New rules for medical insurance negotiations! Supporting "truly innovative" drugs, and there are already successful examples

In 2025, it will be another crucial year for the adjustment of the medical insurance directory. This time, the National Medical Insurance Administration has set the adjustment date in April, which is three months earlier than before. On the surface, this seems to be an acceleration of progress, but behind it lies a test for "truly innovative" drugs. Innovative pharmaceutical companies can hardly relax after the Spring Festival and have to work hard cramming. However, problems also arise: what kind of innovative drugs can be called "truly innovative"?

Those new drugs that are pushed to the negotiating table, can they really live up to the promise that "medical insurance funds should be used on the blade"? If these are just pseudo-innovations with only superficial changes but no real differences, how can both the medical insurance fund and patients bear it?

The reason behind this issue has to be traced back to the emphasis that medical insurance has placed on innovative drugs in recent years. To put it bluntly, China's medical insurance fund is nothing other than the life-saving money of ordinary people. Whether or not innovative drugs can be included in the medical insurance hinges on price negotiations. However, the goal of medical insurance isn't simply to drive down prices; instead, it focuses on "value purchasing". In other words, the money spent must be worthwhile and the medicine should live up to its price.

In recent years, the support from medical insurance funds for innovative drugs has been continuously increasing. According to data, by the end of 2024, the medical insurance fund had invested hundreds of billions of yuan in supporting various innovative drugs, especially those that are "globally new" - meaning they are pioneers on a worldwide scale. In 2024 alone, as many as 38 such drugs were included in the directory, setting a new high in both quantity and proportion.

However, supporting innovation is not about blindly spending money; it's necessary to choose drugs with high clinical value and outstanding therapeutic effects. For example, diffuse large B-cell lymphoma is a difficult-to-treat tumor that has been lacking effective treatment methods. In the past, the R-CHOP regimen was barely able to hold on for 20 years, but the recurrence rate of patients was as high as 40%. This poses a big problem for scientists: Is it possible to find more effective and safer drugs?

The emergence of Polatuzumab vedotin has broken the deadlock. This is a third-generation ADC drug that can precisely target tumor cells and reduce damage to normal cells. According to data from the Phase III POLARIX study, it can reduce the risk of disease progression, recurrence or death by 27%, with a 2-year progression-free survival rate as high as 76.7%. What does this mean? It is the first breakthrough in the first-line treatment scheme beyond R-CHOP in 20 years.

However, in spite of being a "truly innovative" drug, the price is a major issue. When this drug was first launched in 2024, the price per bottle was as high as 9580 yuan, and a full course of treatment would cost up to 180,000 yuan. For ordinary families, this is no different from an astronomical figure.

In November of the same year, Roche brought this drug to the medical insurance negotiating table. At the negotiation site, both sides were deadlocked for 40 minutes. The medical insurance department was focused on the efficacy data while calculating the affordability of the medical insurance fund. Eventually, an agreement was reached: Polatuzumab vedotin will be included in the medical insurance directory at a reasonable price, with indications limited to adult patients with diffuse large B-cell lymphoma.

After the negotiation was reached, Polatuzumab vedotin became a classic case in the industry. It took less than two years for this drug to be approved and included in the medical insurance. This is undoubtedly good news for patients. Because lymphoma patients have a long treatment cycle and face huge financial burdens. After Polatuzumab vedotin entered the medical insurance, the treatment cost for patients was reduced from 180,000 yuan to an affordable range for a family.

However, problems also followed: what about the pressure on the medical insurance fund? China has about 100,000 new lymphoma patients each year, among which diffuse large B-cell lymphoma is the most common type. If all patients use this drug, will the medical insurance fund be able to bear it?

The medical insurance department did the math: Although theThe medical insurance department did the math: Although theumab vedotin is Although the price of Polatuzumab vedotin is higher than that of the R-CHOP regimen, it can significantly reduce the recurrence rate. The cost of second-line treatments for relapsed patients, such as CAR-T therapy, can be as high as one million yuan, and patients have to pay a proportion as high as 56% out of pocket. The addition of Polatuzumab vedotin can reduce the number of second-line treatment patients by 27% in the next decade and save about four billion yuan in medical resources.

The result of this negotiation has undoubtedly brought great benefits to patients. For the medical insurance fund, it is also an attempt at "buying time with money". By investing in Polatuzumab vedotin at the early stage, subsequent high treatment costs can be reduced. This approach provides a new reference direction for future medical insurance negotiations.

However, the story is far from over. In 2025, the curtain on the adjustment of the medical insurance directory is about to be opened. How to find a balance between innovative drugs and medical insurance funds will be a common challenge faced by both the medical insurance departments and pharmaceutical companies.

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