The Average Price Reduction Of 119 Drugs Was 50.64%, And 28 Billion Was Cut Off. The Fifth Year Of Medical Insurance Negotiation, The Battle Of 2021 Under The Three Major Changes

A few families are happy and some are sad. On December 28, a number of pharmaceutical listed companies announced that their products were included in or retained in the national health insurance catalog.

On the same day, the State Medical Security Bureau and the Ministry of human resources and Social Security announced the drug catalog of national basic medical insurance, work injury insurance and maternity insurance (2020), which will be officially implemented from March 1, next year. In this adjustment, 162 kinds of drugs were negotiated, 119 kinds of drugs were successfully negotiated, the success rate of negotiation was 73.46%, and the average price reduction of drugs was 50.64%. Among them, the PD-1 of Hengrui medicine, Baiji Shenzhou and Junshi biology were all included in the medical insurance; ribavirin injection, abidol granules and other drugs related to the treatment of new crown pneumonia were also included in the national medical insurance catalogue.

Xiong Xianjun, director of the medical management department of the National Medical Insurance Bureau, said at a news conference held by the State Medical Insurance Bureau on 28 June, the adjustment adheres to the functional orientation of "basic insurance" to ensure that the expenditure of medical insurance fund can be controlled. In the process of catalog adjustment, through the transfer of drugs with low clinical value, negotiation to reduce the prices of drugs with significantly higher costs in the list and drugs expired in special negotiation, especially in recent years, the "volume for price" policy has further squeezed the price of drugs, realized "cage for bird" and ensured the basic balance of funds.

According to the State Medical Insurance Bureau, from the perspective of patients' burden, it is estimated that about 28 billion yuan of patients' burden will be reduced by 2021 through negotiation of price reduction and reimbursement. 14 exclusive drugs were renewed or renegotiated in accordance with the rules, with an average decrease of 14.95%, of which some first-line anticancer drugs decreased by more than 60%. It is estimated that the price of 14 kinds of anticancer drugs will save more than 3 billion yuan for cancer patients in 2021.

What is different from the past is that the declaration system has been implemented for the first time this year, that is to say, only drugs that meet the conditions listed in this year's adjustment plan can be included in the adjustment scope. As for how to determine the "base price", Liu Guoen, head of the pharmacoeconomics calculation group of the negotiation of the national medical insurance catalogue in 2020, revealed that the experts of pharmacoeconomics compare the price of new drugs with those of existing products. In terms of clinical and side effects, the added value can be converted into a parameter to compare with the price, so as to decide whether to recommend it or not, as well as a reasonable price 。

Acceleration of access to innovative drugs

Compared with previous years, an important feature of this adjustment is that the number of drugs transferred in through negotiation with price reduction is the largest, and the treatment fields benefited the most widely.

Xiong Xianjun introduced that 162 kinds of drugs were negotiated, and 119 kinds of drugs were successfully negotiated (including 96 out of the list and 23 in the list), with a success rate of 73.46% and an average price reduction of 50.64%. A total of 119 drugs (including 96 exclusive drugs and 23 non exclusive drugs) were newly transferred into the catalogue adjustment, involving 31 clinical groups, accounting for 86% of all clinical groups.

"In the future, normalization of medical insurance negotiations has become an irreversible trend. It is also the main theme to realize" changing cages for birds "to ensure the basic balance of funds. Enterprises need to innovate and produce products with high added value." Wang Ying, CEO of Bosia, told reporters of the 21st century economic report.

Jiang Chengjia, deputy director of the medical insurance center of the State Medical Insurance Bureau, also pointed out that after the establishment of the National Medical Insurance Bureau, the medical insurance catalogue has been adjusted for three consecutive years in 2018, 2019 and 2020, and the standard dynamic adjustment mechanism has been established. Through the dynamic adjustment of the medical insurance drug list, there is an import and a output, and a cage for a bird has been realized. It can timely adjust the list of safe, effective and reasonably priced drugs in clinical urgent need The drug structure was more reasonable, and the quality and level of drug use were further improved.

Huang Bin, a representative of AstraZeneca, who has participated in the national health insurance negotiations for four years in a row, said that what he felt most deeply was that the access speed of innovative drugs in China was significantly accelerated, and that the negotiation process of national health insurance was more fair, scientific and transparent, and strive to achieve a win-win situation among patients, medical insurance and enterprises. "No foreign company can ignore the value of medical insurance. Medical insurance negotiation improves the accessibility of drugs." He said.

