The domestic PD-1 annual fee may fall below 30,000? Small molecule inhibitors may fall into a price melee! Where is the way out for sky-high drugs? 2021 Medical Insurance Negotiation Outlook

Entering the end of October, the pace of the 2021 state talks is getting closer
.

From the battlefield of domestic innovative pharmaceutical companies, as each product gradually enters the harvest period, the focus of competition has been shifting from the comparison of indication layout and clinical research and development strength to commercialization capabilities
.

Obviously, the medical insurance negotiation is a microcosm of the commercialization strength competition

Soochow Securities predicts that after this negotiation, Cinda’s PD-1 annual treatment cost will be reduced to about 35,000 yuan, and the more pessimistic expectation is 32,000, which is less likely to be less than 30,000 yuan
.

The PD-1 monoclonal antibodies of Hengrui and BeiGene will likely reduce the annual treatment cost to about 35,000 yuan to cope with competition

In the field of small molecule kinase inhibitors, Soochow Securities predicts that the price reduction of Iris Vometinib may reach 75% this time, and the annual treatment fee will be reduced from 417,000 yuan to about 100,000 yuan
.

The price of Nuocheng Jianhua Obutinib can be reduced by up to 50%, and the annual treatment cost has been reduced from 260,000 to about 130,000

In addition, there are also those expensive and sky-high drugs with millions of treatment costs.
Will the negotiation succeed?

01 “Making extra money” outside the negotiation of innovative medicine and medical insurance

01 “Making extra money” outside the negotiation of innovative medicine and medical insurance

The gunshots of the PD-1 price war have sounded
.

The prices of the fifth and sixth PD-1 companies that missed the medical insurance negotiations this year were 4,875 yuan/piece (100mg) for Kangfang Bio/Zhengda Tianqing, and 3,300 yuan/piece (120mg) for Yuheng Biological
.

Soochow Securities predicts that after the medical insurance negotiations this year, Cinda’s PD-1 annual treatment fee will be reduced to about 35,000 yuan, and the more pessimistic expectation is 32,000, which is less likely to be less than 30,000 yuan
.

The PD-1 monoclonal antibody of Hengrui and BeiGene will likely reduce the annual treatment cost to about 35,000 yuan to cope with competition

Regarding the PD-1 sales that have entered the medical insurance, Hengrui's PD-1 declined in the first half of this year
.

And Cinda Daboshu continued to maintain double growth in sales volume and sales revenue (1.

The industry's discussion of PD-1's internal volume even exceeds that of the innovative drug itself and the company
.

However, there is also a voice in the industry who believes that when many biomedical companies in China can successfully do PD-1, they also have the necessary skills to produce and develop other biopharmaceuticals, indicating that China’s biomedical industry , Resources, and technology themselves have achieved historic breakthroughs, which can be called a milestone event.

Although the track is crowded, the future will be the PD-1 Plus era.
Combined therapy will become the focus of PD-1's future development.
At that time, the competition will be the strength of the "friend circle" of various products
.

In addition, the continuous promotion of PD-1 treatment from the late stage to the early stage means that patients will be more likely to benefit and be cured.

Regarding the price of PD-1, the information that came out at the Junshi Biologics shareholders meeting in June this year showed that even in the face of centralized procurement in the future, PD-1 will be reduced to 10,000 per year, and as a cornerstone drug, there will be 30 billion domestic Market
.

In addition, in the fierce field of small molecule kinase inhibitors, the EGFR TKIs that participated in the talks this year include the renewal negotiations for the first-generation inhibitor icotinib, and the third-generation inhibitor vomitinib access negotiations
.

Soochow Securities predicts that due to the impact of generic drugs, the first-generation inhibitor gefitinib will cost less than 10,000 yuan at the patient's own expense in most regions and most products
.

Coupled with this year's approval of icotinib for postoperative adjuvant therapy, the market has greatly expanded.

