The “big exam” of the pharmaceutical industry is over! Millions of CAR-T “retests”, GLP-1 new indications are difficult to enter…

The “big exam” of the pharmaceutical industry is over! Millions of CAR-T “retests”, GLP-1 new indications are difficult to enter…

Each year’s medical insurance negotiations leave representatives of pharmaceutical companies racking their brains: not participating in medical insurance means sales will be a problem; entering medical insurance, they also have to calculate whether “volume for price” is feasible.

On November 20, the medical insurance negotiation, the annual “big test” of the pharmaceutical industry, came to an end. According to Xinhua News Agency and CCTV news, a total of 25 experts were divided into five groups to conduct four-day negotiations. The final results are expected to be announced around December.

After application, review, and calculation, a total of 168 drugs entered the bidding stage, the largest number of drugs in history, involving fields such as tumors, rare diseases, and chronic diseases.

In addition to the most varieties and the longest duration, another trend in this medical insurance negotiation is “moderate”.

During the medical insurance negotiations in previous years, the term “soul bargaining” was frequently searched. Judging from the current news and policies issued by the National Medical Insurance Administration, in order to encourage pharmaceutical companies to innovate, the price reduction this year has been narrowed.

After the reduction in medical insurance negotiations narrows, will it increase innovation power for pharmaceutical companies? Is the strategy of exchanging volume for price still feasible? Is the highly anticipated million-dollar CAR-T therapy expected to be on the table?

PD-1 “rolls” to indications

Millions of CAR-T “retests”

Judging from various sources, the first day of the medical insurance negotiations focused on drugs in the fields of respiratory, cardiovascular, digestive, and anti-infectious diseases, with Novartis, Joincare, Chia Tai Tianqing and other companies appearing; the next day, antiviral and chronic disease drugs were the focus. AstraZeneca, Sanofi, Bayer, Hengrui Medicine, etc. came to the negotiation table; hot categories such as PD-1 and ADC were concentrated in the last two days.

In the “List of Drug Applications that Passed Formal Review in the 2023 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog Adjustment” (hereinafter referred to as the “Formal Review List”) issued by the National Medical Insurance Administration,The “Volume King” PD-1 has no new off-catalog products, but it has obviously changed from price to indication. In this year’s catalog, the PD-1 immunotherapy drugs of the “Four Domestic PD-1 Dragons” BeiGene, Hengrui Pharmaceuticals, Innovent Biologics, and Junshi Biologics are all applying for new indications.

Among them, Hengrui’s camrelizumab is expected to be negotiated for a new indication in combination with apatinib for the first-line treatment of advanced liver cancer; BeiGene’s tislelizumab is expected to be negotiated for a new indication in combination with fluorouracil. and platinum-based chemotherapy for the first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression, and combination chemotherapy for the first-line treatment of patients with esophageal squamous cell carcinoma; Innovent Biotech’s sintilimab is expected to be negotiated for a new indication in combination with bevacizumab and chemotherapy for the second-line treatment of patients with EGFR-positive non-squamous non-small cell lung cancer who have failed EGFR-TKI treatment; Junshi Biotech’s Toripalimab is expected to have new indications of 1L nasopharyngeal carcinoma, 1L esophageal squamous cell carcinoma and 1LnsqNSCLC.

After the millions of “anti-cancer miracle drug” CAR-T therapy failed in the national talks in 2022, it challenged the “retest” this year. The emergence of CAR-T cell immunotherapy has changed the traditional treatment of lymphoma, especially for patients with refractory and relapsed lymphoma. Currently, a total of 4 CAR-T products have been approved in China, all of which are indicated for hematological tumors, including Fosun Kite’s Ekaida, WuXi Junuo’s Benoda, Reindeer Biotech’s Fucosu, and Heyuan Biotech. Nachiolense injection was just approved at the beginning of the month.

According to regulations, only drugs approved before June 30 of that year are eligible to participate in the national talks, so this time there are only two CARs: Fosun Kite’s Akilenza Injection and WuXi Junuo’s Regionza Injection. -T drug passed form review. But so far, neither pharmaceutical company has reported any good news. An insider revealed to the media that the two products only passed the preliminary review and did not get the “ticket” for the final medical insurance negotiation.

