Ultra-high-priced ‘Kymriah’ is up for DREC deliberations

To be discussed on the 13th… adequacy of fiscal sharing plan etc.

3 months after passing Cancer Disease Deliberation Committee… patient groups are intensely following the results

Whether the new CAR-T therapy ‘Kymriah’ will be applied insurance benefit is receiving wide attention.

 

According to industry sources, the world’s first chimeric antigen receptor T-cell (CAR-T) therapy ‘Kymriah' will be deliberated as an agenda by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 13th of this month, 3 months after the agenda passed the Cancer Disease Deliberation Committee in October last year.

 

Specifically, the drug is indicated for ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse Reimbursement listing of Kymirah is currently the biggest and hottest issue in the industry as this ‘one-shot’ treatment may cure cancer with a single administration but costs up to 500 million won per shot.

 

The company had been going through the reimbursement process for Kymriah since it was approved in March last year through the ‘approval-reimbursement review linkage system.’ Although it was first set an agenda for CDDC deliberation in September, the committee deferred their decision.

 

Immediately upon the news of deferral, the Korea Leukemia Patients Organization strongly criticized the government and the pharmaceutical company.

 

The KLPO had before criticized the authorities over the delay in Kymriah’s agenda being put up for deliberation by the CDDC.

 

Despite overcoming the CDDC obstacle, whether Kymriah will be able to complete its reimbursement journey to the end remains unknown.

 

The CDDC may have passed the Kymriah agenda to DREC pressured by the intense attention focus around the agenda.

 

Therefore DREC’s role is expected to be an important observation point that will play a key role in the listing process.

 

Meanwhile, the CDDC had set the reimbursement standards for Kymriah so that the following conditions should be met for its reimbursement: ▲the company should bear a higher-level risk in consideration of the price level in other countries, ▲a risk-sharing system based on a performance-based payment model that pays according to treatment performance of each patient for relapsed or refractory diffuse large B cell lymphoma (DLBCL) as it has a poorer clinical outcome compared to acute lymphoblastic leukemia, and ▲an expenditure cap should be set on the total expenditure allowed for Kymriah.

 

In other words, the key to the reimbursement listing of Kymriah depends on the fiscal sharing plan submitted by Novartis’ Korean subsidiary and its determination in persuading its head office.