But recently, the Guangdong Collective Procurement Draft has included icotinib.
Does this mean that Betta’s product will not only participate in the 2021 medical insurance negotiations, but also participate in the collective procurement? Facing investors’ questions, Betta responded that the company is now actively complaining and feeding back related issues on the draft for comments
.

The competitive environment faced by Iris' vometinib can be described as "there are wolves before the tigers"
.

Before Iris, there were osimertinib and ametinib, and then there were many third- and fourth-generation inhibitors under research.
Soochow Securities predicts that the price reduction this time may reach 75%, and the annual treatment cost will be reduced from 417,000.
To about 100,000 yuan
.

However, Iris has already obtained benefits through external authorization
.
In July this year, Iris and ArriVent Biopharma, Inc.
of the United States reached an exclusive overseas licensing cooperation agreement on vomitinib mesylate
.
Through this cooperation, Iris will receive a down payment of US$40 million and part of ArriVent’s equity, up to US$765 million in registration and sales milestone payments, and double-digit sales commissions
.

Nuocheng Jianhua's BTK inhibitor abutinib will compete with AbbVie ibrutinib and BeiGene's Zebutinib
.
Among them, the annual fee for ibrutinib is more than 200,000, and the annual fee for zebutinib was reduced to 72,000 after the medical insurance negotiations last year
.
Soochow Securities predicts that in order to compete directly with Zebutinib, the price of Ibrutinib will continue to be reduced this year.
The price of abutinib will be reduced by 50%, and the annual fee will be reduced from 260,000 to about 130,000
.

Like Iris, Nuocheng Jianhua's Obritinib has also "earned extra money
.
" In July of this year, Nuocheng Jianhua and Bojian reached a strategic cooperation on obritinib
.
Biogen will have the exclusive global rights of abutinib in the field of multiple sclerosis, as well as the exclusive rights of certain autoimmune diseases in regions other than China (including Hong Kong, Macau and Taiwan)
.
Nuocheng Jianhua will retain the exclusive global rights of abutinib in the field of oncology and the exclusive rights of certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan)
.
And will be eligible to receive up to $812.
5 million in potential clinical development milestones and commercial milestone payments when it receives an advance payment of 125 million US dollars and when the development milestones, commercial milestones and sales milestones agreed by the cooperation are reached
.

02 Where is the way out for "expensive drugs"?

02 Where is the way out for "expensive drugs"?

Different from the situation of popular target drugs facing price cuts, whether drugs priced at hundreds of thousands of yuan or millions of yuan will enter the medical insurance catalog through negotiations also attracts attention
.
Regardless of the industry or patients, the focus is nothing more than: how much treatment cost can the medical insurance fund afford, and how much is the price reduction of sky-high drug companies?

The first domestic CAR-T product approved in June this year by Fosun Kate’s 1.
2 million yuan/bag of Achilles injection and Bojian’s 550,000 yuan/bottle of rare disease drug Nosina, which set a record of Chinese drug sales Sodium is a widely concerned "sky-price drug" player
.

As a "living cell medicine", CAR-T is a highly personalized treatment method.
Before receiving CAR-T treatment, each patient has received various treatments, such as bone marrow transplantation, chemotherapy, targeted therapy, etc.
, The preparation and programming of the obtained T cells will also vary
.
Therefore, there are highly specialized requirements from research and development, preparation to production.
The high production cost, long production process, and the inability to form a standardized process determine the high price of cell therapy
.

CAR-T therapy has been given high pricing since its launch.
The five CAR-T drugs that have been marketed worldwide are all priced at more than US$300,000
.

In June of this year, Fosun Kate’s Achillesis injection became the first CAR-T cell therapy product approved for marketing in China.
According to the announcement of the National Medical Insurance Administration, Achilles Adult patients with relapsed or refractory large B-cell lymphoma after treatment, including diffuse large B-cell lymphoma (DLBCL) non-specific (NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma DLBCL transformed by tumors and follicular lymphoma
.

