizumab added 2 indications of "first-line + third-line nasopharyngeal carcinoma", and Junshi Biologics' teripulimab added 2 indications
of "third-line nasopharyngeal carcinoma + second-line urothelial carcinoma".
According to the analysis of "China Medical Insurance" under the National Health Insurance Administration, if the new indication follows the traditional negotiation process, it will not only "reduce the price significantly", but also go through complex materials submission and other processes, which will cause "certain pressure on government administrative resources and enterprises"
。 However, on October 12, 2022, the National Health Insurance Administration pointed out in response to the "Suggestions on Improving the Medical Insurance Access Rules for New Indications of Multi-indication Innovative Drugs" proposed by Sun Piaoyang, chairman of Hengrui Pharmaceutical: In the process of drug renewal negotiations for the adjustment of the national medical insurance catalogue in 2022, we fully consider the opinions and suggestions of relevant parties, and include new indications in the scope of simple renewal to simplify the process and improve efficiency
.
.
Therefore, in this national medical insurance negotiation, some innovative drugs with new indications are expected to be directly incorporated into medical insurance
through the "simple renewal" rule without renegotiation.
In this regard, some industry insiders believe that in the new round of national medical insurance negotiations, the price reduction of related products again will not be too large, according to the simple renewal procedure, the reduction may be only 25%
at most.
Direct inclusion of health insurance through the "simple renewal" rule is a major benefit
for enterprises.
through the "simple renewal" rule without renegotiation.
At present, the medical insurance negotiation work in 2022 has officially started, including Hengrui Pharmaceutical's carrelizumab, BeiGene's tislelizumab, Innovent Cindilimab injection, Junshi Biologics teripulimab, and other domestic PD-1 monoclonal antibodies have been added corresponding indications, and it remains to be seen whether they can finally enter the medical insurance catalog
.
When talking about which innovative drugs can be included in medical insurance, so that patients can get more accurate and standardized treatment under the condition of economic affordability, Professor Wu Yilong, president of the Guangdong Medical Doctor Association and lifelong director of Guangdong Provincial People's Hospital, pointed out in an interview with the 21st Century Economic Herald reporter that comprehensive consideration should be carried out from multiple dimensions: First, the effectiveness
of drugs.
how the patient survived overall after using the drug in question; The second is drug safety
.
If the toxic side effects of the drug are large, and the patient has to interrupt and stop after using it for a period of time, the score of the drug is very low, on the contrary, the patient has fewer side effects after medication, and this type of drug is preferred; The third is whether the patient needs long-term medication
.
If the patient can do without the drug and there is a drug alternation, this type of drug has a higher value; Fourth, economic
accessibility.
The value of
medicines needs to be measured from a pharmacoeconomic perspective.
For cancer patients, the inclusion of innovative drugs in medical insurance at a reasonable price can not only provide patients with targeted and individualized clinical treatment options, but also reduce the treatment burden of patients, benefit patients and the overall medical insurance expenditure significantly, and achieve access to drugs that can be cured
.
Innovative drugs are accelerating their entry into the medical insurance catalog
Innovative drugs are accelerating their entry into the medical insurance catalogSouthwest Securities analysis believes that in recent years, centralized procurement and medical insurance negotiations have become normalized, the decline rate of new exclusive varieties has stabilized, and the vast majority of innovative drugs have achieved price for volume
after entering medical insurance.
China's medical insurance access model has shifted from relationship and marketing advantage orientation to product and price advantage orientation, and in the future, drugs with product advantages, clinical advantages and price advantages must be more competitive
in access.
At present, China has carried out a total of 6 rounds of medical insurance drug negotiations for innovative drugs, and the average reduction rate of innovative drugs selected for the first time is basically between 40% and 62%, and the vast majority of innovative drugs have achieved price for volume after entering medical insurance, and sales have increased
significantly.
after entering medical insurance.
In 2022, a total of 344 drugs passed the preliminary formal review (343 passed the formal review), and 199 drugs were not included in the medical insurance list, with a pass rate of 70%, higher than the 57% pass rate last year, which also released a big signal that medical insurance is willing to give innovative drugs more access opportunities
.
From the list of drugs, it is found that a number of blockbuster new drugs that have been approved for marketing are listed, which means that the speed of innovative drugs entering the medical insurance catalog is accelerating
.
For example, China's first approved MET inhibitor sevotinib, approved in June 2021; Envolimab injection, which was approved for marketing in November 2021, is the first approved domestic PD-L1 inhibitor and the world's first subcutaneous PD-L1 inhibitor; Ofatumumab injection, a drug for the treatment of recurrent multiple sclerosis (RMS) in adults with rare diseases, which was only approved for marketing in December 2021; Dalcilide, the first domestic CDK4/6 inhibitor approved for marketing in December 2021; Orebatinib, the first-generation and currently the only third-generation Bcr-Abl inhibitor in China, approved for marketing in November 2021, orebatinib for chronic myeloid leukemia with T315l mutation after tyrosine kinase inhibitor resistance; Upatinib sustained-release tablets, which were only approved in February 2022 and prescribed in June, are the first oral targeted drugs approved in China for the treatment of atopic dermatitis; PD-1 serplulimab, which was approved only in March 2022, is used for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy; Initialaxitinib
, a class 1 innovative drug JAK1 inhibitor approved in April 2022.
Jin Chunlin pointed out that the original intention of the national medical insurance negotiation is to share risks and protect the interests of more patients, and medical insurance reimbursement wants to achieve that the disease has a drug, the drug has insurance, and when conducting drug evaluation, it is necessary to focus on rare targets of innovative drugs and other drugs with different evaluation angles, after all, if the same standards may be difficult to include in the scope of reimbursement
.
