The third day of medical insurance negotiations: Pfizer left the morning session last, some companies said "too much reduction"

　　Sino-Singapore Jingwei, January 7th (Wang Yuling Lin Wansi) The national medical insurance negotiations entered the third day.

Compared with the "crowded crowd" on the first day, there were fewer people at the National People's Congress Conference Center on the 6th and 7th, but there were still pharmaceutical company personnel and the media waiting.

　　At around 13:10 pm on the 7th, the last group of business negotiators in the morning session left, avoiding talking about the negotiation results.

According to public information, Pfizer has passed the formal review list for a total of seven drugs this time, covering one anti-infective drug, one drug for the treatment of atopic dermatitis, four anti-tumor drugs, and Paxlovid, a new crown drug that has attracted much attention. .

In addition to Pfizer, Du Jinhao, the chairman of Iris, and his staff appeared at the negotiation site and said, "The support of the state to enterprises is still quite large."

　　According to on-site information, the pharmaceutical companies present on the 7th may include Betta Pharmaceuticals, Pfizer Pharmaceuticals, Fosun Pharmaceuticals, Biogen, Hengrui Pharmaceuticals, Iris, Novartis, Roche, Real Bio, BeiGene, Hansoh Pharmaceuticals, etc.

Some inquired about competing products, and some said "the drop is too much"

　　The medical insurance negotiation scene is a volume-price game between pharmaceutical companies and the National Medical Insurance Administration.

On the afternoon of the 7th, some companies heard their laughter before seeing the person, and some company representatives who talked about neurological drugs came out and said bluntly, "We talked for 20 minutes, and the talk was very good. Everyone hopes to be included in the (medical insurance catalogue)", And take a group photo at the door.

　　Some enterprise representatives high-fived the waiting colleagues after entering the venue, and some enterprises left quickly.

On the 6th, when a reporter asked about the negotiation situation,

　　At the same time, the medical insurance negotiation scene is also a game between pharmaceutical companies and pharmaceutical companies.

A staff member of a Chinese medicine company asked the reporter whether the person in the photo had finished negotiating and leaving the venue. She told Zhongxin Jingwei that their industry competitors were negotiating on the morning of the 6th, and their company’s similar drugs had not yet been launched. Come to inquire about the news in advance.

　　Analysts from securities companies were also present and said in an interview with the media that information can be formed through the demeanor and actions of pharmaceutical companies on the scene, forming expectations for the decline in this medical insurance negotiation.

　　In this medical insurance negotiation, WuXi Giant Nuo, the manufacturer of the "sky-high priced anticancer drug" CAR-T, also received high attention from the market.

Because the online price of the CAR-T product Ruiji Orunsa injection is 1.29 million yuan per injection, and in the 2021 medical insurance negotiations, the competing product Fosun Kate’s Ajilunsa injection appeared after the national medical insurance directory adjusted the preliminary review list , did not appear at the medical insurance negotiation site, and WuXi Giant Nuo is a veritable star pharmaceutical company in this medical insurance negotiation.

　　It is reported that WuXi Junuo is suspected to have appeared, but Sino-Singapore Jingwei did not find the negotiating team of WuXi Junuo at the scene.

Pfizer shows up, how much can the price of new crown treatment drugs be reduced?

　　After most pharmaceutical companies left the venue after negotiations in the morning, Pfizer was still in the venue at 1:00 noon.

According to on-site news, as on the 6th, Qian Yun, vice president of Pfizer Global Biopharmaceutical Business Group China and head of market access, also appeared at the negotiation scene.

When the Pfizer team left the venue, the reporter asked him about the negotiation situation, but the other party avoided talking and turned away.

　　According to public information, Pfizer has passed the formal review list for a total of seven drugs this time, covering one anti-infective drug, one drug for the treatment of atopic dermatitis, four anti-tumor drugs, and the much-watched new crown treatment drug Paxlovid .

　　According to public information, Pfizer’s new crown treatment drug Paxlovid was conditionally approved by the State Food and Drug Administration in February 2022, and has been temporarily included in the medical insurance. The current medical insurance payment price has dropped from the previous 2,300 yuan/box to 1,890 yuan/box.

Currently, Paxlovid can be prescribed in community centers in many places, but the overall supply is relatively tight.

　　In this national medical insurance negotiation, how much Pfizer's "magic medicine" can reduce the price, and whether it can achieve the world's lowest price is one of the biggest highlights of this negotiation.

　　In the preliminary review list of the national medical insurance catalog adjustment, there are three new crown treatment drugs listed, in addition to Pfizer’s new crown oral drug Paxlovid, as well as the new crown oral drug Azvudine, and Qingfei Paidu Granules.