In China, the median overall survival (OS) of patients with relapsed and refractory DLBCL is only 5.
9 months, and there are a considerable number of refractory patients, with fewer effective treatment options
.
At the same time, the current first- and second-line treatment for DLBCL is chemotherapy, which has limited efficacy.
About 40% of DLBCL patients will relapse or be refractory, and there are no third-line treatment drugs in the catalog
.
As the third-line drug recommended by the CSCO guidelines, Akirensai injection is the only cell therapy drug marketed in China before June 30, which can make up for the lack of clinical treatment of DLBCL
.

Obviously, on the one hand, CAR-T cell therapy is currently the most effective therapy for cancer treatment, but on the other hand, the domestic "sky price" of 1.
2 million yuan per injection has also "persuaded" many patients
.

Bojian's Noxinasheng Sodium Injection has attracted much attention earlier
.
As a rare drug with a sky-high price that has set a record of Chinese drug sales, Noxinat Sodium Injection has attracted much attention on the eve of last year's medical insurance negotiations
.
The "China Rare Disease Medical Insurance City Report 2020" shows that among the six rare disease drugs that have an annual treatment cost of more than one million children, are not covered by medical insurance and have no generic drugs available, the cost of noxinagen sodium injection for the treatment of children Ranked first with an annual of 2.
09 million yuan
.
Not long ago, a bill of 550,000 yuan issued by the Second Affiliated Hospital of Xi'an Jiaotong University once again pushed the Nosinasheng Sodium Injection to the hot search
.

Noxinassen Sodium Injection was approved in China in February 2019 for the treatment of 5q spinal muscular atrophy.
The recommended dose is 12mg (5ml) each time
.
The treatment of this product should be started as soon as possible after diagnosis, and 4 loading doses should be given on the 0th day, 14th day, 28th day, and 63rd day, and a maintenance dose every 4 months thereafter
.

It is reported that spinal muscular atrophy (SMA) is a serious disabling and fatal genetic disease, and the main genetic cause of death in infants and young children.
Nosinasheng Sodium Injection is China's first approved 5q SMA disease modification treatment drug , Intrathecal administration via lumbar puncture, directly delivered to the onset of the central nervous system, can significantly reduce the risk of death in children, maintenance treatment only requires three injections per year, which is conducive to treatment compliance
.

No matter it is Akirensai injection or Noxinat sodium injection, there is no similar drug in the national medical insurance catalog, and these two drugs are really solving the unmet clinical needs
.
From this point of view, these two drugs entered the medical insurance preliminary review list, and they deserved the attention of the Medical Insurance Bureau
.

Even so, the opposition remains unabated
.
The ultra-high payment price is the biggest obstacle to the entry of this type of medicine into medical insurance.
After all, the basic principle of medical insurance payment is "wide coverage and basic guarantee"
.
When the National Medical Insurance Agency announced the review list, it explained whether "sky-priced drugs" could be included in the catalog: "Some of the more expensive drugs have passed the preliminary formal review, which only means that the drug meets the application requirements after the preliminary review and has been awarded Eligibility to enter the next step of adjustment
.
Whether or not such drugs can eventually enter the National Medical Insurance Drug List must undergo rigorous review including economics.
Exclusive drugs must undergo price negotiations, and only those who have successfully negotiated can enter the list
.
"

The industry generally believes that it is unrealistic for the current domestic medical insurance funds to pay for such high expenses as CAR-T
.

Recently, former Fosun Kate CEO Wang Liqun said in an interview with Caijiandao that the high cost makes it difficult for CAR-T products to enter the medical insurance catalog through the existing medical insurance negotiation model.
If you want to improve patient accessibility, you should consider more business Insurance ways, such as innovative payment, critical illness insurance and so on
.
In this regard, there have been industry views that if expensive innovative drugs can achieve the three-party co-payment of medical insurance, commercial insurance, and enterprises, it is a good way to effectively increase patient access in the future
.