This also seems to verify the rumors in the industry that “500,000 yuan is not negotiable” for medical insurance, that is, it is difficult for drugs with annual treatment costs of more than 500,000 yuan to enter the real negotiation process, and the price of the above two CAR-T drugs that have passed the formal review All are around 1.2 million yuan.

COVID-19 drugs that were temporarily included in medical insurance during the epidemic also appeared in national talks. A total of three COVID-19 drugs are expected to participate, namely Simcere Pharmaceuticals’ Xenograft/Ritonavir tablets, Junshi Biologics’ deuterated remidevir hydrobromide, and Zhongsheng Pharmaceutical’s Leretevir tablets. Currently, the treatment costs of the three new coronavirus drugs are approximately 630 yuan/course of treatment, 630 yuan/course of treatment, and 628 yuan/course of treatment respectively. However, the current development of the epidemic has tended to stabilize, and whether new coronavirus drugs can be included in medical insurance again is uncertain.

ADCs are blooming

It is difficult to get new GLP-1 indications on the table

In the field of ADC drugs, there are currently 7 domestically approved drugs, 3 of which have been included in the National Reimbursement Directory before. They are Rongchang Biologics’ Vidicitumab, Roche Pharmaceuticals’ Trastuzumab, and Takeda’s Webu Tuximab. Among them, Rongchang Biotech’s Vidicitomab will be renewed due to its expiration this year, and it once again appears on the “Formal Review List”. This drug is a successful example of “volume-for-price”.

According to Guangdong Securities, the unit price of Vidicitomab dropped by 71.85% after being included in medical insurance, but its sales volume soared 15 times. At present, the annual cost of vedesitomab is about 182,000 yuan (urothelial cancer) or 274,000 yuan (gastric cancer), and it has been approved for two indications: third-line treatment of HER-overexpressing gastric cancer and second-line treatment of urothelial cancer. Negotiations for renewal are ongoing this year.

However, it is worth noting that trastuzumab (HER2-positive breast cancer), which competes with vedicituzumab and is developed and commercialized by AstraZeneca and Japanese pharmaceutical company Daiichi Sankyo, Also appears on the Formal Review List. The drug has been invincible since its launch. It first established a crushing advantage over T-DM1 in traditional indications, and then opened up indications for the subtype of breast cancer with low HER2 expression. Last year, it entered the $1 billion club, becoming the global Sales reached US$1.238 billion.

Some insiders believe that if trastuzumab is included in medical insurance, it may have an impact on the market share of vedicituzumab, both in terms of indications and clinical effects. Huang Bin, vice president of AstraZeneca, told the media on the spot that “only one drug was discussed.” Many people speculated that he was referring to Trastuzumab.

Hengrui Medicine’s HER2ADC small molecule drug pyrotinib, which has been included in medical insurance, will renew its contract during this national negotiation and negotiate for new indications. The current annual cost of the drug is about 128,000 yuan, and it has been approved for a total of 3 indications. Among them, the second-line treatment of HER2-positive breast cancer is subject to renewal negotiations, and the second-line and neoadjuvant treatment of HER2-positive breast cancer are expected to be negotiated for new indications.

GLP-1 target drugs, semaglutide and liraglutide, which have become popular around the world since this year and have high hopes as “drug kings”, have also entered the national discussion.However, judging from the “Formal Review List”, the application conditions for the two drugs in the catalog are renewal, not expansion of new indications.

This means that this time, Novo Nordisk’s two anti-diabetic drugs are due for renewal, while the new weight loss indication and Huadong Medicine’s Rilupine failed to get their “tickets.” There is still uncertainty about whether medical insurance can pay for weight loss, a consumption-oriented indication.

In the field of diabetes medication, in addition to Novo Nordisk, Wuhan Jiuan’s Metformin Hydrochloride Sustained-release Tablets, Shanghai Xuantai’s Sitagliptin Metformin Sustained-release Tablets (II), Hua Medicine’s Doglietain Tablets, and Bayer’s Vitamin D Lixigua tablets and others also appeared on the day after the medical insurance negotiations.