　　It is reported that

　　And the new crown specific neutralizing antibody "ambavirumab/romisvirumab" that has attracted much attention has voluntarily given up the national medical insurance negotiation.

This also means that the drug will miss the on-site negotiation/bidding session.

　　The National Medical Insurance Bureau once pointed out that according to the relevant provisions of the basic medical insurance, all drugs included in the diagnosis and treatment plan for new coronary pneumonia can be temporarily included in the scope of medical insurance payment.

In August 2022, the National Health and Health Commission has issued a notice to include Azvudine Tablets in the diagnosis and treatment plan for new coronavirus pneumonia, so when insured patients use the drug, the medical insurance fund can pay according to regulations.

　　On January 7, multiple departments jointly issued the "Notice on Relevant Policies for Optimizing Treatment Expenses for Patients with New Coronavirus Infection after the Implementation of "Class B and B Controls", which clarifies that the new coronavirus treatment drugs in the diagnosis and treatment plan for new coronavirus infection Continuation of the temporary payment policy for medical insurance, which will be implemented until March 31, 2023.

Negotiation of six PD-1 antineoplastic drugs

　　In terms of PD-1/PD-L1, a total of 6 domestic drugs participated in the negotiation this time, including camrelizumab for injection from Hengrui Medicine, toripalimab from Junshi Biotech, Tislelizumab from BeiGene and sintilimab from Innovent will negotiate new indications this time.

In addition, two newly approved PD-1/PD-L1 from Henlius, Corning Jerry/Studi/Simcere Pharmaceuticals participated in this round of negotiations.

　　As far as the negotiation drug renewal rules are concerned, according to the requirements of “Revising and Improving Negotiating Drug Renewal Rules” in the “Medical Insurance Drug Catalog Adjustment Work Plan”, the core classification basis is the ratio of product sales to the actual expenditure of the medical insurance fund/estimated budget impact .

This time, for the negotiated drugs (including negotiated renewal drugs), three contract renewal methods were adopted: inclusion in the regular catalog management, simple contract renewal, and renegotiation.

　　For varieties with new indications, if the simple contract renewal procedure is followed, the reduction may be up to 25%.

　　According to the research report of Debon Securities, on the whole, the market share of the four domestically produced PD-1 monoclonal antibodies that have been included in medical insurance continues to increase. In particular, BeiGene’s tislelizumab single-handed sales in the third quarter achieved a reversal, leaping to the top of China First.

With the subsequent inclusion of major indications in medical insurance and product price reductions, domestically produced PD-1 will further expand its domestic market share.

　　As for Akeso Biotech, which has entered the negotiation table this time, as the first domestically produced double antibody and the world's first PD-1-based bispecific antibody approved for marketing, Akeso Biotech's PD-1/CTLA4 The dual-antibody Cardiniril will be approved for marketing in June 2022, and its listing will make up for the demand for targeted therapy for second- and third-line cervical cancer.

The current price of the drug is 13220 yuan/125mg/bottle.

　　Akeso Bio once disclosed, "Akeso Bio is actively participating in various national and local medical security systems, and adopts a patient assistance plan, with an annual treatment cost of no more than 198,000 yuan."

Four Rare Disease Drugs Fight Again

　　Sino-Singapore Jingwei combed and found that in this preliminary medical insurance review list,

Among them, in terms of the ultra-high-value rare disease drugs SMA and Fabry disease indications that were included in the medical insurance last year, Roche Pharmaceuticals (hereinafter referred to as Roche)’s Lisporan oral solution powder for the treatment of SMA, and Sanofi’s treatment for Fabry disease The injection of agalsidase β also passed the formal review.

　　Judging from the on-site news, on January 7, Roche appeared at the medical insurance negotiation site, but it is not yet known whether Sanofi will be present.

Will the medical insurance negotiation prices of these two drugs with the same indication this year refer to the last national medical insurance negotiation?

　　Taking Nosina Shengna as an example, the scene of "soul bargaining" in December 2021 is still vivid.

Biogen's Nosinagen Sodium Injection was launched in China on April 28, 2019, for the treatment of 5qSMA (the main type of spinal muscular atrophy).

However, before entering the medical insurance, the price of a dose of Nosinagen Sodium Injection was as high as 700,000 yuan, while the price of the drug entering the new version of the medical insurance drug catalog has been as low as the "floor price" of 33,000 yuan per injection.

Zhang Jinni, Director of the Medicines and Devices Procurement Supervision Department of the Fujian Provincial Medical Insurance Bureau, said at the negotiation scene that "every small group should not be abandoned" has also become an annual hot spot in 2021.

According to Biogen’s official account, Nosinagenat is the first high-value rare disease drug to be included in the National Medical Insurance List.

　　For Biogen, it is more urgent to promote Nosinagen Sodium Injection into the medical insurance.

