[Transfer] US medical insurance control fee failed

Source: Archimedes Biotech

The United States' "Inflation Act" (IRA) has signed for nearly one month, of which the content involved in medical insurance negotiations has continued to ferment, and suddenly the domestic network has attracted attention.

Carefully splitting the US medical insurance premium clauses are greatly shocked.

01

Powerful US cost

The toxic prescriptions for the "Inflation Act" and the US medical insurance negotiations have been held by the interest group. It can neither reduce the current high inflation nor to bring a sense of gain to ordinary American people.

1. It is not from the implementation of medical insurance prices from January 1 next year, but to start in 2026. The first batch of 10 drugs was launched, and 15 drugs were added in 2027 and 2028, respectively. It takes more than 7 years to implement it.

2. It is not that the medical insurance negotiations are included in more than 60 drugs each year. As mentioned above, the time span is 70 years before incorporating 60 drugs.

3. Starting time is the starting point, small molecular drugs have a 9 -year exemption, and large -molecular drugs (biopharmaceuticals) have a 13 -year exemption. There is no need to conduct medical insurance negotiations to reduce prices.

4. Drugs that are about to appear in generic/biological drugs, small BIOTECH drugs, orphan drugs, and drugs with only a single approved indicator obtain negotiation exemption. Among them Cai, but to the market competition to force patent cliffs.

5. Drugs included in medical insurance negotiations, 9-12 years, a minimum decrease of 25%; 12-16 years of listing, a minimum decrease of 35%; 16 years and above on the market, a minimum decrease of 60%. The protection period of the US new drug patent is 20 years from the application date. The climbing period of new drug sales is generally about 10 years. Medical insurance negotiations are based on 9 or 13 years, and basically do not shorten the drug life cycle.

6. Medical insurance negotiations are led by the United States Medicare. Pharmaceutical companies can choose to withdraw from medical insurance negotiations and abandon 30%of MEDICARE market share, rather than losing everything. According to data in 2017, in the overall prescription drug scale, private medical insurance is the largest payer. The proportion of prescription drugs consumed is 42%, while Medicare is the second largest payer, and the proportion of prescription drugs is 30%.

Since the "Medical Insurance Modernization Act" was promulgated in 2003, the US government has been banned from negotiating drug prices with pharmaceutical companies, which means that drugs are completely priced by the market. The Break Act of Inflation broke the ban, but the US medical insurance control fee was really without strength, and domestic innovative pharmaceutical companies had seen strong winds and waves, and it would not be affected to go to sea.

If domestic innovation drugs can enter the first batch of 10 drugs in the US medical insurance negotiations in 2026, it is a blessing, indicating that it has international competitiveness and will successfully achieve price conversion.

02

Cross the river by touching Japan

The development history of biotechnology in the United States is limited to the reference value of domestic innovative pharmaceutical companies. It is worth learning from the breakout of Japanese pharmaceutical companies. Takeda Pharmaceutical provides international (going to sea) experience.

Beginning in the 1980s, Japan began to review the price of drug prices in the medical insurance directory every two years, with an average price reduction of 4%to 5%every two years. In 2016, the video was adjusted to once a year. The relatively mild cost control efforts still put pressure on the pharmaceutical industry. In 2006 and 2014, the overall size of the prescription drug market increased negative growth.

Pharmaceutical companies were forced to leave overseas. The growth history of Takeda Pharmaceutical proves that international transfer is not a fixed pronunciation, but a qualitative change caused by the changes in heavy products.

Liang Bingrein has been listed for more than 30 years, and the sales are still close to $ 1 billion. When this sword is only in hand, Takeda Pharmaceutical has not been able to get rid of the lost 8 years, and the market value has shrunk up to 2/3. Takeda Pharmaceutical can finally summon Shenlong. Unexpectedly, these products are not Shi Ban's FIRST-IN-CLASS, but based on vast clinical needs to make improved innovation.

