Behind the price reduction of ＂sky-high life-saving medicine＂ exceeding 90%： nine domestic generic drugs are listed.
In 2018, a realistic Dying to Survive hit a 3.1 billion summer box office champion. While countless people are sighing and moving, how to make the "sky-high life-saving medicine" accessible to ordinary patients has become a topic of general public concern.
The leukemia drug in this film — — Gleevec (imatinib mesylate) is a microcosm of high-priced drugs. This drug developed by Novartis Pharmaceutical entered China in early 2004, and the price of the original drug was as high as.23,500 yuan(120 tablets/box).
According to the first financial reporter, in the past decade, more and more manufacturers have entered the market of leukemia treatment drugs, making the price of this "life-saving medicine" drop again and again.
According to the data of CHIS kaisi system of Zhongkang Technology, the retail terminal price of Gleevec has been declining in the past three years, and the retail market price in 2022 will be6449.32 yuan. The reporter saw on an e-commerce platform on July 22 that the price of Gleevec’s original drug was mostly1700 yuan ~1800 yuanBetween
With the approval of more and more domestic generic drugs, the lowest price of domestic imatinib mesylate tablets has dropped to.144 yuan/boxIt is about 1.2% of the original price of the drug. At present, the sales price of Gleevec on the e-commerce platform is more than 1,700 yuan, which is nearly 90% lower than when Novartis first entered the China market.
The price of "life-saving medicine" continues to drop.
On July 19th, Hubei Provincial Medical Insurance Bureau posted a Notice on Publicizing the Information about the First to Fifth Batch of Non-selected Varieties in Centralized Drug Purchase by the State Organization, which stated that the first to fifth batches of centralized drug purchase by the State Organization had been carried out with the non-selected varieties under the generic name over-evaluated, the online price adjusted, the online suspension and the handling of complaints. On this basis, the medical insurance payment standard and other related work were drawn up, and a list of non-selected varieties to be online was formed. The publicity date of this list is from July 19 to July 23, 2023.
The online price of drugs refers to the published price of drugs on the centralized procurement platform of medical equipment in Hubei Province for the procurement of public medical institutions in the province. According to the regulations, all public medical institutions in Wuhan must purchase the drugs that have been hung on the net through the provincial centralized procurement platform for medical equipment when implementing the online procurement policy, and must not purchase from offline and other non-prescribed channels. The price of drugs hanging on the net is the highest price limit of public medical institutions in the city.
The list of the first batch of non-selected varieties to be hung on the net shows that there are6 imatinib mesylateAmong them, in addition to the original research drug Novartis Pharmaceutical, there are also five models, namely Zhengda Tianqing, Jiangsu Haosen, Qilu Pharmaceutical, Chongqing Yaoyou and Sinopharm Yixin, all of which have been evaluated.
In terms of price, the highest hanging net is still Gleevec.7182 yuan. Zhengda Tianqing, Jiangsu Haosen, Qilu Pharmaceutical and Sinopharm are all interested in imatinib mesylate. The online price is only.More than 500Yuan.
Even if the net price is 7,182 yuan, the price of the original drug Gleevec has dropped by nearly 40% compared with 23,500 yuan (120 tablets/box) when it first entered the China market.
According to the data of CHIS kaisi system of Zhongkang Technology, although the price of Gleevec in the hospital has remained at around 7182 yuan in the past three years, the price of retail terminals has been declining. In 2022, the retail market price will be6449.32 yuan.
The reporter’s search for "imatinib mesylate" on an e-commerce platform shows that the price of Gleevec’s original drug is only 0.1g*60 tablets/box as the standard in most pharmacies.1700 yuan ~1800 yuanBetween, and the price of domestic medicine is in500 yuanAbout. For example, the price of Xinwei tablets in Jiangsu Haosen is 430 yuan, the price of Genico capsules in Zhengda Tianqing is 441.88 yuan, and the lowest price is Shengdika tablets produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd., with an estimated hand price of 144 yuan.
nineDomestic companies were approved for production.
More and more cheap domestic "life-saving drugs" appeared, which was related to the end of the protection period of the compound patent of imatinib in China in April 2013, and domestic generic drugs began to be produced and listed.
From June 2013 to October 2014, three domestic generic drugs of Jiangsu Haosen, Zhengda Tianqing and Shiyao Ouyi obtained production approval. Because the efficacy of generic drugs has not been verified, the original drug of Novartis, Gleevec, still occupied most of the market. According to public data, in 2016, imatinib mesylate tablets sold more than 4 billion US dollars worldwide.
