BMS Korea has announced that Inrebic (ingredient: fedratinib), its myelofibrosis drug, will now be covered by the national health insurance system in Korea starting from June 1.

Inrebic is a second-line treatment for myelofibrosis that selectively inhibits the JAK2 gene mutation, and can help improve the splenomegaly and associated symptoms of primary myelofibrosis, myelofibrosis after polycythemia vera, and myelofibrosis after essential thrombocythemia in adult patients treated with ruxolitinib.

Accordingly, insurance coverage is available for the treatment of the aforementioned cases based on the clinical improvement response of the International Working Group- European LeukemiaNet (IWG-ELN) guidelines.

Myelofibrosis is a rare blood cancer characterized by excessive fibrous proliferation in the bone marrow and decreased hematopoietic function. In recent years, the number of patients has increased by 19 percent on average over five years, and as of 2021, there were about 1,700 myelofibrosis patients in Korea. Myelofibrosis is a disease whose main symptoms include an enlarged spleen, fatigue, shortness of breath, weight loss, night sweats, fever, and bone pain, and the risk of progression to acute leukemia, so treatment is essential.

In the JAKARTA-2 study of patients with intermediate or high-risk myelofibrosis who were resistant to or poorly tolerated ruxolitinib, 31 percent of patients treated with Inrebic achieved a reduction in spleen volume of 35 percent or more from baseline. Additionally, 27 percent achieved a reduction in the total symptom score (TSS) of 50 percent or more.

Previously, Inrebic’s 400 mg once-daily oral dose was approved in Korea in April 2022 by the Ministry of Food and Drug Safety (MFDS). The expedited reimbursement decision was made by the Health Insurance Review and Assessment Service (HIRA), just two months after it was passed by the Pharmaceutical Benefits Evaluation Committee of HIRA in May.

"Myelofibrosis has a high unmet need in the clinic with a life expectancy of only about one year after the failure of existing treatments," said BMS Korea CEO Lee Hye-young. “Inrebic is the first new drug in more than a decade for myelofibrosis, a disease for which there have been no treatment options, and we are pleased to offer new hope to these patients."