According to public information, at present, pharmaceutical companies have begun to deploy generic drugs of Nosina Senna.

Huaxi Securities’ previous research report analyzed that Nosinagen Sodium may become the first small nucleic acid API launched by the pharmaceutical company Orient, and the original research patent of Nosinagen Sodium will expire in 2025. Has progressed to the pilot stage.

　　Roche’s Riesporam Oral Solution Powder (trade name: Amanxin) will be launched in June 2021. This product is a drug for the treatment of rare diseases in children, and the indication is for spinal muscular atrophy in patients aged 2 months and above. (SMA).

　　Facing the competitive pressure that drugs with the same indication have been included in the medical insurance, and there may be generic drugs in the future, Roche Pharmaceuticals will promote the price reduction of risporam oral solution powder in 2022, which is generally regarded by the industry as a preparation for medical insurance negotiations .

　　In June 2022, according to the Shandong Provincial Pharmaceutical Equipment Purchase Platform, the price of Lisporan Oral Solution Powder was officially reduced to 14,500 yuan per bottle.

According to media estimates, if the maximum dose of patients (2 years old and above and weighing more than 20 kg) is used, the annual treatment burden of risporam will be less than 450,000 yuan, and the economic burden of low-weight patients will be lower. Save up to 2/3 of the maximum dose.

　　It is not only Roche that failed to make progress in the last medical insurance negotiation, but also Sanofi’s agalsidase β for injection for the treatment of Fabry’s disease, Biogen’s dimethyl fumarate enteric-coated capsules for the treatment of relapsing multiple sclerosis, Takeda's lanariumab injection for the treatment of prophylactic hereditary angioedema (HAE).

　　In addition to foreign companies competing for rare disease drugs, in the preliminary review list of the national medical insurance catalog adjustment, some media said that there are 7 Chinese companies, involving 5 listed companies, including Beihai Kangcheng, Li's Pharmaceutical Factory, Wanbangde, Hansoh Pharmaceuticals and BeiGene; a total of 9 drugs have passed the preliminary review, including 5 imported drugs and 4 domestic drugs.

　　Among them, Beihai Kangcheng cooperated with South Korean Green Cross pharmaceutical company and obtained the exclusive license of Idosulfatase β Injection (trade name Hai Ruisi) in Greater China. The drug was approved for marketing in September 2020 for the treatment of mucous Patients with polysaccharide storage disease type II.

　　From the perspective of the commercialization process, Beihai Kangcheng stated in its 2022 semi-annual report that in China, Hai Ruisi has entered the commercial insurance plan approved by the governments of 5 provinces and 42 cities, namely Huiminbao.

　　Hansoh Pharmaceutical announced in March 2022 that inelizumab injection was used to treat adult patients with NMOSD who were positive for AQP4 antibodies, and it had obtained the drug registration approval from the State Food and Drug Administration.

Sino-Singapore Jingwei noticed that Hansoh Pharmaceutical is more active in promoting innovative drugs to enter medical insurance.

In its 2022 semi-annual report, it was disclosed that as of June 30, 2022, Hansoh Pharmaceutical had six innovative drugs approved for marketing, five of which entered the National Medical Insurance Catalogue. And benefit.

　　Zhu Minglai, director of the Health Economics and Medical Security Research Center of Nankai University, analyzed the Sino-Singapore Jingwei, saying that rare diseases have three characteristics: low incidence, high medical expenses, and the value of medication is to prolong survival.

Patients with rare diseases need to take medicine for life, which is very costly.

Huge research and development costs, large medical expenses, and uncertainty in efficacy determine that rare disease drugs are not comparable to other drugs. Therefore, rare disease drugs are included in medical insurance and declared separately, which is equivalent to giving rare disease drugs a "fast track" .

　　At the same time, more and more rare disease drugs are included in the medical insurance, and the medical insurance bureau and rare disease drug research and development companies also face the problem of how to reasonably price them.

Zhu Minglai said that in the early years of national medical insurance negotiations, innovative pharmaceutical companies have already earned back their research and development costs during the patent period of the drug. When it is included in the medical insurance catalog, it is easier for pharmaceutical companies to accept price cuts.

But in the current national medical insurance negotiations, innovative drugs, including drugs for rare diseases, are often developed this year, approved by the drug regulatory department for marketing, and medical insurance negotiations will begin next year.

　　"On the one hand, lower prices will allow more people to use good medicines. On the other hand, profit margins should be left for companies to encourage the research and development of innovative medicines. These two things must be balanced, and a certain amount must be left while bargaining prices. leeway." Zhu Ming said.

(Sino-Singapore Jingwei APP)

(The opinions in this article are for reference only and do not constitute investment advice. Investment is risky, and you need to be cautious when entering the market.)