The competitiveness of domestic drugs began to improve after 2018. From 2018 to 2020, the above three drugs passed the consistency evaluation successively. On July 5, 2018, Jiangsu Haosen Pharmaceutical Co., Ltd. said that it had received the Approval Document for Supplementary Application of Imatinib, a chemical drug approved and issued by National Medical Products Administration, and the National Drug Testing Center recommended that it pass the consistency evaluation, making it the first enterprise to pass the consistency evaluation of this drug.
Overevaluation means that drugs have reached the passing line in quality and efficacy, and generic drugs have become more competitive. In September 2018, Hansen Pharmaceutical (Haosen Pharmaceutical) disclosed the prospectus for listing in Hong Kong, showing that the sales revenue of the core product imatinib mesylate in 2017 was RMB 2.5 billion, up by 7.3% since 2016, and up to June 30, 2018, up by 34.5% compared with the same period of last year.
With the entry of imatinib mesylate tablets into the medical insurance catalogue in 2017, more manufacturers entered this field. National Medical Products Administration website shows that the domestic imatinib mesylateNine manufacturers have been approved.Unacon Ouyi Pharmaceutical, Zhengda Tianqing, Qilu Pharmaceutical, Shenzhen Xinlitai Pharmaceutical, Chongqing Yaoyou Pharmaceutical, Lianyungang Runzhong Pharmaceutical, Shanghai Nuochuang Pharmaceutical, Fujian Nanfang Pharmaceutical and Chongqing Shenghuaxi Pharmaceutical, among which Shanghai Nuochuang Pharmaceutical and Fujian Nanfang Pharmaceutical successivelyMay and June this yearJust approved.
What followed was that prices kept falling.
In 2018, imatinib mesylate tablets of Jiangsu Haosen Pharmaceutical Co., Ltd. won the bid in four municipalities directly under the Central Government, including Beijing, Tianjin, Shanghai and Chongqing, and 11 cities (referred to as "4+7" cities) including Shenyang, Guangzhou, Chengdu and Xi ‘an, with the winning price of 623.82 yuan per box. In 2019, the "4+7" procurement expanded, and Zhengda Tianqing won the bid at a price of 586.39 yuan, further reducing the price of this drug.
In August, 2022, Shanghai issued a price adjustment notice, and the adjusted purchase price of imatinib mesylate tablets produced by Shiyao Ouyi has dropped to 180 yuan/box.
The lower price of domestic drugs also impacts the price of original drugs.
In 2018, the joint bargaining of imported anticancer drugs in 14 provinces including Shaanxi was completed, and 47 anticancer drugs including Gleevec were successfully negotiated. According to the announcement, the bargaining result of Gleevec’s specification of 0.1g*60 tablets was 9998 yuan.
In 2019, according to the previous report of CBN, the price of the original drug Gleevec in Shanghai has dropped to 7182 yuan/box, which is about 30% lower than the market price of around 11,000 yuan at that time.
New progress
It is worth mentioning that with the increase of drug resistance caused by long-term medication, Gleevec’s R&D iteration has also attracted much attention.
The second and third generation BCR-ABL inhibitors have been developed in order to solve the drug resistance problem and improve the safety. Dashatinib from Bristol-Myers Squibb and Nilotinib from Novartis were introduced one after another, which made the second generation BCR-ABL inhibitors gradually occupy an important position in the first-line and second-line treatment of chronic myeloid leukemia. However, the problem of drug resistance still exists during the use of the second generation BCR-ABL inhibitors.
In November, 2021, Nilik, known as the "third generation Gleevec" made in China, was approved for marketing in National Medical Products Administration, China, and was used to treat adult patients who were resistant to any tyrosine kinase inhibitor (TKI) and were diagnosed as chronic myeloid leukemia (CML) with T315I mutation in chronic phase (CP) or accelerated phase (AP) by fully verified detection methods.
This year, on July 6th, Yasheng Medical Officer Wei announced that Nilik had obtained the clinical trial permission from National Medical Products Administration Drug Evaluation Center, and would carry out a key registered phase III clinical trial of combined chemotherapy compared with imatinib combined chemotherapy in the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (referred to as "Ph+ALL").
At the end of 2022, Novartis decided not to be responsible for the sales promotion of Gleevec in China.
The official micro-display of Sinopharm Holdings shows that from January 1, 2023, Sinopharm Holdings officially obtained the commercial promotion right of Novartis Gleevec in China market. Xie Jiong, director of the Drug Shield Public Welfare Fund, said in an interview with the media that for many drugs, it is necessary to adjust the inherent marketing model after a certain development cycle, so as to drive the second peak of sales. This will not only prolong the life cycle of drug sales, but also greatly enhance the accessibility of drugs and benefit a wider range of patients.
Our reporter Lin Zhiyin also contributed to this article.