In fact, 29 kinds of drugs have been called out of the list this time, mainly for the varieties with low clinical value and substitutability, or being revoked by the drug supervision department as "zombie drugs". In the process of evaluation, the experts regard substitutability as an important indicator, and there are drugs with similar or better curative effect in the list of drugs that have been transferred out. At the same time, the transfer of these drugs has made room for more new and good drugs to be included in the list.

New negotiation mode

Different from the previous round of adjustment, which included "all listed drugs" into the scope of review, the declaration system was implemented for the first time this year, that is, only those drugs that meet the conditions listed in this year's adjustment plan can be included in the adjustment scope. The adjustment range of drugs out of the list has realized the transformation from "sea selection" to "optimization".

To set the application conditions, we should better meet the clinical needs, better connect with the new drug approval work, and realize the "seamless connection" between drug approval and medical insurance review. For example, new crown pneumonia treatment drugs, clinical urgent need or encourage imitation of drugs, national essential drugs, centralized purchase of selected drugs and so on.

According to the 21st century economic report, many innovative drugs included in the medical insurance list are considered from the aspects of high clinical value, "seamless connection" between drug approval and medical insurance review.

For example, Novartis tumor (China) tiferol (dalaafinil mesylate capsules) combined with meginib (trimetinib tablets) dual target combination products have passed the national health insurance negotiation, and have been officially included in the national health insurance catalogue in 2020. The two innovative drugs were approved in China in December 2019 and March 2020, respectively. Up to now, with the renewal of the medical insurance contract in 2020, all 13 products of Novartis cancer listed in China have entered the national health insurance catalog.

It is understood that the combination of tiferol and megenin is not only China's first product with dual target drug dual indications included in the national medical insurance, but also the first target product in the field of melanoma adjuvant therapy to enter the medical insurance, bringing innovative and accessible solutions for the precise treatment and adjuvant treatment of melanoma. The 21st century business reporter also learned from Novartis cancer that the first prescription of the dual target treatment drug in China was issued in Peking University Cancer Hospital on April 27, and the drug was fully distributed in 37 cities across the country.

Professor Guo Jun, an academic leader in the field of melanoma treatment in China and vice president of Peking University Cancer Hospital, pointed out that BRAF gene mutation is the driving gene mutation for the development of melanoma, which makes the development of melanoma very fast. In the past, chemotherapy had little effect on patients with BRAF V600 mutation, but now there are double target drugs, and the effective rate is nearly 70%. In terms of survival time, in the past, the survival time of patients was less than one year, and now more than one third of patients with double target therapy lived more than five years.

The three innovative drugs of GSK, fluticamivir inhalation powder aerosol, baileyumab for injection, and alisentan tablets were included in the national health insurance list through direct transfer and medical insurance negotiation. Among them, baileyumab for injection was approved for marketing in July 2019, which is the first new lupus erythematosus drug in China in 60 years.

Qi Xin, general manager of prescription drugs and vaccines of GSK China, said that this not only reflects the determination of the country to continuously promote the medical reform, but also greatly improves the accessibility of innovative and high-quality drugs. While reducing the medical burden for the general public, it constantly improves the diagnosis and treatment results, and further improves the diagnosis and treatment level of related diseases.

The national health insurance catalogue was upgraded again, and 119 new drugs were selected as "high cost performance". Xinhua News Agency

PD-1 war situation: multinational pharmaceutical enterprises lost

It is worth noting that in addition to the national health insurance negotiation for the drugs out of the list, the National Health Insurance Bureau tried to negotiate the price reduction of the drugs in the list for the first time, so as to improve its economy.

According to reports, the evaluation experts selected 14 exclusive drugs with high price and large fund occupation for negotiation. These products are all 1 billion grade products. After negotiation, all 14 products were negotiated, with a decrease rate of 43.46%. Among them are butylphenol of lithospermic, Lanqin oral liquid of Yangzi River, bailing capsule of East China, ameprase of bringer Ingelheim, etc.

According to the State Medical Insurance Bureau, most of the 119 new drugs (96 exclusive and 23 non exclusive) are exclusive drugs with price reduction through negotiation. It is estimated that the increased fund expenditure in 2021 is basically equivalent to the space vacated by negotiation and drug transfer out. At the same time, the validity period of the negotiation drug agreement is two years. After two years, we will adjust the payment standard again according to the actual sales situation to ensure the smooth operation of the fund. In terms of the burden of patients, it is estimated that the total burden of patients will be reduced by about 28 billion yuan in 2021 through negotiation of price reduction and medical insurance reimbursement.

