Ipsen Korea's 'Bylvay' (active ingredient: Odevixibat) and Recordati Korea's 'Qarziba' (active ingredient: Dinutuximab) are currently undergoing a fast-track review for pharmaceutical approval and inclusion in the National Health Insurance Coverage.

The Ministry of Health and Welfare (MOHW) has selected Bylvay and Qarziba as the initial drugs for the concurrent pilot project, which involves approval, Health Insurance Coverage Adequacy Assessment, and drug price negotiation. The aim of this project is to enhance access to high-cost treatments for severe diseases.

According to the MOHW, the selection was made based on a comprehensive assessment of factors such as the severity of the condition, availability of alternative therapies, treatment efficacy, and expert opinions.

The objective of this pilot project is to streamline the process and reduce the time required from approval to reimbursement by conducting simultaneous procedures, including the approval from the Ministry of Food and Drug Safety (MFDS), evaluation from the Health Insurance Review and Assessment Service (HIRA), and negotiation with the National Health Insurance Service (NHIS).

By eliminating the sequential steps and conducting them concurrently, the time taken for approval and inclusion in the reimbursement system can be significantly reduced. Currently, the total process takes over 300 days, including 120 days for approval from the MFDS, 150 days for reimbursement evaluation from the HIRA, and 60 days for price negotiation with the NHIS.

Meanwhile, Bylvay is a medication used for progressive familial intrahepatic cholestasis, with an estimated patient population of 43 individuals in Korea. On the other hand, Qarziba is a treatment for high-risk neuroblastoma, with an estimated patient population of 17 individuals.