The internationalization process of Takeda Pharmaceuticals is divided into three stages: the first stage (1975-1987), ME-TOO dividend+expectations of going to sea, enjoy the first round of stock price rising, which is similar to the initial stage of Chinese innovation medicine; the second stage (1987-1995 ), Economic bubbles are shattered, medical insurance control costs are strict, Western pharmaceutical companies counterattack, Takeda's performance has declined, forced to turn to Me-Better, P/E decreases by 4 times; the third stage (1995-2020), similar best drug Lanso Lazole is listed in the United States, confirming the bottom inflection point, bringing 7 times the increase.

Liang Bingrein micro -ball (prostate cancer): The United States was listed in 1989, with a peak sales of US $ 3.24 billion in 2010.

Lanzozole (gastric ulcer): listed in the United States in 1995, with a peak of $ 4.3 billion in 2003.

Khamartan (hypertension): The United States was listed in 1998. The sales value of more than 2 billion US dollars in 2007.

Pinglidone (diabetes): listed in the United States in 1999, with a peak of $ 4.7 billion in 2010.

Takeda Pharmaceutical's overseas revenue began to exceed Japan in 2007. The highest peak of the four major global heavy products contributed about $ 10 billion in 2010.

The listing speed of 4 heavy products is not the fastest, but it is the best as possible, and the target patient has a huge base. Lanzozole biological utilization is more than 30%higher than Omeprazole, which has a significant effect on the healing of gastric ulcers induced by mucous membrane damage and acid. Khandastan was listed later than osasarta and Sagastean. It is the third ARB antihypertensive drug product in the world. Takeda Pharmaceuticals encountered the main product patent cliff around 2010, and shifted from self -developed growth to extension mergers and acquisitions to achieve non -linear growth. In fiscal revenue in 2021, it was 3569 billion yen (about 27.5 billion US dollars), and overseas revenue accounted for 82%.

Compared with the large-scale Hantian Pharmaceutical, the first and third belongs to the innovation focusing type. With its own power, the ADC track is restless. Its third-generation ADC drug DS-8201 is released. Come to sensational effects and become the most dazzling star.

Facing the pressure of domestic fees and squeezing Western pharmaceutical companies, in 2005, the first pharmaceutical and three -communist pharmaceutical merger of the first pharmaceutical and three -year -old medicine was merged. In the current cold winter, Chinese pharmaceutical companies have not seen mergers.

After the merger is completed, follow the generic drug detours. In 2008, he acquired India's largest generic drug company for $ 4.6 billion

Ranbaxy. Because Lanberi was involved in the counterfeiting storm, the first and third fiscal year was paid 39.9 billion yen for claims for the US Department of Justice.

It was also in 2008, and the first and third co -authorized introduction of the SEAGEN ADC technology platform. After several twists and turns, in 2019, the first and third expressed on the R & D Japan -based R & D Japan, and strive to become the world's number one antibody couplet pharmaceutical company. The first ADC drug ENHERTU (DS-8201) was less than 5 years since the clinic to the listing, and was named the top ten new drugs in 2020 by Fiere Pharma.

From the beginning of the merger, the first three have been determined to develop and innovate. R & D investment has always maintained at about 20%. After 2014, it stabilizes above 20%. ADC drugs: enhertu, Dato-DXD, Her3-DXD. The first and third Communists are also focusing on the development of nucleic acid drugs, cell therapy and genetic treatment. The layout of rare diseases and rare tumors that lack treatment plans at present, and always focus on cutting -edge and differentiated areas.

According to CITIC's construction investment, the first and third ADC research was driven by scientific researchers from the bottom up, and it was not in the company's development focus at the beginning. However, after the 2015 clinical Phase I experimented, there were good results, and the company decisively tilted its resources and hired Antoine YVE, the global tumor executive of Astraon to be responsible for the company's tumor tube line, set up the ADC R & D department, and support the ADC business from R & D, clinical to clinical to production facilities to support the ADC business. Essence

The road is not at the beginning, but a domestic innovative pharmaceutical company is willing to walk out of the mud, and is willing to be in the dark period.

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