Among them, the negotiation of anticancer drugs has always been a key project. In 2018, since the establishment of the National Health Insurance Bureau, negotiations on the special access to anticancer drugs were organized. Finally, 17 kinds of drugs were successfully included in the list, and the agreement expired at the end of this year. Among the 17 kinds of anticancer drugs, 3 kinds of generic drugs were listed and included in category B management. 14 exclusive drugs were renewed or renegotiated in accordance with the rules, with an average decrease of 14.95%, of which some first-line anticancer drugs decreased by more than 60%. It is estimated that the price of 14 kinds of anticancer drugs will save more than 3 billion yuan for cancer patients in 2021. At the same time, 17 new anticancer drugs have been added in this adjustment, including PD-1, lovastatin and other new and good drugs. The guarantee level of cancer drug use in the list has been significantly improved.

In fact, Pd - (L) 1 has become the focus of attention before the national health insurance negotiations begin, and the competition is unprecedented fierce.

Because from a historical point of view, entering the medical insurance means that the sales can be large. If the negotiation is successful, Cinda PD-1 has achieved a large volume, and its sales are expected to exceed 2 billion yuan this year.

Up to now, 8 PD-1 / PD-L1 mAbs have been listed in China, including 4 imported and 4 domestic mAbs, respectively, artelizumab of Roche, navulieu mAb of Bristol Myers Squibb, pabolizumab of moshadong, duvalizumab of AstraZeneca, treprizumab of Junshi bio, tirelizumab of Baiji Shenzhou, carrerizumab of Hengrui medicine and xindasheng The substance of sindilimab. Among them, atilizumab and duvaliew mAb were PD-L1 mAbs, and the other 6 were PD-1 mAbs.

None of the imported PD-1 / PD-L1 has been included in the medical insurance list. A senior person in the pharmaceutical industry pointed out to the reporter of the 21st century economic report that this is expected because multinational pharmaceutical enterprises are facing the global market and need to maintain a unified price system. They prefer to reduce prices in disguised form in the form of free drugs to maintain the balance of the global price system.

In this regard, Xiong Xianjun, director of the medical service management department of the State Medical Security Bureau, revealed in an interview with the media after the press conference that the prices of the three domestic PD-1 newly included are lower than those of Xinda biological Co., Ltd., which was included in the medical insurance before. The import enterprises should consider the international price problem, "the domestic enterprises are mainly the Chinese market and the Chinese price."

New campaign begins

Hu Shanlian of School of public health of Fudan University pointed out in an interview with 21st century economic reporter that the price of PD-1 is the key in the negotiation of national health insurance, and the competition of follow-up indications will be very fierce.

It is understood that Hengrui pharmaceutical carrilezumab is the domestic PD-1 with the most approved indications, and all four indications are listed in the medical insurance list, namely Hodgkin's lymphoma, liver cancer, non-small cell lung cancer and esophageal squamous cell carcinoma. In addition, there are many indications under clinical research and development, including the first-line combined therapy for esophageal cancer, the first-line combined therapy for non-small-cell lung cancer, etc. Junshi bio treprilimab was approved for marketing in December 2018. It is the first PD-1 mAb independently developed in China, and only melanoma indications are approved. At the end of April this year, the application for new indications of treprilimab in the treatment of patients with recurrent / metastatic nasopharyngeal carcinoma (NPC) who had previously failed to receive second-line or above systemic treatment was accepted. It was also the first new drug application for anti PD-1 monoclonal antibody in the treatment of recurrent / metastatic nasopharyngeal carcinoma in the world. In May 2020, the application for new indications for transurethral resection of urothelial carcinoma was accepted. Both Hodgkin's lymphoma and urothelial carcinoma, two indications approved for trelizumab in Baiji, are also covered by medical insurance. Since then, Baiji Shenzhou has submitted the marketing application for the first-line treatment of advanced squamous non-small cell lung cancer and for the treatment of previously treated patients with unresectable hepatocellular carcinoma.

Shi lichen, director of Beijing Dingchen medical management consulting center, pointed out that indications are the core factors determining whether PD-1 mAbs can be sold in large quantities after entering the national medical insurance catalogue. From the perspective of the current entry into medical insurance, all three domestic PD-1 models have overlapping indications, and it is not difficult to imagine the degree of competition in the future.

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