Pemigatinib generics have become the focus: The original drug is expensive and not covered by medical insurance. How can patients find cost-effective alternatives?

As a series of targeted drugs are successively approved for marketing in China, precision cancer treatment is rapidly becoming popular. However, the pricing issue has become a real barrier in front of patients.

Just recently, the FGFR targeted drug - pemigatinib (Pemigatinib), which has attracted much attention for the treatment of cholangiocarcinoma, has become a hot topic. Although this drug is already on the market in China, its price is high because it is not included in the medical insurance list, leaving many patients feeling "unexpectedly disappointed".

At the same time, more and more patients are turning their attention to the generic drug market. In particular, the generic pemetinib drugs launched in Laos, Bangladesh and other countries have become a new option for patients to reduce their burden with price advantages that are several times or even ten times higher.

The price of original research remains high: the domestic price of pemetinib is as high as 2-5 ten thousand yuan

Pemetinib is an oral FGFR1, FGFR2 and developed by the American company Incyte pan>FGFR3 inhibitors are mainly used to treat patients with FGFR2 fusions or rearrangements of locally advanced or metastatic cholangiocarcinoma (CCA). In 2020, this drug received rapid approval from the U.S. FDA and became the first targeted drug approved to treat FGFR2 mutations in cholangiocarcinoma.

In 2023, pemetinib was officially launched in China under the trade name of "pemetinib tablets", filling the gap in my country'sFGFR targeted therapy. But unfortunately, it has not been included in the national medical insurance directory since its launch.

The current specifications sold in the domestic market are 4.5mg14 tablets and 9mg14 tablets. The price range is roughly between 1 yuan and 2 yuan. Based on the recommended daily dosage of 13.5 mg, the cost of medication for one month easily exceeds tens of thousands of yuan.

The high price makes it unaffordable for many families. In particular, diseases such as cholangiocarcinoma have an insidious onset and are mostly late-stage. Patients often require long-term maintenance treatment. This continued high drug cost is a heavy burden for most people.

The price in overseas markets is even more "outrageous": 13.5mgThe specification is as high as 710,000 yuan per box

If patients turn to overseas to purchase original drugs, the situation is not optimistic either. In original research markets such as the United States and Japan, taking 13.5mg*14 tablets of the original drug pemetinib as an example, the price per box can be as high as 7 more than 70,000 yuan, which is much higher than domestic pricing.

Although some patients try to purchase through Hong Kong pharmacies and international e-commerce platforms, not only are the procedures complicated, but the price is also difficult to materially drop. And due to exchange rate fluctuations, once the U.S. dollar appreciates, patients' financial pressure will further increase.

Therefore, more cost-effective "generic drugs" have become a "helpless but pragmatic" choice in reality.

Generic drugs break through: Laos version of pemetinib only costs 700 yuan per box

In the context that medical insurance has not yet covered it and the price of the original drug has not dropped, the generic drug market for pemetinib has developed rapidly, especially pharmaceutical companies in Laos and Bangladesh that took the lead in launching generic versions.

Among them, the one that attracts the most attention from patients is the generic version of pemetinib produced by Lucius Pharmaceuticals in Laos. At present, the factory provides 4.5mg*14 tablets, and each box sells for only a few hundred yuan, which is about 1/20 of the price of the original drug. The price-performance ratio is extremely obvious.

Although these generic drugs have not yet been approved for marketing by China's State Food and Drug Administration, they have been sold in the local legal market for many years. Their drug ingredients are basically the same as the original drugs, and they have high market maturity and usage experience.

Are generic drugs effective? How do patients evaluate risks versus benefits?

The biggest question many patients have when facing generic drugs is: Can it be used? Is the efficacy guaranteed?

The essence of generic drugs refers to drugs that are consistent with the original drugs in terms of ingredients, dosage, dosage form and usage, and have passed bioequivalence verification. The production standards of established overseas generic pharmaceutical companies such as Lucius and Yaopin International have been approaching European and American GMP standards. Most of their products have been exported to dozens of countries and regions such as Africa, the Middle East, and Southeast Asia, and they have relatively reliable quality control systems.

According to feedback from multiple patients who actually took the drug, the drug experience of generic pemetinib is not much different from that of the original drug, and common side effects such as stomatitis, hair loss, brittle nails, and dry eyes are also within the acceptable range. Some patients can observe obvious effects of tumor stabilization or even shrinkage after taking the drug for 3 months.

Of course, there are still uncertainties about generic drugs, such as transportation links, channel legality, batch consistency and other issues. Therefore, patients must purchase through formal channels when choosing to avoid adverse consequences caused by counterfeit or inferior drugs.

Is it difficult to purchase medicines in China? Patients should remember these channels

Currently, there is no legal e-commerce platform selling generic pemetinib drugs in China. Patients who want to obtain this kind of "overseas low-priced drugs" mainly use the following methods:

The first is to contact third-party cross-border medical institutions. Such institutions are usually qualified to cooperate with Laos or Bangladesh pharmacies and can provide services such as prescription review and purchasing on behalf of customers.

The second is to look for formal patient mutual aid platforms and obtain reliable drug source information through certified patient mutual aid communities, but the platform qualifications must be strictly verified.

The third is to go to pharmacies in places such as Hong Kong or Southeast Asia to purchase. However, this method is costly and takes a long time, and is only suitable for individual patients with better economic conditions.

Among the above three methods, the first is relatively more suitable for most patients. It should be noted that no matter which method is used, patients should communicate with the attending doctor in advance to ensure the safety of the medication and do follow-up monitoring during the medication.

Clear clinical value, medical insurance negotiation becomes the futureThe key to "breaking the situation"

Pemetinib, as the firstFGFR inhibitor, is a milestone in the treatment of cholangiocarcinoma. According to data from the FIGHT-202 study, pemetinib has an overall response rate of 35.5%, the disease control rate exceeds 80%, and the median progression-free survival reaches 6.9 months, which is much higher than the standard chemotherapy data.

However, due to the relatively narrow population and heavy economic burden, this drug has not yet been used on a large scale in China. If "price for volume" can be achieved through medical insurance negotiations in the future, it will not only significantly expand its clinical application, but also effectively reduce the financial pressure on patients' families.

The medical insurance directory is usually updated every two years, and patients and doctors are paying close attention to whether pemetinib is expected to enter the next round of medical insurance negotiations. If it is ultimately successful, the average monthly medication cost is expected to drop significantly, thereby truly realizing the "popularization of targeted drugs".

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References:

1.FDAOfficial Pemetinib Instructions

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf

2.ClinicalTrials.govPemetinibFIGHT-202Research Registration Information

https://clinicaltrials.gov/ct2/show/NCT02924376

3. Official website of the Drug Evaluation Center of the State Food and Drug Administration

https://www.nmpa.gov.cn/