KYMRIAH, a good but expensive medicine

Blockbuster anti-cancer drug series 7 - Kymriah

The opening of the era of one-shot therapy

Even though it is an expensive new drug, there are more than five non-reimbursed prescriptions, focusing on benefits

The cost of a single injection is 500 million won, but the era has come when cancer can be expected to be cured with that "once." Ultra-high-priced, high-tech new drugs are already approaching us.

 

Kymriah (Tisagencleucel), a CAR-T treatment called dream anticancer, is the new drug.

 

Kymriah obtained approval from the MFDS in March as the first treatment of the Advanced Regenerative Bio Act.

 

Kymriah dramatically improved the survival period of patients with recurrent and refractory end-stage blood cancer, who no longer had treatment options available with a single treatment, and even confirmed the possibility of long-term survival.

 

◆The essence of process-customized treatment required for each patient Kymriah is an innovative personalized one-shot treatment that utilizes the patient's immune cells, and is an anticancer drug with all the characteristics of cell, gene, and immune treatments.

 

As it is a non-reimbursed treatment, it is different from previous treatments from the mechanism and manufacturing process of manufacturing.

 

First, the patient's immune cells are extracted.

 

Afterwards, a receptor that recognizes cancer cells is inserted into the cell surface to form a cell with strong power, that is, a chimera antigen receptor, and injected into the patient.

 

Kymriah's indication is ▲the treatment of adult patients with recurrent or refractory diffuse large-B-cell lymphoma (DLBCL) after two or more systemic treatments and ▲ the treatment of post-transplantation recurrence or secondary recurrence and subsequent recurrence or refractory B-cell acute lymphocytic leukemia (B-ALL, B-Acute Lymphoblastic leukemia) in children and young adult patients under the age of 25.

 

The number of DLBCL and B-ALL patients who refused or recurred to existing treatment was about 200 in Korea, and until Kymriah's approval, there were no alternative treatment options or standard treatment was not established, so life expectancy was only 6 months.

 

In fact, the median survival period of DLBCL patients who failed secondary treatment in Korea is around 4.73 months, and about 70% of patients who failed secondary treatment repeatedly perform rescue chemotherapy.

 

The Kymriah permit presented patients who were no longer in need of treatment with another hope for long-term survival.

 

According to clinical trials in patients with recurrent or refractory DLBCL, the overall response rate in patients administered Kymriah was 53%, of which 39.1% reached complete remission.

 

In addition, in the case of clinical trials in patients with recurrent or refractory B-ALL, 8 out of 10 patients (82%) reached complete response (CR), and 98% of patients who reached remission were negative.

 

◆ In Korea, more than 5 cases were administered.

 

Kymriah Center was established Kymriah is still a non-reimbursed drug and it is difficult to say that sales have been activated in Korea.

 

However, preparation work for prescription is active.

 

In particular, Big 5 advanced general hospitals are moving rapidly.

 

According to related industries, Big 5 general hospitals, including Seoul National University Hospital, AMC, Seoul St.

 

Mary's Hospital, and Sinchon Severance Hospital, are undergoing management approval procedures such as human cells, and Samsung Medical Center has already completed approval.

 

Among them, in the case of Seoul National University Hospital, Kymriah (Tisagenlecleucel) passed the Drug Commission (DC) in April, and Samsung Medical Center also began prescriptions in May.

 

Novartis, a developer of Kymriah, allows to pay by establishing a general hospital and Kymriah center.

 

Kymriah Center will open in May at Samsung Medical Center and Seoul National University Hospital, respectively, and the rest of the upper-level hospitals are expected to join the center later.

 

In order to establish a center, hospitals must obtain permission for management businesses such as human cells under the newly established Advanced Regeneration Bio Act, which means that medical institutions are actively working on preparing all matters.

 

according to the Dailypharm, more than five Kymriah doses have already been made, even though they are non-reimbursed, and 10 prescriptions will be made within this year.

 

The era of CAR-T is certainly beginning.

 

◆The insurance benefit registration procedure is also an issue Kymriah's insurance benefit registration is also an issue.

 

It is unusual for interest in one drug to increase to this extent because it is such an expensive drug and there are so many patients waiting.

 

In March, the drug was approved by the MFDS using the Drug Approval-Benefit Linkage System.

 

And it was first introduced to The HIRA's Cancer Drugs Benefit Appraisal Committee in September, but was put on hold.

 

When the results were released through the media, the leukemia association criticized the government and pharmaceutical companies in a statement.

 

The patient association earlier criticized Kymriah for the delay in the proposal of the Cancer Drugs Benefit Appraisal Committee.

 

Eventually, Kymriah passed the Cancer Drugs Benefit Appraisal Committee in October.

 

It is encouraging to pass this deliberation, but there is a high possibility that there was a burden as it was so focused on attention.

 

Novartis' Korea subsidiary's plan to share finances and its willingness to persuade its headquarters are expected to be key.

 

Kymriah, a drug that is too good but too expensive, is just the beginning.