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"I'm disappointed with the pricing terms and market distortions of the new law, but I remain optimistic
The Inflation Reduction Act (IRA), passed in mid-August, is an important milestone
For the first time, the IRA allows negotiations on the price of drugs in Medicare (U.
If pharmaceutical companies refuse to negotiate, they will have to pay a large consumption tax, which is levied on 65% of their sales in the previous year for the first year and increased to 95%
1 Drug price control
1 Drug price controlGlobal investment bank RBC Capital Markets predicts that the introduction of IRAs will affect at least 10%-15% of the revenue of
Take the "medicine king" Humira as an example, the drug was first approved by the FDA in 2002, and from 2012 to 2020, it topped the global drug sales list for 9 consecutive years, with cumulative sales of more than 160 billion US dollars in 10 years, repeatedly creating sales records, and until today it has refreshed the annual sales record
The U.
The medical insurance control fee will undoubtedly have a large impact
Specifically, drugs included in the US health insurance negotiations have been listed for 9-12 years, with a minimum reduction of 25%; Listed for 12-16 years, the lowest drop of 35%; Listed for 16 years or more, the minimum decline is 60%.
However, the longer the market time, the greater the decline, pharmaceutical companies still need to maintain new R & D pipelines and products at all times, in order to avoid being led by the price reduction strategy
2 Parties game
2 Parties gameIRAs want to "expand health insurance coverage", which is contrary to the current overly commercial drug price system in the United States, so commercial insurance companies need to bear risk protection for more groups with high incidence and low income, and the profits of insurance companies are bound to decrease; The bill also requires doctors to pay more attention to the results of diagnosis and treatment, which may also harm the interests of drug and medical device manufacturers; Of course, it is inevitable that medicare control costs will reduce hospital medical costs
Mediation between pharmaceutical companies, medical service providers, and insurance companies has also suffered a huge impact
However, in the process of development, PBM gradually "changed its flavor"
In addition to its influence on some "interest groups", the bill itself also treats small molecules and biological drugs
Some people believe that the development difficulty of small molecule primary research drugs is not lower than that of large molecule drugs, and it is usually necessary to start clinically from the late stage and gradually advance to the adjuvant treatment with the largest patient base, which may take 7-9 years
Based on this, this part of the group judged that the bill may reduce the market's enthusiasm
Of course, there are not a few supporters
.
Terminal consumers care about cost performance, and americans are willing
.
And under the IRA, people with diabetes who are covered by medicare will also benefit from a specific drug cap
.
The current cost of multiple bottles of insulin required for adequate control of diabetes is high, and the price of insulin will be limited to $
35 per month starting next year.
3 Hit the pond fish?
3 Hit the pond fish? Some people believe that the introduction of IRA will have a huge impact on the global innovative drug market, especially for Chinese innovative pharmaceutical companies that are undergoing a global layout
.
The average price of drugs in the United States is significantly higher than that of other countries in the world, and the sales price of the same product is about 4 times that of European countries and 5 times that
of Asian countries.
In early June, several researchers at Harvard Medical School jointly released the "2008-2021 Prescription Drug Pricing Trends" study, saying that in the past 13 years, the median price of drugs in the United States has risen from $2115 to $180,000, and the average annual market price of new drugs has increased by 20.
4%.
If domestic innovative pharmaceutical companies can go to sea, they will enjoy a higher premium
.
In addition, they can also withdraw from the whirlpool of China's medical insurance collection and target gathering
.
However, the promotion of this bill may make Chinese innovative drugs that have not been easy to enter the US market face the threat
of price reduction.
Taking PD-1 as an example, in the past two years, domestic PD-1 has been competing in terms of going to sea, but many major indications require additional clinical trials for the American population, which still needs a long time
.
Even if China's PD-1 is approved by the FDA, it will be difficult to reach the previous level in price, and one of the goals of going to sea is a big discount
.
The director of the U.
S.
Center for Oncology Excellence has said that one of the important reasons for initially welcoming China's drug application to the FDA is that it hopes to reduce the price
of U.
S.
drugs through the introduction of competition.
However, in the case of the rejection of Cinda/Eli Lilly PD-1 in the first half of this year, Richard Pazdur changed his mouth, claiming that the price would not affect the FDA's review decision, and ultimately look at the excellent efficacy and data
.
Taking a step back, the logic of the "price difference" still seems to hold, but only if it is an innovation
with real differentiating value.
IRA is more about meeting patients' medication needs and reducing self-payment, but even so, this is difficult to say with the cost control efforts in the Chinese market
.
Those new Chinese drugs that rely on data to "break through" successfully still have no shortage of opportunities to
dig for gold in the US market.
— Summary —
— Summary — For pharmaceutical companies, they want strong intellectual property protection and sustained profitability; For the "ordinary people", it is hoped that the scope of access will be further expanded and out-of-pocket expenses will be
reduced through health insurance reform.
Overall, U.
S.
drug negotiations affect drugs that are close to the patent cliff, and pharmaceutical companies can still set high prices
when they launch new drugs.
However, the impact of the bill on U.
S.
generic drugs and biosimilar companies is still relatively large, and after the U.
S.
drug negotiations, the prices of the above companies will no longer have an advantage
.
Reference Articles:
Reference Articles: Reference Articles: 1.
What impact will the decline in drug prices bring about by the passage of the Inflation Reduction Act in the United States? Sina Finance
What impact will the decline in drug prices bring about by the passage of the Inflation Reduction Act in the United States? Sina Finance
2, the American version of "collection" sharpening knives, what does this mean for the innovative drug industry? Same as freehand
2, the American version of "collection" sharpening knives, what does this mean for the innovative drug industry? Same as freehand3、Navigating a storm that threatens American biotechnology; rapport
3、Navigating a storm that threatens American biotechnology; rapport