On December 13, the adjustment of the medical insurance catalog in 2023 came to an end.
According to the National Health Insurance Administration, a total of 126 new drugs have been added this year. A total of 143 out-of-catalogue drugs participated in the negotiation and bidding process, of which 121 drugs were successfully negotiated and bid, with a success rate of 846%。
There are successful negotiations and there are unsuccessful negotiations. Hengrui's adebelimab, Henlius' serplulimab, and Lepu Biotech's putelimab were not on the formal review list；Although several domestic CAR-T have passed the review, they are still running with them without accidentIn PD-L1, CStone's sugemalimab entered the negotiation for the first time this year, but it missed the medical insurance catalog.
Somewhat unexpectedly,This year, four ADC drugs, detrastuzumab, gosatuzumab, ogainutuzumab, and vepotuzumab, did not appear on the final list。The domestic ADC market still maintains a pattern of two imports and one domestic production, namely Roche's trastuzumab, Takeda's brentuximab and Rongchang's vedicitumab.
The ADC track has been particularly popular in recent years, and there are many more ADCs on the preliminary review list this year than usual. Trastuzumab is a new HER2 ADC drug that has attracted much attention in the adjustment of the medical insurance catalogue this year, and it is also a rising star in the global market. Whether it can enter the medical insurance or not, it will greatly change the competitive landscape of domestic HER2 ADCs
At the national talks in early December 2023, AstraZeneca was still led by Huang Bin, vice president of China. Judging from his on-site reaction at the time, he could not have guessed that trastuzumab would be defeated.
In the Chinese and global markets, the two ADC drugs detrastuzumab and Roche's trastuzumab are the most direct competitors. Trastuzumab was approved in China in January 2020, while trastuzumab was approved in February this year. At present, trastuzumab has only second-line status in HER2-positive** breast cancer.
Trastuzumab did not enter the medical insurance this time, reflecting AstraZeneca's market strategy thinking.
Trastuzumab is currently priced at 8,860 yuan per bottle for 100mg in the mainlandAt present, the competitor trastuzumab has undergone three downward adjustments, with 100mg per bottle of ** being 3580 yuan and 160mg being 5130 yuan per bottle. This year, if the price of trastuzumab is reduced and entered into the medical insurance, the reduction will not be too low, even if the average reduction rate of 61% is calculated, the ** of 100mg may only be about 3500 yuan.
Reduced to the same level as enmetutuzumab**, AstraZeneca is obviously not willing, after all, trastuzumab is a drug that has just been approved in China, and the preliminary market paving work has not yet been done.
Moreover, trastuzumab was approved in the United States in 2019, and sales have been growing at a rapid rate since then, selling about 161.6 billion yen (about 12.) in 2022$300 million), an increase of nearly two times from the previous year. As of September this year, trastuzumab has achieved revenue of 241200 million yen (17.)0.5 billion US dollars), doubling annual sales should not be a problem。However, the sales volume of trastuzumab in 2022 is 20CHF 800 million, an increase of almost 7%.
In the international market, trastuzumab is not worried about selling, and it has a great tendency to surpass its opponent trastuzumab.
AstraZeneca's commercialization capabilities in China are obvious to all. Before the first half of this year, AstraZeneca had been the No. 1 multinational pharmaceutical company in China in terms of revenue. The strength of osimertinib in the domestic EGFR-TKI market far exceeds that of other domestic third-generation EGFRs. In 2022, osimertinib sales in hospitals in China reached 438.6 billion yuan.
Proven experience in the Chinese market, coupled with excellent efficacyTrastuzumab will have a large market in China even if it is not covered by medical insurance。Moreover, the indication of trastuzumab in China is still being developed. In November, the indication of adenocarcinoma of the stomach or gastroesophageal junction with trastuzumab HER2-positive** was proposed to be included in the priority review.
There are very few varieties with increased indications this year, but trastuzumab is currently targeting large cancer speciesIf the indications are negotiated, the price reduction may exceed the company's expectations
In this year's adjustment of the medical insurance catalog, a change often mentioned by the medical insurance bureau and pharmaceutical companies is that the rules for the adjustment of the medical insurance catalog are becoming more and more perfect, and the price reduction expectations conveyed to pharmaceutical companies are more stable and clear.
The mindset of pharmaceutical companies is also changing. The 4 imported ADC drugs that passed the pre-approval list this year have not entered the medical insurance:Pfizer's Oga Ituzumab, Roche's Vepotuzumab, Gilead's Gosatuzumab, and Daiichi Sankyo AstraZeneCa's Trastuzumab
For reasons related to the global pricing system, foreign companies often weigh the impact of price reductions. Some domestic enterprises also have their own abacus.
Getting health insurance is only the first step. In general, the varieties that choose to enter the medical insurance can basically achieve a certain amount of price for quantityHowever, price reduction does not mean that the market is in hand, and pharmaceutical companies need to pay the same or even more commercial promotion costs。Taking sintilimab as an example, the sales team of sintilimab at the end of 2019 was 688 people, and after entering the medical insurance, the team increased to more than 1,100 people in the first half of 2020, covering 1,500 more hospitals, and finally achieved sales of more than 2 billion yuan that year.
Today, the competition in the domestic pharmaceutical market is very different from that of five or six years ago. The clinical gap has been filled to a large extent, and the indications that should be accounted for have also accounted for seventy-seven eighty-eight. Nowadays, domestic innovative drugs have gradually developed a development path: price reduction and hard squeeze is not the way, and product differentiation design is likely to break through.
This change is particularly pronounced in the PD-(L)1 market, which is already fully competitive in China. This year, several new batches of domestic PD-(L)1 with high demand have not entered the medical insurance, in which Alphamab Alphamab envafolimab is predominantly administered by subcutaneous injection;Henlius' serplulimab set a new record for overall survival in first-line** small cell lung cancer, achieving 86.5 billion yuan in sales revenue.
This year, Kangkeso's penpulimab and cadonilimab are still not involved in the medical insurance negotiations. Cadonilimab chose to make a breakthrough in cervical cancer first, and only this year did Yuheng Biopharma PD-1 join the competition. Penpulimab is supported by the commercialization ability of Chia Tai Tianqing, and it can also achieve sufficient volume in the non-medical insurance market.
Judging from what happened to the above-mentioned drugs,This year, the National Health Insurance Administration has adjusted the rules for negotiation and selection, and innovative drugs with "insufficient sincerity" cannot even pass the formal review
Since last year, the National Health Insurance Administration has required enterprises to report core parameters such as drug R&D costs, market standards, and sales data in the past year. These data are not publicly available, but the Health Insurance Bureau obviously uses these data for the selection of negotiated varieties, and there are only a few varieties that have not been negotiated in the negotiation stage, which has achieved the expected effect of medical insurance negotiations in 2023.
This is an important trend in future medical insurance negotiations. What companies really need to do is not to negotiate a few "8s" or "520s" at the negotiation table, or what kind of expression they show when they step out of the negotiation room, but to make the Health Insurance Bureau feel the willingness to enter the medical insurance.
Author丨Yang Xixia.
Edit |Jiang Yun Jia Ting.
Operations |Zhu Ying.
Source丨Visual China.