The first CAR-T therapy, Kymriah (ingredient: tisagenlecleucel), failed to pass a Health Insurance Review and Assessment Service (HIRA) panel review due to its hefty price tag of 500 million won (430,884 $).
According to an HIRA official, the agency’s cancer drug benefit assessment committee discussed whether to grant reimbursement to Kymriah.
However, the panel refused to make the drug reimbursable due to the low cost-effectiveness of the therapy.
Kymriah is personalized immunotherapy. Once a patient’s T cells have been collected, they are genetically recombined so that the chimeric antigen receptor (CAR) can be expressed. And then the injection is reinjected into the patient’s body.
The FDA approved Kymriah on August 30, 2017, for the first time in the world, and the European Medicines Agency followed suit in August 2018, and the Japanese Ministry of Health, Labor and Welfare, in March 2019.
In Korea, the Ministry of Food and Pharmaceutical Safety in March approved Kymriah as the first new drug applied under the Law on Advanced Regenerative Medicine and Advanced Biopharmaceuticals.
Kymriah increases the chances of complete remission with just one injection, gaining a lot of attention as an innovative treatment for patients with end-stage blood cancer.
However, the cost of uninsured Kymriah is around 460 million won.
In March, Novartis Korea applied for insurance benefits for Kymriah using the approval-reimbursement review link system.
However, the therapy failed to pass the HIRA’s Drug Reimbursement Review Committee, a first step in securing reimbursement, due to concerns about its impact on national health insurance funding.
The leukemia patients urged HIRA to approve Kymriah’s reimbursement as soon as possible.
The Korea Leukemia Patients Organization (KLPO) on Tuesday said that Japan allowed Kymriah’s health insurance coverage to reduce the cost per treatment to 350 million won in May 2019. As of July 2021, the drug’s price fell 4.3 percent to 335 million won. said the group of patients. “We wonder what the HIRA and the Department of Health and Welfare have done in the past six months,” KLPO said in a statement.
A single Kymriah treatment is known to ensure long-term survival for eight out of 10 patients with end-stage acute lymphocytic leukemia and four in 10 patients with end-stage lymphoma, the patient group continued. “For patients with terminal leukemia and lymphoma, Kymriah’s reimbursement is like a lifeline. “
Since Kymriah is the first CAR-T treatment and may serve as a reimbursement model for ultra-expensive therapies in the future, the government and the drug maker should make plans for rational health insurance spending and active cost sharing that Kymriah could set a good precedent for quick payback.