Problems with the most expensive CAR-T treatment Kymriah

It is difficult to calculate the drug price due to a manufacturing process different from that of existing drugs

How to pay for super expensive drugs?

We need a virtuous cycle structure to industrialize by nurturing hospitals and universities like foreign hospitals

The CAR-T treatment Kymriah (Tisagenlecleucel), which is considered the hope of terminal blood cancer patients, was launched in Korea after 4 years, but there are problems to be solved.

 

Kymriah is treated in a completely different way from existing medicines, so it is not easy to calculate the drug price, and at a price of ₩500 million, there are many concerns about applying benefits.

 

Kymriah is the first CAR-T treatment in Korea and is currently the most expensive drug.

 

Indications are diffuse large B-cell lymphoma in adults and B-cell acute lymphocytic leukemia in children and young adults.

 

In both cases, terminal patients who are ineffective after two or more treatments, recurrence, or recurrence after transplantation are targeted.

 

CAR-T treatment is different from conventional drugs.

 

Unlike conventional pharmaceutical products, CAR-T collects T cells in the patient's white blood cells at a hospital and then freezes them and sends them to the manufacturing site.

 

Later, it will be sent to the hospital.

 

When the hospital passes the raw material (patient T cells) to the pharmaceutical company, the company makes it into a finished product and sends it back to the hospital.

 

Hospitals maximize the effectiveness of Kymriah by using lymphocyte depletion chemotherapy in patients to lower their white blood cell count.

 

After about 4 to 5 weeks, all work is completed, and Kymriah is administered to the patient's body.

 

Since Kymriah's steps in the manufacturing process are mandatory, the first task is how to calculate and handle these costs.

 

Kim Won-seok, a professor of hematology and oncology at Samsung Medical Center, said at the Novartis Kymriah meeting held on the 23rd, "We have been discussing how to calculate incidental costs such as T-cell collection for patients for almost a year.

 

There are no government guidelines, so this is the first time that we are making unexpected factors." Currently, Novartis is making payments by establishing Kymriah center in a hospital.

 

The Kymriah Center is scheduled to open in May at Samsung Medical Center and Seoul National University Hospital respectively.

 

However, in order to establish a center, hospitals must obtain permission for management business such as human cells in accordance with the newly established 'Advanced Renewable Bio Act'.

 

Kymriah can be administered only in hospitals with centers.

 

According to Novartis, the center will be expanded to Severance Hospital, Seoul St.

 

Mary's Hospital, and the AMC.

 

Since it is an ultra-high priced drug worth ₩500 million, it is not easy to apply the reimbursement.

 

Kymriah is absolutely necessary in situations where life or death is critical, but from the perspective of the government, which has to spend the people's tax, it is questionable whether it is appropriate to spend hundreds of millions of dollars on the possibility of 50-60%.

 

The second problem is to make a reasonable payment plan even for the super high-priced drugs that will come out more in the future.

 

Professor Kang Hyung-jin of the Department of Pediatrics and Oncology at Seoul National University Hospital said, "The problem with Kymriah is how to take ultra-high-priced drugs with life as collateral.

 

When Kymriah first appeared in the United States, patients were very happy.

 

but there are completely different costs than before.

 

Now, the number of patients is not very small, and the number of target patients will increase through additional clinical trials, so we have to think about how to solve the cost problem wisely.

 

It's just the beginning.”

Professor Kim also said, "Kymriah's treatment results are very remarkable.

 

Half of the hopeless patients whose life expectancy is only 3-6 months can get new hope.

 

According to the law, the patient's burden is uniformly 5%, but don't be too tied to it, and it's time to make flexible changes.” Professor Kang emphasized that it is imperative to create a virtuous cycle of costs.

 

He said, "The cost of returning to Korea is very small among the costs paid by patients.

 

MRI, CT, endoscopy, robotic surgery, and expensive drugs are all products of foreign companies, so much of the medical expenses are not recycled.

 

Conversely, foreign countries circulate within them even if they spend medical expenses.

 

This virtuous cycle structure is possible because ideas from hospitals and universities can be industrialized and come back." Kymriah is also a treatment developed by a research team at the University of Pennsylvania in the United States and commercialized by Novartis.

 

This is a representative case in which the researcher's idea was made into a treatment.

 

Professor Kang said, "In Korea, we need to raise a lot of human resources in hospitals and universities, and their ideas are industrialized through companies, so we need a breakthrough to create a structure in which medical costs can be circulated.

 

And we will be able to pay enough for expensive drugs"