Every year before the national health insurance negotiation, potential hot varieties always attract a lot of attention.
On June 29, the National Medical Insurance Bureau announced the “2022 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog Adjustment Work Plan”, announcing the official launch of the fifth round of national medical insurance negotiations. According to the regulations, all the products declared by enterprises must be approved for listing before June 30 this year.
Statistics from the Health and Knowledge Bureau found that from July 1, 2021 to June 30, 2022, the combined domestic innovative drugs and new indications approved for marketing reached 30 There are more than one species, with cancer drugs as the main drug, followed by diabetes and leukemia drugs, and there are as many as 11 traditional Chinese medicine products. These are the highlights of this year’s national talks.
Many new drug “card points” approved
Negotiation battle is imminent
A number of new drug “card points” have been approved, and the negotiation war is imminent
On June 29, the State Food and Drug Administration successively approved 3 new drugs for the market, namely Kangfang Bio’s PD-1/CTLA-4 double-antibody cadonilimumab, Hengrui’s prostate cancer drug revalutamide tablets, and Bayer’s hypoglycemic drug feneridone tablets.
One day later, these three products may not be eligible for this year’s medical insurance negotiation application.
Data from the State Food and Drug Administration shows that in the past year, Hengrui Medicine has listed Proline Henggliflozin Tablets, Dalcilis Isethionate Tablets and Revelutamide Tablets 3 The products are all Class 1 new drugs, and the number of listed products ranks first among domestic enterprises. According to the data disclosed by Hengrui, the cumulative R&D investment of these three drugs is as much as 996 million yuan. After entering the medical insurance, these products can quickly spread to the market.
The record in traditional Chinese medicine is also impressive. From the second half of 2021, Yiling Pharmaceutical’s Yishen Yangxin Anshen Tablets, Jieyu Chufan Capsules, Jianmin Pharmaceutical’s Qirui Weishu Capsules, etc. 11 new traditional Chinese medicines from 10 companies Marketed, accounting for about 40% of the total number of domestically approved new drugs.
In the new products, there are many varieties with complicated “life experience”, such as the Icariin Soft Capsule of Shennuoji Pharmaceutical, a subsidiary of Shengnuoji, the indication is treatment hepatocellular carcinoma.
Epimedium is a unique medicine in traditional Chinese medicine, which is often used to invigorate the kidney and strengthen yang. When Shengnuoji developed an AIDS drug with epimedium as the main ingredient, it was found that it can also work on breast cancer, lung cancer and other diseases, so it has this icariin soft capsule for liver cancer. In May 2020, Shengnuoji submitted an IPO on the Science and Technology Innovation Board with the “core product” icariin soft capsule, which was not yet available at the time, and has yet to make progress.
In the first half of this year, multinational pharmaceutical companies launched at least 5 anticancer drugs in China, including Bayer’s oral NTRK inhibitor larottinib, Incyte’s cholangiocarcinoma target Pemetinib tablets, Pfizer’s ALK inhibitor lorlatinib, etc.
Data source: State Food and Drug Administration
It is worth mentioning that larotrectinib is a “broad-spectrum anticancer drug” that was launched in the United States in 2018. Data released by Bayer at this year’s American Society of Clinical Oncology showed that the objective response rate of larotrectinib in the treatment of NTRK gene fusion children with solid tumors was as high as 84%, and there were no unexpected adverse events.
Multinational pharmaceutical companies are enthusiastic about participating in medical insurance price negotiations, but subject to the global price system, they are reluctant to cut prices too much in China. But often the famous scene of “soul bargaining” every year is caused by multinational pharmaceutical companies.
Star drug draws attention again
Who will win the directory quota
In the 2022 medical insurance negotiation, the PD-1 war ushered in more variables.
On the one hand, new competitors enter the game: in the second half of 2021, Kangfang’s piamplimumab, Henlius’ slulimumab They have been listed one after another, and one has lowered the market price to the lowest level before entering medical insurance, and the other has unique advantages in indications.
The other side is the “four little dragons” that continue to exert their strength: Sintilimab from Cinda, Tislelizumab from BeiGene, and Trepripril from Junshi Monoclonal antibodies have successively won indications for nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and gastric cancer. By convention, it is definitely necessary to participate in the “one-day tour” of medical insurance. In addition, PD-1 in several medical insurances has expired this year, and the battle for “renewal” is imminent.
Another stirring up the market is the kadunilimumab approved by Kangfang “Kadian”. This is the first approved domestic double antibody and the world’s first marketed double antibody drug based on PD-1. At the moment when the market has entered a white-hot period, Kangfang came with an “upgraded version” product, and its intention is self-evident.
The “high-priced drug” CAR-T is another point of interest.
In 2021, Fosun Kate’s CAlthough the AR-T product Akilence injection has passed the formal examination, it has not entered the negotiation stage due to the sky-high price of 1.2 million yuan per injection. In March this year, data disclosed by Fosun showed that as of the end of February this year, only 100 patients had used this product.
This year, Fosun Kate has a rival. At the beginning of September 2021, WuXi Junuo’s CAR-T Ruiki Orenza injection was approved for marketing, priced at 1.29 million yuan per injection, which is a bit more expensive than Fosun’s products. The Health Knowledge Bureau noticed that As of now, neither Fosun nor WuXi Junuo has issued a price reduction notice. According to the current pricing of the two products, they may still miss the medical insurance negotiation this year.
Another thing to watch is rare diseases. In this year’s medical insurance catalog adjustment document, the National Medical Insurance Administration specifically mentioned that it encourages the participation of rare disease drugs and relaxes its listing period. As long as the products are listed before June 30 this year, they can participate.
In 2021, Bojian’s “700,000 yuan per injection” spinal muscular atrophy (SMA) drug Nosinagen Sodium was successfully shortlisted, and the annual fee was reduced to less than 100,000 yuan. This year, Roche’s oral SMA product Lisprolan voluntarily reduced the price in June, keeping the annual fee within 450,000 yuan.
Apparently, Roche is going for health insurance. This year, if Lispolan can really be shortlisted, Biogen may not be so stable as the market leader in SMA.
Writing｜Gu Yue
Editing｜Jiang Yun Jia Ting
Operations｜Valley
Illustration | Visual China