Novartis’ breakthrough cancer treatment Kymriah (ingredient: tisagenlecleucel), which costs over 500 million won ($421,000), has become eligible for reimbursement, the health insurance review agency said. The agency also recognized the need for an expanded reimbursement for Keytruda (pembrolizumab) as the first-line therapy.
On Thursday, the Health Insurance Review and Assessment Service (HIRA) released the review results on three medicines by the Drug Reimbursement Evaluation Committee.
Kymriah, a chimeric antigen receptor T (CAR-T) cell therapy for leukemia and lymphoma, is an ultra-expensive drug costing over 500 million won per treatment that shows a therapeutic effect with only one injection.
Kymriah arrived in Korea in March 2021 under the approval-reimbursement evaluation linkage program.
In October, the Cancer Review Committee set two indications as the criteria for Kymriah reimbursement -- diffuse large B-cell lymphoma (DLBCL) in adults and B-cell acute lymphoblastic leukemia (ALL) in children and young adults. Then, the treatment passed the review of the Drug Reimbursement Evaluation Committee this year.
The drug reimbursement evaluation committee recognized Kymriah’s eligibility for health insurance coverage on the condition of the risk-sharing agreement per DLBCL patient with expenditure cap.
Although Kymriah passed the review of the drug evaluation committee, Novartis Korea still has to go through price negotiations with the National Health Insurance Service (NHIS), pass the Health Insurance Policy Review Committee, and get the Ministry of Health and Welfare’s announcement to make Kymriah reimbursable.
The Drug Reimbursement Review Committee also said five drugmakers’ sodium hyaluronate medicines, including Lesinowon Inj. were eligible for reimbursement for osteoarthritis of the knee joint.
However, Yuhan Corp.’s Nasacare Nasal Spray Sol. 18mL·31mL (mometasone furoate/olopatadine), a treatment for seasonal allergic rhinitis in adults and adolescents aged 12 or more, will be reimbursable only when Yuhan accepts less than the appraised price.
If Yuhan does not accept the evaluated amount suggested by the drug reimbursement review committee, the treatment will remain non-reimbursable.
Patient groups hailed the drug reimbursement review committee’s recognition for reimbursing Kymriah and Keytruda.
“We welcome the decision because it gives treatment opportunities to patients with terminal acute lymphocytic leukemia/lymphoma and stage-4 non-small cell lung cancer who have been desperately waiting for health insurance coverage,” Korea Alliance of Patients Organization (KAPO) said in a statement on Thursday.
The patient group urged the government to speed up drug price negotiations between drugmakers and the NHIS and the Health Insurance Policy Review Committee’s review.
“We hope that these treatments can become reimbursable in two or three months. The government should make sure that eligible patients getting ready for the treatment are not harmed.”
The patient group also called for introducing “a fast reimbursement registration system for new drugs” to manage high-priced new medicines.
“The health and welfare ministry should introduce a fast health insurance registration system for innovative drugs, just as the National Human Rights Commission of Korea advised,” KAPO said.
Presidential candidates should announce measures to strengthen health insurance coverage as part of their presidential campaign to prevent people from receiving treatment due to high medical costs, it added.