Reimbursement for Kymriah will be deliberated by CDRC

PAGs criticized GOV and Novartis after the agenda was not introduced at CDRC meeting in July… will become the testing board for ultra-high-priced drugs

‘Big 5’ general hospitals are making preparations for prescribing Kymirah… preparing to receive license for human cell management business

The discussions on listing the ultra-high-priced, one-shot treatment ‘Kymriah’ for health insurance benefits will begin.

 

According to industry sources, Novartis Korea’s first-in-class CAR-T (chimeric antigen receptor-T) treatment will be put as an agenda for deliberation in September at Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting.

 

Kymriah, which was approved in March in Korea, used the ‘approval-benefit appraisal linkage system’ to promptly apply for insurance benefits.

 

However, the agenda was not put up for deliberation by the Cancer Disease Review Committee last month, which gave rise to harsh criticism from the Korea Leukemia Patients Organization (KLPO) to the government and Novartis on the delay in reimbursement.

 

Kymriah will be put as an agenda for deliberation at the next CDRC meeting, but what the results will be is difficult to predict.

 

With a single shot of the drug costing 500 million won, whether the agreement can be reached smoothly between the government and the pharmaceutical company remains unclear.

 

However, if Kymriah is listed for insurance benefits, the drug is expected to be quickly prescribed at hospitals.

 

Among the ‘Big-5’ tertiary hospitals of Korea, Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St.

 

Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital are in the process of acquiring the ‘human cell management business approval’ from the Ministry of Food and Drug Safety, and the Samsung Medical Center (SMC) already obtained approval.

 

As such, hospitals have been rapidly preparing the environment to prescribe Kymriah.

 

In the Seoul National University Hospital, Kymriah (tisagenlecleucel) passed the drug committee (DC) review in April, and the drug is also expected to land in Samsung Medical Center in May.

 

Kymriah developer Novartis has allowed general hospitals to receive payment for the ancillary costs by establishing Kymriah centers in their institutions.

 

SMC and SNUH will open their Kymriah centers in May, and other tertiary hospitals are expected to follow.

 

To establish the center, hospitals are first required to receive a permit for the human cell management business under the newly implemented ‘Advance Regenerative Bio Act.’ CAR-T therapy takes a different approach in its method of treatment.

 

Unlike conventional drugs that are produced as finished products, for CAR-T, the hospital first collects T cells from the patient's white blood cells, then freezes and sends them to a manufacturing facility.

 

At the facility, the T cells are genetically engineered to express the chimeric antigen receptors (CARs) that allow the T cells to recognize tumor cells, cultivated, then sent back to the hospital.

 

In other words, after the hospital sends the raw material (patient’s T cells) to the company, the company makes the finished ‘Kymriah’ product with the raw material and sends it back to the hospital.

 

The hospital maximizes the effect of Kymriah by using lymphodepleting chemotherapy to reduce the white blood cell count in advance.

 

After 4-5 weeks, the processes are all complete, and Kymriah is finally infused into the patient.

 

“Relapsed/refractory ALL patients are very rare in Korea, however, these few young patients that are diagnosed every year are in the fight for their lives,” said Chuhl Joo Lyu, professor of pediatric Hematology-Oncology at Severance Hospital.

 

“As in the cases seen overseas, the government, pharmaceutical company, and the medical community should work together to create an environment for these young patients to enable timely treatment with Kymriah.” Kymriah is the first CAR-T therapy and the most expensive drug in Korea up to date.

 

The drug is indicated for adult patients with diffuse large B cell lymphoma (DLBCL) and young adult and pediatric patients with acute lymphoblastic leukemia (ALL).

 

Both indications are for late-stage patients that are in relapse post-transplant or in second or later relapse after two or more lines of therapy.