Based on patient benefit

Support innovation of pharmaceutical companies

Why do innovative drugs for rare diseases costing hundreds of thousands of dollars and “miracle anti-cancer drugs” worth millions of dollars appear? The reason is that the research and development process of innovative drugs is difficult and expensive.The “Double Ten Project” is another name for new drug research and development in the industry. That is, developing a new drug requires an investment of US$1 billion and 10 years.

A staff member who once worked in the R&D department of a well-known multinational pharmaceutical company said that the production cost of a capsule or tablet is not high, but drug pricing must consider multiple factors such as early R&D investment, subsequent drug patent protection years, and market demand.If you want to not only meet clinical drug needs, but also ensure the profitability of pharmaceutical companies as much as possible, the best way out now is to cooperate with the government. The same strategy applies to medical insurance negotiations, which must take into account the interests of patients and the development of pharmaceutical companies.

Take an oral drug for the treatment of the rare disease spinal muscular atrophy (SMA) in the 2022 medical insurance negotiation as an example. Its listing price is 63,800 yuan per bottle. Judging from the live video of the medical insurance negotiation released after the end, representatives of the pharmaceutical company that produced the drug made several quotations and requests for instructions during the negotiation process and were rejected. The final price was determined at 3,780 yuan/bottle, a decrease of nearly 95%.

In order to inject impetus into the innovation of drug companies, we should seek a balance between drug and patients. Huang Xinyu, director of the Medical Service Management Department of the National Medical Insurance Administration, previously stated at a press conference of the National Medical Insurance Administration that the review methods and specific rules for the adjustment of this year’s medical insurance catalog have been further optimized and improved to fully reflect the value purchase of medical insurance and reflect the importance of medical innovation. support.

The “Rules for Negotiating Drug Contract Renewals” (hereinafter referred to as “Renewal Rules”) adjusted in July also released a signal to encourage pharmaceutical companies to innovate. It is stated in the “Contract Renewal Rules” thatFor Category 1 chemical drugs, Category 1 biological drugs, Category 1 and Category 3 proprietary Chinese medicines approved in accordance with the current drug registration management methods, those who meet the conditions can apply for negotiation and renewal, and the negotiated reduction does not have to be higher than the proportion determined according to the simple rules.

When interpreting the “Renewal Rules”, the National Medical Insurance Administration stated that supporting innovation is a common practice in various countries. The medical insurance department has always attached great importance to supporting drug innovation, and has taken practical actions to effectively support pharmaceutical innovation by shortening the negotiation cycle, improving the review and evaluation mechanism, and accelerating the implementation of drugs.However, supporting innovation must be based on the premise of “guaranteeing basics”, that is, “benefiting patients”.

The “Contract Renewal Rules” also mention that,For negotiated drugs that have reached 8 years, they will be included in the regular catalog management; for negotiated drugs that have not reached 8 years, if the continuous agreement period reaches or exceeds 4 years, if the contract is renewed in a simple way or a new indication triggers a price reduction, the price reduction will be halved; For drugs included in the national “Novel Coronavirus Infection Diagnosis and Treatment Plan”, if the actual expenditure of the fund exceeds the budget, the price will not be reduced when the contract is renewed in 2023 and 2024.

Liao Zangyi, associate professor at the School of Politics and Public Administration of China University of Political Science and Law, believes that for products that have been included in the catalog for a long time (more than 8 years) through negotiation, inclusion in the regular catalog will reduce the pressure to reduce prices and help stabilize corporate expectations. From a long-term perspective, it will definitely benefit the development of the industry, optimize medical insurance access expectations, and improve the accessibility and supply capacity of drugs to patients.

In an interview with a reporter from the International Finance News, a senior executive of a multinational pharmaceutical company said: “Centralized procurement actually transfers some of the ‘waste’ that occurs in the value chain to investment in innovative industries. The first step for companies is to strengthen their understanding of policies, Understand and learn about the supply chain and hospital-side conditions, and the second is to achieve ‘true innovation’ and enrich the product pipeline. Even if there is a price reduction on a product, it can be compensated for by other products.”

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