For the medical insurance negotiations, some executives of pharmaceutical companies who did not want to be named pointed out in an interview with the 21st Century Business Herald that through national medical insurance negotiations, more innovative drugs can be given access to medical insurance, so that innovative drugs can be quickly increased and quickly benefit patients
.
However, at any time, we need to look at it objectively, not that the lower the price of innovative drugs, the better, the lower the price means that the ability to innovate may be stifled, in the future, in some fields, enterprises will lack research and development capabilities and financial motivation to invest in innovation
.
"It is more critical
to control the price within the reasonable range that our medical insurance deems and have a say in the innovative industry.
" The executive believes that from the perspective of national strategy, there will definitely be a coordination mechanism for multiple departments, and while achieving price reductions for innovative drugs through medical insurance negotiations, promoting the sustainable development of the industry will become an important direction
.
to control the price within the reasonable range that our medical insurance deems and have a say in the innovative industry.
"
New crown treatment drugs have become a big focus
New crown treatment drugs have become a big focusIn addition to innovative drugs, new crown treatment drugs have also become a highlight
of this medical insurance negotiation.
Up to now, there are three new crown oral drugs approved for marketing in China, including Paxlovid (nematevir tablets/ritonavir tablets), Henan Real Bio Azvudine, and Merck Sharp & Dohme Monoravir
.
According to the 21st Century Business Herald reporter, in the list of drugs that have passed the preliminary form review, azvudine, Pfizer new crown oral drug PAXLOVID (nematevir tablets / ritonavir tablets combination packaging) are listed
.
of this medical insurance negotiation.
Previously, on August 12, 2022, the National Health Insurance Administration announced that in accordance with the relevant provisions of basic medical insurance, in order to better protect the needs of diagnosis and treatment, all drugs included in the new crown pneumonia diagnosis and treatment plan can be temporarily included in the scope of medical insurance payment
.
The National Health Commission also issued a notice to include azvudine tablets in the diagnosis and treatment plan for novel coronavirus pneumonia, so the medical insurance fund can pay
for the use of the drug by insured patients according to regulations.
The National Health Insurance Administration also said that in the context of the normalization of epidemic prevention and control, since the first implementation of the self-declaration system for medical insurance drug list enterprises in 2020, the National Medical Insurance Administration has attached great importance to the treatment of new coronary pneumonia, and has taken "drugs included in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia" (hereinafter referred to as the "Diagnosis and Treatment Plan") as one of
the declaration conditions.
A batch of new crown treatment drugs has been included in the medical insurance drug list
.
The ninth edition of the "Diagnosis and Treatment Plan" includes a batch of drugs
that have just been marketed in China.
The National Health Insurance Administration pointed out that in the process of this declaration, some drugs have self-declared and passed the preliminary formal review, and some drugs have not been declared, and we respect the choice
of enterprises.
For drugs that have been declared and passed the formal examination, we will carry out follow-up work in accordance with the procedures and strive to be formally included in the medical insurance catalogue
at a reasonable price.
The reporter of the 21st Century Business Herald learned from Fosun Pharma that azvudine tablets have been included in the scope of medical insurance payment, and medical insurance has been registered in 31 provinces, municipalities and autonomous regions across the country, with a price of 270 yuan per bottle
.
In terms of pricing, Pfizer's new crown oral drug Paxlovid was approved for marketing in China in February 2022 and included in the ninth edition of the "Diagnosis and Treatment Plan"
in March.
At present, the medical insurance payment price has been reduced from 2,300 yuan per box to 1,890 yuan per box, and has been temporarily included in the medical insurance payment coverage
in many provinces.
Liu Xin, consulting manager of CIC Consulting, told the 21st Century Business Herald reporter that the gradual inclusion of new crown oral drugs into medical insurance reflects the state's attitude
of responsibility for people's livelihood.
Once azvudine tablets, as the first domestic new crown oral drug, enter the medical insurance catalog through negotiation, it will undoubtedly inject a shot in the arm into the domestic innovative drug industry and promote the further development of
new crown treatment drugs.
At present, the fastest domestic research and development products include VV116 of Junshi Biologics and Proclomide
of Pioneer Pharmaceutical.
As for another new crown oral drug that has just been approved for marketing, Merck Mercury Monolavir, the drug is priced at $700 a course
in the United States.
Regarding the pricing of monoravir in the domestic market and whether it will enter medical insurance, relevant people from Merck told the 21st Century Business Herald reporter that globally, Merck is committed to accelerating the improvement of monolavir's widespread, fair and affordable patient access after authorization or approval; In China, this commitment remains unchanged, and we are pricing tiered based on the World Bank's classification of countries' financial capacity to respond to the pandemic, a pricing framework designed to enable rapid access to monoravir
for patients.
We are confident in the clinical performance of monoravir and believe that this drug has the potential to provide significant benefits to patients and add value
to healthcare systems.
"
"Regarding whether and when monoravir will enter the national medical insurance catalog, please refer to the public information released by the government
.
We are actively communicating with relevant departments and hope that monoravir can benefit Chinese patients
as soon as possible.
Merck said
.
A number of securities research reports believe that the price adjustment of innovative drugs should be relatively moderate in the overall negotiation of the medical insurance catalogue access, and give greater support to "promoting innovation" on the basis of "basic protection", on this basis, large pharmaceutical companies with large innovation value, excellent clinical effects and cost advantages are expected to gain advantages in the fierce negotiations and fully share the dividends
of the medical insurance fund.
