Bukwang Pharm, New Insurance Coverage for Schizophrenia and Bipolar Disorder Treatment 'Latuda Tablets'

Bukwang Pharmaceutical announced on the 18th that it has applied for the inclusion of the new drug for the treatment of schizophrenia and bipolar disorder type 1 depression, Latuda tablets (generic name: lurasidone), in the pharmaceutical insurance reimbursement list.

Bukwang Pharmaceutical Logo [Photo by Bukwang Pharmaceutical]

Latuda tablets are a treatment for schizophrenia and bipolar disorder type 1 depression developed by Sumitomo Pharma in Japan. It is an atypical antipsychotic drug, and Bukwang Pharmaceutical secured exclusive development and sales rights in South Korea in April 2017. Bukwang Pharmaceutical applied for the product approval of Latuda tablets in October last year. At that time, they applied for a linked review of new drug approval and insurance reimbursement evaluation, and accordingly, after the Ministry of Food and Drug Safety recently completed the safety and efficacy review, they submitted the application for insurance reimbursement listing.

The linked review of drug approval and insurance reimbursement evaluation is a system that allows the application for reimbursement decision even before drug approval, aiming to advance the timing of reimbursement decisions for insured drugs and provide patients with prompt treatment opportunities. Once the Ministry of Food and Drug Safety completes the safety and efficacy review, pharmaceutical companies can apply for reimbursement decisions to the Health Insurance Review and Assessment Service. After the review and assessment by the HIRA is completed, the final reimbursement status and drug price are determined through price negotiations with the National Health Insurance Service.

According to Bukwang Pharmaceutical, Latuda tablets have already been approved as a treatment for adult schizophrenia in 53 countries including the United States and the European Union (EU), and in some countries, it has also been approved for the treatment of schizophrenia in adolescents aged 13 to 17. Additionally, in 20 countries including the United States, it has been approved for the treatment of depressive episodes in adults with bipolar disorder type 1 as monotherapy or as adjunctive therapy with lithium or valproate, and in some countries, it has also been approved as monotherapy for depressive episodes in children aged 10 to 17 with bipolar disorder type 1.

Bukwang Pharmaceutical stated, “If Latuda tablets are approved in Korea, we expect it to become a welcomed treatment option for patients with schizophrenia and bipolar disorder type 1 depression based on the efficacy, safety, and tolerability demonstrated in clinical trials,” and added, “As a major product with potential annual sales of several hundred billion won, we plan to make further efforts to strengthen our central nervous system (CNS) product portfolio and boost sales growth.”