The government set the maximum reimbursement price of the world’s first CAR-T cell therapy Kymriah (tisagenlecleucel), developed by Novartis, at 360,039,359 won ($296,138) per treatment.
It also newly established reimbursement for medical practices for cell collection, in vitro treatment, treatment preparation, and treatment injection that accompany CAR-T cell therapy.
On Thursday, the Ministry of Health and Welfare held a Health Insurance Policy Review Committee meeting and decided to revise the list of reimbursed drugs and the maximum reimbursement rates.
Kymriah’s reimbursement will be valid from Friday.
Regarding the application of the risk-sharing system to Kymriah, the government decided to grant an increase in health insurance coverage for both two indications -- B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma.
To indicate diffuse large B-cell lymphoma, the government decided to apply a performance-based risk-sharing agreement (RSA) on a patient-by-patient basis. Therefore, patients without any treatment effect will have an additional refund.
On Thursday, the Korea Leukemia Patients Organization (KLPO) welcomed the news of Kymriah's reimbursement.
“There is no better news than this for some 200 patients who are at risk of dying within three to six months if they did not receive Kymriah treatment,” the patient group said.
The government authorities must thoroughly manage Kymriah’s effects and side effects so that the refund-type RSA and expenditure cap RSA of 70.9 billion won per year, which are conditions for Kymriah's health insurance listing, but the performance-based RSA applicable only to lymphoma are properly implemented, it added.
KLPO said Kymriah, which was the nation’s first high-tech biological drug to win the license and health insurance coverage, will become the role model in reimbursement for ultra-expensive CAR-T therapies.
KLPO predicted that there would be more CAR-T therapies available in the market, including Zolgensma (onasemnogene abeparvovec), a CAR-T treatment for spinal muscular atrophy (SMA) seeking reimbursement, and Luxturna (voretigene neparvovec), gene therapy for inherited retinal disease.