The popular anti-cancer targeted drug Erdafitinib has been launched in China but the price is high. How can patients break through the price barrier without medical insurance?

The discussion of new anti-cancer drugs in China continues to rise. One of the targeted drugs, Erdafitinib (Erdafitinib), which is hailed as"a key weapon in the precise fight against bladder cancer", has been successfully approved to enter the Chinese market. However, its "high price but not covered by medical insurance" has attracted widespread attention.

Especially in the context where "drug price reductions", "medical insurance negotiations" and "new drug accessibility" and other public issues have frequently become the focus of public opinion, the launch of erdafitinib comes at the right time. While patients gain new hope in treatment, they also face a practical question: Is the price affordable?

Domestic launch is coming, but the lack of medical insurance makes patients“It is difficult to use the medicine”

At the end of 2024, erdafitinib was officially approved by the National Medical Products Administration for the treatment of patients with previously treated locally advanced or metastatic bladder cancer, provided that these patients carry FGFR2 or FGFR3 gene mutations. This is the first anti-cancer drug in China that targets the FGFR mutation pathway, breaking the long-term lack of precise treatment methods for bladder cancer patients.

However, although this drug has entered the Chinese market, it has not yet been included in the national medical insurance directory. This means that all medication costs are borne by the patient. Compared with some targeted drugs that have been included in medical insurance, there is still a huge gap in terms of "price threshold" for erdafitinib.

It is understood that the original erdafitinib drug that can be prescribed by domestic hospitals or specific pharmacies is mainly the original Italian version, and the price is very high.

Such prices put many families in a dilemma: either insist on treatment but face huge financial pressure, or discontinue medication due to cost issues. A large number of patients have flocked to online platforms and patient forums, hoping to find cheaper solutions.

Overseas generic drugs"Substitute" options, significant price advantage but need to be cautious in purchasing

While the prices of original drugs remain high, more and more patients are turning their attention to the overseas generic drug market. Currently, there are two main countries where imitation versions have become mainstream: Laos and Bangladesh.

The generic version of erdafitinib produced by Laos Lucius Pharmaceutical Factory (Lucius) has the same specifications as the original drug, 4mg×28 tablets costs about 1000yuan.

Another major source of generic drugs is Bangladesh. The Erdafitinib version launched by Yash International (Everest/Yash), 5mg×30 tablets, costs about more than one thousand yuan.

Although these generic drugs have not been approved for marketing in China, they have been used legally in Southeast Asia, the Middle East and some African countries for many years. The ingredients, dosage and dosage of the drug are basically the same as the original drug, making it the first choice for many patients under financial pressure.

However, it must be noted that patients should pay special attention to channel compliance when choosing overseas generic drugs. At present, there is no official e-commerce company selling this kind of medicine in China, and most of them are purchased by cross-border third parties. It is recommended that patients give priority to purchasing through well-known medical resource service institutions, cooperative pharmacies or qualified overseas channels, and take it under the guidance of a doctor to avoid risks caused by medication errors.

Can generic drugs replace original drugs? The issues that patients care most about are revealed

The question that many patients are most concerned about is: Do generic drugs really have the same effect? From a pharmacological perspective, as long as they pass bioequivalence verification and have the same active ingredients, the efficacy of generic drugs is similar to that of the original drugs.

In fact, many pharmaceutical companies, including Bangladesh and Laos, are already qualified to export generic drugs to the European and American markets, and their production standards are close to European and American certification. During the use of generic erdafitinib, most patients also reported that its efficacy was similar to that of the original Hong Kong drug. Some patients observed positive reactions such as tumor shrinkage and reduction of metastatic lesions after two to three months of treatment.

However, some patients have reported that generic drugs are slightly inferior in controlling side effects, such as hyperphosphatemia, rash, fatigue, etc. are more obvious. It can be seen from this that although generic drugs are affordable, they still require individualized evaluation and cannot be simply "one size fits all".

Why are high-efficiency drugs so expensive? The R&D costs and business game behind it

Many people wonder: Why is erdafitinib so expensive? The answer lies in the fact that the development, approval and market access of targeted drugs are extremely complex.

According to public information, erdafitinib was developed by Johnson & Johnson of the United States and was first approved for marketing by the U.S. FDA in 2019. As the world's first FGFR inhibitor, it fills the gap in precision treatment of bladder cancer. The entire development cycle lasted more than 10 years, with billions of dollars invested in clinical trials, data analysis, and approval processes.

In addition, the domestic market is still in the pilot stage and the patient base is limited, which also leads to high initial prices to recover costs. Without the intervention of medical insurance, pharmaceutical companies charge relatively high prices for individual patients.

The anticipated medical insurance negotiations: Will they replicate the price reduction path of “price for volume”?

At present, what patients and medical institutions are most looking forward to is whether the price of erdafitinib can be loosened in the next round of medical insurance negotiations and the threshold for drug use can be lowered.

Previous cases can provide hope: many targeted drugs such as pemetinib and ivonib have reduced their prices by more than 50% after being included in medical insurance negotiations, rapidly expanding the scope of use and benefiting a wider range of patients.

Experts predict that if erdafitinib is successfully included in the medical insurance catalog, its price may drop to less than 10,000 yuan per box, or even lower. This will be a substantial benefit to the domestic patient group, especially for patients with intermediate and advanced cancer, and will undoubtedly be a "timely help".

The clinical efficacy is confirmed and the indications are clear. Why are there still patients waiting to see?

In terms of therapeutic effect, erdafitinib has shown good results in multiple global phase III clinical trials. Data show that ORR (overall response rate) exceeds 40%, and some patients can see tumor shrinkage within 4 weeks, PF The average S (progression-free survival time) can reach 5.5 to 6.9 months, and individual patients maintain treatment for more than 12 months.

In terms of indications, it is only suitable for bladder cancer patients carrying FGFR2 or FGFR3 mutations. In other words, not all bladder cancer patients will benefit from the drug. Patients need to confirm their mutation status through genetic testing before determining whether they are suitable for use.

This also leaves some patients in a wait-and-see state: on the one hand, the high price makes people hesitate, and on the other hand, it is suitable for a small group of people, which limits its widespread application. However, as genetic testing gradually becomes more popular in China, it is believed that more potential beneficiaries will be identified.

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Reference links:

1.United StatesFDAOfficial website Erdafitinib Approval information

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-erdafitinib-metastatic-urothelial-carcinoma

2.ClinicalTrials.gov Erdafitinib Key Clinical Research Data

https://clinicaltrials.gov/ct2/show/NCT02365597

3.Official website of the State Food and Drug Administration Domestic launch announcement of erdafitinib

https://www.nmpa.gov.cn